chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Atrial fibrillation, Borrelia test negative, CSF culture negative, CSF oligoclonal band
Clinical narrative: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: CSF protein increased, CSF test abnormal, CSF virus no organisms observed, CSF white blood cell count, Coma
Clinical narrative: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Deep vein thrombosis, Electrocardiogram abnormal, Encephalitis, Endotracheal intubation, Grand mal convulsion
Clinical narrative: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: HIV test negative, Hepatitis C test negative, Herpes simplex serology negative, Intensive care, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Polymerase chain reaction, Pulmonary embolism, Rheumatoid factor, Unresponsive to stimuli
Clinical narrative: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nodule
Clinical narrative: Nodules to (B) le.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Measles, Rash morbilliform
Clinical narrative: Per staff pt has measle rash on body, rash will clear up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician assistant via company representative refers to a patient of unknown age(reported as appropriate age range to receive the vaccine). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced rash after receiving ZOSTAVAX. The outcome of rash was unknown. The patient sought medical attention (office visit). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no drug reactions/allergies. On 25-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number was reported as J001002, expiry date was 25-APR-2014, route and dose were not reported). On 26-MAY-2013, the patient developed a varicella like rash around the injection site. The patient sought medical attention (contacted pharmacist). The outcome of a varicella like rash around the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye swelling, Nausea, Polymerase chain reaction, Rash
Clinical narrative: 10 days after vaccine given, nausea and rash developed on forehead (R) and eye swollen, (R) neck, (L) forearm and antecub, papular, red ? vesicles.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Viral test
Clinical narrative: 10 days after vaccine given, nausea and rash developed on forehead (R) and eye swollen, (R) neck, (L) forearm and antecub, papular, red ? vesicles.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event, Product label confusion
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The vaccine (oka-merck) PROQUAD (lot# J001054, expiration date 28-JUL-2014, route not reported) was accidently placed in the refrigerator on Friday, 24-MAY-2013, at noon, where it remained for the next 100 hours at 4-5 degree Centigrade (C). The reporter stated that when (oka-merck) PROQUAD was unpacked from the shipper, the person who stored the PROQUAD saw the "A" on the carton and thought it was hepatitis a vaccine. This confusion was the reason the (oka-merck) PROQUAD was stored in the refrigerator. None of the doses of (oka-merck) PROQUAD were administered to any patients for whom hepatitis a vaccine was intended; therefore no adverse event (AE). No patients were effected by this product confusion. No Product Quality Complaint (PQC) identified. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age (reported as most likely been over 18 years of age in order to handle the vaccine at all). Reporter informed that there had been e-mail's circulation in pharmacy society that informed that pharmacist should were masks when reconstituting ZOSTAVAX. Reporter informed that she never had read or copied those e-mail. On an unknown date the patient may have developed shingles after working with or reconstituting the ZOSTAVAX. It was not made clear, nor was any of the information confirmed if the pharmacist had ever been administered the vaccine at all or what her specific interaction, with ZOSTAVAX, acutally was. The outcome of shingles was unknown. The reporter did not reported relatedness. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site reaction, Injection site warmth, Local reaction, Rash erythematous
Clinical narrative: Rigth arm red rash with warmth measuring 9cmx9cm. Left arm red rash with warmth measuring 8cmx8cm (local vaccine reaction). Red rash with warmth to injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. No medical history was reported. On 14-MAY-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 668262/0841AA, expiry date 08-APR-2013) 0.5 ml, first dose, unknown route. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 year old female patient. On 23-MAY-2013 the patient was vaccinated with a dose of VARIVAX (lot # 1321AA, exp. date: 18-AUG-2013) 0.5 ml, intramuscular injection. The patient did state that the injection hurt. The outcome of event was unknown. It was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: 1 yr old shots given on 5/22/13. Dad noted rash to abd, back, torso, neck primarily; began 6/3/13. No itching, fevers, discomforts associated with many individulized bumps to body. Several are grouping but mostly individual with no centers.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site streaking, Injection site urticaria, Urticaria
