chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: This spontaneous report was received from a 55 year old female patient regarding herself. The patient had no pertinent medical history and no drug reactions or allergies. On 03-JUN-2013 (on Monday), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On 05-JUN-2013 (on Wednesday), her arm started swelling. On 07-JUN-2013 (by Friday), it was red, raised, itchy and was about 3 inches in diameter. The patient did not seek any medical attention. No treatment was given and no lab tests were performed. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: HIBV, MMR
Symptoms: Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Fever 7 days after vaccine, swollen suboccipital lymph nodes, rash 10 days after vaccine, sore throat, cold symptoms.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients many have received VAQTA, RECOMBIVAX HB, (merck) VARIVAX, PEDVAXHIB and GARDASIL that was improperly stored. This report concerns RECOMBIVAX HB. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases MARRS ID 1305USA003372, 1306USA007107, 1306USA007108 and 1306USA007109 which concern VAQTA, (merck) VARIVAX, PEDVAXHIB and GARDASIL respectively. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: 10 days after receiving vaccine pt had rash on both upper arms and upper inner thighs. The rash was oval shaped fluid filled was slightly itchy. Pt used "brown laundry soap" and rash mostly resolved after 4-5 days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache
Clinical narrative: Within 26 hours of getting 2nd MENACTRA (6/6/13 pt. developed severe (R) parietal headache 8/10 and severe fatigue, headache better when reclining; no N/V.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1 week after vaccination, developed hives on face, arms and torso 2 days in a row - late afternoon. Relieved with BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Injection site scab, Injection site vesicles
Clinical narrative: Received PROQUAD 6/4/13. Called office 6/8/13. Patient c/o blister rash around injection site. Some have scabbed. Dr discussed with mom. Told not unusual watch.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Ligament disorder, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Extreme soreness numbness from time of vaccination, MD explains as nicked ligament. Later MRI shows calcification.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial infection, Injection site infection, Musculoskeletal pain, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Sore throat for 2 days after vaccination (5/30/13 and 5/31/13). Pt. states (L) side of neck and (L) shoulder stiff and painful from 5/31/13 to 6/5/13. Pt. states no relief with Tylenol, muscle relaxer or massage. Pt. denies redness or swelling at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 73 year old female patient with no pertinent medical history and no drug reactions or allergies. On 03-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000494 and 14-APR-2014 respectively, dose unspecified), subcutaneously. No concomitant medications were reported. On 04-JUN-2013 (the day after vaccination), the patient experienced an injection site reaction. The injection site was swollen, red, sore and had blisters. The patient sought medical attention (called pharmacist). No treatment was given. The patient had not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age. On an unknown date, the two patients were vaccinated with PNEUMOVAX23 (lot # H017759) at different unspecified time. The dose, frequency and route of PNEUMOVAX23 was not specified. At an unspecified time after administered PNEUMOVAX23, one patient experienced cellulitis and fever, and the other patient just started to develop symptoms similar to the patient just mentioned. The outcome of the patient with cellulitis and fever was unknown; the outcome of the other patient was unknown. The primary reporter required a lot check. No PDC reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no known drug reactions/allergies. The patient's medical history included cancer. On 11-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000427, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included omeprazole (manufacturer unknown) and clobetasol propionate. Few days later, in approximately May 2013, the patient experienced throbbing and aching at the injection site. Recently, in approximately June 2013, the patient noticed blisters on the lower quadrant of the stomach, buttocks and scalp. The outcome of the events was reported as not recovered/not resolved. On 05-JUN-3013 the patient was given valacyclovir as a treatment for the AE. The patient saw physician seeking for medical attention, who gave the patient a prescription that was brought to the pharmacy. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Irritability
