chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient came in 6 days after vaccination with redness and warmth that had radiated 6 plus inches from injection site. It was very sore the first few days and the soreness has decreased but the redness is still there.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient exhibited no reaction during administration, but then commented that it burned inside his arm.  This continued through 15 min onsite. Checking in with patient via phone call later, he reported it had resolved in about 1 hour after administration.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Mobility decreased, Muscle spasms
Clinical narrative: Lower back, painful spasm. Happened between tying left shoe and tying right shoe laces. Could not move until 1 hour after taking cyclobenzaprine 10 mg. Could not go to work all day. Still suffering spasms if cyclobenzaprine not taken.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient came in to pharmacy 3/18/18 reporting a rash on forearm. There was a dime-sized spot blister-looking spot on forearm. Patient reported no itching or pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, headache, mild nausea, ache in lower back and muscles, fatigue. Treated with aspirin and acetominophen and rest. Recovered in about 4 days. Also had soreness at injection site for several days, but that is pretty normal for me.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, headache, mild nausea, ache in lower back and muscles, fatigue. Treated with aspirin and acetominophen and rest. Recovered in about 4 days. Also had soreness at injection site for several days, but that is pretty normal for me.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy 6 days later and reported swollen injection site. The site is warm to the touch, visibly red (4 inch diameter), and swollen. I advised the patient to take benadryl and apply hydrocortisone cream topically to see if it reduces the symptoms and if not, she needs to call her doctor for further evaluation.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Pain in arm, 2nd day Aches and pains throughout body, 9 pm - 6 am Fever and chills, less on 3rd day, but bruise appeared on opposite side of right arm from injection. 4th day fever of 100 F till noon. Six inch wide red mark appeared around arm, height centered at injection sight - faded two days later.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain in arm, 2nd day Aches and pains throughout body, 9 pm - 6 am Fever and chills, less on 3rd day, but bruise appeared on opposite side of right arm from injection. 4th day fever of 100 F till noon. Six inch wide red mark appeared around arm, height centered at injection sight - faded two days later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Malaise, Nausea, Sciatica
Clinical narrative: Nauseous, sciatic pain, stomach pain, overall sick feeling.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Arrhythmia, Electroencephalogram abnormal, Epilepsy, Febrile convulsion, Influenza virus test
Clinical narrative: Hib, Heb B, Hep A, Varicella, MMR, flu shot given on date of vaccinations 2/8/2016. No details available on specifics of vaccines manufacturer etc...Febrile seizures x 2 on 2/10/16. Taken to ER and ran a flu test, rectal temp and diagnosed with febrile seizure. Had a total of 8 seizures between 2/10/16 and 4/16/2017. Had EEG done and diagnosed with Epilepsy 07/14/2017. Put on KEPPRA 12/13/2017. Now under care of cardiologist for heart arrhythmia 2/6/2018.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Seizure
Clinical narrative: Hib, Heb B, Hep A, Varicella, MMR, flu shot given on date of vaccinations 2/8/2016. No details available on specifics of vaccines manufacturer etc...Febrile seizures x 2 on 2/10/16. Taken to ER and ran a flu test, rectal temp and diagnosed with febrile seizure. Had a total of 8 seizures between 2/10/16 and 4/16/2017. Had EEG done and diagnosed with Epilepsy 07/14/2017. Put on KEPPRA 12/13/2017. Now under care of cardiologist for heart arrhythmia 2/6/2018.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: SHINGRIX shot received; severe swelling of lips and jaw; lasted about 24 hours.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy muscle, Cytogenetic analysis normal, Immunology test, Muscular weakness
Clinical narrative: She is now 21 and has muscle weakness throughout her body. She has been tested for all genetic disorders and they have all come back negative. Has been seeing a Neuromuscular doctor for over a year and he still cannot determine what it is or what caused it. Is also seeing a holistic doctor and he feels there is some connection to the GARDASIL shots she received when she was 15 years old.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received on 07-Mar-2018, was reported by other non-healthcare professional (patient) and concerns a female patient of unspecified age. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 mg (as reported), route of administration: intra muscular, anatomical location: left deltoid, batch number: 195210, expiry date: not reported). On 07-Mar-2018, after 5 months 8 days of vaccination, the patient was diagnosed with flu type B. At the time of this report, outcome of the event flu type B was not reported.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received on 12-Feb-2018, was reported by other non-healthcare professional (patient's mother), concerning a female patient of unspecified age. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 mg (as reported), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195210, expiry date: not reported). On 12-Feb-2018, after 4 months 14 days of vaccination, the patient was diagnosed with Influenza B virus infection. At the time of this report, outcome of the event (Influenza B virus infection) was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Radiculitis brachial
Clinical narrative: This serious spontaneous case, initially received on 08-Mar-2018, reported by other non-health professional, concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with FLUCELVAX QIV (batch number: 195124 (reported as 185124), expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, 2 months after the administration of vaccine, the patient developed brachial neuritis. It was reported that, no surgery or trauma was performed. At the time of this report, the outcome of the event was not reported.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dysphagia, Lip swelling
Clinical narrative: Call placed to our after hours NP at 1902. Mother explained that over the last 15 minutes patient began complaining of swollen lips and difficulty swallowing. Our NP directed them to go immediately to the ER. Patient did report to ER. Per ER notes she did have angioedema of the upper lip. No tongue swelling and trachea and uvula are midline. Patient continues to be slightly SOB and having some difficulty with swallowing. She was given BENADRYL, PEPCID and SOLU-MEDROL per IV. After one hour she continued with some lip swelling and at that time was given an additional 1/2 dose of BENADRYL IV and VISTARIL per oral route. After further observation the patient was sent home in stable condition on Prednisone and ATARAX and to follow up with PCP as needed. She did not need to return to our clinic and she remained stable after treatment at the ER on 01/24/18.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Angioedema, Dysphagia, Dyspnoea, Lip swelling
