chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for adminsitered dose was not specified by reporter, lot # may include: lot # L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016, lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports 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 an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for administered dose was not specified by reporter, lot # may include: lot # L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016 or lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with 8 doses of improperly stored (Merck) VARIVAX (lot # L012038 and expiration date 07-MAR-2017) (dose and route were not reported). No adverse effects were reported. No Product Quality complaint (PQC) was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an approximately 76-year-old female patient. The patient's medical history included shingles and prior history of post herpetic neuralgia pain in the right shoulder. The patient had no allergies and no drug reactions. On an unspecified date, in 2015 reported as "earlier this year", while she was suffering from shingles, she was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not provided). Concomitant therapies were not reported. On an unspecified date, in 2015, the patient experienced shingles again. At the time of this report, she was treated with prednisone (manufacturer unknown), acyclovir and ZITHROMAX. The outcome of the event was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age with allergy to tree nuts, pineapple, celery and latex. The patient did not have a history of chickenpox. On 27-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX vial (lot # L003215, expiry date 30-APR-2016), 0.65 ml, subcutaneously (SQ) as vaccination. On an unknown date in August 2015, the patient's arm which had received the vaccination then developed swelling. Additionally, the patient's face developed swelling. The patient went to an urgent care facility and was told she might possible be developing shingles. She was prescribed an unspecified antiviral medication. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of MMR II (albumin status of recombinant human albumin (rHA), dose and route were not reported, lot # K000174, expiry date 08-JAN-2016; lot # K011188, expiry date 12-AUG-2016; lot # K020189, expiry date 11-SEP-2016). Concomitant medications were not reported. No adverse reactions 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 initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant mediation or drug allergies/drug reactions described. On 11-SEP-2015, the patient was vaccinated with a dose of an improperly stored (Merck) VARIVAX injection (lot # L009203 with expiration date 17-MAR-2017; strength, dose and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 11-SEP-2015 the four month old patient was vaccinated with a dose of PNEUMOVAX 23 lot # K008409 with expiration date 04-MAR-2016, intramuscularly (dose and dose number were not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: The prospective pregnancy report, has been received from a nurse practitioner referring to a 18 year old female patient without pertinent medical history or drug reactions/allergies. On 08-SEP-2015, the patient was vaccinated with her second dose of (Oka/Merck) VARIVAX (Lot#, expiration date, dose and route were unknown) and GARDASIL (Lot#, expiration date, dose and route were unknown) both. There was no concomitant therapy taken. The reporter stated that after the patient received the vaccines, on the same day, a urine screening was done for pregnancy which showed a positive result. The patient became pregnant with last menstrual period (LMP) of 26-AUG-2015 and estimated delivery date (EDD) of 01-JUL-2016. Initial exposure to (Oka/Merck) VARIVAX and GARDASIL was at 2 weeks. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, doses of (Merck) VARIVAX (lot number L004653, expiration date 11-FEB-2017; route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients. No adverse experience had been reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was vaccinated intramuscularly with 0.5 ml dose of PNEUMOVAX 23 (lot number KK004542 and expiration date 19-AUG-2015) after the expiration date. Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patient of unknown age and gender. On unspecified dates, doses of GARDASIL (lot number K006124, expiration date 02-FEB-2017 and lot number "K001562", expiration date 08-APR-2017; route unspecified) dates, which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients. No adverse experience had been reported. Lot number K001562 is an invalid lot number for GARDASIL. 