chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with a dose of improperly stored M-M-R II, lot # L012482, expiry date 10-APR-2017 via subcutaneous and intramuscular routes (dose, strength, vaccination site unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M011117, expiry date 07-DEC-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX with lots # L046885, expiry date 23-NOV-2017 and lot # L035129 and expiry date 14-SEP-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored VAQTA (lot # M009377, expiration date on 17-JUN-2017/lot # M011839, expiration date on 13-SEP-2017). It was reported that the vaccine was exposed for 22 hours at 30.9 F degrees. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD albumin status of rHA (recombinant human albumin), lot # M007961 (expiration date 15-AUG-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was stored in 15.4F for 13 hours 30 minutes. There were no previous excursions. Temperature was back in range at the time of this report. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter's source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 50 year old female patient, which was a pharmacy technician at the reporter's pharmacy. The patient had no allergies, concurrent conditions or medical history reported. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018453 expiration date 28-AUG-2016), subcutaneously. Information about concomitant therapy was not provided. After vaccination, on the same date the patient stated that there was "a quarter sized red area" that was swollen and raised at the site (injection site erythema and injection site swelling). On 26-AUG-2016, had a "red and swollen area the size of the patient's palm at the injection site", also the patient mentioned some itching at the site of the injection (injection site pruritus). The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as recovering.  The relationship between the vaccine and the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This solicited report as received from the patient's mother refers to a female patient of unknown age enrolled in a Market Research. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #,  dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient began having problems (unspecified). The outcome of problems was unknown. The relatedness between the problems and GARDASIL was unknown. Additional information is not expected as the reporter is not willing to be contacted to discuss further.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 16-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-JUN-2006, the patient was subcutaneously vaccinated with the first 0.5 ml dose of VARIVAX and on 08-AUG-2016, the patient was subcutaneously vaccinated with the second 0.5 ml dose of VARIVAX. On 15-AUG-2016, the patient developed an area on her body that was itchy, red, swollen and sore but there were no bumps. The affected area was on an unspecified part of the patient's body. The medical attention was sought, the patient's father called the reporter. The reporter had not seen the patient regarding her symptoms. The outcomes of the events were reported as recovering/resolving. The causality between the events and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). No adverse effects were reported. RECOMBIVAX HB was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Thrombocytopenia
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to a female patient who was currently 21 years old. The pertinent medical history, current conditions and concomitant therapies were not reported. In February 1995, the patient was vaccinated with RECOMBIVAX HB lot # 612921/1152A (strength, doses, expiration date and administration route were not reported). On an unknown date, the patient experienced thrombocytopenia after receiving the RECOMBIVAX HB and was hospitalized at an unspecified hospital. The outcome of thrombocytopenia was unknown. The causality between the event and the RECOMBIVAX HB was not reported. Upon internal review thrombocytopenia was considered to be medically significant event. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. The reporter stated that, on 18-AUG-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB with lot # M017127, expiry date 15-SEP-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K021444 with an expiration date: 17-SEP-2016 and lot# M010671 with an expiration date: 02-JUN-2016 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53.8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. 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 refers to an unknown number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# L041204, expiration date: 20-OCT-2017, subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX with lots # M023379, expiry date 11-MAY-2018 or lot # M010482 and expiry date 01-MAR-2018 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L045117, expiration date: 06-OCT-2018 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to himself, a 60 year old male patient. Information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On 27-MAR-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously, lot # K020187 - expiration date: 27-JAN-2016 (strength, dosage schedule were not reported). On 25-JUN-2016, the patient experienced herpes zoster (reported as "shingles"). The patient was seen by his healthcare professional and was treated with acyclovir (manufacturer unknown) orally. No labs were performing.  On 11-JUN-2016, the patient recovered from the shingles. At the reporting time, he did not have lesions. The reporter did not assessed causality between the event and the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 33 years old patient of unknown gender. Pertinent medical history, drug reactions/allergies and information regarding concomitant medication were not reported. On an unknown date, the patient received by mistake ZOSTAVAX (route, strength, dosage schedule, lot # and expiration date were not reported) instead of VARIVAX. No adverse event was reported. Additional information is not expected as the reporter denied consent to contact the physician.
