chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. The reporter was checking to see if there was an alternative schedule for GARDASIL 9 (dose and route of administration was not provided) which would be 0,1 month and 6 month (inappropriate schedule of vaccine administered). The outcome of the event was unknown. No product quality issue was involved. Additional information hs been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 23-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot# was reported as L035881, expiration date 26-JUN-2017, dose and route were unknown). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On 19-OCT-2015 the patient was inadvertently administered a dose of (Oka/Merck) VARIVAX (lot # J014407 with expiration date of 13-NOV-2015; strength, dosage, frequency and route unspecified) and (Oka/Merck) PROQUAD (lot# L017140 with expiration date of 13-NOV-2016; strength, dosage, frequency and route unspecified) (overdose). No adverse reactions were 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 registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K010216, expiry date 17-SEP-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician regarding a patient of unknown age and gender. On 11-NOV-2013 the patient was vaccinated with first dose of ZOSTAVAX lot # J004311; expiry: 12-JUL-2014, 0.65 ml, subcutaneous. On 22-OCT-2015 the patient was vaccinated with second dose of ZOSTAVAX lot # L003217; expiry: 30-APR-2016, 0.65 ml, subcutaneous (extra dose administered). No concomitant medications were reported. No adverse effects were reported. No further information was provided. The outcome of extra dose administered was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, 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 pertinent medical history and drug reactions or allergies were not reported. On 20-JUL-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). On 27-JUN-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). The third dose that was administered was GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) given on 17-AUG-2015. Concomitant therapy was not reported. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. 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 an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patient's were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L004754, expiry date 10-NOV-2016; dose and route were not reported). No adverse effects were 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 registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored of RECOMBIVAX HB (lot # K010216, expiry date 17-SEP-2016; dose and route were not reported). No adverse effects were reported. 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 registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, lot # L010144, expiration date- 24-MAR-2017, lot # L017144, expiration date- 13-MAY-2017, lot # L013827, expiration date- 21-APR-2017, lot # L001333, expiration date- 13-JAN-2017, and lot # L013827, expiration date- 21-APR-2017. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-SEP-2015, the patient was vaccinated orally with an unknown dose of ROTATEQ (lot # K004480, expiry date 05-FEB-2016), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Muscle twitching
Clinical narrative: Information has been received from a female patient (who is also a pharmacist) of unknown age referring to herself. The patient's pertinent medical history and concurrent were not reported. No previous drug reactions or allergies were reported. Reproter stated that on 20-OCT-2015, she was preparing a syringe of ZOSTAVAX (dosing details were not reported) (lot # L011537 with an expiry date of 03-JUL-2015) for administration to and unspecified patient, when administering inadvertently splashed some of vaccine "close to or may be into the eye" (accidental exposure to product). Reporter also stated that she flushed her eye with water and that it felt "twitchy". No concomitant medications were reported. The outcome of the event twitching was unknown. Causal relation with ZOSTAVAX was not reported. There was no product quality complaint. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient stated a high fever of 104 on the same day vaccines were administered; seizures were also developing. Patient was taken twice to medical center for fever and seizures.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date in 2015, a few weeks ago, (Oka/Merck) VARIVAX [lot # J013728, Expiry: 30-OCT-2015] was improperly exposed to 54 degree Fahrenheit for 8 hours. On 21-OCT-2015 the patient received a dose of the improperly stored (Oka/Merck) VARIVAX via the subcutaneous route. No adverse effects were reported. Outcome of the improperly stored vaccine was not known. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash under left armpit to center chest and upper back. Painful and itchy. Presenting 9 days after administration then again 14 days after with worsening. Treated with valacyclovir and Hydroxyzine.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling at and above injection site and into armpit. Took TYLENOL, BENADRYL, and applied cold compress.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain, itchy, swelling, red, warm on injection site after the shot and lasts more than one week (pain went away in coup days).
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash. Broke out in chickenpox like rash per dad (started 2 hrs after shot).