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 nurse regarding multiple unspecified 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 RECOMBIVAX HB, 56 mcg/0.5 ml, lot # J013394, expiration date 25-AUG-2016; lot # L004754, expiration date 10-NOV-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 fr om the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Information has been received from a medical assistant referring to a 23 year old female patient with none pertinent medical history and none drug reactions/allergies. On 02-SEP-2015 the patient was vaccinated with a dos of GARDASIL 9 (lot # L006547, expiration date: 04-MAR-2017, route and dose were unknown). Concomitant therapies included LO MINASTRIN FE, biotin and SOLODYN. On 11-SEP-2015, the patient started to have pain and difficulty ambulating with her right arm. Then the patient visited an urgent care center where x-rays were taken (results unknown) on an unknown date in September 2015. Two shots of an unspecified pain medication (dose and frequency unspecified) were administered, and an unspecified pain medication (unspecified dose and frequency) were prescribed. At the time of report, the outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner referring to a 23 years old unpregnant female patient. There were no pertinent medical history or drug reaction/allergies of the patient. On 20-AUG-2015 the patient was vaccinated with a dose of GARDASIL 9 (lot # L014198, expiration date 05-SEP-2017, dose was not reported) intramuscularly. Concomitant therapy included GILDESS FE. On 28-AUG-2015, the patient developed a swollen area at the site of the GARDASIL 9 injection. The patient went to the nurse practitioner's and started BENADRYL and naproxen for the swelling on an unknown date in 2015. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. The causality was not reported. 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 a patient of unknown age. There was no information about concurrent condition and historical medication. On 10-SEP-2015, the patient was vaccinated with improperly stored ROTATEQ lot # K006456, expiration date 08-MAR-2016 and lot # L000568, expiration date 10-JUL-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. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Disorientation, Hallucination, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Panic attack
Clinical narrative: Information has been received from a pharmacist referring to a currently 23 year old female patient who was not pregnant. No other relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an initial dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported). In May 2012 the patient was vaccinated with a "booster" dose of (Merck) VARIVAX (lot#, expiration date and route not reported). On unknown dates the patient presented with "severe mental hallucinations, problems with her ability with thinking, disorientation and panic attacks" after receiving the "booster" dose of (Merck) VARIVAX. The patient had a Magnetic Resonance Imaging (MRI) on an unknown date and was found to have her "grey matter affected". The patient went to the doctor to seek medical attention. The patient's mother reported that the patient was recovered on an unspecified date and had no further effects. Causality assessment was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Thinking abnormal
Clinical narrative: Information has been received from a pharmacist referring to a currently 23 year old female patient who was not pregnant. No other relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an initial dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported). In May 2012 the patient was vaccinated with a "booster" dose of (Merck) VARIVAX (lot#, expiration date and route not reported). On unknown dates the patient presented with "severe mental hallucinations, problems with her ability with thinking, disorientation and panic attacks" after receiving the "booster" dose of (Merck) VARIVAX. The patient had a Magnetic Resonance Imaging (MRI) on an unknown date and was found to have her "grey matter affected". The patient went to the doctor to seek medical attention. The patient's mother reported that the patient was recovered on an unspecified date and had no further effects. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with an improperly stored dose of (Merck) VARIVAX (lot # J014152, expiration date 06-JAN-2017; lot # L008270, expiration date 11-MAR-2017; lot # L015046, expiration date 29-APR-2017 or lot # J014152, expiration date 07-NOV-2015) (strength, dose and route were not reported). No adverse effects reported. It was unspecified if the patients sought medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist directly and via agency (case # US15042779) and refers to a 13 month old male patient. The patient was normally a healthy child. No information about his pertinent medical history, past drug history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 11-SEP-2015, the patient was inadvertently vaccinated with both: the first dose of (Oka-Merck) PROQUAD (dose, route of administration, lot#, expiration date were unknown) and a dose of (Oka/Merck) VARIVAX (also reported as "unknown vaccine containing varicella") (dose, route of administration, lot#, expiration date were unknown) during his 12-month well child visit. The patient did not have any reactions. No adverse effect was reported. It was unknown if any relevant lab work was performed and if the patient will continue on the (Oka-Merck) PROQUAD or the (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Dyspepsia, Dysuria, Erythema