Clinical narrative: Patient has whelps and streaking on both legs and on his face following vaccines that were given today. Mom advised to give 2.5 ml Childrens BENADRYL Q6 hrs up to 24 hrs. come to office tomorrow if no improvement ER if resp. distress/excessive drooling.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Day after vaccine pt reports warmth, redness and swelling on inner aspect of left upper arm. Injection was LU deltoid region.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swelling and itchy rash at injection site. No breathing difficulty, no SOB. Advised use of diphenhydramine and MD referral if worse.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Painful, swollen arm around injection site radiating down to elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Large 4-5 inch rash w/ bump (very large), itchy, hot, fever; lasted approximately 1 wk. Pt used BENADRYL.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient had no drug reactions/allergies. On an unknown date the patient was vaccinated with hepatitis B vaccine (manufacturer unknown and RECOMBIVAX HB could not be ruled out) (dose, route and lot # were unknown). The patient had negative titers. Her hepatitis surface AG and hepatitis surface AB were both negative. The outcome of event was unknown. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient had no drug reactions/allergies. On an unknown date the patient was vaccinated with hepatitis B vaccine (manufacturer unknown and RECOMBIVAX HB could not be ruled out) (dose, route and lot # were unknown). The patient had negative titers. Her AB quantitative was 6.7 and hepatitis surface AB was negative. The outcome of event was unknown. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Irritability, Pyrexia, Skin warm
Clinical narrative: Shots 510 yesterday, noted to be warm 930 pm. This am fever to 105.1 by otic therm. In ER temp to 103.6 with TYLENOL - fussy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients of unknown age and gender. The Nurse reported that GARDASIL (lot # and expiration date unavailable at time of the call), has had multiple excursions since 14-MAR-2013 reaching the lowest temperature of 30F (Fahrenheit). She was unsure of the total amount of hours for the excursions. The nurse believed that since the start of the excursions on 14-MAR-2013, the patients were vaccinated with this GARDASIL (Lot number, expiry date, route and dose were not reported) since an unknown date in 2013. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old female patient with no drug reactions/allergies. The patient received the RECOMBIVAX HB (lot number and expiry date were not reported) series as follows: first dose 0.5 milliliter (ml) intramuscularly on 06-JUL-1993, second dose 0.5 ml intramuscularly on 06-AUG-1993 (reported as four weeks after the first dose), and the third dose 0.5 ml intramuscularly approximately on an unknown date in 1995 (reported as when the patient was 2 years old). Concomitant medication was none. On 24-MAY-2013, titers were drawn on the patient for school purpose and the results of the titers were negative. The patient sought medical attention (contacted the physician's office). No treatment was given. The outcome of the event titers were negative was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt received PNEUMOVAX on 5/29/13. Woke up on 5/31/12 with pain and redness at site (L) deltoid) radiating to under arm. Deltoid region tender to palpation.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Condition aggravated, Drug withdrawal syndrome, Lung infection, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of lung infection in a 47-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified) and FLOVENT 44 mcg hfa-cfc inhaler for asthma. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, lung infection, muscle pain in back and neck pain. Historic medications included Prednisone and AUGMENTIN. On an unspecified date in 2013 the subject received unspecified dose of Influenza vaccine (unknown). In 2013, at an unspecified time after vaccination with Influenza vaccine, the subject experienced "getting worse quickly" with lung infection, muscle pain in back, neck pain exacerbation. The subject was hospitalised. The subject was treated with prednisone. In March 2013 the subject was re-hospitalized because he continued to be sick. He started Fluticasone propionate at 2 puff (s) twice per day and also received prednisone. In 2013, at an unspecified time after reducing Fluticasone propionate, the subject experienced withdrawal symptoms, the return of muscle back pain and neck pain. At the time of reporting, the outcome of the aggravated lung condition and sick were unknown; the aggravated muscle pain in back, neck pain exacerbation and withdrawal symptoms were unresolved. Patient stated that he's always had asthma. He had a bad lung infection in November 2012 with pain in his muscles in the back and the back of his neck. He went to the physician's office and he had prednisone and AUGMENTIN to try to kill his infection. He got better with this treatment, but the symptoms came back when he went off these medications. At an unknown date, he was still sick with the