chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (Merck) injection, lot# L007229, exp. date 03-SEP-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reprots 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 health care professional refer to ten unspecified patients of demographics. On an unknown date in 2015 (reported as since 06-MAY-2015) the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot # unspecified). No concomitant medications were reported. The nurse called on 20-JUL-2015, and reported that ten unspecified patients doses of an improperly stored (Oka/Merck) VARIVAX on unspecified dates since 06-MAY-2015. No adverse effect reported. No further information was provided. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 10-MAR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# K008814, expiration date: 19-JUN-2016, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administrated unspecified number of improperly stored doses of M-M-R II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were administered unspecified number of improperly stored doses of ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2016) (oral, strength and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. The patient received improperly stored doses of ROTATEQ (oral, dose was unknown) on 03-APR-2015 and 26-MAY-2015, respectively. This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products, events and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of M-M-R II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported.  Follow up information has been receive from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored MMR II injection, lot# K016153, exp. date: 24-SEP-2016; lot# J013431, exp. date: 24-OCT-2017 and lot# K022285, exp. date: 12-NOV-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. 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 registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were administered unspecified number of improperly stored doses of ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2016) (oral, strength and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 09-APR-2015, the patient received an improperly stored dose of ROTATEQ (lot#K006455, expiration date 10-FEB-2016, oral, dose was unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products, events and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with a 0.5 ml dose of improperly stored (Oka/Merck) VARIVAX subcutaneously in the left arm (lot # L001325, expiration date 13-JAN-2017). No adverse events were reported. Additional information is not expected since the reporter would not like to be contacted.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to an approximately 23 year old male patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On 14-JUN-1993 and 29-SEP-1996, the patient was vaccinated with the first and the second doses of MMR II injection, 0.5 ml subcutaneously (therapy type: HSA, lot# and site unspecified), respectively. On an unknown date the patient failed to seroconvert to mumps. On 22-MAY-2015 the antibody titer test was drawn and result was the patient was non immune to mumps. The third dose of MMR II injection, 0.5 ml subcutaneously (therapy type: unknown, lot# and site unspecified) was administered on an unknown date in June 2015. The reporter questioned if they need to draw another titer after the third dose of MMR II was administered. No adverse effects were reported. At the time of the report, the patient still failed to seroconvert to mumps. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a female patient of unknown age. The concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with either GARDASIL or GARDASIL 9 (route, dose and lot details unavailable. The concomitant medication was not reported. On an unknown date the patient experienced unspecified adverse event. The field employee could not confirm if the vaccine was GARDASIL or GARDASIL 9. The action taken was not applicable. The outcome of adverse event was unknown. The causality was unspecified. Additional information is not expected as the physician does not wish to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site warmth, Rash
Clinical narrative: Information has been received from a physician and a female patient of unknown age referring to herself. There was no pertinent medical history or drug reactions/allergies reported. On 26-JUN-2015 (also reported as 10-JUL-2015) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administration were unspecified) in her left arm. No concomitant medication was reported. On 03-JUL-2015 the patient experienced warm to hot, painful large redness with 2 small round dots at the injection site on her left arm. On 13-JUL-2015, the patient experienced red dots that itched and a "line" connecting the dots in her inner right arm below the elbow. The physician reported that on 14-JUL-2015 the left arm developed a non-vesicular rash, and the right arm in which no vaccination was administered developed a vesicular rash. The patient reported on 15-JUL-2015 she experienced two big blisters on her right arm, one of which was bigger than the other, and also tiny blisters where the "line" was on her right arm. On 16-JUL-2015 both arms had small little red areas that were slightly raised. The patient was started on famciclovir by her unspecified primary care physician on an unspecified date. No lab tests were performed. The patient had an appointment in reporter's office for evaluation on 17-JUL-2015. At the time of the report, the patient did not recover and causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician and a female patient of unknown age referring to herself. There was no pertinent medical history or drug reactions/allergies reported. On 26-JUN-2015 (also reported as 10-JUL-2015) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administration were unspecified) in her left arm. No concomitant medication was reported. On 03-JUL-2015 the patient experienced warm to hot, painful large redness with 2 small round dots at the injection site on her left arm. On 13-JUL-2015, the patient experienced red dots that itched and a "line" connecting the dots in her inner right arm below the elbow. The physician reported that on 14-JUL-2015 the left arm developed a non-vesicular rash, and the right arm in which no vaccination was administered developed a vesicular rash. The patient reported on 15-JUL-2015 she experienced two big blisters on her right arm, one of which was bigger than the other, and also tiny blisters where the "line" was on her right arm. On 16-JUL-2015 both arms had small little red areas that were slightly raised. The patient was started on famciclovir by her unspecified primary care physician on an unspecified date. No lab tests were performed. The patient had an appointment in reporter's office for evaluation on 17-JUL-2015. At the time of the report, the patient did not recover and causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 16-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports 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 registered nurse refers to multiple unspecified patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a doses of VARIVAX (lot number, expiration date, dose, route of administration not specified). The reporter stated that the vaccines were improperly stored. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner and a healthcare worker (also reported as an office manager) referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-JUL-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2015, dose, frequency and route were unknown). Concomitant therapies were not reported. On the same day after the vaccination, it was reported that the patient was experiencing nausea and vomiting. The outcome of nausea and vomiting was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of ROTATEQ (oral, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of GARDASIL (route, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician via a field employee referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unknown number of doses of GARDASIL (dose, strength, route, and lot# were not reported). On unknown dates the patients experienced chronic headaches. The outcome of the event was not reported. The causality was not reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect 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 Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Agitation, Immediate post-injection reaction, Inappropriate schedule of drug administration, Irritability