Age: 0.33
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 4 month old patient of unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 18-MAY-2016, the patient was inadvertently vaccinated with unspecified dose of VARIVAX (lot number L045954 with an expiration date of 17-NOV-2017 (strength, dose, route of administration and anatomical location were not provided) (Inappropriate schedule of drug administration). No adverse effects were reported. Concomitant medications were not provided. No product quality complaint (PQC) was involved. Follow up information has been received on 17-AUG-2016 for an unspecified reporter concerning a patient with no known drug allergies and no illness at the time of vaccination. The patient was vaccinated with the first dose of VARIVAX on 17-MAY-2016 at 11:00, subcutaneously, in the right thigh. Additional information has been requested. The reporter details, the patient details, product, event and narrative were update.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M010212, expiration date: 21-JAN-2019, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 0.4 degrees Celsius for 4 days 5 hours and 45 minutes and 9.2 degrees Celsius for 23 hours and 30 minutes, respectively. The temperature excursion was captured using data logger. No previous temperature excursions were reported. No adverse effects were reported. At the time of reporting, the temperature was back in range. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 28-JUL-2016, the patient was inadvertently vaccinated with an improperly dose of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017)(concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted. A product quality complaint (PQC) was not involved. This is one of several received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included shingles (herpes zoster), which was treated on 27-JUL-2016. The patient had no current conditions or concomitant therapies. On 25-AUG-2016, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, concentration, via, dose and frequency were not reported). On 26-AUG-2016, the patient experienced "rash across her chest, back, breast and scalp. No pain, just itchy" (rash pruritic). It was stated that the patient sought for medical attention by calling the pharmacy.  At the time of the report, the outcome of rash pruritic was unknown. The causality between ZOSTAVAX and rash pruritic was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: Information was received from a nurse practitioner referring to a 19 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 16-AUG-2016, the patient was administered an adult dose of RECOMBIVAX HB injection (lot # L035881, expired date 26-JUN-2017, the 2nd dose of 3 doses series, dose and route unknown) by the nurse practitioner (unapproved dose administered). No adverse effect was reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 3 month old male patient. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On 07-JUL-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L029615, expiration date: 15-MAY-2017, a dose of 2 ml, orally (dose number and frequency were unknown). The vaccine was exposed to an unknown temperature excursion during an unspecified period of time. At the time of reporting there was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L044529 and expiration date 09-FEB-2017, lot number M003486 and expiration date 27-MAR-2017, dose and route of administration were not reported). The temperature of the excursion was 23F with the time frame of 1 hour and 30 minutes. Those conditions were back in range. There was previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unknown dates (reported as "starting on or after 20-AUG-2016"), an unknown number of unspecified patients were vaccinated with doses of improperly stored PEDVAXHIB (dose and route unknown, lot # M014926 expiration date: 05-SEP-2017). The vaccines were stored at 31.5 Fahrenheit degree for 27.5 hours. There was no previous temperature excursion. The call was due to a "data logger". No adverse effect was reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a medical assistant referring to a 2 months old female patient. The patient's medical history included acid reflux. There were no drug reactions or allergies. The patient did not take concomitant medications. On 29-AUG-2016, the patient was vaccinated with a dose of ROTATEQ (strength, dose and frequency were unknown; lot number L039141 and expiration date 16-AUG-2017) orally. Right after administration, the patient had exorcist style throw up. At the time of the event, the patient was in the office and sought unspecified medical attention. No treatment was given for the event and no lab diagnostics studies were performed. The outcome of the event was unknown. The causal relationship between ROTATEQ was not provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's medical history, concurrent conditions and drug reactions/allergies were reported as unknown. On 05-AUG-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (Concentration, lot#, expiration date and dose were not reported), via intramuscular in the left deltoid reported as "for pre-employment". Patient's concomitant medication was unknown by the reporter. On approximately 07-AUG-2016, reported as 3 to 4 days after administration of RECOMBIVAX HB, the patient experienced numbness and tingling in the arm where she was vaccinated. The physician reported that treatment was given for the events. However, there were no lab diagnostics studies performed. The outcome of hypoaesthesia and paraesthesia was reported as not recovered. The relationship between RECOMBIVAX HB and the events was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and drug reactions/allergies were not reported. On 28-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017, (concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted.  A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