Clinical narrative: Extreme irritability aggravated by movement. High pitch cry. Lasted 6-8 hrs. No treatment.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 79 year old female patient. On 05-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494, expired date: April 2014). On 06-JUN-2013, the patient developed injection site reaction after receiving ZOSTAVAX. The physician mentioned the area was a 3 to 4 inch red oval, consistent with where the vaccine was administered. The patient had sought medical attention via office visit and was given treatment with ice. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a 50 year old male patient who is a police officer regarding himself. No medical history was reported. On an unknown date in late 1900 or early 2000, the patient was vaccinated with a dose of Hepatitis B (Recombinant)(manufacturer unknown) (lot #, expiry, dose, route not reported) and had a low titer of 2 or no titer. No concomitant medications were reported. Police officer believes he received a primary series for Hepatitis B (Recombinant) (manufacturer unknown), boosters doses and another set of the series. Police Office believed he received 3 complete sets of Hepatitis B (Recombinant)(manufacturer unknown). Police officer in order for the police department to pay for the Hepatitis B (Recombinant) (manufacturer unknown), the titers needed to be done to justify getting the vaccines if necessary. The outcome of low titer of 2 or no titer was unknown. This is 1 of 2 reports regarding the same patient. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Headache, Nausea, Vomiting
Clinical narrative: 6/13/13 Patient here for follow-up. Two days ago, he received HPV vaccine. He tells me when he was sitting in the waiting room he had a mild headache. He felt anxious. He tells me he gets nervous easily. At about 5:00 p.m., he developed nausea. Then about 7:00 p.m., after going out to dinner, he vomited and his headache increased. He was brought to the ER. ER note is on chart. Today, he tells me he is back to normal.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients many have received VAQTA, RECOMBIVAX HB, (merck) VARIVAX, PEDVAXHIB and GARDASIL that was improperly stored. This report concerns PEDVAX HIB. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007107 and 1306USA007109 which concern VAQTA, RECOMBIVAX HB, (merck) VARIVAX and GARDASIL respectively. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients may have received VAQTA, RECOMBIVAX HB, VARIVAX (Merck), LIQUID PEDVAXHIB and GARDASIL that was improperly stored. This report concerns VARIVAX (Merck). No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007108 and 1306USA007109 which concern VAQTA, RECOMBIVAX HB, LIQUID PEDVAXHIB and GARDASIL, respectively. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative
Clinical narrative: This spontaneous report was received from a 50 year old male patient who is a police officer. No medical history was reported. On an unknown date in late 1900 or early 2000, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown) (lot #, expiry, dose, route not reported) and had a low titer of 2 or no titer. No concomitant medications were reported. Police Officer believes he received a primary series for hepatitis A vaccine, inactivated(manufacturer unknown), boosters doses and another set of the series. Police Officer believed he received 3 complete sets of hepatitis A vaccine, inactivated(manufacturer unknown). Police Office stated in order for the police department to pay for the hepatitis A vaccine, inactivated(manufacturer unknown), the titers needed to be done to justify getting the vaccines if necessary. The outcome of low titer of 2 or no titer was unknown. This is 1 of 2 reports regarding the same patient. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a 55 year old female consumer refers to herself. The patient's medical history included gallbladder removed and she had drug reactions of broke out in hives by Penicillin. On 10-JAN-2000 and 27-MAR-2000 the patient was separately vaccinated with first and second doses of VARIVAX (Merck) (dose unknown) because she never had chickenpox so was recommended by physician. Concomitant therapies included TENORMIN, ZOLOFT, SYNTHROID and triamterene. On 07-DEC-2010, the patient had titers drawn. She went to the physician office and the viral titer results were "low .60 eia". At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Irritability