Clinical narrative: Wednesday 9/2/15 - redness at injection site. Thursday 9/3/15 - Large (2) hives on right hip. Red line down spine, and larger area of redness and warmth around injection site. Injection site stung and itched. Was sick to stomach, little lightheaded, which continued through Friday. On Friday 9/4/15 still had all the above symptoms, but it would burn and hurt to urinate and was very tender in that area. Saturday 9/5 and Sunday 9/6/15 - still had all above symptoms, but also had heartburn, it hurt to take a deep breath and had lots of chest tightness. I was so bad on Sunday evening with tightness in my chest that I was contemplating going to emergency. 9/8/15 - One week later, still have hives on hip, somewhat painful urinating, chest tightness doesn't seem to be like it was on Sunday, and injection site still a little red and stinging off and on.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Nausea
Clinical narrative: Wednesday 9/2/15 - redness at injection site. Thursday 9/3/15 - Large (2) hives on right hip. Red line down spine, and larger area of redness and warmth around injection site. Injection site stung and itched. Was sick to stomach, little lightheaded, which continued through Friday. On Friday 9/4/15 still had all the above symptoms, but it would burn and hurt to urinate and was very tender in that area. Saturday 9/5 and Sunday 9/6/15 - still had all above symptoms, but also had heartburn, it hurt to take a deep breath and had lots of chest tightness. I was so bad on Sunday evening with tightness in my chest that I was contemplating going to emergency. 9/8/15 - One week later, still have hives on hip, somewhat painful urinating, chest tightness doesn't seem to be like it was on Sunday, and injection site still a little red and stinging off and on.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Tenderness, Urticaria
Clinical narrative: Wednesday 9/2/15 - redness at injection site. Thursday 9/3/15 - Large (2) hives on right hip. Red line down spine, and larger area of redness and warmth around injection site. Injection site stung and itched. Was sick to stomach, little lightheaded, which continued through Friday. On Friday 9/4/15 still had all the above symptoms, but it would burn and hurt to urinate and was very tender in that area. Saturday 9/5 and Sunday 9/6/15 - still had all above symptoms, but also had heartburn, it hurt to take a deep breath and had lots of chest tightness. I was so bad on Sunday evening with tightness in my chest that I was contemplating going to emergency. 9/8/15 - One week later, still have hives on hip, somewhat painful urinating, chest tightness doesn't seem to be like it was on Sunday, and injection site still a little red and stinging off and on.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were4 vaccinated with RECOMBIVAX HB that was improperly stored (dose, strength and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for RECOMBIVAX HB was K010535 with expiration date on 27-AUG-2016. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with (Merck) VARIVAX that was improperly stored (dose, strength and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for (Merck) VARIVAX was L001333 with expiration date on 13-Jan-2017. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates,  between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with PNEUMOVAX23 that was improperly stored (dose, strength, and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for PNEUMOVAX23 was K006681 with expiration date on 21-OCT-2015. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified doses VAQTA (lot # K005958, expiry date: 09-FEB-2017) that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1509USA008456, 1509USA009767, 1509USA009768 and 1509USA009769 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with ROTATEQ that was improperly stored, oral route (dose and strength were not provided). Co-suspect or concomitant therapies were not reported. The lot numbers reported for ROTATEQ were: L000569 with expiration date on 13-JUL-2016, K009753 with expiration date on 28-APR-2016 and K014826 with expiration date on 28-MAY-2016. This is one of several reports from the same source. 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 nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified doses of GARDASIL (lot # K006117, expiry date: 14-JAN-2017) immunization series that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA009766, 1509USA009767, 1509USA009768 and 1509USA009769 (same reporter link). 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 nurse refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL lot # J010668 expiration date 29-APR-2016, Lot # K006124 expiration date 02-FEB-2017, Lot # K007264 expiration date 02-MAR-2017 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that Department of Health requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX23 lot # K004483 expiration date 16-AUG-2015 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that Department of Health requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on  unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator.  