chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, male patient with no pertinent medical history reported. On 14-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 16-APR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 11 years old, male patient with no pertinent medical history reported. On 24-OCT-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant therapies included Hepatitis A vaccine (manufacturer unknown) administered on 24-OCT-2012 (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature 26 F (Fahrenheit) for a total of 135 hours. No adverse effect reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow-up information has been received from the medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 03-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medication MENACTRA administered on 03-SEP-2012 (intramuscular in the right arm, dose not reported). On 06-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-APR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). This is one of the several reports from the same source. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 17 years old, male patient with no pertinent medical history reported. On 11-JAN-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 15-MAR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature 26 F(Fahrenheit)for a total of 135 hours. No adverse effect reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 15-MAR-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On an unknown date the patient received another dose of GARDASIL (lot number and expiration date not reported) (route and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 28-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site rash, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a Registered pharmacist refers to a 67 year old female patient with glaucoma and with no drug allergies/drug reactions. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65) (lot # H021459, expiration date 30-APR-2014) subcutaneous in the left triceps to prevent shingles. Concomitant therapies included COSOPT and BONIVA. On 07-MAY-2013, the patient experienced nausea. The patient also experienced a hard knot, redness "a little bigger than a half dollar", soreness, "a little bit of a tingling effect", "itched somewhat", swelling and a slight rash at the injection site, which worsened on 08-MAY-2013. The patient did not seek medical attention. The treatment was BENADRYL on an unspecified date. At the time of the report the patient was recovering. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a Registered pharmacist refers to a 67 year old female patient with glaucoma and with no drug allergies/drug reactions. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65) (lot # H021459, expiration date 30-APR-2014) subcutaneous in the left triceps to prevent shingles. Concomitant therapies included COSOPT and BONIVA. On 07-MAY-2013, the patient experienced nausea. The patient also experienced a hard knot, redness "a little bigger than a half dollar", soreness, "a little bit of a tingling effect", "itched somewhat", swelling and a slight rash at the injection site, which worsened on 08-MAY-2013. The patient did not seek medical attention. The treatment was BENADRYL on an unspecified date. At the time of the report the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route an dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received PEDBAXHIB. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 04-SEP-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant therapies include MENACTRA (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 05-FEB-2013 the patient was vaccinated with a dose of VARIVAX, 0.5 ml (therapy route and lot # was not reported). The patient was given VARIVAX instead of ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 18 years old, male patient with no pertinent medical history reported. On 04-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 11-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender patient with no pertinent medical history reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Feeling abnormal, Feeling cold, Gait disturbance
Clinical narrative: This spontaneous report as received from a 37 year old smoking female patient with asthma and unspecified allergy to latex refers to herself. On 17-MAY-2013 the patient was vaccinated with "one shot" of PNEUMOVAX23 0.5 ml, batch number reported H022064 valid number 0291AE expiration date 25-JAN-2014 dose and route not reported. The patient reported that she was prescribed PNEUMOVAX23 because of her asthma. Concomitant therapies included SINGULAIR (formulation not provided), albuterol, FLOVENT and unspecified hydrocodones, all of which she has taken for 10 or more years. The consumer called to find out what vaccine she had received during the call she paused to call her doctor and verified the vaccine as PNEUMOVAX 23. During the call the consumer started that PNEUMOVAX23 out her on her death bed, the vaccine was not safe. The caller used some profanity and became so distraught that she cried. Afterwards she calmed down and apologize for losing her temper. On 18-MAY-2013, the following day after onset of therapy the patient experienced an adverse reaction that includes feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up to the point that (she was) barely able to walk', coughing so severe that it felt like her 'brain busted out on her head'. wheezing, being unable to breathe and she feared she will die. The patient reported that she has never been sick like this before had any kind of serious reaction to any vaccine before. The patient had screening x-rays for pneumonia performed on 23-MAY-2013 but results were not provided. The patient