Clinical narrative: S/S: Fussy, right thigh with quarter-sizes area of erythema, red and hot - cellulitis - 6.15.13? Tx: Cephalexin (antibiotic) given 6.15.13.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient had no known drug reactions/allergies. On 30-MAY-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # H022153, expiration date 18-MAR-2014), subcutaneously, at right arm. Concomitant therapies included LANTUS, TRADJENTA, acetaminophen, NORCO, atenolol, CELEBREX, glipizide, LIPITOR, K-DUR, trazodone hydrochloride, PAXIL, NEURONTIN, metformin and FOSAMAX. On 02-JUN-2013, the patient noticed red, warm to touch area "about the size of a half dollar" on her right arm where she had received the ZOSTAVAX vaccination. The patient did not sought medical attention. The patient was still experiencing an injection site reaction and was not fully recovered. The patient present status was recovering. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dysphemia
Clinical narrative: Within 3 hrs of Prevnar13, child woke up from nap and begun to stutter. Constant stuttering lasted around 3.5 days. Woke up after this time with no stuttering.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cyanosis, Febrile convulsion, Pyrexia, Resuscitation
Clinical narrative: Within 3 hrs of Prevnar13, child woke up from nap and begun to stutter. Constant stuttering lasted around 3.5 days. Woke up after this time with no stuttering.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Pain in right armpit and at back of right upper arm.  I first noticed the rash in the morning of 06/16/13.  A doctor at urgent care identifed it as shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Cold sweat, Cyanosis, Hypotonia, Somnolence, Unresponsive to stimuli
Clinical narrative: Upon leaving clinic, patient bacame sleepy, cold/clammy, blue lips, vomited 3-4 times, and eventually became limp and unresponsive.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Vomiting
Clinical narrative: Upon leaving clinic, patient bacame sleepy, cold/clammy, blue lips, vomited 3-4 times, and eventually became limp and unresponsive.
Age: 25.0
Sex: F
Vaccine: DTAP, MUR, YF
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Intermittent dizziness, nausea, chills. Persistent 4-cm round area of redness/pain/swelling around injection site of yellow fever vaccine.
Age: 25.0
Sex: F
Vaccine: DTAP, MUR, YF
Symptoms: Nausea
Clinical narrative: Intermittent dizziness, nausea, chills. Persistent 4-cm round area of redness/pain/swelling around injection site of yellow fever vaccine.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Red and warm to touch, about the size of a tennis ball.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient immediately had pain at injection sight.  Patient was instructed to take Extra Stength Tylenol.  Returned the following day and area of arm was swollen and still extremely painful.  Patient was given Rx for Hydrocodone 5/325mg.  Patient is still not able to extend arm out in front of her and still has swelling.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Hypoaesthesia, Local swelling, Monoplegia
Clinical narrative: Pt sts entire Right Arm was numb and with mild paralysis. Right side of neck was swollen and pt was also unable to move right side of mouth for several hours.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient was readmitted to hospital on 5/30 after transfer to skilled nursing facility.  Patient had post vaccination fever.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Acute injection site reaction treated with NSAIDs.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Rash erythematous, Vaccination complication
Clinical narrative: Patient had acute allergic reaction to flu vaccine with erythematous eruptions to left arm, treated with Benadryl and Tylenol.
Age: 0.59
Sex: M
Vaccine: HEP, IPV
Symptoms: Cough, Pyrexia, Vomiting
Clinical narrative: Fever cough emesis after got vaccination today at clinic. Discharged on ibuprofen and Zofran.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dyskinesia, Eating disorder, Injection site bruising, Motor dysfunction, Muscle mass
Clinical narrative: Fever, vomiting, muscle knot, bruising at injection site. About two weeks after vaccine we noticed abnormal hand flapping, arm flailing and leg tensing. Which later progressed to odd head and torso movements. These things lasted for over a year. She is currently in Oral Motor and Occupational therapies because she had speech delays, poor oral motor function and difficulties eating, as well as sensory processing issues.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Muscle tightness, Pyrexia, Sensory disturbance, Speech disorder developmental, Vomiting