same symptoms and patient stated that he should not have had the flu shot under those conditions. However, at an unknown date he received the flu shot, he got worse quickly and was hospitalized. At the hospital he was given prednisone. He continued being sick and was hospitalized again in March 2013. At the hospital he got more prednisone as well as FLOVENT HFA prescriptions. He was also seeing by some respiratory physicians and was asked to cough up to take a culture and examine it. He has to make an appointment with the clinic to find out the results. Patient said that he discontinued taking prednisone in March 2013 after being on prednisone for three months. He weaned off the prednisone well and did not have any side effects from taking prednisone. Patient said that FLOVENT helped him with his symptoms. However, he's been trying to wean off the medication since it's so expensive and he has no insurance. At an unknown date patient has been taking one puff once a day. Patient said that every time he skips the medication his symptoms of having pain in the muscles of his back and the back of his neck come back. As soon as he takes one puff of FLOVENT, these symptoms go away. Patient believes he is having symptoms from withdrawing the FLOVENT treatment.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain, Pain, Sputum culture
Clinical narrative: This case was reported by a consumer and described the occurrence of lung infection in a 47-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified) and FLOVENT 44 mcg hfa-cfc inhaler for asthma. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, lung infection, muscle pain in back and neck pain. Historic medications included Prednisone and AUGMENTIN. On an unspecified date in 2013 the subject received unspecified dose of Influenza vaccine (unknown). In 2013, at an unspecified time after vaccination with Influenza vaccine, the subject experienced "getting worse quickly" with lung infection, muscle pain in back, neck pain exacerbation. The subject was hospitalised. The subject was treated with prednisone. In March 2013 the subject was re-hospitalized because he continued to be sick. He started Fluticasone propionate at 2 puff (s) twice per day and also received prednisone. In 2013, at an unspecified time after reducing Fluticasone propionate, the subject experienced withdrawal symptoms, the return of muscle back pain and neck pain. At the time of reporting, the outcome of the aggravated lung condition and sick were unknown; the aggravated muscle pain in back, neck pain exacerbation and withdrawal symptoms were unresolved. Patient stated that he's always had asthma. He had a bad lung infection in November 2012 with pain in his muscles in the back and the back of his neck. He went to the physician's office and he had prednisone and AUGMENTIN to try to kill his infection. He got better with this treatment, but the symptoms came back when he went off these medications. At an unknown date, he was still sick with the same symptoms and patient stated that he should not have had the flu shot under those conditions. However, at an unknown date he received the flu shot, he got worse quickly and was hospitalized. At the hospital he was given prednisone. He continued being sick and was hospitalized again in March 2013. At the hospital he got more prednisone as well as FLOVENT HFA prescriptions. He was also seeing by some respiratory physicians and was asked to cough up to take a culture and examine it. He has to make an appointment with the clinic to find out the results. Patient said that he discontinued taking prednisone in March 2013 after being on prednisone for three months. He weaned off the prednisone well and did not have any side effects from taking prednisone. Patient said that FLOVENT helped him with his symptoms. However, he's been trying to wean off the medication since it's so expensive and he has no insurance. At an unknown date patient has been taking one puff once a day. Patient said that every time he skips the medication his symptoms of having pain in the muscles of his back and the back of his neck come back. As soon as he takes one puff of FLOVENT, these symptoms go away. Patient believes he is having symptoms from withdrawing the FLOVENT treatment.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age. On an unknown date in MAR-2013 (reported as end of March), the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported) and found out that she was pregnant on the same day. Concomitant medications were not reported. The last menstrual period and estimated date of delivery were not reported. The patient stated that she had not had any side effects. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 6 month old female patient. Approximately on an unknown date in 2006(reported as approximately 7 years ago), the patient was vaccinated with a third dose of ROTATEQ (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in 2006(reported as approximately 7 years ago), the patient experienced intussusception. It was not clear if there was any hospitalization but they did diagnosis the patient with intussusception. The outcome of intussusception was unknown. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Injection site erythema, Injection site mass, Screaming