No adverse effects reported. This is one of several reports 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 nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot # J007946, expiration date 24-MAR-2016, lot # J014855 expiration date 16-APR-2016, lot # K008334,  expiration date 09-JUN-2016 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that Department of Health requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports 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 as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ (dose and route were not reported, lot # K020182, expiry date 25-JUN-2016; lot # L008053, expiry date 30-NOV-2016). concomitant medications were not reported. No adverse reactions 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified number of patients were inadvertently vaccinated with improperly stored doses (also reported as 10 doses in total of all administered vaccines) of (Merck) VARIVAX (dose and route of administration were not reported; lot #L013068 with expiration date on 14-APR-2017). No adverse effects were 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified number of patients were inadvertently vaccinated with improperly stored doses (also reported as 10 doses in total of all administered vaccines) of PROQUAD (dose and route of administration were not reported; lot #L019997 with expiration date on 02-DEC-2016 and lot #L005293 with expiration date on 17-AUG-2016). No adverse effects were 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, since 03-AUG-2015 the patients had been administered doses of (Merck) VARIVAX (lot number L012038 with expiration date of 07-APR-2017, dose, strength and route unknown), which underwent a supported temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old female patient. In June 2015, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Other suspect therapies included MENACTRA (doses, route and lot numbers were not reported). In June 2015, the patient experienced Bell's palsy. The patient sought medical attention-she had an office visit. Treatment given for adverse event included unspecified steroids. The patient recovered from adverse event on an unknown date in 2015. Relatedness between the event and the suspect products was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of (Merck) VARIVAX (dose and route were not reported, lot # L017146, expiry date 13-MAY-2017; lot # L008270, expiry date 11-MAR-2017). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # K009753 with expiration date 28-APR-2016 and lot # K024700 with expiration date 30-JUL-2016; dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K010215 with expiration date 05-MAY-2017, lot # K006117 with expiration date 14-JAN-2017 and lot # K010574 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K019560 with expiration date 02-JUN-2017 and lot # K005958 with expiration date 09-FEB-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse and registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX23 (lot # K006681 with expiration date 21-OCT-2015; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL 9. No adverse event was reported. The outcome was unknown. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates since 03-AUG-2015 the patients had been administered doses of PROQUAD (lot # L009210 with expiration date of 17-SEP-2016, dose, strength and route unknown), which underwent a supported temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUN-1992, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot # and expiration date not reported). On 11-APR-1996, she received the second dose of M-M-R II (dose, route of administration, lot # and expiration date not reported). On 20-MAY-2013, the patient was vaccinated with third dose of M-M-R II (dose, route of administration not reported) lot # H014989, expiration date 10-AUG-2014. On 05-AUG-2013, she received the fourth dose of M-M-R II (dose, route of administration not reported), lot # H014989, expiration date 10-AUG-2014. On an unknown date after the administration of all doses of M-M-R II, the patient was tested for measles antibody with a negative result. No adverse effect was reported. The outcome of measles antibody negative and the relatedness between this event and M-M-R II were not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastritis
Clinical narrative: This spontaneous report was received from a 58-years-old female patient via company representative. The patient was reporting on herself. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml/injection, subcutaneously, to "prevent shingles" (lot# and expiration date were not reported). Concomitant medications were not provided. On an unknown date (reported as "after the patient received her ZOSTAVAX"), the patient developed gastritis, which was treated with an unspecified treatment. The patient's present status was reported as recovering at the time of the report. The patient sought medical attention - she called her doctor. The relatedness between gastritis and ZOSTAVAX was not 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 healthcare worker referring to an unspecified number of patients of unknown age and gender. No medical history or drug reaction/allergies was reported.  On unknown dates since 13-AUG-2015, doses of PNEUMOVAX23 (pre-filled syringes, lot# L002310 with expired date 08-JUL-2016, dose and route were unknown), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients. No concomitant medication was reported. The reporter was not aware of any adverse effects. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria onset shortly after injection.  Worsening over the next several hours, seen in the emergency room at 2230, treated with diphenhydramine and methylprednisolone.