sought unspecified medical attention and was given a treatment which included penicillin, ZITHROMAX and unspecified steroids. The outcomes of feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up the point that (she was) barely able to walk', coughing so severe that it felt like 'her brain busted out of her head', wheezing, being unable to breather and she feared she will dead adverse events were reported as not recovered/not resolved, and the outcomes of crying and abnormal behaviour were recovering/resolving. The patient claimed that she was 'getting worse.' The reporter considered feeling like she was 'on her death bed'/PNEUMOVAX23 put her on her death bed adverse events to be related to PNEUMOVAX23. The patient also reported that an unspecified neighbor died from PNEUMOVAX23. (MARRS # 1305USA015672) This is one of several reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Muscle tightness, Pallor, Wheezing, X-ray
Clinical narrative: This spontaneous report as received from a 37 year old smoking female patient with asthma and unspecified allergy to latex refers to herself. On 17-MAY-2013 the patient was vaccinated with "one shot" of PNEUMOVAX23 0.5 ml, batch number reported H022064 valid number 0291AE expiration date 25-JAN-2014 dose and route not reported. The patient reported that she was prescribed PNEUMOVAX23 because of her asthma. Concomitant therapies included SINGULAIR (formulation not provided), albuterol, FLOVENT and unspecified hydrocodones, all of which she has taken for 10 or more years. The consumer called to find out what vaccine she had received during the call she paused to call her doctor and verified the vaccine as PNEUMOVAX 23. During the call the consumer started that PNEUMOVAX23 out her on her death bed, the vaccine was not safe. The caller used some profanity and became so distraught that she cried. Afterwards she calmed down and apologize for losing her temper. On 18-MAY-2013, the following day after onset of therapy the patient experienced an adverse reaction that includes feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up to the point that (she was) barely able to walk', coughing so severe that it felt like her 'brain busted out on her head'. wheezing, being unable to breathe and she feared she will die. The patient reported that she has never been sick like this before had any kind of serious reaction to any vaccine before. The patient had screening x-rays for pneumonia performed on 23-MAY-2013 but results were not provided. The patient sought unspecified medical attention and was given a treatment which included penicillin, ZITHROMAX and unspecified steroids. The outcomes of feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up the point that (she was) barely able to walk', coughing so severe that it felt like 'her brain busted out of her head', wheezing, being unable to breather and she feared she will dead adverse events were reported as not recovered/not resolved, and the outcomes of crying and abnormal behaviour were recovering/resolving. The patient claimed that she was 'getting worse.' The reporter considered feeling like she was 'on her death bed'/PNEUMOVAX23 put her on her death bed adverse events to be related to PNEUMOVAX23. The patient also reported that an unspecified neighbor died from PNEUMOVAX23. (MARRS # 1305USA015672) This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness near injection site, advised to go to ER where I received IV antibiotic. Went to ER again next day and saw my private physician three times. Was on antibiotics for 10 days.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Presyncope
Clinical narrative: Patient appeared to have a vasovagal response to vaccine administratoin. She almost immediately passed out after her HPV#1 immunization, which was administered after Hep A#1.
Sex: U
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: Rec'd PCV and DTaP on 5/22/2013 with subsequent redness and induration at both vaccine sites.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were possibly vaccinated with doses of an improperly stored ZOSTAVAX (lot number and expiry date reported as J000445 and 11-APR-2014 respectively, dose and route unspecified) that were exposed to -0.3 degree Celsius for 13 days. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 12 years old, female patient with no pertinent medical history reported. On 15-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 19-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Diarrhoea, Hallucination, Headache, Pyrexia, Vomiting
Clinical narrative: Mom thinks headaches started right after HPV (2). Mom reported on 5-29-13 possible severe reaction right after HPV (3) 4-23-13. Went to ER for low grade fever, V and D, hallucinations.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: This healthy 12 month old female received routine immunizations on 5/13/2013 - first hepatitis A lot # AHAVB690CA (SK) to right thigh and MMRV combo lot # (? H011233 Merck) to left thigh. That evening mom reported seeing 2 small red slightly raised hives "like a bug bite" to child's right forearm. These hives lasted about 20 minutes and resolved. However over the next 3-4 days 1-2 hives would return 2-4 times a day to one extremity (either left or right arms/legs) and would be gone within 20 minutes. No hives were seen on the torso. Mom denied child had any fever, crying, shortness of breath, wheezing, or any systemic symptoms. Child was very active, playful with bright eyes and eating, behaving normally. These hives did not appear to itch as child acted oblivious to them. Mom did not treat hives with any medication. 2 hives were present this morning to right arm prior to visit pediatrician; however they had resolved prior to MD arrival. Child is currently hive free.
