chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 31-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 27-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II  lot # L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II rHA (recombinant human albumin) (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 25-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest pain, Diagnostic procedure, Herpes zoster, Laboratory test
Clinical narrative: This spontaneous report was received from a currently 72-year-old female patient with no concurrent conditions, and drug reactions or allergies. The medical history include that she was in a "great health ". It was reported that the patient took unspecified medications as concomitant therapies. On 18-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. On 05-MAR-2017, the patient developed shingles, and then, on the same date, the patient was hospitalized due to chest pains and muscle spasms. Subsequently, on 06-MAR-2017, the patient was discharged from the hospital and later, approximately in March 2017, the patient developed a rash which spread from the front of her chest to her back, and which was painful in the locations it was. On an unknown date, the patient sought unspecified medical attention and consequently, some unspecified laboratory test and diagnostic procedures were performed (results not provided). The patient was treated with unspecified pain medications which made her nauseous, and without which, she would not be able "to function, walk or breathe"; but given that it upset her stomach, on an unspecified date in 2017, she had to start to cut down. The patient stated that before she was in great health, but now it hurts to put clothes on and she had a post herpetic neuralgia, therefore, she wanted to see a pain specialist to assist her. At the time of reporting, the patient did not recover from the adverse events. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Pain, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a currently 72-year-old female patient with no concurrent conditions, and drug reactions or allergies. The medical history include that she was in a "great health ". It was reported that the patient took unspecified medications as concomitant therapies. On 18-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. On 05-MAR-2017, the patient developed shingles, and then, on the same date, the patient was hospitalized due to chest pains and muscle spasms. Subsequently, on 06-MAR-2017, the patient was discharged from the hospital and later, approximately in March 2017, the patient developed a rash which spread from the front of her chest to her back, and which was painful in the locations it was. On an unknown date, the patient sought unspecified medical attention and consequently, some unspecified laboratory test and diagnostic procedures were performed (results not provided). The patient was treated with unspecified pain medications which made her nauseous, and without which, she would not be able "to function, walk or breathe"; but given that it upset her stomach, on an unspecified date in 2017, she had to start to cut down. The patient stated that before she was in great health, but now it hurts to put clothes on and she had a post herpetic neuralgia, therefore, she wanted to see a pain specialist to assist her. At the time of reporting, the patient did not recover from the adverse events. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a 25 year old female patient, referring to herself, with no pertinent medical history and no drug reactions or allergies. Concomitant therapies included LOW-OGESTREL for unknown an indication. On an unknown date in November 2016, the patient was vaccinated with the first dose of GARDASIL for prevention of human papilloma virus (HPV) (dose, route, frequency, lot/batch # and expiration date were not reported) and it was used DILUENT MRK (dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date in February 2016, her second vaccine was GARDASIL 9 for prevention of human papilloma virus (HPV) (dose, route, frequency, lot/batch # and expiration date were not reported) and it was used DILUENT MRK (dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date in February 2017, reported as "after receiving the GARDASIL 9", the patient had pain at the injection site immediately afterward and then developed a lump a week after and "felt like a bruise". The patient did not seek medical attention, did not received treatment for the adverse events, did not have laboratory diagnostic studies performed, and did not need hospitalization. The adverse events lasted until "sometime in April of 2017", and it was reported that the patient was waiting for medical information from her health care provider before receiving further vaccinations. The causality between pain at the injection site, lump and felt like a bruise with GARDASIL, DILUENT MRK and GARDASIL 9 was not reported. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 for prophylaxis, lot # L017265 with expiration date of 10-FEB-2017 (dose, route and frequency were not reported). No adverse effect was reported. No Product Quality Complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients older than 26 year old. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported), for prophylaxis. As reported above, the vaccinated patients were older than 26 year old. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an approximately 11 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-MAR-2016, when the patient was 10 year old, he received the first dose of GARDASIL 9 for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). The reporting nurse referred that the patient would receive the second dose of GARDASIL 9 on 23-MAY-2017 (14 months later). No adverse effect was reported. 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 Medical Assistant referring to 2 patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M045204, expiration date 11-NOV-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the VARIVAX underwent a temperature excursion between 15 to 46 Fahrenheit degrees for 24 hours. The temperature excursion was captured using a digital data logger. No previous temperature excursion was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient reports having pain that radiates down his arm since receiving shot.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Peripheral swelling