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Crying, Pyrexia, Urticaria
Clinical narrative: Fever followed by full body hives, consistent crying for over 3 hours.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Chills, Rash
Clinical narrative: Weak, Chill, Rash.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching throughout body, mainly back, head, palms of hands. Taking Benadryl.
Age: 1.45
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Asthenia, Extra dose administered, Lethargy, Pyrexia
Clinical narrative: Child started with fever with a max temp of 103F. Child continued with fever, lethargy, weakness x 2 weeks. child was given MMRV AND Varicella vaccine same day. So child received extra Varicella vaccine.
Age: 65.0
Sex: F
Vaccine: JEVX
Symptoms: Cough, Dysphonia, Eye pruritus, Fatigue, Headache
Clinical narrative: Soreness of shot area, hoarseness, sore swollen throat, red itchy eyes, cough, aches, headache (I worn sunglasses because light made it worse), fatigue, runny and congested nose. First reaction I have had to a vaccine.
Age: 65.0
Sex: F
Vaccine: JEVX
Symptoms: Injection site pain, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Soreness of shot area, hoarseness, sore swollen throat, red itchy eyes, cough, aches, headache (I worn sunglasses because light made it worse), fatigue, runny and congested nose. First reaction I have had to a vaccine.
Age: 65.0
Sex: F
Vaccine: JEVX
Symptoms: Pharyngeal oedema, Photophobia, Rhinorrhoea
Clinical narrative: Soreness of shot area, hoarseness, sore swollen throat, red itchy eyes, cough, aches, headache (I worn sunglasses because light made it worse), fatigue, runny and congested nose. First reaction I have had to a vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: RED BUMP ABOUT THE SIZE OF A QUARTER THAT GREW TO 4CM IN DIAMETER BY THE NEXT DAY (9/19/15).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site about the size of a quarter.  No itching or discomfort.  Patient sat and relaxed and swelling decreased slightly.  Patient took his BP at the pharmacy and it was 135/84 (he is not sure what his normal BP is).  Patient felt fine when he left the pharmacy after 15min or so but was instructed to watch for signs/symptoms and to call MD if necessary and to call us with any questions.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Headache, Pain
Clinical narrative: Aches all over my body; headache, extremely tired, very hot (but did not take temp).
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Patient came in and stated that on 9/17/15 her arm was swollen and painful. She states that she could not lift her arm all the way up and had a small bump on her arm.
Age: 0.17
Sex: M
Vaccine: DTPPHIB, PPV, RVX
Symptoms: Blood culture, Chest X-ray, Crying, Culture urine, Irritability
Clinical narrative: Infant received her 3 month shots at 3:15PM. She was given 3 shots and one oral vaccination. Infant started to get fussy around 9PM. By 1130Pm infant was screaming everytime she was moved. Infant woke to nurse at 1AM and at that time temperature was taken under her armpit using a digital termometer. Her temp at 1:15AM was 103.3. Infant was then rushed to the ER. She was would go from screaming to lethargic during the drive to the hospital. Once at the hospital her fever was taken once again under the arm. Temp at that time was 38.9. She was given Tylenol to bring the fever down. Doctors drew blood, blood cultures, urine, spinal and a chest x ray. Infant was stuck over twelve times in order to get an IV line. She was given two antibiotics IM because they were unable to start a line. Infant was also given a MRI to rule out stroke. During this whole time she would scream and cry. Very stressful for her. She was admitted onto the general medical ped unit. She was treated with antibiotics and fluids.
