chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a Nurse referring to an unspecified number of patients with not ages and genders reported. Patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that since 05-SEP-2017 the patients were administered Improperly Stored PEDVAXHIB (strength, route of administration and dose were not reported) lot # N003537 indicated for prophylaxis. The temperature of storage was reported as 32 Fahrenheit degrees to 35 Fahrenheit degrees, for a time frame of 9 hours and 12 min. Previous temperature excursion was not reported. Digital Data logger was involved. No adverse event was reported. The outcome of the improper storage was reported as Supported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008048.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M044717 expiration date: 19-JUL-2019 and lot # N002720 expiration date: 12-MAY-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that the incorrect product storage had a time frame of 16 hours at 31°F or colder (21.7 °F). This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008873:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were most likely vaccinated with doses of improperly stored M-M-R II (rHA) lot # M028130, expiration date of 03-JUN-2018 or lot # M049212, expiration date of 16-DEC-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9.8  Celcius degrees for 1 hour. Previous temperature excursion was reported: 14.7 Celcius degrees for 3 hours. Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1709USA006502:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. On an unknown date the patients were vaccinated with PEDVAXHIB lot # M027882 (Expiration date: 14-APR-2019), M032147 (Expiration date: 14-APR-2019), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: Temperature: 32°F to 35°F; Time frame: 8 hours. Previous temperature excursion: No. No adverse were events reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008707.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a Nurse referring to an unspecified number of patients with not ages and genders reported. Patients medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that since 05-SEP-2017, the patients were administered Improperly Stored GARDASIL 9 (strength, route of administration and dose were not reported) lot # M042853; indicated for prophylaxis.The temperature of storage was reported as 32 Fahrenheit degrees to 35 Fahrenheit degrees, for a time frame of 9 hours and 12 min. Previous temperature excursion was not reported. Digital Data logger was involved. No adverse event was reported. The outcome of the improper storage was reported as Supported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA004102:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of M-M-R II lot number M039904 with expiration date of 26-SEP-2018 and lot number M045390 with expiration date of 14-NOV-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported). The administered doses experienced a temperature excursion of 60 degree Fahrenheit for 4 weeks; data logger was involved. No previous temperature excursion was reported. No adverse events were reported and no product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009559: US-009507513-1709USA009560:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (dosage and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion of -1°C or colder for a time frame of 15 minutes because of data logger. There was no previous temperature excursion. No adverse effects were reported.; Sender's Comments:  US-009507513-1709USA010108:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003698 expiration date: 31-OCT-2019 and lot # N003700 expiration date: 01-NOV-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that the incorrect product storage had a time frame of 16 hours at 31°F or colder (21.7 °F). This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005611:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring an unknown number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, since 12-SEP-2017, the patients were vaccinated with improperly stored dose of VARIVAX lot # N014369 with expiration date of 09-MAY-2019 and lot # N014630 with expiration date of 11-MAY-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 15°F (degrees Fahrenheit) to 46°F (32F) for 1 hour; no previous temperature excursion was done. The call was because of a "data logger".
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 21 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). It was reported that, between 15-AUG-2017 and 18-SEP-2017, patients received 21 separate doses of improperly stored VARIVAX reported lot# N00204 with expiration date of 19-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of -9°C (degrees Celsius) to 8°C for 1 hour and 6 minutes; previous temperature excursion was -9°C to 8°C for 1 hour and 54 minutes (worst case). The call was because of a "data logger". Lot number N00204 is an invalid lot number for varicella virus vaccine live (oka/merck). Sender's Comments: US-009507513-1709USA010133.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Since 06-SEP-2017, the patients were vaccinated with M-M-R II (lot # M034387 with expiration date 19-JUL-2018) rHA (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 1 hour and 20 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009573:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) lot # N000383, expiration date on 28-JUN-2019. On 18-SEP-2017, the patient was vaccinated with an expired dose of PROQUAD lot # M010476 expiration date on 01-SEP-2017 (strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effect were reported.