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site vesicles
Clinical narrative: Patient's arm is red with blisters where vaccination was given. Patient was given VALTREX to treat the shingles.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Aspiration pleural cavity, Chest X-ray abnormal, Computerised tomogram head normal, Confusional state, Coordination abnormal
Clinical narrative: Patient had cardiac bypass surgery in Nov 1997.On 08-25-15 he had his aortic valve replaced. He was recovering well (09-28-15 seen by heart surgeon, 10-05-15 seen by cardiologist). He was seen by his PCP on 10-08-15 and was given a PREVNAR injection. A few hours later he developed neurological symptoms of mental confusion, tremors, issues with coordination, vision and hearing problems.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Hearing impaired, Neurological symptom, Tremor, Visual impairment
Clinical narrative: Patient had cardiac bypass surgery in Nov 1997.On 08-25-15 he had his aortic valve replaced. He was recovering well (09-28-15 seen by heart surgeon, 10-05-15 seen by cardiologist). He was seen by his PCP on 10-08-15 and was given a PREVNAR injection. A few hours later he developed neurological symptoms of mental confusion, tremors, issues with coordination, vision and hearing problems.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored PROQUAD (Merck) (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored ROTATEQ, oral (Lot #, doses and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified dose of improperly stored GARDASIL (lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored M-M-R II (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored RECOMBIVAX (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored VAQTA (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored (Oka/Merck) VARIVAX (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. 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 referring to multiple unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K021444 with expiration date 17-SEP-2016 and lot # K024552 with expiration date 22-OCT-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effect were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 15-OCT-2015 from a 32 year old female patient consumer reporting on herself. The patient reported that she received her first dose of PNEUMOVAX 23 (dose and injection site not specified) 10 years ago when she was 32 years old. The patient is now 42 years old and on an unknown date, she received a booster shot of the vaccine. No adverse effects were reported. The patient did not wish to provided any additional information. Additional information is not expected. No contact details were provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial and follow up information has been received from a pharmacist via a company representative, and refers to a 69 year old male patient. The patient's medical history and concurrent conditions were not reported. On 17-JUN-2014, the patient was vaccinated with a single dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # J014811, expiration date 21-FEB-2015). No concomitant medications were reported. On 02-OCT-2015, the patient presented to a pharmacy with a case of shingles and a prescription for acyclovir. The patient sought medical attention by going to the pharmacy. At the time of the report, the outcome of shingles was reported as not recovered. The relatedness between shingles and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple, unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # K011952 with expiration date 17-JUN-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015 (reported as "a couple of weeks ago"), the patient was vaccinated with the 0.65 ml dose of ZOSTAVAX (route, lot# and expiry date were not reported). Concomitant medications were not reported. On an unknown date in 2015, during the administration of ZOSTAVAX, the patient experienced an immediate stinging sensation. The outcome of the event was unknown. The relatedness between the event 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 was received from a registered nurse referring to multiple, unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L007560 with expiration date 15-JUN-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of the 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: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L004754, expiration date: 10-NOV-2016 (dose and route were not reported). There was no concomitant medication provided. No adverse effects reported and there was no a product quality complaint (PQC) involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history or known drug reactions or allergies. On 24-OCT-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX injection (lot# L021610; expiry date 10-SEP-2016). Concomitant therapies included lisinopril (manufacturer unknown). On 25-OCT-2015, the patient experienced soreness, redness, warmth, pain, and a lump at the injection site. It was reported that the lump was initially "the size of a 50 cent piece" on 25-OCT-2015, and the size increased to "approximately the size of three to four 50 cent pieces" on 26-OCT-2015. The patient sought medical attention- she saw a pharmacist and the events were treated with BENADRYL. No diagnostic lab studies were performed. The outcome of the events was not reported. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 58 year old male patient, reporting on himself. The patient concurrent conditions included asthma, diabetes mellitus and hypertension. The patient had no drug reactions or allergies. "About 6 years ago" in approximately 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not provided). Concomitant therapies included unspecified diabetes, hypertension and asthma medications. The patient reported that in July 2014, he had gotten shingles, after getting the ZOSTAVAX. The patient was given topical creams as treatment for the adverse event. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 14-OCT-2015 from an other health professional. The healthcare worker reported that 3 unspecified patients each was vaccinated on an unknown date with a dose of (Merck) VARIVAX (lot # K007781, expiration date 28-MAY-2016) that was improperly stored. No adverse effects were reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 23-OCT-2015, the patient was inadvertently vaccinated with (Merck) VARIVAX instead of ZOSTAVAX (lot#, dose, frequency and route of administration not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L007720 with expiration date of 08-JUL-2016, dose 0.5 ml, frequency unknown, intramuscular). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates since 23-SEP-2015, the patients were vaccinated with doses of improperly stored ZOSTAVAX, lot # L016283, expiration date: 07-AUG-2016, (dose, route of administration and injection site were not reported). No adverse effects were reported. Aditional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Peripheral swelling