Clinical narrative: Mom reported baby to "bolt out of sleep"-screaming approx. 2-3 hrs after vaccines given. T 100. Consoled about an hour after TYLENOL given. Baby then also started with diarrhea, having up to 10 stools/day. Parents and gm also with stomach bug s/s. Child had red lump (L) leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 7.5 x 11 cm area of erythema and warmth with smaller area of induration - on (L) upper arm/(L) deltoid, mildly tender, occurred w/in 24 hrs of vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Muscle spasms, Nausea, Pain, Pyrexia
Clinical narrative: Body aches 5/24/13. Fever 5/25/13 x 2 days (102 degrees) with cramps, diarrhea, nausea. Above resolved 5/29/13.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling and tenderness of entire right arm from shoulder (injection site) to wrist starting Friday evening and ending on Monday morning.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Redness, heat, swelling and tenderness of entire right arm from shoulder (injection site) to wrist starting Friday evening and ending on Monday morning.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Injection site erythema, Myalgia, Oedema peripheral
Clinical narrative: Myalgia; diarrhea; fever 102.6 5/23, then resolved; arm redness and swelling 5/23 x 2d then better. Exam 3.5 cm area around injection. Pink, not warm tender.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Myalgia; diarrhea; fever 102.6 5/23, then resolved; arm redness and swelling 5/23 x 2d then better. Exam 3.5 cm area around injection. Pink, not warm tender.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Headache
Clinical narrative: Headache, dizziness, abdominal pain. Monitored in clinic for one hour before feeling better.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV4
Symptoms: Dyspnoea, Head injury, Hyperhidrosis, Loss of consciousness, Muscle rigidity
Clinical narrative: PATIENT RECEIVED IN LEFT DELTOID HEP A AND HEP B ON RIGHT DELTOID GARDASIL VACCINE. PATIENT GOT UP AND SAT DOWN IN ANOTHER CHAIR AT WHICH POINT STARTED TO BREATHE HEAVY AND THEN HIT HIS HEAD ON SIDE WALL OF IMMUNIZATION DESK. PATIENT WAS COMPLETELY PASSED OUT, UPPER BODY STIFF/RIDGID, PALE, EYES OPEN NOT BREATHING. PATIENT ASSISTED TO FLOOR AND BEGAN TO DO STERNAL RUB AND AND HIT SHOULDER CALLING OUT TO PATIENT ARE YOU ALRIGHT. PATIENT GASPED AND CAME TO QUICKLY. IMMEDIATELY SAT UP AND BEGAN TO REPLY WHAT HE FELT AND WHAT HAPPENED JUST PRIOR TO PASSING OUT. PATIENT WAS PALE AND SWEATY AND TAKEN TO TREATMENT ROOOM. PROVIDER NOTIFIED.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Respiration abnormal, Respiratory arrest
Clinical narrative: PATIENT RECEIVED IN LEFT DELTOID HEP A AND HEP B ON RIGHT DELTOID GARDASIL VACCINE. PATIENT GOT UP AND SAT DOWN IN ANOTHER CHAIR AT WHICH POINT STARTED TO BREATHE HEAVY AND THEN HIT HIS HEAD ON SIDE WALL OF IMMUNIZATION DESK. PATIENT WAS COMPLETELY PASSED OUT, UPPER BODY STIFF/RIDGID, PALE, EYES OPEN NOT BREATHING. PATIENT ASSISTED TO FLOOR AND BEGAN TO DO STERNAL RUB AND AND HIT SHOULDER CALLING OUT TO PATIENT ARE YOU ALRIGHT. PATIENT GASPED AND CAME TO QUICKLY. IMMEDIATELY SAT UP AND BEGAN TO REPLY WHAT HE FELT AND WHAT HAPPENED JUST PRIOR TO PASSING OUT. PATIENT WAS PALE AND SWEATY AND TAKEN TO TREATMENT ROOOM. PROVIDER NOTIFIED.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Convulsion, Crying, Pyrexia, Screaming
Clinical narrative: Fever, high pitched non stop screaming for 24 hours, seizure. Was given Tylenol for the fever.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Joint swelling, Lymph node pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Started with painful swollen glands at base of skull, moved to neck and base of ears, next day stiff swollen foot and ankle then the next day stiff swollen knee (while foot improved), next day both knees swollen. The next day both knees were improving and elbow was stiff and swollen and it ended with stiff wrists and hands for several days. Symptoms lasted altogether about 9 days.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Convulsion, Crying, Injection site rash, Pyrexia, Screaming
Clinical narrative: Fever, rash at injection site, seizure, high pitched screaming for 24 hours. Did not want to be held, screamed whenever touched.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Tenderness
Clinical narrative: Fever, rash at injection site, seizure, high pitched screaming for 24 hours. Did not want to be held, screamed whenever touched.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Malaise
Clinical narrative: Serious pain in injection site; got worse the following day, lasted three days. Fever, aching joints, extreme tiredness, weakness, lack of stamina. Lasted nine (9) days.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Serious pain in injection site; got worse the following day, lasted three days. Fever, aching joints, extreme tiredness, weakness, lack of stamina. Lasted nine (9) days.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: After the MMR vaccine my son developed a quarter sized lump on his neck.  The same Doctor's office diagnosed it as "clumped lymph nodes."