Clinical narrative: Call placed to our after hours NP at 1902. Mother explained that over the last 15 minutes patient began complaining of swollen lips and difficulty swallowing. Our NP directed them to go immediately to the ER. Patient did report to ER. Per ER notes she did have angioedema of the upper lip. No tongue swelling and trachea and uvula are midline. Patient continues to be slightly SOB and having some difficulty with swallowing. She was given BENADRYL, PEPCID and SOLU-MEDROL per IV. After one hour she continued with some lip swelling and at that time was given an additional 1/2 dose of BENADRYL IV and VISTARIL per oral route. After further observation the patient was sent home in stable condition on Prednisone and ATARAX and to follow up with PCP as needed. She did not need to return to our clinic and she remained stable after treatment at the ER on 01/24/18.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: Patient experienced skin rash, redness and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: Patient experienced skin rash, redness and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient experienced skin rash, redness and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Patient experienced skin rash, redness and pain.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5 inch swelling and redness in the area of injection, hard, hot to the touch, itchy.
Age: 1.33
Sex: M
Vaccine: UNK
Symptoms: Rash generalised, Skin discolouration
Clinical narrative: Slight rash appeared Thursday morning, it had quickly spread all over his body and brightened in color. I have him medicine for the reaction and some pain reliever. It's almost gone now.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Eye pruritus, Oedema
Clinical narrative: Edema, erythema, itchy eyes and dizziness. Patient was given BENADRYL IM and SOLU-MEDROL IV.
Age: 74.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site reaction, Lethargy
Clinical narrative: Chills on night of administration; flu-like aches and lethargy the entire next day; red blotch at injection site on left arm where pneumonia shot administered with sore muscle; red blotch at injection site on right arm where shingles shot administered with sore muscles. Symptoms persist from Friday until Monday at time of reporting.
Age: 74.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash macular
Clinical narrative: Chills on night of administration; flu-like aches and lethargy the entire next day; red blotch at injection site on left arm where pneumonia shot administered with sore muscle; red blotch at injection site on right arm where shingles shot administered with sore muscles. Symptoms persist from Friday until Monday at time of reporting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 72 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant therapies included unspecified blood pressure medication, unspecified stomach medication and unspecified sulfa medication. On an unknown date in the fall of 2012, the patient was vaccinated with ZOSTAVAX, 1 unspecified dose (lot number, route of administration and expiration date were not reported). On an unspecified date in 2015, the patient got shingles, but they never appeared as a rash, and she described it as pain and burning on unspecified areas of the body. The patient reported that she saw her physician at that time and was treated, but the treatment was unknown. The patient recovered from shingles on an unknown date (reported as "shingles lasted for about 6 weeks"). On 12-FEB-2018, the patient got shingles again, which was not showing as a rash again, but just severe burning and pain. The patient went to her physician on 16-FEB-2018, and was treated with valacyclovir hydrochloride, acetaminophen, and acyclovir. On an unknown date in February 2018, the patient felt sick to the stomach, which lasted for an unspecified amount of time. The patient reported that she still had the shingles but they were improving. The outcome of abdominal discomfort was not reported. The reporter considered the abdominal discomfort to be related to treatment with valacyclovir hydrochloride and acetaminophen. The causality between the ZOSTAVAX and herpes zoster was not reported.
Age: 0.75
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 9 month old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date in February 2018 (reported as "some time last week" 12-FEB-2018 to 16-FEB-2018), the patient inadvertently received a dose of PNEUMOVAX 23 lot number N014188, expiration date 22-JAN-2019 (exact dose and route of administration were not provided). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a 12 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2014, at the age of 12 years old, the patient was vaccinated with GARDASIL (dose, route of administration, lot # and expiry date were not reported). On 01-MAR-2018, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, route of administration, lot # and expiry date were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA007255: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007258: US-009507513-1803USA007259.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Heart rate decreased, Respiratory disorder, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to male patient, currently 83 year old. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 07-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # and expiry date were not reported) for vaccination. Shortly after administration of the PNEUMOVAX 23, the patient experienced respiratory issues, fainted and also had slow heart rate, on 07-MAR-2018. The outcome of syncope, heart rate decreased and respiratory disorder was reported as recovered/resolved on 07-MAR-2018 (reported as symptoms resolved after about one hour). The relationship between the events and PNEUMOVAX 23 was not provided. No product quality complaint involved.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On 13-MAR-2018, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # N020923, with expiration date of 01-AUG-2019, by intramuscular route, (strength, dose and anatomical location was not provided) for prophylaxis (incorrect route of drug administration). No adverse events were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative referring to an 11 year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-JUL-2017, the patient was vaccinated with her first dose of GARDASIL 9 for prophylaxis (strength, dose, route, lot # and expiration date were not reported) and on an unknown date experienced pain at the injection site for two weeks. Then, on 22-JAN-2018, the patient was vaccinated with her second dose of GARDASIL 9 for prophylaxis (strength, dose, route, lot # and expiration date were not reported) and on an unknown date in 2018, she experienced again pain at the unspecified injection site for two months. The causality assessment between the events and vaccination with GARDASIL 9 was not provided.