Clinical narrative: Fever, vomiting, muscle knot, bruising at injection site. About two weeks after vaccine we noticed abnormal hand flapping, arm flailing and leg tensing. Which later progressed to odd head and torso movements. These things lasted for over a year. She is currently in Oral Motor and Occupational therapies because she had speech delays, poor oral motor function and difficulties eating, as well as sensory processing issues.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: As described by mother. Pt developed a single "hive" where ENGERIX-B was given on 6/13/13. Reports "hive" was noticed at 1pm on 6/14/13 on (L) outer thigh; approximate size of a quarter red and warm. Mom denies opening or drainage. Mother continues to observe. No treatment given.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Started with a fever on 6-14-13 had one spot on arm on 6-15-13.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Aphasia, Cardiac telemetry, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Differential white blood cell count normal, Dysphemia, Electrocardiogram, Electroencephalogram normal, Full blood count normal
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Glycosylated haemoglobin decreased, Hemiparesis, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Speech disorder, Transient ischaemic attack, Troponin I normal, VIIth nerve paralysis
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Aphasia, Cardiac telemetry normal, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Differential white blood cell count normal, Dysphemia, Electrocardiogram, Electroencephalogram normal, Feeling hot
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, Hemiparesis, Hypoaesthesia, Laboratory test normal
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Speech disorder, Transient ischaemic attack, Troponin I normal, VIIth nerve paralysis
Clinical narrative: Pt was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt developed hot tingling sensation in (L) face involving cheek down to chin as well as LUE/LLE weakness, no other neuro sxs reported. EKG performed and pt sent to ED for stroke evaluation. Pt was seen in ED and stroke were called. Not determined a TIA candidate per neurology. Pt was admitted and found to have (L) facial droop, (L) facial numbness, and (L) hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt stated feeling good but still having trouble with words. On ER call 5/31/13, pt reporting worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (not aphasic speech) but otherwise normal and CT/MRI was negative. Pt was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, C-reactive protein increased, Computerised tomogram normal, Incontinence, Injection site pain
Clinical narrative: June 7, 2013 - injection. June 8, 2013 - sore at injection site, AM - arm swelling, and pain PM. June 9, 2013 - right arm weakness, (R) breast swollen, (R) leg weakness, incontinence -> ER.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Oedema peripheral, Pain in extremity, White blood cell count increased, X-ray of pelvis and hip normal
Clinical narrative: June 7, 2013 - injection. June 8, 2013 - sore at injection site, AM - arm swelling, and pain PM. June 9, 2013 - right arm weakness, (R) breast swollen, (R) leg weakness, incontinence -> ER.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: White blood cells urine positive
Clinical narrative: Information has been received from an investigator concerning an 8 week old female with gastrooesophageal reflux disease and a history of right lacrimal duct obstruction congenital and toxic erythema who entered a study. Previous vaccine history included 0.5 ml IM injection, one dose on 02-NOV-2011 of ENGERIX-B. On 03-Jan-2012 the subject was randomized to receive DTaP-HepB-Hib-IPV at 2 months, 4 months and 6 months. On 03-JAN-2012 the subject was vaccinated with the first in series of IM 0.5 ml (injection site not reported) DTaP-HepB-Hib-IPV. Additional vaccine therapy on 03-Jan-2012 included oral 2.0 ml ROTATEQ and IM 0.5 ml PREVNAR 13 as part of the childhood series. Concomitant therapy included TRI-VI-SOL. On 03-JAN-2012 the subject experienced fever (moderate intensity) and was hospitalized on 04-Jan-2012. The subject presented to the local ER on 03-JAN-2012 reporting a fever of 102.2 degrees Fahrenheit (previously unit of measure not provided) taken rectally at home. Temperature taken in the ER was 100.8 degrees Fahrenheit (previously unit of measure not reported) rectally after TYLENOL had been given at home. The subject was admitted for observation and to rule out infection only and discharged on the same day (04-Jan-2012) in stable condition, (previously reported as remained hospitalized at time of reporting). No medications given during hospitalization. The lab/diagnostic results (previously reported as unknown) revealed the following: 03-Jan-2012 urine culture negative, 03-Jan-2012 blood culture negative, 03-Jan-2012 urinalysis WBC 5-10 (units unknown), otherwise normal urine, on 03-Jan-2012 (day approximate) CBC negative and CRP normal. On 04-Jan-2012, lumbar puncture was attempted but was unsuccessful during hospitalization (date not reported). The action taken with the study vaccine therapy was none. On 04-JAN-2012, the fever resolved (previously