Clinical narrative: Swelling of upper arm, skin bubbles, redness over most of upper arm.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: 10 x 10 mm swelling at injection site.  Signs and symptoms worsened over the next 48 hours.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: Had flu shot 3 times in the past. With first dose 3 yrs ago within one to two hours noticed red, watery, itchy eyes and throat. Denies swelling. Was able to swallow, no cough, no wheezing, no rashes or GI symptoms. Sx lasted one day. Cleared on its owned.   The following year had a less sevever recurrence- within one hour mild itchy eyes, no discharge, no redness, and had mild itchy throat. No swelling, no rashes. Lasted one day and cleared on its own.  The third episode in Oct 2016 was milder than the previous two. She had an itchy throat, no problems with eyes, no rashes, no swelling. Sx persisted for one day.   No medical attention or medication was required with each episode.   No problems with other immunizations. Never had anything like this before. No problems with food/eggs, or insects.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Throat irritation
Clinical narrative: Had flu shot 3 times in the past. With first dose 3 yrs ago within one to two hours noticed red, watery, itchy eyes and throat. Denies swelling. Was able to swallow, no cough, no wheezing, no rashes or GI symptoms. Sx lasted one day. Cleared on its owned.   The following year had a less sevever recurrence- within one hour mild itchy eyes, no discharge, no redness, and had mild itchy throat. No swelling, no rashes. Lasted one day and cleared on its own.  The third episode in Oct 2016 was milder than the previous two. She had an itchy throat, no problems with eyes, no rashes, no swelling. Sx persisted for one day.   No medical attention or medication was required with each episode.   No problems with other immunizations. Never had anything like this before. No problems with food/eggs, or insects.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Throat irritation
Clinical narrative: Had flu shot 3 times in the past. With first dose 3 yrs ago within one to two hours noticed red, watery, itchy eyes and throat. Denies swelling. Was able to swallow, no cough, no wheezing, no rashes or GI symptoms. Sx lasted one day. Cleared on its owned.   The following year had a less sevever recurrence- within one hour mild itchy eyes, no discharge, no redness, and had mild itchy throat. No swelling, no rashes. Lasted one day and cleared on its own.  The third episode in Oct 2016 was milder than the previous two. She had an itchy throat, no problems with eyes, no rashes, no swelling. Sx persisted for one day.   No medical attention or medication was required with each episode.   No problems with other immunizations. Never had anything like this before. No problems with food/eggs, or insects.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Patient was in waiting room after vaccination and reported to parents "I'm going to pass out" and proceeded to. Pt was assisted to a seated position from standing. No injuries in process. Quickly recovered from incident - loss of consciousness was approximately only 1-2 minutes. Patient responded to both verbal and physical stimuli. Was noted diaphoretic and with pallor for approximately 10 minutes after vasovagal episode. Patient placed on stretcher and remained supine with feet elevated for 10 minutes during which time color returned. Was offered juice and food during this time as well. Recovered fully. Patient and parents did report that patient did not eat since dinner last night, 05/25/17.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 19-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004944: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1608USA012794: US-009507513-1705USA004968: US-009507513-1705USA004972: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004953: US-009507513-1705USA004951: US-009507513-1705USA004950: US-009507513-1705USA004974: US-009507513-1705USA004942: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, 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 concurrent condition, medical history and concomitant therapy were not provided. On 10-JAN-2017, the patient was vaccinated with GARDASIL 9 dose 1 (route, lot number and expiration date were not provided) for prophylaxis. On 09-MAY-2017, the patient was vaccinated with GARDASIL 9 dose 2, lot # M040412, expiration date: 30-JUN-2019 (route not provided) for prophylaxis which is outside of the recommendations in GARDASIL 9 prescribing information. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was also a pharmacist and refers to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient experienced 2 inch diameter (or little less) of hive or welt around the injection site. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for contact with the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Inflammation, Pain
Clinical narrative: This spontaneous report has been received from a 62 year old female company representative who was also a patient and reporting on herself. The patient's concomitant therapies included estrogens (unspecified), levothyroxine sodium (SYNTHROID), iron (unspecified) and vitamin b (unspecified). There was no information about the patient's concurrent conditions or medical history provided. The patient did not have any known drug reactions or allergies. In April 2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque forming units) subcutaneously (dose, lot # and expiration date were not reported) reconstituted with sterile diluent (DILUENT MRK) (dose,lot # and expiration date were not reported). On 10-MAY-2017, the patient had root canal. On 11-MAY-2017, the patient started breaking out into what she called one of the worst cases of shingles that she had ever seen. The patient reported that at first she had discomfort, but the pain kept getting worse. The patient also reported secondary inflammation from the shingles outbreak (onset date in May 2017). The patient started self treating the shingles outbreak with lidocaine cream and unspecified ibuprofen. On 15-MAY-2017, she visited the physician assistant and was diagnosed with shingles and was treated with unspecified tramadol three times daily and unspecified valacyclovir hydrochloride (VALTREX) in addition to the lidodocaine and ibuprofen. There were no lab diagnostic studies performed. No product quality complaint was involved. The outcome of the events of shingles and secondary inflammation was not recovered (reported as awful and the patient was in pain as of the time of this report). The relatedness between the events and ZOSTAVAX was not reported. The reporter considered the events of shingles and secondary inflammation as disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA011831.