Age: 73.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 73 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 29-AUG-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) (Inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Physician concerning an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with ROTATEQ lot number L008059 with an expiration date of 18-DEC-2016 (strength, dosage schedule, route of administration and anatomical location were not provided) which were involved in a temperature excursion. Concomitant therapies were not provided. It was unknown whether laboratory diagnostics studies were performed. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not reported. On 30-OCT-2015, 05-JAN-2016 and 18-APR-2016, the patient was vaccinated with the first second and third dose of GARDASIL 9 (strength, dose lot and expirations dates were not provided). After that, on 01-SEP-2016, a fourth dose of 0.5 ml of GARDASIL 9 (lot # K010215, expiration date 05-MAY-2017) was administered to the patient (product use issue). There were no concomitant medications and adverse effects reported. No temperature exclusion occurred and no product quality complain was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 70 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2013, the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, Lot # and expiration date were unspecified. The reporter stated that, the patient had been experiencing shingles every 2 months since she received ZOSTAVAX. The outcome of the singles was unknown. The relatedness between the shingles and ZOSTAVAX was not reported. Additional information has been requested. -
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 12-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, (Concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccination with improperly stored doses (temperature: 35 F, time frame: 84 hours) of RECOMBIVAX HB (lot# L045117, expiration date not reported), dose and route of administration were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient complained of soreness and redness at injection site on 9/2/16 early afternoon. Recommended cool compress and Ibuprofen. Arm was red, warm to touch on 9/3/16. Patient to see Dr. on 9/3/16. (Arm much better on 9/4/16 AM).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: PNEUMOVAX23 administered on 8/31/16, 2 hrs later her arm was swollen and hurt, tender to the touch, no mark at immunization site. Dissipated after 48 hrs.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm was really sore for 2 weeks. No fever. Patient took 600mg Ibuprofen every 6 hours which help with soreness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information was received from a physician referring to a 21 years old female patient who was not pregnant. The patient had no pertinent medical history or drug reaction/allergies. Concomitant therapy included MACROBID. On 22-AUG-2016, the patient received her first dose of GARDASIL injection (lot # K016966, expiration date 10-MAY-2017, dose unknown) intramuscularly. On 25-AUG-2016, patient developed hives all over her body. On 26-AUG-2016, the patient went to an unspecified urgent care facility and was prescribed prednisone (manufacturer unknown) and BENADRYL there. No lab diagnosis was performed. On 30-AUG-2016, the patient returned to the physician's office for evaluation, and patient reported to the physician that the hives were getting worse. No additional treatment was prescribed. At the time of this report, the patient had not recovered from the event. The causality assessment between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 25-AUG-2016, the patient was vaccinated with an expired dose of ZOSTAVAX had no known temperature excursions. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medication history and drug reactions or allergies were not reported. On 23-AUG-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot number reported as M012992 and expiration date 14-MAR-2108, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. That was supported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of VAQTA (lot #, expiration date, dose and route were not reported). No adverse effects were reported. VAQTA was supported until the labeled expiry. 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: Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccinated with improperly stored doses (temperature: 35F, time frame: 84 hours) of ROTATEQ (lot# L033546 with an expiry date: 30-MAY-2017; lot# L046318 with an expiration date: 28-SEP-2017 and lot# M002252, expiration date not provided), orally dose was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccinated with improperly stored doses (temperature: 35 F, time frame: 84 hours) of VAQTA (lot# M009377, expiration date unknown), dose and route of administration were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccinated with improperly stored doses (temperature: 35 F, time frame: 84 hours) of GARDASIL 9 (lot # M004116 with an expiry date: 12-OCT-2017 and lot # M007764, expiration date was not reported), dose and route of administration were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified type of reporter on behalf of physician refers to a 16-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The physician reported that on an unknown date, the patient might have been vaccinated with and adult dose of RECOMBIVAX (dose, lot#, expiration date and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was inadvertently vaccinated with doses of RECOMBIVAX HB, in a series, (dosing details not reported). The first dose was administered on 26-FEB-2002, second dose on 26-MAR-2002 and the third dose was on 16-MAY-2002. No adverse effects and no product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacy manager via company representative referring to three patients of unknown age and gender. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On unknown dates the patients developed swollen red rash at the injection site. The outcome and causality of the event were unknown. Additional information has been requested.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Injection site pain, Rash vesicular, Skin lesion
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 633962. This case involves a 19-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: VV04003A, expiry date, dose and route of administration were not reported) on left arm on 14 April 2016. Patient's current illness, medical history was reported as none. Concomitant medications were reported as none. On 27 April 2016, 13 days post vaccination, patient experienced palmar and interdigital surfaces, small erythemic raised lesions with vesicular lesions noted on the left index finger and the right ring MP joint, rash vesicular and injection site pain. Due the presentation and recent vaccination, patient was taken to hospital (Emergency Visit) for further evaluation. The Dermatologist specializing in infectious disease believed the symptoms did not correlate with the smallpox vaccine. Laboratory investigations were not reported. Corrective treatment included CLARICORT twice a day for 7 days. The outcomes of the events were reported as unknown. It was reported that the patient's symptoms did not progress until today 02 May 2016, with small eruptions forming over elbows. The sites are slightly tender to palpation. List of documents held by sender: none.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Erythema, Injection site pain, Rash vesicular, Skin lesion
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 633962. This case involves a 19-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: VV04003A, expiry date, dose and route of administration were not reported) on left arm on 14 April 2016. Patient's current illness, medical history was reported as none. Concomitant medications were reported as none. On 27 April 2016, 13 days post vaccination, patient experienced palmar and interdigital surfaces, small erythemic raised lesions with vesicular lesions noted on the left index finger and the right ring MP joint, rash vesicular and injection site pain. Due the presentation and recent vaccination, patient was taken to hospital (Emergency Visit) for further evaluation. The Dermatologist specializing in infectious disease believed the symptoms did not correlate with the smallpox vaccine. Laboratory investigations were not reported. Corrective treatment included CLARICORT twice a day for 7 days. The outcomes of the events were reported as unknown. It was reported that the patient's symptoms did not progress until today 02 May 2016, with small eruptions forming over elbows. The sites are slightly tender to palpation. List of documents held by sender: none.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tenderness
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 633962. This case involves a 19-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: VV04003A, expiry date, dose and route of administration were not reported) on left arm on 14 April 2016. Patient's current illness, medical history was reported as none. Concomitant medications were reported as none. On 27 April 2016, 13 days post vaccination, patient experienced palmar and interdigital surfaces, small erythemic raised lesions with vesicular lesions noted on the left index finger and the right ring MP joint, rash vesicular and injection site pain. Due the presentation and recent vaccination, patient was taken to hospital (Emergency Visit) for further evaluation. The Dermatologist specializing in infectious disease believed the symptoms did not correlate with the smallpox vaccine. Laboratory investigations were not reported. Corrective treatment included CLARICORT twice a day for 7 days. The outcomes of the events were reported as unknown. It was reported that the patient's symptoms did not progress until today 02 May 2016, with small eruptions forming over elbows. The sites are slightly tender to palpation. List of documents held by sender: none.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Mass, Tenderness
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 635036. This case involves a 25-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: vv03-019-C, expiry date, dose were not reported, route of administration was unknown) on left arm on 26 April 2016. Patient's current illness, medical history was reported as none. Concomitant medications were reported as none. On 30 April 2016, four days post vaccination, lump appeared on distal end of left clavicle approx 2 and half x 1 and half which was tender to touch. It was reported that patient was evaluated on May 2, May 4 and May 10, 2016. No change was reported. Laboratory investigations and corrective treatment were not reported. The outcomes of the events were not reported. List of documents held by sender: none.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin mass, Tenderness
