chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old female patient with a positive history of herpes simplex. It was reported that the patient  had multiple (3 to 4) outbreaks per year (maximum of 7 under extremes of sun exposure or stress) since an unknown date, reported as since the age of 17. The patient did not have any outbreaks of shingles, but had chickenpox as a child at the age of 6 or 7 (date unspecified). The patient stated that the chickenpox was severe with whole body pocks, though no hospitalization, pneumonia, seizures or encephalitis was involved. The patient did not use any prophylactic medication, but she used acyclovir pills and acyclovir ointment as treatment for individual outbreaks of herpes simplex. She had never had a genital herpes outbreak. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. The physician reported that the patient's herpes simplex cold sores did not return over the last two  years after the patients were vaccinated with ZOSTAVAX (onset date approximately in 2013). She had zero outbreaks since she had the vaccine. The patient stated that her sister-in-law had the same effect after her vaccination with ZOSTAVAX (captured in MARRS#1512USA001048). The physician stated that this occurrence might be "just a fluke" and there was no way of knowing the causality. All telephone attempts to obtain follow up information had been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immune system disorder, Migraine
Clinical narrative: This spontaneous report has been received from a registered nurse (also a healthcare worker) via the article of social media referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (disposable syringe, dose, frequency, route and lot# not reported). Concomitant therapy was not reported. On an unknown date the patient experienced migraine headaches and immune system issues as a result of GARDASIL therapy. The outcome of the events was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with a dose of improperly stored RECOMBIVAX HB (lot# L027733 and expiration date 13-SEP-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old female patient. The patient's concurrent condition included allergy to latex. The patient had no pertinent medical history and no concomitant medications. On an unknown date, (also reported as "kid", the patient was vaccinated with M-M-R II (dose, lot #, expiry date, route of administration were not reported). On 04-DEC-2008, the patient had a measles, mumps and rubella titer drawn which resulted "non immune". On 13-JUL-2009, the patient had a second measles, mumps, and rubella titer which results "equivocal". The patient had a third measles, mumps and rubella titer drawn on 21-DEC-2015 which resulted "negative for measles but not mumps and rubella". It was reported that the patient has not received any additional doses of M-M-R II after any of the three titers that were drawn. The outcome of measles antibody negative was reported as not recovered/not resolved. The outcome of rubella negative and mumps antibody tests negative was reported as recovered/resolved on 21-DEC-2015. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 22-JAN-2016 the patient was administered with a dose of improperly stored GARDASIL 9 (lot# L004014 and expiration date 04-MAR-2016, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L030869, expiration date 08-JUN-2018, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (incorrect product storage) (lot # L023230, expiration date 28-JUL-2017, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified numbers of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose and route unspecified (lot # L008996, expiry date 01-DEC-2016). No adverse effects were reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of GARDASIL injection, lot # K011325, expiration date 08-APR-2017 (dose and route were not reported) that was improperly stored. The vaccine had 3 temperature excursions and was administered between the second and third. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-JAN-2015, the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is  one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a 71 years old male retired nurse regarding himself. The patient's historical and concurrent conditions included aortic valve replacement, non-Hodgkin's lymphoma in 2002, 2005 and 2010 (in remission for over 5 years), melanoma in 2007 (in remission for over 5 years) and neuropathy in the toes (since approximately 2006, reported as "for 10 years"). The patient was reactive/allergic to NORVASC, ZOCOR, TENEX and FERAHEME. On approximately 17-JAN-2016 ("10 days ago"), the patient was vaccinated with ZOSTAVAX (lot# unspecified), vial, for vaccination. Concomitant therapies included COUMADIN and atorvastatin. The patient stated that since receiving the ZOSTAVAX, the numbness and tingling in his toes had begun to fade away, it got better with each day (unexpected therapeutic benefit). The patient related this improvement to ZOSTAVAX. No treatment was given. No lab diagnostics studies were performed. No Product Quality Complaint (PQC) was reported. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old patient (gender and race unspecified). There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On 09-JAN-2016, the patient received a dose of M-M-R II injection (Lot # J008728 with expiration date of 26-JUL-2015) (strength, dose, frequency and route were not reported) (Expired drug administered). No adverse effects have been reported. 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 referring to unspecified numbers of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECMOBIVAX HB (dose and route unspecified) (lot # L004754, expiry date 10-NOV-2016, five doses totally, or lot # L018501, expiry date 22-JUN-2017, four doses totally). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever. Fatigue. Swelling, redness and warmth around inj site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and routed unspecified) (lot # L018499, expiry date 25-FEB-2017, ten doses totally, or lot# K018181, expiry date 04-JUN-2017, 3 doses totally). No adverse effects were reported. This is one of several reports received from 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 healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # K026246 exp: 28-JAN-2017. The vaccine was stored at 47F and administered within in a time frame of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received 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 was received from a pharmacy technician (other) refers to multiple patients of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the multiple patients were vaccinated with RECOMBIVAX HB lot # L025738 exp: 14-AUG-2017 that was stored improperly at a temperature of 1.1 degree Celsius within a time frame of 45 minutes. Previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 29-JAN-2016, the patient was vaccinated with expired dose of ZOSTAVAX (dose, frequency and route of administration were not reported, lot # K016324 with expiration date: 24-DEC-2015) as prevention of shingles. 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 healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored M-M-R II lot # K002527 exp: 18-FEB-2016. The vaccine was stored at 47F and administered within a time from of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses of VAQTA (lot # L008665, expiry date 10-FEB-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three 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 was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses of M-M-R II (lot # K022285, expiry date 12-NOV-2016 and lot # L012482, expiry date 10-APR-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker 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 09-DEC-2015, the patient as vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period and the estimated delivery date were not known. The pregnancy outcome was pending. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Alpha 1 foetoprotein normal, Amniotic cavity infection, Antibody test negative, Blood glucose normal, Caesarean section
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker 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 09-DEC-2015, the patient as vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period and the estimated delivery date were not known. The pregnancy outcome was pending. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Complication of delivery, Congenital anomaly, Maternal exposure before pregnancy, Pregnancy test positive, Pyrexia
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker 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 09-DEC-2015, the patient as vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period and the estimated delivery date were not known. The pregnancy outcome was pending. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Streptococcus test positive, Toxoplasma serology negative, Ultrasound antenatal screen normal, Varicella virus test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker 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 09-DEC-2015, the patient as vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period and the estimated delivery date were not known. The pregnancy outcome was pending. No adverse symptoms were reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 week old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-JAN-2016, at the age of 23 weeks, the patient was administered the first dose of ROTATEQ (lot # L020859, expiry date 19-JAN-2017, orally). No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia, Tremor
Clinical narrative: My daughter got her last GARDASIL vaccine yesterday. Woke up with shakes through the night and it very dizzy today. Feels feverish.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: My daughter experienced extreme thinning of her hair after having the GARDASIL vaccine about 5 years ago. It has not grown back. Thyroid testing was normal. Her hair was very thick before the vaccine, and now you can see her scalp.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K006681, expiration date on 21-OCT-2015 (dose and route were not provided). There was no concomitant medication described. No adverse effects were reported. 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 healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored oral, ROTATEQ lot # L004453 exp:27-MAY-2016. The vaccine was stored at 47F and administered within a time frame of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding his medical history, concurrent condition and concomitant therapy was not provided. Reporting nurse practitioner stated that she noted on an unspecified date, the patient may have been vaccinated with a third dose of M-M-R II (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to an approximately 20 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-OCT-2008, the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). It was reported that the patient received the second dose of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported) in the human papillomavirus (HPV) vaccines series on 29-OCT-2015 (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Seizure
