chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored VAQTA (lot # K011304 and expiry date: 28-APR-2017: Lot# L000718 and expiry date: 28-APR-2017; lot# K023019 and expiry date: 28-APR-2017) that was not supported. No adverse effects were reported. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose and route were not reported), lot # K007825, expiration date 03-JAN-2016 and lot # K020214, expiration date 25-MAR-2016. Total number of doses administered was 29. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse and refers to a patient of unknown age and gender. On 02-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse and refers to a patient of unknown age and gender. On 03-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion in 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Chills, Dizziness, Erythema, Local swelling
Clinical narrative: Pt developed redness and swelling localized. Pt also developed dizziness, achy feeling and chills less than 24 hrs after vaccine. Temp 99.9 in office.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pain
Clinical narrative: Pt developed redness and swelling localized. Pt also developed dizziness, achy feeling and chills less than 24 hrs after vaccine. Temp 99.9 in office.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Dyspepsia
Clinical narrative: Severe diarrhea and heartburn every day since starting oral Typhoid vaccine. No change after one week after finishing all capsules. Took ZANTAC several days. Did not help.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swelling to site of injection (DTaP) 3" to 4" circ. (L) arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of improperly stored (Oka/Merck) VARIVAX (lot # K015971, exp. date: 23-SEP-2016, 3 doses: lot# K010339, exp. date: 22-JUL-2016, 1 dose, lot#L000454, exp. date: 06-JAN-2017, 6 doses) (strength and frequency were not reported) 0.5 ml, subcutaneously. No adverse event was reported. The outcome of patient's event was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Myalgia
Clinical narrative: Fatigue, muscle and joint pain chills, temperature going on 6 days. I went back to cwork today appears to be reaction.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 14 year old patient of unknown gendfer. No concurrent condition and medical history was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry date: 14-JAN-2017, intramuscularl in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: VARIVAX administered on (R) leg on 5/12/15. On 5/16/15 a localized erythematous reaction began which was: 4 cm of erythema with (x5) discrete vesicles near original site on 5/21/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 08-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (also reported as PEDVAXHIB) (dose and route were not reported), lot # J009714, expiration date 20-MAY-2016. Total number of doses administered was 6. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered  nurse and refers to a patient of unknown age and gender. On 09-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several; reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at injection site of (L) deltoid and biceps leading to warmth and erythema.
Age: 74.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Cellulitis, Discomfort, Electrocardiogram abnormal, Erythema
Clinical narrative: Swelling and redness at injection site of (L) deltoid and biceps leading to warmth and erythema.
Age: 74.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Investigation, Myalgia, Sinus bradycardia, Swelling
Clinical narrative: Swelling and redness at injection site of (L) deltoid and biceps leading to warmth and erythema.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. On 11-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) that had been improperly stored. On 13-MAY-2015, another unspecified patient received a dose of VARIVAX (Merck) which had been improperly stored too. Dosing, routes of administration, lot numbers were not provided. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 14 year old patient of unknown gender. No concurrent condition and medical history was reported. On 12-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot # K006117, expiry date: 14-JAN-2017, intramuscularly in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 58 year old male patient of with Crohn's disease, irritable bowel syndrome and abnormal blood pressure. Concomitant medications included unspecified blood pressure medications. The patient had no drug reactions nor allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route of administration not reported). On an unknown date, the patient experienced shingles. The pharmacist reported that the patient had pain and itchiness in an unspecified location of the body. The patient sought medical attention (he saw a doctor). No lab diagnostics studies were performed. The patient was treated with VALTREX. The outcome of herpes zoster was reported as recovered (on an unknown date). The relatedness between shingles and ZOSTAVAX was not reported. Varicella Zoster Virus Identification Program packet was declined. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to 2 patients of unknown demographics. The concurrent condition and medical history were not reported. On an unknown date the patients were vaccinated with GARDASIL dose 1m intramuscular. The concomitant medications were not reported. On an unknown date, the patients were vaccinated with the second dose of GARDASIL just 20 days after the first dose. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. The concurrent condition, medical history and concomitant medications was not reported. On 27-MAY-2015, the patient was vaccinated with tone dose of VARIVAX (Merck). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody increased, Keratoconus, Myalgia
