chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Rash, Rash macular, Upper respiratory tract infection
Clinical narrative: Received Flu shot (L) arm 9/5/17. Developed malaise, sleeplessness-remained afebrile. Symptoms progressed to upper respiratory; nasal congestion and sore throat. Then developed mild low back pain and broke out in fine macular red rash on trunk of body from neck to waist. Increased redness noted at injection site. Rash also noted upper arm and in antecubital areas. Denies change in appetite, nausea, problems breathing or itching of rash. Remained afebrile. Symptoms resolved on own. ZYRTEC recommended-none used by employee.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt stated 2 days after receiving FLUZONE she had rash extending down her arm and on chest (of arm that vaccine was administered). She already takes BENADRYL and allergy medication so she did not take anything extra for her rash.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and redness all around the arm, fever, chills, severe pain in the arm (left arm). Patient took TYLENOL (3 doses of 3).
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Urticaria
Clinical narrative: Hives developed 2 d after immunization - well appear and no other symptoms.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: FLUZONE HD administered (3rd year in a row) on 9/24/17. Pt woke up w/rash on 1 side of body around trunk. Possible allergic (uncommon since she's gotten the vaccine every year) reaction. Pt is calling MD incase it's a shingles flair or allergic reaction. Needsto be treated.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site bruising, Skin warm
Clinical narrative: 6 days after receiving the vaccine, the patient woke up feeling like her left arm was "hot". A few hours later she presented in the pharmacy. There was a bruise that she states was where the vaccine was injected and below that a palm-sized area of red. She said she thought it had expanded slightly since the morning.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Rash, Tremor
Clinical narrative: Pt said she experienced the following reactions: Rash, tremors, nausea, headache, stomach cramping.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, golf ball size swelling at injection site. Pain scale-7.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt presented to pharmacy on 9/25 w/redness at injection site for ZOSTAVAX. Today pt informed RPh of HX of shingles approximately 4 wks prior. Was not mentioned at time of inject. See note at continuation site.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced swelling, pain and redness on the bicep on the opposite site of the arm close to the elbow. Injection site did not show any swelling or redness. Redness appeared 24 hours after injections were given and have subsided at his writing.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Loss of consciousness, Syncope
Clinical narrative: Pass out/fainted, we had call 911, when EMS arrived and checked BP = 137/89, glucose = 98. Pt was normal by that time and patient decided to go home and decline any further assistance from EMS.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red, raised area of vaccination; headache, tender, burn/itch at site; area warm to touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Red, raised area of vaccination; headache, tender, burn/itch at site; area warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Pt had an all-over body rash with onset the evening after she had the flu shot. She has previously had the high dose flu shot with no issues. MD recommends getting low dose flu shots in the future.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Anxiety, Chills, Confusional state, Depression, Dizziness
Clinical narrative: Patient called Health Department on 9/26/17, almost two years after the vaccination, stating that she has "depression, anxiety, chills, dizziness, and fatigue form the HPV vaccine I got two years ago.  "I have been to several medical professionals that agree with me that the vaccine has caused these problems." "I want nurses educated about these effects because I didn't have these problems until after I received the HPV vaccine."  I advised patient to complete the VAERS report online and directed her to the website. I also stressed the importance of continuing medical treatment.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Weight increased
Clinical narrative: Patient called Health Department on 9/26/17, almost two years after the vaccination, stating that she has "depression, anxiety, chills, dizziness, and fatigue form the HPV vaccine I got two years ago.  "I have been to several medical professionals that agree with me that the vaccine has caused these problems." "I want nurses educated about these effects because I didn't have these problems until after I received the HPV vaccine."  I advised patient to complete the VAERS report online and directed her to the website. I also stressed the importance of continuing medical treatment.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Anxiety, Chills, Depression, Dizziness, Fatigue
Clinical narrative: Patient called Health Department on 9/26/17, almost two years after the vaccination, stating that she has "depression, anxiety, chills, dizziness, and fatigue form the HPV vaccine I got two years ago.  "I have been to several medical professionals that agree with me that the vaccine has caused these problems." "I want nurses educated about these effects because I didn't have these problems until after I received the HPV vaccine."  I advised patient to complete the VAERS report online and directed her to the website. I also stressed the importance of continuing medical treatment.