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old female patient with familial risk factor. The patient did not have any pertinent medical history, drug reactions or allergies. On 27-JUL-2015, the patient was vaccinated with the first dose in the series of three RECOMBIVAX HB, lot # K026666, expiry date: 22-OCT-2016, 0.5 ml, intramuscular. None concomitant medication was reported. On the same date, immediately following vaccination, the patient experienced extreme agitation and irritability. It was reported that the symptoms lasted between 5 to 6 hours in duration and as of 29-JUL-2015, reported as "currently", the patient was not experiencing any symptoms of irritability or agitation. The patient was treated with TYLENOL. None laboratory studies were performed. The patient was seen in the medical office. The medical assistant also reported that the first dose of RECOMBIVAX HB was delayed and not given according to the recommended dosing schedule due to a family history of unspecified neurological problems. The outcome of agitation and irritability was reported as recovered on an unknown date in July 2015. 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. Concurrent condition and medical history were not reported. On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K011967, expiration date 21-FEB-2016) (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports 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 Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA adult formation 50 U/1.0 ml (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. 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 healthcare worker refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was vaccinated with a first dose of GARDASIL. Then on 09-DEC-2014, the patient was vaccinated with a second dose of GARDASIL (doses, route, lot # and expiration date were not provided). On 25-FEB-2015, the patient was vaccinated with a third dose of GARDASIL which was considered an inappropriate schedule of drug administration. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. 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. Concurrent condition and medical history were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot #s K021487, expiration date 03-NOV-2016; L008271, expiration date 11-MAR-2017) (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports 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 Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA pediatric formation 25/0.5 (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB adult formation 10/1.0 microgram/ml (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB pediatric formulation 5 microgram/0.5 ml (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patient have been administered with a dose of MMR II (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014065, 1507USA014066, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Oral mucosal blistering, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 54 year old female patient. The patient had no pertinent medical history. It was reported that the patient experienced hives during treatment with KEFLEX. On 23-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (Lot # L013546; expiration date: 17-JUL-2016) (dose and route not provided). On 23-JUL-2015, the patient experienced "7 inch circumference circle" that was warm to the touch at the injection site. Pharmacist reported that the patient stated that it was painful to move the arm where she got the injection and that she had blisters in her mouth since 23-JUL-2015. Pharmacist also reported that the patient felt feverish the "past couple of days". No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered.  The patient sought medical attention by seeing the pharmacist. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 54 year old female patient. The patient had no pertinent medical history. It was reported that the patient experienced hives during treatment with KEFLEX. On 23-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (Lot # L013546; expiration date: 17-JUL-2016) (dose and route not provided). On 23-JUL-2015, the patient experienced "7 inch circumference circle" that was warm to the touch at the injection site. Pharmacist reported that the patient stated that it was painful to move the arm where she got the injection and that she had blisters in her mouth since 23-JUL-2015. Pharmacist also reported that the patient felt feverish the "past couple of days". No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered.  The patient sought medical attention by seeing the pharmacist. 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 Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of RECOMBIVAX HB (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014066, 1507USA014067 and 1507USA013244). Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received BOOSTRIX (batch number 34EB5, expiry date 14th February 2017). On 10th July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In July 2015, 17 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be probably related to BOOSTRIX. Additional details received as follow: The patient came to the doctors office because he was experiencing sharp, stabbing pain in left arm whenever he moved. The lot number was reported as 34EB (B or S) from the reporter. However, based on a safety lot number review, the lot number was updated to 34EB5.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's wife refers to her 60 years old husband with a medical history included esophageal cancer no drug reactions or allergies. On 01-JUL-2015, the patient was vaccinated with one dose of ZOSTAVAX, (dose, route, lot number and expiration date were not reported). The patient's concomitant therapies included FLOMAX and REMERON. On 09-JUL-2015, the patient developed shingles after received ZOSTAVAX. The reporter stated that the shingles developed on his abdomen area and have already begun to blister over. The patient sought medical attention by office visit and was treated with unspecified antiviral medication. No laboratory diagnostic tests were performed. At the time of the report the patient was recovering from herpes zoster. Additional information is not expected because the physician cannot be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of RECOMBIVAX HB (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014066, 1507USA014068 and 1507USA013244). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of PNEUMOVAX 23 (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014066, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Peripheral swelling
Clinical narrative: ErythemaMultiform and arm swelling.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of ROTATEQ (oral by default, dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown age and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of GARDASIL (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014066, 1507USA014067 and 1507USA014068). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever to 103 degrees F. Fatigue. Headache.