at the time of initial reporting, the subject had not recovered from the fever). The subject was discharged from the hospital on 04-JAN-2012. The hospital discharge diagnosis was fever, no other etiology was determined for fever. No discharge summary was available as the hospitalization was for observation only. The history and physical were reviewed by the investigator and no other diagnosis was given other than fever. The reporting investigator considered that the fever was possibly related to all three study vaccines. Follow up information was received from the investigator on 06-Jan-2012 and the following fields were update: AE screen, episodes profile, lab/diagnostic screen and the narrative. Follow up information was received from the investigator on 10-Jan-2012 and the following fields were updated: episode profile and the narrative. Follow-up information was received on 12-JAN-2012 from the investigator. The following field was updated: narrative. Additional information is not expected. This is an amended report, it was requested to provide the relationship to ROTATEQ and Pneumococcal 13 as related.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Headache, Malaise, Nausea, Seizure like phenomena
Clinical narrative: Initial information has been received from a Licensed Practical Nurse concerning a 19 year old female patient with none pertinent medical history and none drug reactions / allergies. On 15-MAY-2013, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number H021861 exp date 08-AUG-2015). Concomitant therapies included CLARITIN, doxycycline, DIFLUCAN and unspecified birth control pills, methylphenidate. On 15-MAY-2013, the patient experienced syncopal event after her first dose of GARDASIL. Right after patient was administered a dose of GARDASIL, patient's eyes rolled back little bit and for about 10 seconds she had very mild seizure-like movements. The nurse laid the patient down and observed her. The patient complained of nausea but no vomiting was reported. This incident was over in about total of 5 minutes. The patient complained of headaches and "not feeling well" for a few days after GARDASIL administration. Treatment was not given for the event. There was not laboratory studies performed. On an unspecified date, the patient recovered from the events. The patient sought medical attention by visiting physician's office and by phone calls. Upon internal review, mild seizure-like movements was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial information has been received from a Licensed Practical Nurse concerning a 19 year old female patient with none pertinent medical history and none drug reactions / allergies. On 15-MAY-2013, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number H021861 exp date 08-AUG-2015). Concomitant therapies included CLARITIN, doxycycline, DIFLUCAN and unspecified birth control pills, methylphenidate. On 15-MAY-2013, the patient experienced syncopal event after her first dose of GARDASIL. Right after patient was administered a dose of GARDASIL, patient's eyes rolled back little bit and for about 10 seconds she had very mild seizure-like movements. The nurse laid the patient down and observed her. The patient complained of nausea but no vomiting was reported. This incident was over in about total of 5 minutes. The patient complained of headaches and "not feeling well" for a few days after GARDASIL administration. Treatment was not given for the event. There was not laboratory studies performed. On an unspecified date, the patient recovered from the events. The patient sought medical attention by visiting physician's office and by phone calls. Upon internal review, mild seizure-like movements was considered to be medically significant. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Grand mal convulsion, Loss of consciousness, Urinary incontinence
Clinical narrative: PASSED OUT AND HAD 2 GRAND MAL SEIZURES LOST CONTROL OF BLADDER X 2.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Blood pressure increased, Cardiac stress test normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Approx 10 min after receiving Zostavax, pt c/o dizziness, headache, chest/neck tightness.  No difficult breathing, no swollen tongue/throat, speech clear and fluent.  Evaluated in Imms clinic by Dr. and then taken to ER for further evaluation at 1120. Pt reported progressively worsening sx, now tongue felt "weird" and like "I might have trouble swallowing if I tried".  But speech still clear and fluent. Started on IV H-blocker, diphenhydramine, and PO prednisone at 1145.  At 1248 she was feeling better but sx seemed to be lessening.  BP still elevated 170's/80's.  Dc'd with spouse approx 2 PM.  Approx 7:30 PM pt initial sx returned:  headache, dizziness, chest/neck tightness. Spouse took her to local fire station for eval by paramedics.  HR in 190's.  Taken by Paramedics to ER where she lives.  Tightness/fullness extended to both axilla.  No SOB c/o or noted.  Given SL NTG, ASA 325 mg, IV Morphine. Given complete cardiac workup including stress test.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Muscle tightness, Paraesthesia oral, Renal failure