Clinical narrative: This spontaneous report as received from the patient's mother concerning her daughter of unknown age. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, strength, frequency, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, after receiving GARDASIL the patient experienced muscle pain and ache, elevated keratoconus (KC) levels and antinuclear antibody (ANA) levels. The outcome of the events was not reported. The reporter did not confirm if the patient would discontinued the product. No product quality complain was reported. Additional information is not expected there is no contact details.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling cold, Feeling hot, Rash
Clinical narrative: About 5 minutes after patient received Tdap she became hot and started seeing purple spots. She then became cold and shivered.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abasia, Injection site swelling, Posture abnormal, Pyrexia, Screaming
Clinical narrative: Swelling at the site of the shot. Hard to wake up. Unable to walk for two days. Fever of 104. Suddenly scared of water and screamed every time it touched her skin. Held her hands suspended in the air. I called health dept. was told it was normal.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Somnolence
Clinical narrative: Swelling at the site of the shot. Hard to wake up. Unable to walk for two days. Fever of 104. Suddenly scared of water and screamed every time it touched her skin. Held her hands suspended in the air. I called health dept. was told it was normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had some erythema and warmth distal to injection site on (R) leg. Occurred several minutes after injection. Gave BENADRYL with quick resolution.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Started with soreness at site of injection. Redness and swelling spread down the arm beginning on Saturday. By Monday, redness and swelling directly above elbow area. Very painful Friday and Saturday.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: Frequent loose stools since getting ROTATEQ.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot #, expiry date, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 27-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # J004161, expiration date 05-APR-2015), after the expiration date. Concomitant medication was not provided. No adverse events were reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026384, expiry date 15-DEC-2016, dose and route of administration not reported). No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) in question could not be evaluated at the time of reporting as the healthcare worker did not know how long the product was stored outside of the proper storage temperature range. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 14-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). Concomitant medication was not reported. No symptoms were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Dtap site on left thigh. Left thigh erythema 10cm x 9cm itchy mildly tender no induration. Per mom she may have had a similar reaction from her earlier infant vaccines but not like this big.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes ophthalmic
Clinical narrative: This spontaneous report as received from a consumer refers to herself/himself, an adult patient of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. In approximately 2013, reported as "2 years ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided) in a pharmacy. Concomitant therapy was not reported. On an unknown date in 2015, reported as "now", the patient experienced shingles of the eye, around the eye and in the eye, so the patient would like to receive part reimbursement. The outcome of the herpes ophthalmic was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Serology abnormal, Unevaluable event
Clinical narrative: Information has been received from a published literature article. Over 16,000 patients were listed for liver transplantation (LT). The medical evaluation prior to listing for LT was rigorous and included screening for potentially preventable infections like viral hepatitis and Pneumococcus. Super-infection of hepatitis A (HAV) or hepatitis B virus (HBV) in patients with cirrhosis can lead to decompensated liver failure and increased mortality. A study of LT candidates showed that almost three quarters met criteria for needing HBV vaccination, but screening and vaccination rates were unknown. This study aims to determine the frequency of HAV, HBV and pneumococcal screening and vaccination at a high volume LT center. There were 297 patients on the LT list in July 2014. The cohort was 63% male with median age 60 years and 49% having hepatitis C cirrhosis. The median listed MELD (Model For End-Stage Liver Disease) was 17 and 39% had hepatocellular carcinoma. Overall, there was nearly universal HAV and HBV serologic testing (97% and 98%, respectively). Of 70 HAV non-immune candidates, 7 (10%) received HAV vaccination with 2 having confirmation of successful vaccination. Pneumococcal vaccine was more frequent with 63/297 (21%) having a documented vaccination. There was no association between age, gender, listed MELD, and etiology of liver disease on the likelihood of receiving any vaccine. This is one of 2 reports received from the same literature (other case # 1506USA000178). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Hepatitis B surface antigen positive, Serology test