Age: 0.17
Sex: M
Vaccine: DTPPHIB, PPV, RVX
Symptoms: Lethargy, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Screaming
Clinical narrative: Infant received her 3 month shots at 3:15PM. She was given 3 shots and one oral vaccination. Infant started to get fussy around 9PM. By 1130Pm infant was screaming everytime she was moved. Infant woke to nurse at 1AM and at that time temperature was taken under her armpit using a digital termometer. Her temp at 1:15AM was 103.3. Infant was then rushed to the ER. She was would go from screaming to lethargic during the drive to the hospital. Once at the hospital her fever was taken once again under the arm. Temp at that time was 38.9. She was given Tylenol to bring the fever down. Doctors drew blood, blood cultures, urine, spinal and a chest x ray. Infant was stuck over twelve times in order to get an IV line. She was given two antibiotics IM because they were unable to start a line. Infant was also given a MRI to rule out stroke. During this whole time she would scream and cry. Very stressful for her. She was admitted onto the general medical ped unit. She was treated with antibiotics and fluids.
Age: 0.17
Sex: M
Vaccine: DTPPHIB, PPV, RVX
Symptoms: Stress
Clinical narrative: Infant received her 3 month shots at 3:15PM. She was given 3 shots and one oral vaccination. Infant started to get fussy around 9PM. By 1130Pm infant was screaming everytime she was moved. Infant woke to nurse at 1AM and at that time temperature was taken under her armpit using a digital termometer. Her temp at 1:15AM was 103.3. Infant was then rushed to the ER. She was would go from screaming to lethargic during the drive to the hospital. Once at the hospital her fever was taken once again under the arm. Temp at that time was 38.9. She was given Tylenol to bring the fever down. Doctors drew blood, blood cultures, urine, spinal and a chest x ray. Infant was stuck over twelve times in order to get an IV line. She was given two antibiotics IM because they were unable to start a line. Infant was also given a MRI to rule out stroke. During this whole time she would scream and cry. Very stressful for her. She was admitted onto the general medical ped unit. She was treated with antibiotics and fluids.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea and Shortness of Breath Monday night (night of administration) and all Tuesday (day after administration).
Age: 52.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Initial fatigue, nausea and lightheadedness at 3:00 PM, onset of muscle aches at 6:00 PM, on 9/17 woke up with severe headache, muscle ache, nausea and fever of 101 degrees.  Symptoms unchanged throughout day of 9/17.  9/8 which was day 2, woke up without fever but ongoing muscle ache, slight headache, fatigue.  9/19, today, only light muscle ache, no fever, slightly sweaty, fatigued.
Age: 52.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Nausea, Pyrexia
Clinical narrative: Initial fatigue, nausea and lightheadedness at 3:00 PM, onset of muscle aches at 6:00 PM, on 9/17 woke up with severe headache, muscle ache, nausea and fever of 101 degrees.  Symptoms unchanged throughout day of 9/17.  9/8 which was day 2, woke up without fever but ongoing muscle ache, slight headache, fatigue.  9/19, today, only light muscle ache, no fever, slightly sweaty, fatigued.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Papule
Clinical narrative: Patient reports experiencing papules on various areas of skin in the days after receiving vaccine, papules not near or at injection site.  Papules resolved after a few days with no residual scars or redness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Papule
Clinical narrative: Patient reports via spouse that she experienced papules on various area of skin in days following vaccination, not near or at site of vaccine injection however.  Papules resolved.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Very sore arm (painful to move), Nausea, diarrhea, headache.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Very sore arm (painful to move), Nausea, diarrhea, headache.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: Very sore arm (painful to move), Nausea, diarrhea, headache.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Very sore arm (painful to move arm), nausea, headache.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Very sore arm (painful to move arm), nausea, headache.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: Very sore arm (painful to move arm), nausea, headache.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Lip swelling, Paraesthesia
Clinical narrative: Patient woke up the following day with for lip slightly swollen and tingling all over her face.  The symptoms did not go away, she called us on 09/19/2015 at 10am for advice.  Patient had problems with Benadryl in the past so she decided to have a doctor visit.  MD prescribed Medrol 4mg dosepak.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Paraesthesia oral, Rash
Clinical narrative: Tingling around lips, rash to bilateral upper shoulders, rash to bilateral palms.