Clinical narrative: Pt had HPV #1 done 9/9/15 - had seizure on 10/11/15. There is no specific correlation b/w (2) however neurology can also not explain the sudden seizure.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse (LVN) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the patients were administered improperly stored doses of ROTATEQ (lot # L013202, expiration date 27-JAN-2017) (dosage and strength unknown) (temperature 30.6 degree F, time frame: 63 hours) orally. No adverse effect was reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received a ZOSTAVAX vaccine at our facility on 1/21/16. Approximately 24 hours later, his arm swelled up and was in considerable pain. Physician confirmed it was allergic in nature and suggested BENADRYL. Sx resolved approximately 10 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 65 year old female patient with lymphoma and none history of drug reactions or allergies. Approximately on July 2015 (reported as: 6 months ago) the patient was vaccinated with a dose of PREVNAR 13. On 28-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot # K020215, expiration date: 15-MAY-2016, (dose number and anatomical place of vaccination were not reported). The patient was not taking any concomitant medication. On 28-JAN-2016, the patient developed supraclavicular and axillary swelling on her left side (local swelling), so the patient sought for medical attention, but no treatment was given for the local swelling. The Nurse reported there was no injection site reaction. At the time of the report, the outcome of the local swelling was reported as not recovered. The reporter did not provide a causality assessment and no product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored M-M-R II (incorrect product storage) (lot # L015279, expiration date 30-APR-2017, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Cephalexin 500mg 1 po BID x 10 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site reaction, Pyrexia, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a physician via Pfizer (MFR # 2015305092), and refers to a 67 year old female patient allergic to sulfa. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, route, anatomic site of administration, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date, after the PNEUMOVAX 23 administration, the patient experienced an allergy, fever, vomiting and welts at the injection site. At the time of the report, the outcome of all events was unknown. The relatedness between the events and the PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Racing heart and lightheadedness, resolved spontaneously, blood work nml.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Palpitations
Clinical narrative: Racing heart and lightheadedness, resolved spontaneously, blood work nml.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse referring to a male patient of unknown age. No medical history or concurrent conditions were reported. On 21-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 dose 1 (strength, route and lot number were not provided). Concomitant medication was not reported. On 27-JAN-2016, the patient was vaccinated accidentally with a second dose of PNEUMOVAX 23 (strength, route and lot number were not provided). No adverse effect was reported. It was also reported that no product quality complain was involved. The patient's outcome 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 Licensed Practical Nurse referring to unspecified numbers of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (dose and route unspecified) (lot # K011188, expiry date 12-AUG-2016, lot # L012481, expiry date 10-APR-2017, unspecified doses). No adverse effects were 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 was received from a nurse concerning an unspecified number of patients of unknown age and gender. Pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients received an unspecified dose of PROQUAD (Lot # L002420; expiration date 23-JUL-2016) (route not reported), which was improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1601USA011667). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 11-FEB-2015, the patient was vaccinated with VARIVAX (Merck) lot # L006385, expiration date- 25-FEB-2017, which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 9F, Time frame- less than 1 hour and there was temperature excursion earlier also. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # K009752, expiration date- 15-APR-2016, (incorrect product storage). No adverse event was reported. The outcome of event was unknown. Temperature was 10.5C, time frame- 2 hours and there was no temperature excursion earlier. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Information has been received from a certified medical assistant referring to a 53 year old female patient. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 22-JAN-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L029073, expired date 19-APR-2017, one single dose, subcutaneous) in the arm. On an unknown date in January 2016 the patient experienced pain in the arm at the injection site, decrease in range in motion of arm, had trouble moving her arm above head. The pain woke the patient up, that pain had worsen and was in the armpit at the time of reporting after receiving PNEUMOVAX 23. The patient was given TYLENOL as treatment. The outcome of the adverse events was reported as not recovered. The patient had called the physician for medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an other health professional referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients was vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L002215, expiration date 21-JAN-2017 or lot# L013824, expiration date 21-APR-2017). These doses of vaccine had been exposed under temperature 27F for 4 hours. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Feeling cold, Flushing, Injection site erythema, Nervousness