Clinical narrative: Information has been received from a published literature article. Over 16,000 patients were listed for liver transplantation (LT). The medical evaluation prior to listing for LT was rigorous and included screening for potentially preventable infections like viral hepatitis and Pneumococcus. Super-infection of hepatitis A (HAV) or hepatitis B virus (HBV) in patients with cirrhosis can lead to decompensated liver failure and increased mortality. A study of LT candidates showed that almost three quarters met criteria for needing HBV vaccination, but screening and vaccination rates were unknown. This study aims to determine the frequency of HAV, HBV and pneumococcal screening and vaccination at a high volume LT center. There were 297 patients on the LT list in July 2014. The cohort was 63% male with median age 60 years and 49% having hepatitis C cirrhosis. The median listed MELD (Model For End-Stage Liver Disease) was 17 and 39% had hepatocellular carcinoma. Overall, there was nearly universal HAV and HBV serologic testing (97% and 98%, respectively). Hepatitis B surface antibody (HBsAb) was positive in 36% and 127 (43%) had either positive hepatitis B surface antigen (HBsAg) or isolated core antibody. There were 123 HBsAb negative candidates without chronic HBV qualifying them for HBV vaccination. Only 23/123 (19%), candidates received HBV vaccination. Of 14 patients with repeat post-vaccination HBV serologies, 9 (64%) achieved seroconversion. Pneumococcal vaccine was more frequent with 63/297 (21%) having a documented vaccination. There was no association between age, gender, listed MELD, and etiology of liver disease on the likelihood of receiving any vaccine. This is one of 2 reports received from the same literature (other case # 1505USA015709). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. There was no information about pertinent medical history or drug reaction. On 20-MAY-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot # K021953, expiration date 10-FEB-2016) subcutaneously in the left deltoid region. No concomitant medication was reported. On 21-MAY-2015 the patient experienced swelling and tenderness at her injection site with the size of a golf-ball. The patient reported that the injection site was sore when she rubbed her hand over it. The pharmacist stated that she did not see any evidence of a rash, nor was the patient experiencing a fever or headache. The patient had not notified her nurse practitioner. The pharmacist stated that the patient was otherwise fine. No treatment was given to the patient. At the time of reporting, the patient was not recovered from the events. This is one of two reports received from the same reporter (1505USA015283). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to an approximately 73 years old female patient. The patient had no medical history or drug reactions/allergies. Approximately in March 2015 (reported as "2 months ago") the patient was vaccinated with a dose of ZOSTAVAX (lot # K008886, expire date 20-SEP-2015, dose, frequency were not reported). Concomitant therapy included NORCO. In 2015 the patient had experienced "redness" at the injection site since an unspecified date following the administration. The patient sought medical attention via pharmacy call. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. No lab diagnostics studies were performed. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, an unspecified number of patients were vaccinated with an improperly stored doses of VARIVAX , (dose, route, lot number and indication were not reported); no adverse events and concomitant therapies of the patients were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 1.02
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown gender of currently 1 year old. Concurrent conditions and pertinent medical history were not reported. On 20-MAY-2015, the patient was vaccinated with PROQUAD (Lot # K025764, expiration date 08-JUN-2016), injection (route, strength and dose were not provided) and a dose of VARIVAX (Merck) (Lot # L001325, expiration date on 13-JAN-2017), injection (route, strength and dose were not provided), simultaneously on the same date. The patient did not demonstrate any adverse effects. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site discomfort, Muscle spasms, Vaccination site reaction