Clinical narrative: Approx 10 min after receiving Zostavax, pt c/o dizziness, headache, chest/neck tightness.  No difficult breathing, no swollen tongue/throat, speech clear and fluent.  Evaluated in Imms clinic by Dr. and then taken to ER for further evaluation at 1120. Pt reported progressively worsening sx, now tongue felt "weird" and like "I might have trouble swallowing if I tried".  But speech still clear and fluent. Started on IV H-blocker, diphenhydramine, and PO prednisone at 1145.  At 1248 she was feeling better but sx seemed to be lessening.  BP still elevated 170's/80's.  Dc'd with spouse approx 2 PM.  Approx 7:30 PM pt initial sx returned:  headache, dizziness, chest/neck tightness. Spouse took her to local fire station for eval by paramedics.  HR in 190's.  Taken by Paramedics to ER where she lives.  Tightness/fullness extended to both axilla.  No SOB c/o or noted.  Given SL NTG, ASA 325 mg, IV Morphine. Given complete cardiac workup including stress test.
Age: 10.0
Sex: F
Vaccine: DTAP, HEPA, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Increased upper airway secretion, Pharyngeal disorder, Pharyngeal oedema
Clinical narrative: Patient called store the following morning stating her throat was closed/swelled. She contacted her physician and was told to take Claritin and to go to hospital if needed. She was better, but said throat raw with clear mucous.
Age: 19.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood electrolytes normal, Feeling abnormal, Feeling cold, Full blood count, Injection site erythema
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritis or rash. No respiratory distress.  Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritis at site of injection, left deltoid.
Age: 19.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pruritus, Local reaction, Malaise, Tachycardia, White blood cell count increased
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritis or rash. No respiratory distress.  Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritis at site of injection, left deltoid.
Age: 19.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood electrolytes normal, Feeling abnormal, Feeling cold, Full blood count abnormal, Injection site erythema
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritis or rash. No respiratory distress.  Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritis at site of injection, left deltoid.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood electrolytes normal, Feeling abnormal, Feeling cold, Full blood count, Injection site erythema
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritus or rash. No respiratory distress. Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritus at site of injection, left deltoid.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pruritus, Local reaction, Malaise, Tachycardia, White blood cell count increased
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritus or rash. No respiratory distress. Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritus at site of injection, left deltoid.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood electrolytes normal, Feeling abnormal, Feeling cold, Full blood count abnormal, Injection site erythema
Clinical narrative: "Does not feel right", felt cold, tachycardia (114/min). No pruritus or rash. No respiratory distress. Afebrile. Gave Acetaminophen extra strength 1000 mg and Diphenhydramine 25 mg IM. Follow-up on 6/17/13 now with erythema and pruritus at site of injection, left deltoid.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Convulsion
Clinical narrative: Seizure lasting a minute.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Since then I have had a deep, constant pain that runs down the length of my arm, almost as if I badly strained a ligament. It lasted 10 days. It seems to originate in my rotator cuff making certain movements give me acute pain. I have been taking Tylenol to sleep, but I usually wake up from the pain exactly 6 hours after I take it. I have been using ice also.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Local swelling, Pain in extremity
Clinical narrative: Since then I have had a deep, constant pain that runs down the length of my arm, almost as if I badly strained a ligament. It lasted 10 days. It seems to originate in my rotator cuff making certain movements give me acute pain. I have been taking Tylenol to sleep, but I usually wake up from the pain exactly 6 hours after I take it. I have been using ice also.