Age: 11.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of axillary pain in a 11-year-old female patient who received FLUARIX QUADRIVALENT (batch number 27LY3, expiry date 5th June 2018). On 16th September 2017, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced axillary pain and enlargement of lymph nodes. On an unknown date, the outcome of the axillary pain and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the axillary pain and enlargement of lymph nodes to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT in left deltoid. The patient experienced armpit pain and swollen lymph nodes specific to left side (side of FLUARIX QUADRIVALENT).
Age: 11.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of axillary pain in a 11-year-old female patient who received FLUARIX QUADRIVALENT (batch number 27LY3, expiry date 5th June 2018). On 16th September 2017, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced axillary pain and enlargement of lymph nodes. On an unknown date, the outcome of the axillary pain and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the axillary pain and enlargement of lymph nodes to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT in left deltoid. The patient experienced armpit pain and swollen lymph nodes specific to left side (side of FLUARIX QUADRIVALENT).
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Asthenia, Groin pain, Loss of personal independence in daily activities, Myalgia, Weight bearing difficulty
Clinical narrative: Intermittent bilateral pain in biceps, triceps, groin(s), weakness in arms, overall weakness/tiredness.  Pain in both elbows.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Asthenia, Fatigue, Groin pain, Muscular weakness
Clinical narrative: Intermittent bilateral pain in biceps, triceps, groin(s), weakness in arms, overall weakness/tiredness.  Pain in both elbows.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia
Clinical narrative: Intermittent bilateral pain in biceps, triceps, groin(s), weakness in arms, overall weakness/tiredness.  Pain in both elbows.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Vaccine error: Fifth dtap administered prior to minimum age of 4, and potentially unnecessary 4th dose of Hep B administered at 2.5 year well visit. Prior vaccination spacing had been questionable, but later determined that the dtap dose spacing was acceptable and the dose administered on 09.21.17 was unnecessary. The clinic's opinion is that the Hep B prior spacing was also not acceptable and a repeat dose was needed, however the spacing in the record appears to meet the CDC recommendations on minimum age and minimum interval (Hep B history per clinic record: Dose 1 on 03/01/15, Dose 2 on 04/01/15, Dose 3 on 07/08/16.) Illegibility of a hand-written record from the prior clinic was given as the reason for questioning the prior vaccine spacing. Vaccine adverse events: Diarrhea within one hour of vaccine administration, repeat episode of diarrhea later that night and once the next day; swelling at the injection site on the day/evening of the injection (right arm), swelling worse the next day (9.22.17) with redness and hot to the touch spreading about 2-3 inches from the injection site, almost reaching the elbow. Swelling and redness continued through third day, and subsided on the fourth day. A bruise was apparent about 2 inches below the injection site which was about 1 inch in diameter on the fourth day after the injections. On 9.26.17, the bruise had resolved, and  a mouth ulcer appeared on the inside of the lower lip and she also was uncharacteristically irritable.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Extra dose administered, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine error: Fifth dtap administered prior to minimum age of 4, and potentially unnecessary 4th dose of Hep B administered at 2.5 year well visit. Prior vaccination spacing had been questionable, but later determined that the dtap dose spacing was acceptable and the dose administered on 09.21.17 was unnecessary. The clinic's opinion is that the Hep B prior spacing was also not acceptable and a repeat dose was needed, however the spacing in the record appears to meet the CDC recommendations on minimum age and minimum interval (Hep B history per clinic record: Dose 1 on 03/01/15, Dose 2 on 04/01/15, Dose 3 on 07/08/16.) Illegibility of a hand-written record from the prior clinic was given as the reason for questioning the prior vaccine spacing. Vaccine adverse events: Diarrhea within one hour of vaccine administration, repeat episode of diarrhea later that night and once the next day; swelling at the injection site on the day/evening of the injection (right arm), swelling worse the next day (9.22.17) with redness and hot to the touch spreading about 2-3 inches from the injection site, almost reaching the elbow. Swelling and redness continued through third day, and subsided on the fourth day. A bruise was apparent about 2 inches below the injection site which was about 1 inch in diameter on the fourth day after the injections. On 9.26.17, the bruise had resolved, and  a mouth ulcer appeared on the inside of the lower lip and she also was uncharacteristically irritable.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Injection site warmth, Irritability, Mouth ulceration