Sex: U
Vaccine: FLUX, MMR, UNK
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, during the same office visit, the patient was vaccinated with 1 dose of M-M-R II with sterile diluent (MERCK) in the left thigh (dosage, lot number and expiration date were not reported) for prophylaxis; with 1 dose of influenza virus vaccine (unspecified) in the left thigh (dosage, lot number and expiration date were not reported) for prophylaxis; and 2 other unspecified vaccines (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, about 4 days later, the patient got a rash at the injection sites of the M-M-R II and influenza virus vaccine (unspecified). The outcome of injection site rash was not reported. The causal relationship between the event injection site rash and the suspect therapies M-M-R II, sterile diluent (MERCK), influenza virus vaccine (unspecified) and unspecified vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a 27 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dosage, route, lot number and expiration date were not reported) for prophylaxis. The pharmacy technician reported that on an unknown date, the patient received the second dose of GARDASIL 9 (dosage, route, lot number and expiration date were not reported) "1 year after first dose of GARDASIL 9"  (inappropriate schedule of drug administration). No adverse effects reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with PEDVAXHIB lot # M036612 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of GARDASIL lot number reported as M044717 with expiration date of 19-JUL-2017, lot number reported as N007931 with expiration date of 17-NOV-2019, and lot number reported as M041990  with expiration date 28-JUN-2019, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported).  The administered doses experienced a temperature excursion of 60 degree Fahrenheit for 4 weeks; data logger was involved. No previous temperature excursion was reported. No adverse events were reported and no product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009560: US-009507513-1709USA008052:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # M032636 with expiration date of 06-APR-201, lot # M044030 with expiration date of 13-JUN-2018; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees Centigrade degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009565: US-009507513-1709USA009566: US-009507513-1709USA009276.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified multiple patients.     There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # M035487 with expiration date of 23-FEB-2019, lot# M044031 with expiration date of 01-FEB-2019, lot# N009802 with expiration date of 19-DEC-2019 and lot# M036156 with expiration date of 23-FEB-2019; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009566: US-009507513-1709USA009276:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was administered with a dose of GARDASIL at the age of 12 year old. Then, on an unspecified date in 2016, the patient received a dose of GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified for both vaccines) for prophylaxis (interchange of vaccine products). No adverse effects were reported. no product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX with lot number M038351 and expiration date on 06-DEC-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using a properly stored sterile diluent (lot number and expiration date were not provided). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees (20 F) for 9 hours. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse (also reported as medical assisstant) referring to an unspecified amount of unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. From  01-JUL-2017 until 19-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014371, expiration date 09-MAY-2019, subcutaneously (strength and dose were not provided) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent(manufacturer unknown). On an unspecified date, the vaccines were exposed to temperature ranges between -9° Celcius (C) to 8°C during a time frame of 10 hours. There was previous temperature excursion from -9°C to 8°C, during a time frame of 11 hours 30 minutes. The temperature excursion was called by a data logger. Adverse effects were not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant therapies were not reported. From 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M038572, expiration date 11-MAR-2018 (dosage and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion of -1°C or colder for a time frame of 15 minutes because of data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1709USA008713.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified amount of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M042172 and expiration date on 08-JUN-2018, (dose was no provided) for prophylaxis. The doses of ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010123: US-009507513-1709USA009967.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified amount of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N019923 and expiration date on 28-APR-2019 (dose and route of administration were no provided) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009967: US-009507513-1709USA010122:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 2 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). It was reported that, between 15-AUG-2017 and 18-SEP-2017, patients received 2 separate doses of improperly stored ZOSTAVAX lot# M035147 with expiration date of 25-OCT-2017, for prophylaxis (strength, dose, route and frequency were not reported).  