Clinical narrative: This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on 27th May 2015. The subject received BOOSTRIX at week 19 of the pregnancy and during the second trimester of pregnancy. On 27th May 2015, 1 hr after receiving BOOSTRIX, the subject developed injection site discomfort (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of injection site discomfort was not recovered/not resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the injection site discomfort to be almost certainly related to BOOSTRIX. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to BOOSTRIX. Additional information received: One hour after administration of vaccine, the patient started to have spasm in arm where the vaccine was administered. The patient did not the estimated delivery date.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site reaction, Injection site swelling, Muscle tightness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 31-year-old male patient who received BOOSTRIX. On 27th May 2015 10:00, the patient received BOOSTRIX (injection) .5 ml. On 27th May 2015 18:00, 8 hrs after receiving BOOSTRIX, the patient experienced injection site swelling, injection site muscle reaction and chills. On an unknown date, the outcome of the injection site swelling, injection site muscle reaction and chills were unknown. The reporter considered the injection site swelling, injection site muscle reaction and chills to be related to BOOSTRIX. Additional information received: The subject experienced severe swelling, chills and muscle tightness. Most of the reactions were at the injection site. The pharmacist reported she adviced to take anti-inflammatory medication, use ice pack and referred to Emergency Room is condition worsened.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 17-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1 , lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician via a field representative referring to two or three patients of unknown ages and gender. On unknown dates the patients were vaccinated with GARDASIL (strength, lot#, dose in the series and dosage unspecified). On an unknown dates after receiving the vaccines, all the patients experienced dizziness. The patient sought medical attention via office visit, but no treatment was given for the event. The outcome of dizziness was unknown. Causality was not provided. Additional information is not expected because the reporting physician did not want to be contacted.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Abdominal pain, Activities of daily living impaired, Gastric emptying study, Impaired gastric emptying, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with abdominal pain from chronic constipation and no medical history reported, was vaccinated on 02-NOV-2011 with first dose of GARDASIL, (lot # reported as 1140AA) I.M, in the left arm. Secondary suspect vaccine given on the same date included second dose of VARIVAX (Merck), (lot # reported as 0823AA), given subcutaneously, in the right arm. Concomitant vaccine given on the same date included first dose of BOOSTRIX, (lot no. AC52B074AA), I.M, in the left arm, FLUZONE (lot no. UH478AC), I.M, in the left arm and HAVRIX, (lot no. AHAVB533CA), given I.M, in the right arm. The reporter could not remember all vaccines patient received that day, but the patient was not on any medications that day. On 03-NOV-2011, the patient experienced nausea, abdominal pain, vomiting for several weeks. Patient had missed 6 weeks of normal activity due to (d/t) this illness. Patient was hospitalized for 7 days and was now diagnosed with Gastroparesis. It was thought the patient caught a virus but realized after several days that something else was wrong, and also realized, after a couple of weeks of patient being ill, that the symptoms started the day after the vaccine. Laboratory tests performed included gastric emptying study, laboratories, x-rays and upper gastrointestinal (GI) (results not provided). The patient was on ZOFRAN, NEXIUM and azithromycin. Patient had BOTOX injections into pyloric sphincter during scope. The outcome of events was not reported. The original reporting source was not provided. The VAERS ID # is 445813. This report was considered serious, ER/doctor visit and hospitalization required by the agency. Follow up information has been received on 21-MAY-2015. Information received in the form of a literature article. Information has been received from the authors of the article. The literature article describes about twenty-one individual case reports describing gastrointestinal motility disorders using the WHO ART preferred terms of "gastric dilatation" and "bowel motility disorder" in association with HPV vaccines which were identified in the Safety Report, and were assessed as constituting a potential signal. Of these case reports, 17 were identified for the GARDASIL, and 4 case reports were identified for the CERVARIX. All cases were female with ages ranging from 11 to 26 years (age unknown in 2 reports). This is one of several reports received from the same source. Additional information has been requested. Report type, reporter details, product information, event information and narrative were updated.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Nausea, Vomiting, X-ray gastrointestinal tract