Clinical narrative: Vaccine error: Fifth dtap administered prior to minimum age of 4, and potentially unnecessary 4th dose of Hep B administered at 2.5 year well visit. Prior vaccination spacing had been questionable, but later determined that the dtap dose spacing was acceptable and the dose administered on 09.21.17 was unnecessary. The clinic's opinion is that the Hep B prior spacing was also not acceptable and a repeat dose was needed, however the spacing in the record appears to meet the CDC recommendations on minimum age and minimum interval (Hep B history per clinic record: Dose 1 on 03/01/15, Dose 2 on 04/01/15, Dose 3 on 07/08/16.) Illegibility of a hand-written record from the prior clinic was given as the reason for questioning the prior vaccine spacing. Vaccine adverse events: Diarrhea within one hour of vaccine administration, repeat episode of diarrhea later that night and once the next day; swelling at the injection site on the day/evening of the injection (right arm), swelling worse the next day (9.22.17) with redness and hot to the touch spreading about 2-3 inches from the injection site, almost reaching the elbow. Swelling and redness continued through third day, and subsided on the fourth day. A bruise was apparent about 2 inches below the injection site which was about 1 inch in diameter on the fourth day after the injections. On 9.26.17, the bruise had resolved, and  a mouth ulcer appeared on the inside of the lower lip and she also was uncharacteristically irritable.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Body temperature increased, Diarrhoea, Headache, Injection site pain
Clinical narrative: Patient developed a three inch rash around DTaP injection site and had a 101.3f ear temperature in the first two days. By day three it grew to over five inches. Pt has abnormally complained of pain at the injection site, stomach pain, and headaches. The rash itches and is still hot to the touch. He began having diarrhea within 24 hours. Currently on day six with little improvement of any symptoms.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site rash, Rash pruritic, Skin warm
Clinical narrative: Patient developed a three inch rash around DTaP injection site and had a 101.3f ear temperature in the first two days. By day three it grew to over five inches. Pt has abnormally complained of pain at the injection site, stomach pain, and headaches. The rash itches and is still hot to the touch. He began having diarrhea within 24 hours. Currently on day six with little improvement of any symptoms.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Severe whole body aches, so painful i could not even pull my pants up my legs. Severe abdominal cramps, severe enough that I had to leave work. Diarrhea. Severe migraine. Extreme fatigue. Fever. The headache was the same day as the vaccine all day. All other symptoms appeared 20 hours after the vaccine was received.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Severe whole body aches, so painful i could not even pull my pants up my legs. Severe abdominal cramps, severe enough that I had to leave work. Diarrhea. Severe migraine. Extreme fatigue. Fever. The headache was the same day as the vaccine all day. All other symptoms appeared 20 hours after the vaccine was received.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Evening of shot began experiencing severe left upper arm pain at site of injection. Over the course of 1 1/2 weeks, pain continued and began radiating down arm. Has experienced weakness in left arm and decreased range of motion. No numbness or tingling. No erythema or edema at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified date in June 2017, two doses of improperly stored (due to defrost cycle) VARIVAX lot # L034372 and expiration date 08-SEP-2017 (strength, dose, route and anatomical location were not provided), were administered to the patients for prophylaxis. On unspecified date in August-2017, were administered 2 doses of improperly stored (due to defrost cycle) VARIVAX lot # M017290, expiration date 07-APR-2018 (strength, dose, route and anatomical location were not provided), were administered to the patients for prophylaxis. The temperature ranges and time frames were not provided. A data logger was involved, and no previous temperature ranges were reported. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (lot # M038728,expiration date 25-APR-2018 or lot # M044724, expiration date 13-JUN-2018) (dose not reported) for prophylaxis. The vaccine was exposed to 1.9 degrees Celsius (°C) for 30 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA011513:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from Norlanco Family Medicine refers to a 4 year old White male patient. The patient's past medical history included bilateral hydrocele and autism spectrum disorder. On 30-AUG-2017, the patient was vaccinated with M-M-R II (lot # N008825, 12-SEP-2018), once, 0.5 ml, subcutaneous in the left leg for immunisation. On 30-AUG-2017 the patient experienced localized reaction with dermatological problem of leg soreness, lump at the site along with itching and irritation (injection site pain, vaccination site irritation and vaccination site mass). The following day, on 31-AUG-2017, the patient experienced some redness and swelling which was sore along with a very large reaction at the left lateral thigh (vaccination site erythema and vaccination site swelling). It was reported that the patient had calmed down and had no fever but had continued to scratch the area. As of 02-SEP-2017, the patient was reported to be recovering from the events. Causality assessment was not provided by the reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Local reaction, Pain in extremity