Age: 59.0
Sex: F
Vaccine: TYP
Symptoms: Hyperhidrosis
Clinical narrative: Increased perspiration after 2nd dose.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood folate normal, Blood iron normal, Blood magnesium normal, Exercise tolerance decreased, Injection site erythema
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Iron binding capacity total normal, Pain in extremity
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vitamin B12 normal
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blindness, Blood folate normal, Blood magnesium normal, Blood test normal
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Exercise tolerance decreased, Fatigue, Headache, Injection site erythema
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site hypersensitivity, Injection site infection, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Iron binding capacity total normal, Iron binding capacity unsaturated, Nausea, Pain in extremity
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Restless legs syndrome, Retching, Vitamin B12 normal
Clinical narrative: 4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Erythema, Hyperhidrosis
Clinical narrative: Received ZOSTAVAX - within 1 hr developed red face and hands, SOB, diaphoresis, itchiness (hands and forearms); took 50mg BENADRYL in 2 divided doses. F/U with ER: discharged with ZANTAC (x 3 days), Prednisone (x 2 days) and BENADRYL Q4 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Received ZOSTAVAX - within 1 hr developed red face and hands, SOB, diaphoresis, itchiness (hands and forearms); took 50mg BENADRYL in 2 divided doses. F/U with ER: discharged with ZANTAC (x 3 days), Prednisone (x 2 days) and BENADRYL Q4 hours.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever for 3 days, rash, vomiting.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Myalgia, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Day of immunization 5/22/13 (L) arm red, itchy and painful. Muscle aches and neck pain. WO fever. 5/30/13 lump (L) arm 20mm and redness 40mm.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Upper extremity mass
Clinical narrative: Day of immunization 5/22/13 (L) arm red, itchy and painful. Muscle aches and neck pain. WO fever. 5/30/13 lump (L) arm 20mm and redness 40mm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt called to say injection site was red, itchy and slightly painful. Pt is taking BENADRYL and will contact PCP.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling, Wheezing
Clinical narrative: Swollen, red, hot to the touch, wheeze.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and hot 2 1/2" in diameter.
Age: 1.73
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Firm erythematous circ. area 2 in x 1 inch to (L) thigh at vaccination site. No fever. Placed on KEFLEX (250/5) 4.2 ml po TID x 10 days.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Dysphonia
Clinical narrative: Hoarseness the day after vaccination for a couple of days.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, male patient with no pertinent medical history reported. On 26-SEP-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hepatitis A Vaccine (manufacturer unknown) intramuscular in the left arm, dose not reported) and MENACTRA (intramuscular on the left arm, dose not reported) both administered on 26-SEP-2012. On 29-NOV-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 24-OCT-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (dose and route not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) administered on 24-OCT-2012 (dose and route not reported). On 08-JAN-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, female patient with no pertinent medical history reported. On 04-DEC-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age, male patient with no pertinent medical history reported. On 24-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). On 28-DEC-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). It was reported that the patient did not seek medical attention. It was also reported that the patient did not have any illness at the time of vaccination. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.71
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Chest X-ray, Choking, Haemoglobin normal, Loss of consciousness
Clinical narrative: On 5-29-13 at 9:30 pm mom reports pt appeared to be choking and spit-up clear liquid about 1/2 cup and 5-10 minutes later threw up clear yellow liquid. It appeared to mom that baby had passed out, was pale but awake couldn't hold her own head up, "rolled eyes" per dad then after this baby was quiet with eyes open, no noises, nor crying. Lasted for about 3 minutes. When paramedics got to patients home child was reacting normal. Patient was transferred to medical ctr. Chest X-ray-normal rectal temp 101.1 at hospital. Pt discharge home same nt.