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with abdominal pain from chronic constipation and no medical history reported, was vaccinated on 02-NOV-2011 with first dose of GARDASIL, (lot # reported as 1140AA) I.M, in the left arm. Secondary suspect vaccine given on the same date included second dose of VARIVAX (Merck), (lot # reported as 0823AA), given subcutaneously, in the right arm. Concomitant vaccine given on the same date included first dose of BOOSTRIX, (lot no. AC52B074AA), I.M, in the left arm, FLUZONE (lot no. UH478AC), I.M, in the left arm and HAVRIX, (lot no. AHAVB533CA), given I.M, in the right arm. The reporter could not remember all vaccines patient received that day, but the patient was not on any medications that day. On 03-NOV-2011, the patient experienced nausea, abdominal pain, vomiting for several weeks. Patient had missed 6 weeks of normal activity due to (d/t) this illness. Patient was hospitalized for 7 days and was now diagnosed with Gastroparesis. It was thought the patient caught a virus but realized after several days that something else was wrong, and also realized, after a couple of weeks of patient being ill, that the symptoms started the day after the vaccine. Laboratory tests performed included gastric emptying study, laboratories, x-rays and upper gastrointestinal (GI) (results not provided). The patient was on ZOFRAN, NEXIUM and azithromycin. Patient had BOTOX injections into pyloric sphincter during scope. The outcome of events was not reported. The original reporting source was not provided. The VAERS ID # is 445813. This report was considered serious, ER/doctor visit and hospitalization required by the agency. Follow up information has been received on 21-MAY-2015. Information received in the form of a literature article. Information has been received from the authors of the article. The literature article describes about twenty-one individual case reports describing gastrointestinal motility disorders using the WHO ART preferred terms of "gastric dilatation" and "bowel motility disorder" in association with HPV vaccines which were identified in the Safety Report, and were assessed as constituting a potential signal. Of these case reports, 17 were identified for the GARDASIL, and 4 case reports were identified for the CERVARIX. All cases were female with ages ranging from 11 to 26 years (age unknown in 2 reports). This is one of several reports received from the same source. Additional information has been requested. Report type, reporter details, product information, event information and narrative were updated.
Age: 61.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Abasia, Hypoaesthesia
Clinical narrative: Beginning with aching in knees. Upon returning home, noticed that shoulders and hands were aching also. Next morning couldn't barely walk. Notified Pharmacist, she suggested that I report to my P. A. for treatment or referral to emergency room.
Age: 61.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Gait disturbance, Musculoskeletal pain, Pain in extremity
Clinical narrative: Beginning with aching in knees. Upon returning home, noticed that shoulders and hands were aching also. Next morning couldn't barely walk. Notified Pharmacist, she suggested that I report to my P. A. for treatment or referral to emergency room.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Allergy test, Anaphylactic reaction, Cough, Rash, Skin discomfort
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient with deaf in both ears since his birth. The patient had no drug reactions and allergies. On 12-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, subcutaneous). There was no concomitant medication. On 12-JAN-2015, after receiving the PROQUAD (Merck), the patient had an anaphylaxis reaction on his way home. The nurse reported that the patient was immediately sent to emergency room and was administered epinephrine and BENADRYL. There was no lab diagnostics studies performed. The patient recovered after receiving the epinephrine and BENADRYL on 12-JAN-2015. The patient was not admitted to the hospital. The reporter considered the anaphylaxis reaction was life threatening. Upon internal review, anaphylaxis reaction treated with epinephrine was determined to be medical significant event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient with deaf in both ears since his birth. The patient had no drug reactions and allergies. On 12-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, subcutaneous). There was no concomitant medication. On 12-JAN-2015, after receiving the PROQUAD (Merck), the patient had an anaphylaxis reaction on his way home. The nurse reported that the patient was immediately sent to emergency room and was administered epinephrine and BENADRYL. There was no lab diagnostics studies performed. The patient recovered after receiving the epinephrine and BENADRYL on 12-JAN-2015. The patient was not admitted to the hospital. The reporter considered the anaphylaxis reaction was life threatening. Upon internal review, anaphylaxis reaction treated with epinephrine was determined to be medical significant event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Rash generalised
Clinical narrative: Patient received PNEUMOVAX 23 from pharmacy on 5/20/2015. Rash around injection site as well as whole body rash. Site also with edema-pt warmth. Develop shortness of breath, diffuse maculopapular rash, periorbital edema. Pharmacy has lot# for PNEUMOVAX- they refuse to report.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site oedema, Injection site rash, Injection site warmth, Periorbital oedema
Clinical narrative: Patient received PNEUMOVAX 23 from pharmacy on 5/20/2015. Rash around injection site as well as whole body rash. Site also with edema-pt warmth. Develop shortness of breath, diffuse maculopapular rash, periorbital edema. Pharmacy has lot# for PNEUMOVAX- they refuse to report.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Patient received PNEUMOVAX 23 from pharmacy on 5/20/2015. Rash around injection site as well as whole body rash. Site also with edema-pt warmth. Develop shortness of breath, diffuse maculopapular rash, periorbital edema. Pharmacy has lot# for PNEUMOVAX- they refuse to report.