Clinical narrative: This spontaneous report as received from Norlanco Family Medicine refers to a 4 year old White male patient. The patient's past medical history included bilateral hydrocele and autism spectrum disorder. On 30-AUG-2017, the patient was vaccinated with M-M-R II (lot # N008825, 12-SEP-2018), once, 0.5 ml, subcutaneous in the left leg for immunisation. On 30-AUG-2017 the patient experienced localized reaction with dermatological problem of leg soreness, lump at the site along with itching and irritation (injection site pain, vaccination site irritation and vaccination site mass). The following day, on 31-AUG-2017, the patient experienced some redness and swelling which was sore along with a very large reaction at the left lateral thigh (vaccination site erythema and vaccination site swelling). It was reported that the patient had calmed down and had no fever but had continued to scratch the area. As of 02-SEP-2017, the patient was reported to be recovering from the events. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist 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 19-SEP-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX lot # reported as M376655, expiration date 29-NOV-2017 (dosage and route were not reported) for prophylaxis, which  was exposed to temperature excursion of 47°F to 77°F for a time frame of 4 hour. There was a previous temperature excursion with a temperature of 15°F to 46°F for 6 hours. There was no data logger reported. No adverse effects reported. The vaccine was reconstituted with properly stored sterile diluent (MERCK) lot # K026802, expiration date 21-OCT-2017 (dosage and route were not reported). Lot number M376655 is an invalid lot number for ZOSTAVAX.
Age: 1.5
Sex: F
Vaccine: MMR, MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old patient. The patient's concurrent conditions, medical history, and allergies were not reported. In approximately June 2017, at the age of 15 months, the patient was vaccinated with the first dose of M-M-R II for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (strength, dose, route, anatomical location, lot number and expiration date were not reported). Then, on 19-SEP-2017, at the age of 18 months, the patient was vaccinated with the second dose of M-M-R II, subcutaneously for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (inappropriate schedule of drug administration). No adverse event was reported.
Age: 1.5
Sex: F
Vaccine: MMR, MMR
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old patient. The patient's concurrent conditions, medical history, and allergies were not reported. In approximately June 2017, at the age of 15 months, the patient was vaccinated with the first dose of M-M-R II for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (strength, dose, route, anatomical location, lot number and expiration date were not reported). Then, on 19-SEP-2017, at the age of 18 months, the patient was vaccinated with the second dose of M-M-R II, subcutaneously for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (inappropriate schedule of drug administration). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent. On an unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX 19400 PFU, for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported). The administered dose of the vaccine experienced a temperature excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours, as recorded by a data logger. There was no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012332.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 75 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with a second dose of PNEUMOVAX 23 (strength, frequency and administration route were not reported) for prophylaxis; not knowing if the patient had received the first dose of the vaccine when was 74 years old. No adverse effects were reported
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, medical history or concomitant medication. On 21-SEP-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscularly for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). Previous to the vaccine administration, the patient denied being vaccinated previously with PNEUMOVAX 23. Later that same day, the patient called informing that had received a dose of PNEUMOVAX 23 on an unspecified date in September 2016. No adverse effect reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On 15-SEP-2017, the patient was vaccinated with an unspecified improperly stored dose of VARIVAX), lot number M033905 with expiration date 28-JUL-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported), which was reconstituted with a properly stored sterile diluent. No adverse event was reported. The administered dose experienced a temperature excursion of 15 to 46 degree Fahrenheit for 1 hour and 20 minutes; it was also reported that due to a natural event the VARIVAX was transported from the physician's facility to another in a refrigerator container instead of a freezer, and the container temperature was 40 degree Fahrenheit for 40 minutes for both outgoing and return trips, data logger was involved. No previous temperature excursion was reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA008728.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse reporting on an unknown number of patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On unspecified dates in September 2017 (reported as on "07-SEP-2017 or after"), the patients received improperly stored doses of VARIVAX for prophylaxis lot # N017698 expiry date 09-JUN-2019 or lot # N001530 expiry date 13-JAN-2019 (anatomical location, dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent (MRK). It was reported that on an unspecified date, the vaccines were exposed to a temperature between - 9 Celsius degrees and 8 Celsius degrees for 11 hours. The vaccine underwent a previous temperature excursion between - 9 Celsius degrees and 8 Celsius degrees for 2 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA011270.