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LEFT ARM PAIN, REDNESS AND SWELLING.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Gastroenteritis, Vomiting projectile
Clinical narrative: Mom called office and said the baby had projectile emesis 4 days after her vaccinations. She gave Pedialyte and Zofran with no further emesis. Mother states the baby had a similar episode about 4 days after her 4 month immunizations with similar projectile vomiting and it occurred several times so they took the baby to the local ER where the baby was DX with gastroenteritis and given Zofran and Pedialyte. Mom thinks her reaction is related to the vaccines.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Blood electrolytes normal, Dehydration, Full blood count normal, Intussusception
Clinical narrative: Small-bowel/Small-bowel intussusception discovered on 5/10/13. Several days of vomiting, abdominal pain, and dehydration.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Laboratory test normal, Liver function test normal, Renal function test normal, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: Small-bowel/Small-bowel intussusception discovered on 5/10/13. Several days of vomiting, abdominal pain, and dehydration.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: Small-bowel/Small-bowel intussusception discovered on 5/10/13. Several days of vomiting, abdominal pain, and dehydration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Within a half hour of vaccination, site had a bruise. By the next morning, May 29, site still appeared bruised, but redness was beginning. By May 30, site was extremely red, raised, swollen & painful. By May 31, area welt had grown to about 3" x 2" big, was bright red, raised, swollen, rash was beginning around area, hot to touch with pain going down to elbow & going up my neck, & I had a headache. My daughter who is a Licensed Vocational Nurse, her boyfriend who is a Registered Nurse, and my older daughter who is a Certified Nursing Assistant all insisted that I go to the ER to be treated & seen for the reaction to the vaccination because my symptoms seemed to be getting worse. On May 31, I went to the ER, where I was examined by 2 doctors. One doctor decided that perhaps I was having an infection (?) so he prescribed, & I am still taking the antibiotic, K-Flex, which really does not seem to be doing anything. The area is greatly improved, although there is still some pain at the site, but I believe it was more of an allergic reaction than an infection and just time has improved it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Within a half hour of vaccination, site had a bruise. By the next morning, May 29, site still appeared bruised, but redness was beginning. By May 30, site was extremely red, raised, swollen & painful. By May 31, area welt had grown to about 3" x 2" big, was bright red, raised, swollen, rash was beginning around area, hot to touch with pain going down to elbow & going up my neck, & I had a headache. My daughter who is a Licensed Vocational Nurse, her boyfriend who is a Registered Nurse, and my older daughter who is a Certified Nursing Assistant all insisted that I go to the ER to be treated & seen for the reaction to the vaccination because my symptoms seemed to be getting worse. On May 31, I went to the ER, where I was examined by 2 doctors. One doctor decided that perhaps I was having an infection (?) so he prescribed, & I am still taking the antibiotic, K-Flex, which really does not seem to be doing anything. The area is greatly improved, although there is still some pain at the site, but I believe it was more of an allergic reaction than an infection and just time has improved it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Within a half hour of vaccination, site had a bruise. By the next morning, May 29, site still appeared bruised, but redness was beginning. By May 30, site was extremely red, raised, swollen & painful. By May 31, area welt had grown to about 3" x 2" big, was bright red, raised, swollen, rash was beginning around area, hot to touch with pain going down to elbow & going up my neck, & I had a headache. My daughter who is a Licensed Vocational Nurse, her boyfriend who is a Registered Nurse, and my older daughter who is a Certified Nursing Assistant all insisted that I go to the ER to be treated & seen for the reaction to the vaccination because my symptoms seemed to be getting worse. On May 31, I went to the ER, where I was examined by 2 doctors. One doctor decided that perhaps I was having an infection (?) so he prescribed, & I am still taking the antibiotic, K-Flex, which really does not seem to be doing anything. The area is greatly improved, although there is still some pain at the site, but I believe it was more of an allergic reaction than an infection and just time has improved it.