No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of -9°C (degrees Celsius) to 8°C for 1 hour and 6 minutes; previous temperature excursion was -9°C to 8°C for 1 hour and 54 minutes (worst case). The call was because of a "data logger". Sender's Comments: US-009507513-1709USA009333.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. In 2017 the patients were vaccinated with M-M-R II lot # M000768 for prophylaxis.    Concomitant therapies included sterile diluent. In 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. Sender's Comments: US-009507513-1709USA009319.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Insomnia, Myalgia, Pyrexia, Restless legs syndrome
Clinical narrative: Fever, chills, muscle aches, restless legs, insomnia.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site reaction, Muscular weakness, Myalgia, Weight bearing difficulty
Clinical narrative: This was the patient's first flu shot, however, she has had other vaccinations. She received the shot on 9/15/17 and experienced as expected muscle tenderness the day of the shot. Starting the next day she began to experience periods of muscle numbness at the site of injection which reached from her shoulder to elbow. She said the numbness comes and goes but she experiences weakness during the numbness. She approached me on 9/21/17 saying this has been going on a few days now and it seems to be worse today. She is an employee at the store and has noticed difficulty lifting heavier objects. I counseled her on the fact that there is a risk of rare but serious side effect that starts with muscle numbness/weakness and told her that if the symptoms have been progressing she should seek medical attention from a physician. She declined seeing an MD and informed me she currently has no health insurance so she is going to give it a few more days and see how it progresses because she doesn't want to pay out of pocket if she does not have to. Told her she can follow up with any of the pharmacists here with any other questions.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Contusion, Pain in extremity, Pyrexia
Clinical narrative: Youth had pain and small bruise on L arm, Had fever to 101.5 a few hours after vaccine given.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Hypersomnia, Lethargy
Clinical narrative: Fatigue, weakness, lethargy, sleeping for 14+ hours for about 5 days following immunization. Patient states these symptoms are more severe compared to her past experience with influenza vaccines.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: PATIENT HAD SYNCOPAL EPISODE IMMEDIATELY FOLLOWING THE ADMINISTRATION OF 4 INJECTIONS. PATIENT OPENED EYES AND WAS ABLE TO TALK WITHIN SECONDS FOLLOWING THE EPISODE. (PASSED OUT AND WOKE UP IMMEDIATELY).
Age: 32.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting. Subjective fever. Supportive treatment (ZOFRAN and rest).
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pruritus
Clinical narrative: After observation, patient reported some nausea and itching. Patient went home and reported that they were going to take BENADRYL.
Age: 40.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Arthralgia, Fatigue, Headache, Injection site swelling, Myalgia
Clinical narrative: Swelling of injection site the size of half a baseball, overall joint pain, muscle soreness, fatigue, headache that would last for 1-2 weeks.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient noticed a rash to the anterior left side of her neck.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Diarrhoea, Ear pain, Immediate post-injection reaction, Pain in extremity, Pyrexia
Clinical narrative: Hives immediately, ear aches and diarrhea within3-4 days, waking up screaming about her leg hurting5-7 days after. High fever 8 days after. Bumps showing back up near where the hives were from by the MMR vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Rash, Screaming, Urticaria
Clinical narrative: Hives immediately, ear aches and diarrhea within3-4 days, waking up screaming about her leg hurting5-7 days after. High fever 8 days after. Bumps showing back up near where the hives were from by the MMR vaccine.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dysstasia, Heart rate increased, Injected limb mobility decreased
Clinical narrative: States went directly home after vaccination at Health Department, felt nauseated and vomited upon arrival at home, which was approximately 1/2 hour after vaccine administration. States felt "very weak and extremely dizzy", felt heart palpitations and rapid heart rate, went to lay down and woke up approximately 12 hours later needing to void. Was unable to stand due to vertigo, had to lay back down and wait until morning. Was able to stand the next morning but "barely" could tolerate being upright and standing. Legs were extremely weak. States was still experiencing some vertigo but was able to make it to bathroom. Right arm injection site extremely edematous, red and warm, arm also extremely sore and difficult to move. States "feels like I'm getting pneumonia, there's stuff in my chest, I can feel it in there." Also states "I didn't feel like this before", states "I took some Mucinex and that seems to be helping loosen whatever's in there up".