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported). The administered dose of the vaccine experienced a temperature excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours, as recorded by a data logger. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011274.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13 (Lot R75238, Expiration Date May2018, NDC# 0005197102), intramuscular in right arm on 13Sep2017 11:20 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness around the area and it is warm to the touch 19Sep2017. Both events were reported as worsened on unspecified date. The patient visited physician office. The events were considered medically significant and related to pneumococcal 13-val conjugate vaccine (dipht crm197 protein). The outcome of the events was not recovered. Sender's Comments: Based on the information currently available, the reported events with pneumococcal 13-valent conjugate vaccine in this patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: SMALL
Symptoms: Angina pectoris, Echocardiogram, Electrocardiogram, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator (Health Agency) in the trial on 21 September 2017. This case involves a 19 year-old female subject with no significant medical history. The subject's concomitant medication was not reported. The subject received. On 18 October 2016, 28 days after receiving a dose of ACAM2000 on 20 September 2016 (lot number, site of administration not reported) the subject was diagnosed with I20.9 angina pectoris, unspecified. The lab data of Troponin I result, ECG, and Echocardiogram was not available. MRI of brain, spinal cord and heart and lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the event, I20.9 angina pectoris, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 19-year-old female subject who developed angina pectoris unspecified with favorable temporal association post vaccination with ACAM200. Angina is a listed event for ACAM2000 vaccine. Additional information on electrocardiogram, cardiac enzymes and final diagnosis is needed to further assess this event. Based on data available, the sponsor assesses this event as possibly related to study vaccine.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a 30-year-old male subject with significant medical history of dizziness or fainting and headaches developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM200. Pericarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dizziness postural, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Electrocardiogram repolarisation abnormality
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a 30-year-old male subject with significant medical history of dizziness or fainting and headaches developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM200. Pericarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Migraine, Nausea, Nuclear magnetic resonance imaging brain normal, Pericardial effusion, Pericarditis
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a 30-year-old male subject with significant medical history of dizziness or fainting and headaches developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM200. Pericarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Photophobia, Troponin I increased, Vertigo
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a 30-year-old male subject with significant medical history of dizziness or fainting and headaches developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM200. Pericarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 22 year-old male subject with no significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 11 April 2017. On 27 April 2017, 11 days after vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I31.9 disease of pericardium, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 22-year-old male subject who developed acute pericarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Pericarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Pericardial disease, Pericarditis, Tricuspid valve incompetence
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 22 year-old male subject with no significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 11 April 2017. On 27 April 2017, 11 days after vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I31.9 disease of pericardium, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 22-year-old male subject who developed acute pericarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Pericarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 22 year-old male subject with no significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 11 April 2017. On 27 April 2017, 11 days after vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I31.9 disease of pericardium, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 22-year-old male subject who developed acute pericarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Pericarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the above mentioned trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 00.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves an 18-year-old male subject with significant medical history of dizziness or fainting spells who developed myocarditis unspecified and acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Myocarditis and pericarditis are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.