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 27-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 08-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 23-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 28-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, albumin status recombinant human albumin (rHA), lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, albumin status recombinant human albumin (rHA), lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA008742.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 21-MAY-2017, the patient was vaccinated with ZOSTAVAX (lot # M042849 with expiration date: 18-JAN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F for 2 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician concerning a currently 18 year old male patient. The patient did not have historical drugs. The patient's concurrent conditions included ulcerative colitis. On 15-SEP-2000, the patient was vaccinated with M-M-R II (dose, route, lot number and expiration date were not reported) for prophylaxis. The concomitant medication included REMICADE. On an unknown date, antibody testing was performed, showing that the patient had negative titers for measles and mumps. At the time of reporting, the outcome of the events was not reported. The causal relationship between the events and M-M-R II was not reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, in approximately 2013 (reported as "at 12 years of patient age"), the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 24-MAY-2017, the patient at 16 year-old, would receive the second dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer reporting for herself. A 70 (unspecified unit) female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vaccination site pain for days after and painful red arm both on an unspecified date with outcome of unknown.
Age: 6.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient is in her 50s of an unspecified age and ethnicity received PREVNAR 13 for protection against pneumococcal pneumonia at single dose for immunization on unknown date. The patient was also on an immunodepressive medication. On unknown date the patient the patient experienced a rash on the left side of her body and swelling of her left arm and down the left side of her body. The outcome of the events was recovered.
Sex: U
Vaccine: PNC13
Symptoms: Influenza
Clinical narrative: This is a spontaneous report from a non-contactable consumer reported for oneself. A patient of an unspecified age and race received PREVNAR 13 at single dose for immunization on unknown date. Relevant medical history and concomitant medication. The patient experienced a bad case of flu. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Death, Musculoskeletal stiffness, Pallor, Pulse absent
Clinical narrative: Fever the evening after receiving vaccines. Parents gave TYLENOL. The infant was sleeping-then at 4:30 AM, the child cried out, then stiff and unresponsive; mother brought directly to ER. She was pale and pulseless upon arrival. Multiple rounds of CPR/epinephrine/atropine. Brief returns of sinus bradycardia. CPR discontinued at 07:19.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Resuscitation, Sinus bradycardia, Unresponsive to stimuli
Clinical narrative: Fever the evening after receiving vaccines. Parents gave TYLENOL. The infant was sleeping-then at 4:30 AM, the child cried out, then stiff and unresponsive; mother brought directly to ER. She was pale and pulseless upon arrival. Multiple rounds of CPR/epinephrine/atropine. Brief returns of sinus bradycardia. CPR discontinued at 07:19.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Pruritus, Tenderness, Vaccination site rash
Clinical narrative: Rash at site of vaccination. Small, red, tender, pruritic on upper left arm. Required antibiotics.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: Fainting.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: Hard red two quarter sized inflammed area on the back of her arms where ZOSTAVAX was given. The area was very warm to touch. Instructed patient to apply cold compress and take Benadryl.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Large area of errythema and severe pain in upper arm.
Age: 69.0
Sex: F
Vaccine: PNC
Symptoms: Headache, Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Hot to touch, itching, headache, swollen, 4 inch by 3 inch red spot on right arm at injection site. It was brought to my attention on 5/25/2017 about 6pm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Facial paralysis
Clinical narrative: Left Bell's palsy.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever of 100.6, severe pain at injection site, & large area of erythema.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red, raised, itchy rash at injection site.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: THERE WAS A MALFUNCTION WITH THE SYRINGE WHICH CAUSED THE PATIENT TO NOT RECEIVE THE FULL AMOUNT OF BOOSTRIX.
Age: 27.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: The evening of the 24th had a itchy pimply rash on face. It subsided.  The next night on 5/25/17 had a similar rash on neck and arm. All symptoms subsided after a few hours only to reappear the next day.  Patient reported on 5/26/17, has no further symptoms since.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a licensed practical nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 27-APR-2017, the patient inadvertently received an expired dose of VARIVAX (lot # L013825, expiration date 21-APR-2017) (dosage and route of administration not provided) which was reconstituted with sterile diluent (lot #M017520, expiration date 25-SEP-2018). No adverse effects reported. Additional information has been requested.