Clinical narrative: Patient complained of patchy redness on upper arm where shot was given. Experienced fever and chills. Flushing of face, burning of ears bit of swelling of tongue. Severe shaky. Patient took BENADRYL for face flushing; TYLENOL for fever.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Patient complained of patchy redness on upper arm where shot was given. Experienced fever and chills. Flushing of face, burning of ears bit of swelling of tongue. Severe shaky. Patient took BENADRYL for face flushing; TYLENOL for fever.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Joint crepitation, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Began Kw/pain in the arm after shot. Currently pt. unable to move arm and arm makes clicking sound. Current as of 2/1/2016. MRI scheduled for week of 1/31/2016.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 22-JAN-2016 the patient was administered with a dose of improperly stored MMR II (albumin status rHA, lot# L010488 and expiration date 26-MAR-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information it not expected since there was no consent for follow up contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-JAN-2016 the patient was administered with a dose of improperly stored M-M-R II (albumin status rHA, lot# L019989 and expiration date 01-JUN-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-JAN-2016 the patient was administered with a dose of improperly stored M-M-R II (albumin status rHA, lot# L010488 and expiration date 26-MAR-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot #: K007828, expiration date on 02-MAR-2017 and lot #: K011562, expiration date on 08-APR-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, Oral, route defaulted to oral, lot #: K016261, expiration date on 23-JUL-2016 and lot #: L008578, expiration date on 14-DEC-2016 (dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were unknown. It was reported that improperly stored doses of ZOSTAVAX Lot # L035285, expiry date 15-DEC-2016 (dose and route were not reported), were given to unspecified number of patients on unspecified dates. It was reported that the vaccine was at 4 degrees C of temperature and its time frame was 15 days/360 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Patient received the PPSV-23 vaccine 1/26/16 and presented back to the clinic on 1/28/16 c/o a rash and pruritus. RN Care Manager note states the rash was a pinpoint rash all over. These were patient's only signs/sx. He was given MEDROL dose pack from clinic stock and was instructed to purchase OTC PEPCID and ZYRTEC 10mg daily.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot #: L025737, expiration date on 28-JUL-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. 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 practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot #: L014458, expiration date on 11-FEB-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm is red, swollen, and hot to touch. The redness starts from the deltoid muscle to the elbow and the width of the arm.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Ear infection, Lethargy
Clinical narrative: High fever 104.5 four days after vaccination this continued to go up and down for 1 week. He was lethargic with fever. He had turned gray/greenish color and almost passed out - 6 days after vaccine. He had loose stools - low energy. His arm muscles were twitching with the fever. He had low white blood cell count. March 19, 2007 - varicella (VARIVAX) was administered - this was the only vaccine given at this well child appointment. March 23, 2007 - I called doctor's office because of high fever 104.5, lethargy and his arm muscles were twitching  - asked if this was a reaction to this vaccine. Doctor said it wasn't' typical of the vaccine said to make an appointment to be seen. March 27, 2007 - office visit doctor said not typical of vaccine but she also said she didn't know what was really going on. Doctor prescribed Amoxicillin in case there was something bacterial going on. (When I called to get these dates I was also told the doctor had a diagnosis of an ear infection in the right ear as the reason for prescribing the Amoxicillin. In my actual conversation with the doctor she said absolutely nothing about an ear infection, the only thing she said was she didn't know exactly, but to try an antibiotic in case it was something bacterial - no mention of ear infection). March 27, 2007 ordered 1st of 4 labs/blood test. March 28, 2007 phone call w/results indicated very low white blood cell count - 2.8. Doctor changed diagnosis to "viral". April 3 and 4, 2007 labs and results of labs - white blood cell count at 3.9. April 17, 2007 3rd lab test - white blood cell count at 4.0. June 3, 2007 4th lab results white blood cell count. I also reported this situation to the Health Department. In the process of all of these weeks and months of doctor office visits and blood work/labs we also sought help from a chiropractor who also recommended a immune boosting standard process IMMUNUPLEX supplement which we gave our son during this time to help boost his immune system. To our knowledge he did make a full recovery from this event. This has been a very frustrating situation for our family. With all that happened the doctor's office was in this denial that it had anything to do with this vaccine because "it didn't happen within the "normal" time frame of when a person could react" - every body is different and every body reacts whenever it is going to react, just because it's not "by the book" doesn't mean that our experience had nothing to do with this vaccine. My son reacted at day 4 and we were told a reaction usually occurs 7-10 days after..."by the book", therefore "no connection" I beg to differ. Why did his white blood cell count go so dangerously low? Why the fevers?