Sex: U
Vaccine: MMR
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. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccinated with MMR II (route of administration, dose, lot# and expiration date not reported). The MMR II was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Blood creatine phosphokinase, Dizziness, Full blood count, Headache, Metabolic function test
Clinical narrative: After 3rd dose, about 1-2 hours with fever, body aches, headache, dizziness.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: After 3rd dose, about 1-2 hours with fever, body aches, headache, dizziness.
Sex: U
Vaccine: VARCEL
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. The patient's medical history and concurrent conditions were not reported. On 20-JUL-2015, the patient was vaccinated with an improperly stored VARIVAX, lot # reported L010148, expiration date 20-JUL-2017. There was not concomitant medication reported. No adverse symptoms were reported. Lot number L010148 has been verified to be a valid lot number for VARIVAX. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 24-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 27-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 16-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 08-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. 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 on 02-JUL-2015 concerning a patient of an unknown age and gender. On 28-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose #1 of CERVARIX (dose, route, lot # and expiration date were not reported). On an unknown date, the patient was vaccinated with a dose #2 of GARDASIL (dose, route, lot # and expiration date were not reported). On an unknown date, the patient was vaccinated with a dose #3 of CERVARIX (dose #3, dose, route, lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccinated with GARDASIL (route of administration, dose, lot# and expiration date not reported). The GARDASIL was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccination with ROTATEQ, orally (dose, lot# and expiration date not reported). ROTATEQ was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age/gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported. On 26-JUN-2015 the patient was vaccinated with improperly stored GARDASIL (Lot# reported as K0101574) 0.5 ml, intramuscular. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot# K0101574 is not a valid lot number for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report was received from a licensed vocational nurse of unknown age reporting on herself. No medical history or concurrent conditions were reported. On 28-JUL-2015, the nurse called to report a vial of PNEUMOVAX 23 that was underfilled. During the call, the nurse felt some moisture on her hand when she handled the vial; therefore, she washed her hands during the conversation. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of MMR II (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of GARDASIL (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of COMVAX (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pruritus, Rash, Throat irritation, Urticaria
Clinical narrative: Arthralgia, skin rash, rash, urticaria pruritus and scratchy throat. Methylprednisolone 40 mg once, prednisone tapering pack, diphenhydramine 50 mg once.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 38 year old female patient. The patient's medical history included splenectomy. On 21-JUL-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # K012424, expiration date: June 2016), (dose, route and frequency were not described). The reporter stated that the patient received this vaccine every 5 years. Concomitant medications included tramadol (reported as tramadal). Later, on 22-JUL-2015, the patient experienced soreness and a hard time moving her arm. For treatment, the patient used an ice pack. The patient sought medical attention. No product quality complaint was reported. At the time of this report, the outcome of soreness and the hard time moving her arm events, was recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to herself a non pregnant female patient, via a company representative, with unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot/batch number and expiration date were not provided). No concomitant medication was reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced a large red swollen area around the injection site that lasted about a week. The patient sought for medical attention (unspecified) and was treated with prednisone (manufacturer unknown). The outcome of the events, was reported as recovered on an unspecified date which "lasted about a week". Additional information is not expected since no permission was given for further contact.