Age: 38.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Balance disorder, CSF protein increased, Chills, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: Numbness on face, dizziness, pain and weakness both legs, chills (hot and cold), left sided facial droop. Also states that he has had "dysequilibrium" x 2 days, falling more than usual (though at baseline, occasionally stumbles). Denies room-spinnning sensation. No fever, HA, head trauma. No back pain, no loss of bowel or bladder control.
Age: 38.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Fall, Feeling of body temperature change, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Numbness on face, dizziness, pain and weakness both legs, chills (hot and cold), left sided facial droop. Also states that he has had "dysequilibrium" x 2 days, falling more than usual (though at baseline, occasionally stumbles). Denies room-spinnning sensation. No fever, HA, head trauma. No back pain, no loss of bowel or bladder control.
Age: 38.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Hyperreflexia, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: Numbness on face, dizziness, pain and weakness both legs, chills (hot and cold), left sided facial droop. Also states that he has had "dysequilibrium" x 2 days, falling more than usual (though at baseline, occasionally stumbles). Denies room-spinnning sensation. No fever, HA, head trauma. No back pain, no loss of bowel or bladder control.
Age: 38.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: VIIth nerve paralysis
Clinical narrative: Numbness on face, dizziness, pain and weakness both legs, chills (hot and cold), left sided facial droop. Also states that he has had "dysequilibrium" x 2 days, falling more than usual (though at baseline, occasionally stumbles). Denies room-spinnning sensation. No fever, HA, head trauma. No back pain, no loss of bowel or bladder control.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant refers to a female patient of unknown age. No medical history was reported. On an unknown date in April 2010, the patient received her first dose of GARDASIL (lot #, expiry, route, dose not reported) and just received her second dose of GARDASIL (lot #, expiry, route, dose not reported) on an unknown date in May 2013. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: Redness with little red bumps all around injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around the injection site. Redness became hot and increased in size to the size of a grapefruit in circumference. The doctor gave me antibiotics. By three after the shot I was extremely dizzy and when I stood up I would fall over. Doctor gave me cortisone shot. Relieved some of the systems. Two weeks later I broke out with shingles in the same spot as I had over a year ago. Dr gave me medicine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Swelling and redness around the injection site. Redness became hot and increased in size to the size of a grapefruit in circumference. The doctor gave me antibiotics. By three after the shot I was extremely dizzy and when I stood up I would fall over. Doctor gave me cortisone shot. Relieved some of the systems. Two weeks later I broke out with shingles in the same spot as I had over a year ago. Dr gave me medicine.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Patient noted onset of edema, erythema and pruritis around injection site approximately 4 hours after administration. Exam revealed circular area of erythema, approximately 8cm in diameter, around injection site with mild edema.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Employee stated that he had a fever and his arm at injection was red and painful.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB decreased, C-reactive protein increased, Cardiac enzymes increased, Chest X-ray normal, Chest pain
Clinical narrative: Vomiting x1 on day of onset. Substernal chest pain x 3 days.  Pt recently vaccinated with Small Pox vaccine 12 days prior, subsequent viral URI type symptoms 1 week later, resolved and two days later CP symptoms began.  CP located substernal L>R side of chest.  Described as throbbing/aching in nature.  No aggravating factors.  Alleviated w/ Ibuprofen, learning forward, rest.  Pt presented to ED at MC for eval and treatment of myopericarditis.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Myopericarditis, Pain, Troponin T increased
Clinical narrative: Vomiting x1 on day of onset. Substernal chest pain x 3 days.  Pt recently vaccinated with Small Pox vaccine 12 days prior, subsequent viral URI type symptoms 1 week later, resolved and two days later CP symptoms began.  CP located substernal L>R side of chest.  Described as throbbing/aching in nature.  No aggravating factors.  Alleviated w/ Ibuprofen, learning forward, rest.  Pt presented to ED at MC for eval and treatment of myopericarditis.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Viral upper respiratory tract infection, Vomiting
Clinical narrative: Vomiting x1 on day of onset. Substernal chest pain x 3 days.  Pt recently vaccinated with Small Pox vaccine 12 days prior, subsequent viral URI type symptoms 1 week later, resolved and two days later CP symptoms began.  CP located substernal L>R side of chest.  Described as throbbing/aching in nature.  No aggravating factors.  Alleviated w/ Ibuprofen, learning forward, rest.  Pt presented to ED at MC for eval and treatment of myopericarditis.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion
Clinical narrative: PATIENT EXPERIENCED A SEIZURE OF APPROXIMATELY 5 TO 7 SECONDS AFTER APPROXIMATELY 5 MINUTES OF VACCINE ADMINISTRATION.