Age: 0.5
Sex: F
Vaccine: DTPHIB, HEP, IPV, PPV, RVX
Symptoms: Vomiting
Clinical narrative: Around 2 PM, baby began vomiting continuously for one hour (including bile). Vomiting slowed and then ceased after about 6 PM. No fever or other symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Liver function test abnormal, Myalgia, Pain
Clinical narrative: Fever, chills body/muscles aches, sweats, shakes, red/purple rash discoloration on both legs.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash erythematous, Skin discolouration, Tremor, White blood cell count increased
Clinical narrative: Fever, chills body/muscles aches, sweats, shakes, red/purple rash discoloration on both legs.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Seizure, Urinary incontinence
Clinical narrative: HPV 9 given 10 mins later, LOC, urine incontinence, and convulsion x 10-20 seconds. Patient came to, brought to exam room, A and O X3, given juice. Evaluated by MD BP 103/68, CV normal. Laid down x 15+ minutes, able to leave department- ambulatory on own.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngeal oedema, Pruritus
Clinical narrative: Received varicella vaccine at 2:30 p.m. Denied problems with previous vaccine-went to E.R. at 3:40 p.m. C/O itching and swelling of throat-treated with epinephrine and DECADRON and discharged at 8:30 p.m.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult hepatitis A administered instead of pediatric hepatitis A because patient 18 yrs old.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal discomfort, Listless, Pallor, Screaming, Tachycardia
Clinical narrative: Baby received vaccines 11a-PREVNAR, PENTACEL, Rotavirus at routine WCE. At approx 4 pm, mom who is also a physician noted baby was gray, pale and listless and belly seemed tense. She was brought to office and baby was pale, listless, screamed when not held for approximately 1hr and then improved, transported to hospital for observation with full recovery.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient presented to office on 05/19/15 with complaints of right arm pain, tenderness, swelling and erythema at injection site of right deltoid, post-PREVNAR 13 vaccine administered on 5/11/15. Advised to apply cool compress and to return to office should condition not resolve itself.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Grunting, Hypotonia, Loss of consciousness, Respiratory arrest
Clinical narrative: Pt was receiving immunizations at outreach clinic.  Pt was seated on exam table, and first received Menactra IM Left deltoid, then received Gardasil IM Right deltoid.  Pt went limp and lost consciousness.  Nurse was able to lay her back on exam table.  Pt. began to have a seizure: grunting, pulling legs, and moving head back and forth.  Pt. stopped breathing for a period of time.  Nurse and pt's mother stayed at her side ensuring safety.  911 was called to respond.  Pt came of out seizure and regained consciousness on her own.  Was oriented to person and place.  EMS arrived and evaluated patient, vitals and blood sugar were stable.  Patient refused transport, but was taken to Hospital by her mother.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Seizure
Clinical narrative: Pt was receiving immunizations at outreach clinic.  Pt was seated on exam table, and first received Menactra IM Left deltoid, then received Gardasil IM Right deltoid.  Pt went limp and lost consciousness.  Nurse was able to lay her back on exam table.  Pt. began to have a seizure: grunting, pulling legs, and moving head back and forth.  Pt. stopped breathing for a period of time.  Nurse and pt's mother stayed at her side ensuring safety.  911 was called to respond.  Pt came of out seizure and regained consciousness on her own.  Was oriented to person and place.  EMS arrived and evaluated patient, vitals and blood sugar were stable.  Patient refused transport, but was taken to Hospital by her mother.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Rash on right flank and abdomen, painful, dxed with shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash on right flank and abdomen, painful, dxed with shingles.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Abnormal behaviour, Aplastic anaemia, Asthenia, Cardiac function test normal, Chest pain
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.