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 635036. This case involves a 25-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: vv03-019-C, expiry date, dose were not reported, route of administration was unknown) on left arm on 26 April 2016. Patient's current illness, medical history was reported as none. Concomitant medications were reported as none. On 30 April 2016, four days post vaccination, lump appeared on distal end of left clavicle approx 2 and half x 1 and half which was tender to touch. It was reported that patient was evaluated on May 2, May 4 and May 10, 2016. No change was reported. Laboratory investigations and corrective treatment were not reported. The outcomes of the events were not reported. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Differential white blood cell count normal, Echocardiogram, Electrocardiogram normal
Clinical narrative: Initial unsolicited report received on 06 September 2016 from a healthcare professional via health authority via third party query tool search on the VAERS database, under reference number. This case involves a 23-year-old male patient who was vaccinated with a dose of ACAM2000 intradermally (batch number: VV030019C) (dose in series and expiry date were not reported) in the left arm on 28 April 2016. He was vaccinated at a military facility. The patient had a medical history of Restless Leg Syndrome and Cystic Acne (remote, resolved). He had no known allergies and had no current illness. Concomitant medications included Flonase and Zyrtec. On 06 May 2016, 8 days following the vaccination, the patient experienced sub sternal chest tightness that worsened with exertion. The patient had a visit to the urgent care center. Lab data included Troponin 0.06 (13 May 16, 9:11AM); Troponin 0.036 (13 May 16, 3:46PM); ECG (13 May 16): Early repolarization, otherwise normal; ECG (16 May 16): Unchanged compared to initial; CXR PA and Lateral (13 May 16): No acute pulmonary findings. CBC with AutoDiff (13 May 16). The patient received corrective treatment with colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The patient was treated with Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The event's outcome was as reported recovered ("and gradually improved over the week prior to presenting". List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Haematocrit normal, Haemoglobin normal, Troponin increased, White blood cell count normal
Clinical narrative: Initial unsolicited report received on 06 September 2016 from a healthcare professional via health authority via third party query tool search on the VAERS database, under reference number. This case involves a 23-year-old male patient who was vaccinated with a dose of ACAM2000 intradermally (batch number: VV030019C) (dose in series and expiry date were not reported) in the left arm on 28 April 2016. He was vaccinated at a military facility. The patient had a medical history of Restless Leg Syndrome and Cystic Acne (remote, resolved). He had no known allergies and had no current illness. Concomitant medications included Flonase and Zyrtec. On 06 May 2016, 8 days following the vaccination, the patient experienced sub sternal chest tightness that worsened with exertion. The patient had a visit to the urgent care center. Lab data included Troponin 0.06 (13 May 16, 9:11AM); Troponin 0.036 (13 May 16, 3:46PM); ECG (13 May 16): Early repolarization, otherwise normal; ECG (16 May 16): Unchanged compared to initial; CXR PA and Lateral (13 May 16): No acute pulmonary findings. CBC with AutoDiff (13 May 16). The patient received corrective treatment with colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The patient was treated with Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The event's outcome was as reported recovered ("and gradually improved over the week prior to presenting". List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Differential white blood cell count normal, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Initial unsolicited report received on 06 September 2016 from a healthcare professional via health authority via third party query tool search on the VAERS database, under reference number. This case involves a 23-year-old male patient who was vaccinated with a dose of ACAM2000 intradermally (batch number: VV030019C) (dose in series and expiry date were not reported) in the left arm on 28 April 2016. He was vaccinated at a military facility. The patient had a medical history of Restless Leg Syndrome and Cystic Acne (remote, resolved). He had no known allergies and had no current illness. Concomitant medications included Flonase and Zyrtec. On 06 May 2016, 8 days following the vaccination, the patient experienced sub sternal chest tightness that worsened with exertion. The patient had a visit to the urgent care center. Lab data included Troponin 0.06 (13 May 16, 9:11AM); Troponin 0.036 (13 May 16, 3:46PM); ECG (13 May 16): Early repolarization, otherwise normal; ECG (16 May 16): Unchanged compared to initial; CXR PA and Lateral (13 May 16): No acute pulmonary findings. CBC with AutoDiff (13 May 16). The patient received corrective treatment with colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The patient was treated with Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The event's outcome was as reported recovered ("and gradually improved over the week prior to presenting". List of documents held by sender: none.