Age: 1.22
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Fever to 104F, generalized tonic clonic seizure.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Autonomic neuropathy, Blood pressure fluctuation, Blood pressure increased, Blood test, Body temperature decreased
Clinical narrative: Initially, I had redness and soreness at the injection site (back of right arm) which eventually covered the entire back side of my right arm from shoulder to elbow.  Approximately, 24 hours after receiving the injection, I had facial flushing, hot feeling on the face and ears, and elevated blood pressure.  On December 17, 2012, my blood pressure was elevated to the point of requiring emergency room treatment.  My body temperature dropped to 92.5, my face was flushed, and my face and ears were hot. On December 20, 2012, I began to have symptoms of a cold and upper respiratory infection; these symptoms lasted until January 2, 2013. On December 31, 2012, January 5, 2013, January 7th, 2013, January 9th, 2013, and February 5, 2013, I had to go to the ER because of elevated blood pressures around 220/115 and elevated heart rate (140). Around the end of March, 2013, my symptoms started to subside, with the exception of elevated heart rate, which persists until today. My doctors determined I had a reaction to the shingles vaccination which affected my autonomic nervous system.  For 90+ days, I did not perspire, I had very low body temperature, extreme fluctuations in blood pressure, rapid heart rate, loss of sense of smell, severe flushing, feeling hot on face and ears.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Catecholamines urine, Feeling hot, Flushing, Heart rate increased, Hypohidrosis
Clinical narrative: Initially, I had redness and soreness at the injection site (back of right arm) which eventually covered the entire back side of my right arm from shoulder to elbow.  Approximately, 24 hours after receiving the injection, I had facial flushing, hot feeling on the face and ears, and elevated blood pressure.  On December 17, 2012, my blood pressure was elevated to the point of requiring emergency room treatment.  My body temperature dropped to 92.5, my face was flushed, and my face and ears were hot. On December 20, 2012, I began to have symptoms of a cold and upper respiratory infection; these symptoms lasted until January 2, 2013. On December 31, 2012, January 5, 2013, January 7th, 2013, January 9th, 2013, and February 5, 2013, I had to go to the ER because of elevated blood pressures around 220/115 and elevated heart rate (140). Around the end of March, 2013, my symptoms started to subside, with the exception of elevated heart rate, which persists until today. My doctors determined I had a reaction to the shingles vaccination which affected my autonomic nervous system.  For 90+ days, I did not perspire, I had very low body temperature, extreme fluctuations in blood pressure, rapid heart rate, loss of sense of smell, severe flushing, feeling hot on face and ears.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyposmia, Injection site erythema, Injection site pain, Nasopharyngitis, Nuclear magnetic resonance imaging abdominal
Clinical narrative: Initially, I had redness and soreness at the injection site (back of right arm) which eventually covered the entire back side of my right arm from shoulder to elbow.  Approximately, 24 hours after receiving the injection, I had facial flushing, hot feeling on the face and ears, and elevated blood pressure.  On December 17, 2012, my blood pressure was elevated to the point of requiring emergency room treatment.  My body temperature dropped to 92.5, my face was flushed, and my face and ears were hot. On December 20, 2012, I began to have symptoms of a cold and upper respiratory infection; these symptoms lasted until January 2, 2013. On December 31, 2012, January 5, 2013, January 7th, 2013, January 9th, 2013, and February 5, 2013, I had to go to the ER because of elevated blood pressures around 220/115 and elevated heart rate (140). Around the end of March, 2013, my symptoms started to subside, with the exception of elevated heart rate, which persists until today. My doctors determined I had a reaction to the shingles vaccination which affected my autonomic nervous system.  For 90+ days, I did not perspire, I had very low body temperature, extreme fluctuations in blood pressure, rapid heart rate, loss of sense of smell, severe flushing, feeling hot on face and ears.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain, Phaeochromocytoma, Ultrasound kidney, Upper respiratory tract infection, Vaccination complication