Clinical narrative: This report was received from Pfizer, Inc. and was assigned manufacturer report number 2015344694 for PREVENAR 13. This was originally reported by a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date, the patient experienced that her hands/arms swell (oedema peripheral) and she believed that she was allergic phenol (drug hypersensitivity). The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. 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 medical assistant regarding 2 patients of unknown age and gender. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the 2 patients were vaccinated with improperly stored GARDASIL 9 (dose and route were not provided; lots numbers were L011846, expiration date 15-JUN-2017 and L014415, expiration date 25-JUL-2017). Concomitant medications were not provided. The reporter did not specify if both lots of GARDASIL 9 were administered. No adverse effects were reported. Additional information is not expected since the reporter did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a multiple different unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The patients were vaccinated with a dose PNEUMOVAX23 (dose, route, lot number and expiration date were not reported) "every year" since an unspecified date. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information was received from a pharmacist concerning a 69 year old male patient with allergy to CIPRO (unspecified reaction), high blood pressure and hypothyroidism. The patient had received ZOSTAVAX (lot number and dosage not provided) approximately 4-5 years ago. The patient reported that he experienced a rash on the right arm, near the hand and thumb, after receiving a second dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # L007222, expiration date 03-JUN-2016) and FLUZONE in the left arm on 25-SEP-2015. The patient informed the pharmacist of the event on 06-OCT-2015. Concomitant therapies also included SYNTHROID and losartan potassium (manufacturer unknown). The outcome of the rash is unknown. No treatment was given. The relatedness of the rash to ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # J014854, expiration date 16-JAN-2016 or lot # L009445, expiration date 01-JUN-2017, exact doses and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unspecified dates, an unknown number of patients were inadvertently administered PEDVAXHIB (dose and route of administration were not provided) lot#L012838 exp. 10-MAR-2018, that had been improperly stored. No adverse effects reported. No PQC involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 14 year old female patient. Concurrent conditions or pertinent medical history were not reported. On unknown dates, the patient received her 3 doses of GARDASIL (lot numbers, expiration dates, doses, routes of administration and frequency were unspecified), and was stated that she received one of the doses at the age of 12 years (unspecified dose number on approximately in 2013). However, her pediatrician vaccinated her with the first dose of GARDASIL 9 (lot#, dose, route and frequency were unspecified) in August 2015. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected since the reporter did not want to be contacted.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: This spontaneous report as received from a consumer refers to her 78 year old husband with high blood pressure, depression, gout, allergy to "caines" and prednisone. On 16-MAY-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously. The consumer reported that on 13-JAN-2014, the patient had a routine blood done and the patient's platelet count decreased. The patient had follow up tests performed and the results showed the patient's blood platelet counts continuing to decrease. The patient did not receive treatment for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's current conditions and medical history were not provided. On 27-FEB-2014, the patient was vaccinated with the first dose of GARDASIL (route, dose and Lot No. were unspecified). On 04-MAR-2015, the patient was vaccinated with the second dose of GARDASIL (route, dose and Lot No. were unspecified). On 13-AUG-2015, the patient was vaccinated with the third dose of GARDASIL (route, dose and Lot No. were unspecified). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored GARDAISL 9 (Lot #, doses, route and sites of administration not reported). This is one of 8 report from the same source. No additional information provided. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Fatigue, Muscle tightness, Musculoskeletal pain, Sluggishness
Clinical narrative: Patient reported tightness/heaviness in her neck and shoulder on the (L) side as well as pain in that shoulder blade area. Also reported fatigue/"sluggishness". Symptoms lasted 2 mo.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse regarding a patient of unknown age and gender. The reporter stated that on 10-FEB-2015 the patient was administered a dose of ZOSTAVAX subcutaneously and then on 20-OCT-2015 (19 days after first dose) the patient was administered a second dose of ZOSTAVAX, lot # and expiration date for each dose of ZOSTAVAX is unspecified. The patient did not experience any adverse event. There was no report of Product Quality Complaint. 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 nurse and refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L015047 with expiration date 29-APR-2017, dose, route and anatomical location were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a patient of unknown age and gender. The patient's medical history included herpes zoster (shingles). The patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported) "every year" since an unspecified date. There was no concomitant medication provided. No adverse effect reported. The reporter also inquired if should ZOSTAVAX ever be given as a repeat dose, said every 5 years. As the reporter recently heard that it was no longer given as a one-time only dose. This is one of two reports received from the same reporter. 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 medical assistant refers to an unknown number of patients. On unspecified dates, an unknown number of patients were inadvertently administered GARDASIL (dose and route of administration were not provided) lot# K016966 exp. 10-MAY-2017, that had been improperly stored. No adverse effects reported. No PQC involved. 