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Muscular weakness, Nausea
Clinical narrative: States went directly home after vaccination at Health Department, felt nauseated and vomited upon arrival at home, which was approximately 1/2 hour after vaccine administration. States felt "very weak and extremely dizzy", felt heart palpitations and rapid heart rate, went to lay down and woke up approximately 12 hours later needing to void. Was unable to stand due to vertigo, had to lay back down and wait until morning. Was able to stand the next morning but "barely" could tolerate being upright and standing. Legs were extremely weak. States was still experiencing some vertigo but was able to make it to bathroom. Right arm injection site extremely edematous, red and warm, arm also extremely sore and difficult to move. States "feels like I'm getting pneumonia, there's stuff in my chest, I can feel it in there." Also states "I didn't feel like this before", states "I took some Mucinex and that seems to be helping loosen whatever's in there up".
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Palpitations, Respiratory tract congestion, Vertigo, Vomiting
Clinical narrative: States went directly home after vaccination at Health Department, felt nauseated and vomited upon arrival at home, which was approximately 1/2 hour after vaccine administration. States felt "very weak and extremely dizzy", felt heart palpitations and rapid heart rate, went to lay down and woke up approximately 12 hours later needing to void. Was unable to stand due to vertigo, had to lay back down and wait until morning. Was able to stand the next morning but "barely" could tolerate being upright and standing. Legs were extremely weak. States was still experiencing some vertigo but was able to make it to bathroom. Right arm injection site extremely edematous, red and warm, arm also extremely sore and difficult to move. States "feels like I'm getting pneumonia, there's stuff in my chest, I can feel it in there." Also states "I didn't feel like this before", states "I took some Mucinex and that seems to be helping loosen whatever's in there up".
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Upper Arm is still painful as of 9/21.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD albumin status RHA, lot# N010866, expiration date 01-OCT-2018 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (also reported as 6.8 degrees Fahrenheit) for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA002037:
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This literature marketed report was received from the authors of published literature article and refers to a male pediatric patient of unknown age with natural killer T-cell deficiency. On an unknown date, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose and route of administration were not reported). On an unknown date, the patient experienced diffuse varicella infection. The outcome of the event was unknown. The reporter considered diffuse varicella infection to be related to varicella virus vaccine live (manufacturer unknown).
Sex: M
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was a physician and was reporting on himself. The patient's concurrent conditions included asthma and an allergy to animal dander. His concomitant medications included QVAR. On 12-SEP-2017, around 10:30 AM, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for pneumonia prophylaxis. On 12-SEP-2017, around 03:00 PM, the patient experienced shortness of breath. The symptoms resolved after use of a levalbuterol inhaler. On 13-SEP-2017, the patient experienced another bout of shortness of breath after a light workout. This time the event was not resolved by the use of the levalbuterol inhaler and the outcome was reported as not recovered/not resolved. The patient sought medical attention by calling his asthma specialist. No laboratory diagnostics were performed. The patient reported that he would use an albuterol nebulizer, which he expected would resolve his symptoms. The patient's asthma symptoms were well controlled prior to the PNEUMOVAX 23 vaccination. The relatedness between the events and the PNEUMOVAX 23 was not assessed by the reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 12-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M037655 and expiration date 29-NOV-2017 for prophylaxis (dose and route of administration were not reported).  Other suspect therapies included sterile diluent (MERCK). On 13-SEP-2017, the patient noticed on her arm a two inch round circular rash that was slightly red and warm. The patient sought medical attention. However, no treatment was given for the adverse events, none laboratories were performed. The outcome of the patient's red rash and warmth was reported as not recovered. The causal relationship between the events and therapy with ZOSTAVAX was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with incorrect storage doses of VARIVAX lot # M027886 and expiration date: 03-JUN-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot # M010689 and expiration date: 11-MAR-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that incorrect product storage had a time frame of 10 hours at 9° F; and the call was given because of a data logger. Previous temperature excursion had not occurred. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005003.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of one of the following incorrectly stored vaccines: VARIVAX lot # M045205 with expiration date 11-NOV-2017, lot# N014632 with expiration date 11-MAY-2019 and lot# N014632 (dose, route and anatomical location were not reported), or ZOSTAVAX lot# M041511 with expiration date 01-OCT-2018 (dose, route and anatomical location were not reported), or PROQUAD lot# N010866 with expiration date 01-OCT-2018, lot# N013864 with expiration date 31-OCT-2018, or lot# N015621 with expiration date 15-NOV-2018 (dose, route and anatomical location were not reported). The doses were stored in the range from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 49 minutes. There was no previous temperature excursion reported. No adverse event was reported. Digital data logger was involved.