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Muscle twitching, Pyrexia, Skin discolouration, White blood cell count decreased
Clinical narrative: High fever 104.5 four days after vaccination this continued to go up and down for 1 week. He was lethargic with fever. He had turned gray/greenish color and almost passed out - 6 days after vaccine. He had loose stools - low energy. His arm muscles were twitching with the fever. He had low white blood cell count. March 19, 2007 - varicella (VARIVAX) was administered - this was the only vaccine given at this well child appointment. March 23, 2007 - I called doctor's office because of high fever 104.5, lethargy and his arm muscles were twitching  - asked if this was a reaction to this vaccine. Doctor said it wasn't' typical of the vaccine said to make an appointment to be seen. March 27, 2007 - office visit doctor said not typical of vaccine but she also said she didn't know what was really going on. Doctor prescribed Amoxicillin in case there was something bacterial going on. (When I called to get these dates I was also told the doctor had a diagnosis of an ear infection in the right ear as the reason for prescribing the Amoxicillin. In my actual conversation with the doctor she said absolutely nothing about an ear infection, the only thing she said was she didn't know exactly, but to try an antibiotic in case it was something bacterial - no mention of ear infection). March 27, 2007 ordered 1st of 4 labs/blood test. March 28, 2007 phone call w/results indicated very low white blood cell count - 2.8. Doctor changed diagnosis to "viral". April 3 and 4, 2007 labs and results of labs - white blood cell count at 3.9. April 17, 2007 3rd lab test - white blood cell count at 4.0. June 3, 2007 4th lab results white blood cell count. I also reported this situation to the Health Department. In the process of all of these weeks and months of doctor office visits and blood work/labs we also sought help from a chiropractor who also recommended a immune boosting standard process IMMUNUPLEX supplement which we gave our son during this time to help boost his immune system. To our knowledge he did make a full recovery from this event. This has been a very frustrating situation for our family. With all that happened the doctor's office was in this denial that it had anything to do with this vaccine because "it didn't happen within the "normal" time frame of when a person could react" - every body is different and every body reacts whenever it is going to react, just because it's not "by the book" doesn't mean that our experience had nothing to do with this vaccine. My son reacted at day 4 and we were told a reaction usually occurs 7-10 days after..."by the book", therefore "no connection" I beg to differ. Why did his white blood cell count go so dangerously low? Why the fevers?
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: 2.5 cm x 1 cm localized reaction. BENADRYL 10mg.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses ROTATEQ (lot # L013192, expiry date 19-JAN-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Upper (R) arm edema with erythema 10 cm x 7 cm warmth (most around the injection site scratched and 2nd cellulitis developed), distal to injection site redness.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Cough, Dyspnoea, Headache, Paraesthesia
Clinical narrative: Went on 1/18/16 in the afternoon to employee health received Hep B in upper (R) arm couple hours later had the following tingling legs, arms, headache, blurred vision, burning throat, chest pain, difficulty breathing, fever, cough.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Throat irritation, Vision blurred
Clinical narrative: Went on 1/18/16 in the afternoon to employee health received Hep B in upper (R) arm couple hours later had the following tingling legs, arms, headache, blurred vision, burning throat, chest pain, difficulty breathing, fever, cough.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Chest X-ray abnormal, Electrocardiogram normal, Fatigue, Respiration abnormal
Clinical narrative: On Jan 7th 2016, was given a TDAP vaccine, shot made me very tired, went home had a drink of grape juice, layed down and slept for 2hrs. When I awoke my breathing was worse and my inhalers are not helping like they were before shot. Anxiety is worse medication not helping as before.