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 nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016, exact doses and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # K025006, expiration date 22-JUL-2017, exact doses and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a male pharmacist of unknown age referring to himself. The patient had no pertinent medical history or drug reactions/allergies. On 25-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not reported) as a vaccination. There was no concomitant medication. On the same day the patient developed redness, swelling, and itching at the injection site after administration of ZOSTAVAX. No lab diagnostics studies were performed. The patient did not seek medical attention. The injection site reactions resolved in 1 week without requiring medical treatment (in 2014). The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of elderly patients of unknown gender. On an unknown date, the patients were vaccinated with ZOSTAVAX, 0.65 ml, (route of administration, lot # and expiration date were not provided). Concomitantly, the patients received high dose flu (manufacturer unknown). On an unspecified date, the patients were complaining of lethargy or complaining of injection site soreness. No treatment was given. At the time of reporting, the outcome of lethargy and injection site soreness was reported as recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative referring to a 66 year old female patient. Information concerning medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, once, intramuscular). There was no concomitant therapy. On an unknown date the patient experienced pain at the injection site. The injection site was also red and swollen. The patient had contacted the physician for medical attention. The patient was treated with unspecified antibiotics and was scheduled for a follow up visit with the physician 26-OCT-2015. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of VAQTA, lot # L018499, expiration date 25-FEB-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. This is one of 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 regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L011079, expiration date- 01-OCT-2016, lot # L017140, expiration date- 13-NOV-2016, lot # L016394, expiration date- 08-NOV-2016, lot # L019997, expiration date- 2-DEC-2016, lot # K018144, expiration date- 10-APR-2016 and lot # K008185, expiration date- 05-DEC-2015. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. 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 as received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # L012478, expiration date- 10-JUL-2016, lot # L011537, expiration date- 03-JUL-2016, lot # L011529, expiration date- 03-JUL-2016, lot # L021608, expiration date- 15-MAY-2016, and lot # L021612, expiration date- 10-JUN-2016. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Colitis, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician referring to a now 13 year old male patient. The first dose was vaccinated with RECOMBIVAX HB (dose, lot number not provided) to the patient at birth; and schedule was maintained as per the prescribing information of 0, 1, 6 months. On an unknown date the patient developed colitis. The antibody titer was drawn in 2014 and it was no number value but the result showed non-reactive to Hepatitis B. In March 2015, client was vaccinated with one booster dose of Hepatitis B and antibody titer drawn in May 2015 showed result of 8.76; still not at the level it should be (failed to seroconvert). Physician states when the booster dose was administered in March 2015 client was on Infliximab therapy. The outcome and reporter's causality of colitis was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning two patients of unknown age and gender. The patients' concurrent conditions and medical history were unspecified. On an unknown date, the patients were inadvertently vaccinated with VARIVAX (dose, route, Lot No. and expiration date were unspecified), instead of a dose of ZOSTAVAX. There was no concomitant medication described. No adverse effects were reported. It was unknown if the patient sought medical attention. There was not a product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 14 year old female patient. On approximately 08-OCT-2015,"about two weeks ago", the patient was vaccinated with a dose of VARIVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that "a few days later", on an unspecified date in October 2015, the patient experienced a shingles-type rash. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, 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 25-SEP-2015, the patient was vaccinated with the third dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-APR-2014 (dose and route were not reported). No concomitant medications were reported. No adverse reactions were reported. No product quality complaint was involved. 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 licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL, lot # K010215, expiration date 05-MAY-2017 (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. This is one of several 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 concerning an unspecified number of patients of unknown age and unknown gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9, Lot # L018499, expiration date 16-JUN-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored does of oral, ROTATEQ, lot # L008034, expiration date 05-AUG-2016, (dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses of PEDVAXHIB immunization series (dose and route were not provided, Lot number L009649 and expiration date 29-NOV-2017). Concomitant medications were not provided. There was no adverse effects reported. This is one of three reports from the same source (MARRS #1510USA008696 and 1510USA013292). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's current conditions and medical history were not provided. Obn 15-OCT-2015, the patient was vaccinated with an expired dose of with PNEUMOVAX 23 (lot # K010016, expiration date 05-AUG-2015) (strength, dose, anatomical location and route of administration were not provided). No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses in Oral, ROTATEQ (dose and route were not provided, Lot number L000425, expiration date 21-JUN-2016 and Lot number K023159, expiration date 26-JUL-2016). Concomitant medications were not provided. There was no adverse effects reported. This is one of three reports from the same source (MARRS #1510USA008696 and 1510USA013291). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old female patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) and experienced allergy to vaccine. There was no concomitant medication provided. The outcome of allergy to vaccine was unknown at the time of the report. The reporter considered allergy to vaccine to be related to PNEUMOVAX 23. Additional information has been requested.