Clinical narrative: Initially, I had redness and soreness at the injection site (back of right arm) which eventually covered the entire back side of my right arm from shoulder to elbow.  Approximately, 24 hours after receiving the injection, I had facial flushing, hot feeling on the face and ears, and elevated blood pressure.  On December 17, 2012, my blood pressure was elevated to the point of requiring emergency room treatment.  My body temperature dropped to 92.5, my face was flushed, and my face and ears were hot. On December 20, 2012, I began to have symptoms of a cold and upper respiratory infection; these symptoms lasted until January 2, 2013. On December 31, 2012, January 5, 2013, January 7th, 2013, January 9th, 2013, and February 5, 2013, I had to go to the ER because of elevated blood pressures around 220/115 and elevated heart rate (140). Around the end of March, 2013, my symptoms started to subside, with the exception of elevated heart rate, which persists until today. My doctors determined I had a reaction to the shingles vaccination which affected my autonomic nervous system.  For 90+ days, I did not perspire, I had very low body temperature, extreme fluctuations in blood pressure, rapid heart rate, loss of sense of smell, severe flushing, feeling hot on face and ears.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received via company representative from a registered nurse refers to herself. An drug reactions/allergies and pertinent medical history were not specified by reporter. In January 2013 (date unspecified) the patient nurse was vaccinated with ZOSTAVAX (dose, lot number were not provided), subcutaneously. In January 2013 the patient experienced shingles. On an unspecified date, approximately in January 2013, shortly after the vaccination the patient developed a rash. The rash consisted of 10 painful blisters that were located on an unspecified area of her leg. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Age: 1.37
Sex: F
Vaccine: HIBV, MMR
Symptoms: Erythema, Local swelling, Swelling face
Clinical narrative: Two days post MMR/HIB titer vaccinations, patient developed redness and swelling of cheeks and upper neck. Afebrile. No change in appetite. Normal activity.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: I was busy forget to check the expired dated of vaccine I gave patient. No system report. No treatment. No adverse events.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Face oedema, Ocular hyperaemia, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pt was given 1st HPV, 1st Hep A, and 2nd MENACTRA this morning at 11:15 today. Pt came back to office at 1500 today with hives. Facial edema, fever, red eyes, and itching. Pt took 2 BENADRYL prior to arrival. Pt was placed in room and doctor advised and went in to see pt and continues to monitor.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccine on Friday (5/31/13) and returned on Monday to report that his arm at injection site was swollen and red. Doctor recommended an office visit only if symptoms worsen. Upon follow-up, patient symptoms were resolving (6/4).
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Hypoaesthesia
Clinical narrative: Dizziness - weakness - numbness 5th digit at home for about 10 - 15 mins. Patient treated with Epinephrine SQ.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Snoring, Sudden onset of sleep
Clinical narrative: Dizziness - weakness - numbness 5th digit at home for about 10 - 15 mins. Patient treated with Epinephrine SQ.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Computerised tomogram head normal, Condition aggravated, Headache, Pyrexia
Clinical narrative: Worsening of a current headache, fever, vomiting, joint pain - ER visit 6/1/13 at midnight.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Worsening of a current headache, fever, vomiting, joint pain - ER visit 6/1/13 at midnight.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness / severe pain at injection site, swelling, hardened skin below.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 2 inch red circle at injection site "just appeared" - alarming to patient/wife.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Limb discomfort
Clinical narrative: Redness from top of arm to elbow, area hard per pt. Not visualized by writer. Used ice to area, redness better but does have discomfort with use.