Age: 0.71
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Posture abnormal, Vomiting
Clinical narrative: On 5-29-13 at 9:30 pm mom reports pt appeared to be choking and spit-up clear liquid about 1/2 cup and 5-10 minutes later threw up clear yellow liquid. It appeared to mom that baby had passed out, was pale but awake couldn't hold her own head up, "rolled eyes" per dad then after this baby was quiet with eyes open, no noises, nor crying. Lasted for about 3 minutes. When paramedics got to patients home child was reacting normal. Patient was transferred to medical ctr. Chest X-ray-normal rectal temp 101.1 at hospital. Pt discharge home same nt.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD) and heart disease. The patient had no drug allergy. On 21-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # J000429, exp. date 10-APR-2014, 0.65 ml, once, subcutaneous in the backside of the upper left arm. Concomitant therapies included SPIRIVA, SINGULAIR, PRILOSEC and ADVAIR. On an unspecified date in May 2013, after receiving ZOSTAVAX on 21-MAY-2013, he experienced a golf ball size raised area where the shot was given. The patient came in to see the pharmacist on 23-MAY-2013 to report the adverse event. The pharmacist did not know when the "golf ball size raised area" first appeared. No treatment was given. No lab test was done. The outcome of golf ball size raised area where the shot was given was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Scar, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On August 2012 the patient was vaccinated with a dose of VARIVAX (merck) (dose number, route, concentration and lot number unknown). On AUG-2012 (reported as after receiving vaccine) the patient experienced scarring on buttocks from rash with lesions. The outcome of scarring on buttocks and rash with lesion was unknown. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old infant patient of an unknown gender. On 16-MAY-2013 the patient was vaccinated with the first dose ROTATEQ (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an 11 years old, female patient with no pertinent medical history reported. On 14-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 16-APR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse drug reaction, Arthralgia, Condition aggravated, Convulsion, Diplopia
Clinical narrative: Seizures, leg pain, head pressure, loss of sensation in legs, stroking migraines, MS-like symptoms, complete exhaustion, gastroparesis, weight loss, blurred/doubled vision, injury to vagus verve in swallow, bronchial branch w/ damage to same nerve in stomach, abnormal-complex migraines, vitamin D dropped to non-existent levels, return of Epstein-Barr virus,  recurring bouts of Guillain-Barre symptoms, severe body pain (muscles & joints), POTS, loss of sensation in finger tips, and many other symptoms. Treatment over five years by various doctors have caused reactions using typical medicine. Recently began change in diet, IV therapy weekly, which is helping.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus infection, Fatigue, Guillain-Barre syndrome, Headache, Impaired gastric emptying
Clinical narrative: Seizures, leg pain, head pressure, loss of sensation in legs, stroking migraines, MS-like symptoms, complete exhaustion, gastroparesis, weight loss, blurred/doubled vision, injury to vagus verve in swallow, bronchial branch w/ damage to same nerve in stomach, abnormal-complex migraines, vitamin D dropped to non-existent levels, return of Epstein-Barr virus,  recurring bouts of Guillain-Barre symptoms, severe body pain (muscles & joints), POTS, loss of sensation in finger tips, and many other symptoms. Treatment over five years by various doctors have caused reactions using typical medicine. Recently began change in diet, IV therapy weekly, which is helping.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Multiple sclerosis, Myalgia, Nerve injury, Pain