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year-old female patient. The patient was allergic to penicillin. She had no pertinent medical history or concomitant medications. On 08-SEP-2017, the patient was vaccinated with ZOSTAVAX (exact dose and route of administration were not reported; lot # M041085 with the expiration date of 03-JAN-2018), for vaccination. The vaccine was reconstituted with sterile diluent (lot # N007932 with the expiration date of 06-MAY-2018). On 08-SEP-2017, the patient reported a raised red reaction at the injection site, which went away in a few days (exact date was not reported). On 18-SEP-2017, the patient came into the pharmacy and complained of having red splotches on both arms and redness at the injection site. The pharmacist reported seeing the redness at the injection site, but not the red splotches on both arms. No treatment was given for the events. No lab diagnostic studies were performed. No Product Quality Complaint (PQC) was involved. The patient's present status was reported as not recovered. The relatedness between the events and ZOSTAVAX or sterile diluent was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003536, expiry date 02-NOV-2019 or lot # 003701, expiry date 01-NOV-2019 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes . No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA010540: US-009507513-1709USA010541: US-009507513-1709USA010539:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB lot # N001348 with expiration date of 31-OCT-2019, lot # N012120 with expiration date of 30-JAN-2020, lot # N012920 with expiration date of 07-FEB-2020, and lot # N007752 with expiration date of 01-DEC-2019; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009565: US-009507513-1709USA009566.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. In 2017 the patients were vaccinated with VARIVAX lot # M024678 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). In 2017 the patients experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to VARIVAX; Sender's Comments:  US-009507513-1709USA010135:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M042324 with expiration date of 10-JUN-2018, for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009565: US-009507513-1709USA009566.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse referring to an unspecified  patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. The reporter stated that from 15-AUG-2017 to 18-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (strength and dose were not provided) lot# M040269 with expiration date 28-APR-2018, and lot # M043563, with expiration date 09-JUN-2018,  for prophylaxis. The doses of ROTATEQ, were exposed to a temperature excursion of 47°Fahrenheit (°F) to 77°F during a time frame of 2 hours and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions included fibromyalgia. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient's arm that was vaccinated became swollen. The patient sought medical attention by contacting the pharmacist and she was advised to apply ice to the affected arm. The outcome of peripheral swelling was reported as not recovered. The causality between PNEUMOVAX 23 and peripheral swelling was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was initially received from a pharmacist and additional information from an office manager, concerning an unspecified  patient. Patient's medical history, concurrent condition, concomitant medication and previous drug reactions/ allergies were not reported. On 18-SEP-2017, the patient was vaccinated with one dose of an improperly stored ZOSTAVAX lot # M037015, expiry date 22-NOV-2017, for prophylaxis (strength, dosing details and anatomical location were unknown). No adverse symptoms were reported. The vaccine was exposed to the temperature of 29.8 F. The vaccine had previous temperature excursions. No data logger was involved. This is one of two reports received from the same reporters.; Sender's Comments: US-009507513-1708USA004943:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ oral route (strength, dose, lot number and expiration date were not reported) for prophylaxis. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA010092: US-009507513-1709USA010092.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 76 year old female patient. On 18-SEP-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. On 18-SEP-2017, 1 day after onset of therapy the patient experienced incorrect dose administered and drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of incorrect dose administered, no adverse event and drug administered to patient of inappropriate age is unknown.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 19-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB (dose and route not reported) (lot # M007763 and expiration date 15-SEP-2017) for prophylaxis. No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a female registered nurse of unknown age, referring herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-SEP-2017, the patient was inadvertently vaccinated with ZOSTAVAX, one dose, lot # M024700 and expiration date on 18-JUL-2017 (route of administration was not provided) for prophylaxis; which was reconstituted with sterile diluent (MRK). It was additionally reported that, there was no adverse effects and no any product quality complaint was present.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On 18-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot # L027733, expiration date: 13-SEP-2017) for prophylaxis. No adverse effects were reported.