Clinical narrative: Seizures, leg pain, head pressure, loss of sensation in legs, stroking migraines, MS-like symptoms, complete exhaustion, gastroparesis, weight loss, blurred/doubled vision, injury to vagus verve in swallow, bronchial branch w/ damage to same nerve in stomach, abnormal-complex migraines, vitamin D dropped to non-existent levels, return of Epstein-Barr virus,  recurring bouts of Guillain-Barre symptoms, severe body pain (muscles & joints), POTS, loss of sensation in finger tips, and many other symptoms. Treatment over five years by various doctors have caused reactions using typical medicine. Recently began change in diet, IV therapy weekly, which is helping.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Postural orthostatic tachycardia syndrome, Sensory loss, Vision blurred, Vitamin D decreased
Clinical narrative: Seizures, leg pain, head pressure, loss of sensation in legs, stroking migraines, MS-like symptoms, complete exhaustion, gastroparesis, weight loss, blurred/doubled vision, injury to vagus verve in swallow, bronchial branch w/ damage to same nerve in stomach, abnormal-complex migraines, vitamin D dropped to non-existent levels, return of Epstein-Barr virus,  recurring bouts of Guillain-Barre symptoms, severe body pain (muscles & joints), POTS, loss of sensation in finger tips, and many other symptoms. Treatment over five years by various doctors have caused reactions using typical medicine. Recently began change in diet, IV therapy weekly, which is helping.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Seizures, leg pain, head pressure, loss of sensation in legs, stroking migraines, MS-like symptoms, complete exhaustion, gastroparesis, weight loss, blurred/doubled vision, injury to vagus verve in swallow, bronchial branch w/ damage to same nerve in stomach, abnormal-complex migraines, vitamin D dropped to non-existent levels, return of Epstein-Barr virus,  recurring bouts of Guillain-Barre symptoms, severe body pain (muscles & joints), POTS, loss of sensation in finger tips, and many other symptoms. Treatment over five years by various doctors have caused reactions using typical medicine. Recently began change in diet, IV therapy weekly, which is helping.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Activated partial thromboplastin time prolonged, Blood creatine increased, Blood creatine phosphokinase increased, Blood fibrinogen decreased, Blood product transfusion
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Body temperature increased, Cardioversion, Culture, Death, Disseminated intravascular coagulation
Clinical narrative: This case was received on 23 January 2012 via a third party query tool search on the VAERS database, under reference 443712. An 18-year-old male patient with allergy to PRIMAQUINE, and who was G6PD deficient had received the following vaccinations on 15 November 2011: ACAM2000 (lot number VV040003A), TYPHIM Vi, (lot number B1026), and BIOTHRAX, (lot number FAV294) and eight days later, on 23 November 2011 the patient was on a 5 mile run and passed out. His heart rate was greater than 180 beats/minute and he had a temperature of 102.9 degrees Fahrenheit. He was administered adenosine and underwent cardioversion with intravenous fluids (IVF), and was admitted to the ICU and placed on broad spectrum antibiotics. An unspecified culture was drawn without reported results. The patient experienced progressive rhabdomyolysis, disseminated intravascular coagulation (DIC), renal failure, pain, and encephalopathy. He was treated with "cryo", fresh frozen plasma (FFP), fluids, pressors and ultimately transferred to another facility. Laboratory data revealed leukocytosis, thrombocytosis, decreased fibrinogen and prolonged prothrombin-time/partial thromboplastin time (PT/PTT), elevated liver enzymes, increased creatine, increased creatine kinase, transient elevated troponin I (TNIs). The patient had no other active medications except for doxycycline taken prophylactically for malaria approximately 2 days prior to deployment. The patient died on unspecified date. Follow-up information was received 13 March 2012. According to the reporter, they had no report in their files indicating the patient expired, and they were unable to provide any additional information at the time of the report. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 23 May 2013. Eight days post vaccination, on 23 November 2011, the subject was diagnosed with non-specific myocarditis. On 27 November 2011, the Troponin I results (01.31) were abnormal. On 25 November 2011, ECG an Echocardiogram were abnormal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The event outcome was fatal (date of fatal outcome not reported). Documents held by sender: None.