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Laboratory test normal, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 74 year old male patient regarding himself. Patient's pertinent medical history and drug allergies was unknown. Patient's pertinent concurrent condition included high blood pressure and lymphocytic leukaemia. Concomitant therapies included mercaptopurine, clopidogrel and atorvastatin. On 26-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, vaccine dose for vaccine for Pneumonia (route, lot#, expiry date were unknown). The patient experienced extreme fatigue, body aches, fever, and a loss of appetite approximately three hours after PNEUMOVAX 23 administration on 26-FEB-2018. On 09-MAR-2018, the patient was still experiencing the same symptoms and went to the Emergency Room. The patient was admitted on 09-MAR-2018, and released on 10-MAR-2018. The patient had unspecified tests done on the patient's lungs and head and the results were normal. The patient sought medical attention by visiting the physician and received unspecified treatment. Outcome of decreased appetite, pyrexia, pain and fatigue was reported as not recovered. The reporter causality of the event decreased appetite, pyrexia, pain and fatigue was not reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 12-OCT-2016 and on 14-JAN-2017, the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). At the reporting time, the patient liked to receive a dose of GARDASIL 9. No adverse symptoms were reported.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a Nurse Prescriber via company representative, referring to a 21 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9, for immunization (route of administration, anatomical location, lot number and expiration date were not reported). On 12-MAR-2018, after receipt of the vaccine, the patient "collapsed, almost like a seizure". The patient was kept in the office until she recovered from the event and then she was sent home. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse event or if lab diagnostics or studies were performed. The reporter did not assess the causal relationship between the event and vaccination with GARDASIL 9.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 13-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck rHA PROQUAD with lot # N022972 and expiration date 19-FEB-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA006667: US-009507513-1803USA006668: US-009507513-1803USA006669: US-009507513-1803USA006670.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA 25/0.5, for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported), instead of an adult dose. No adverse effects were reported for the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-MAR-2018, the patient was vaccinated with  an expired dose of (wistar ra 27-3) M-M-R II  0.5 ml, once via intramuscular route, lot number M007277 with expiration date on 09-FEB-2018 (dose and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent used for reconstitution was not expired (lot number M006117 with expiration date on 24-AUG-2018) and that both products were stored appropriately. There was no adverse effect reported. No product quality complaint was involved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 60 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-MAR-2018, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU, lot number N011366 with and expiration date on 12-MAR-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was stated that the expired dose did not had a temperature excursions prior to administration and the sterile diluent (manufacturer unknown) used for reconstitution was properly stored. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included (MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-1803USA007257: US-009507513-1803USA007258: US-009507513-1803USA007259.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD  injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-180 USA007256: US-009507513-1803USA007258: US-009507513-1803USA007259.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck) PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007259.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007258.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling to local area ranging from shoulder AC area. Patient reported significant improvement with taking antihistamines. Provided recommendation was to continue current treatment and follow up should s/s worsen over the weekend. Patient followed-up today 03/19/2017 and had significant improvement. No follow-up care recommended by provider at this point.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Acute myocardial infarction, Blood test, Cardiac monitoring, Cardiac stress test, Chest pain
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram QT interval normal, Electrocardiogram ST segment normal, Electrocardiogram T wave peaked
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Pericarditis
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Sinus bradycardia, Troponin increased, Ultrasound scan, Vaccination complication
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Exercise test, Laboratory test
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin increased
Clinical narrative: 22y/o M presents for a follow up after going to the ER on 13Mar18. Pt states that on the morning of, he developed chest pain. Pt denies any active chest pain and say that he had a series of labs and tests performed to include: blood work, EKG, ECHO, stress test, and ultrasound. Pt states that he was later diagnosed as having pericarditis from the smallpox vaccine he had received about 2 weeks ago. Pt was given a cardiac monitor and told to follow up within the next couple weeks with the cardiologist who treated him. Pt does not have any medical conditions and denies a family history of cardiac related issues. Pt also states that approximately a week ago, he was going to another country. Pt states that on the plane ride there, he wasn't feeling well. Pt states that he experienced loss of consciousness while on the plane. Pt states that he didn't have any problems during the rest of his trip but once again felt ill when he got back on the plane to return home. Pt was given LIPITOR, Ibuprofen, and aspirin to take and says that he has no plans of being compliant with the medication. Acute pericarditis, unspecified: 22yoM with no risk factors was admitted to MC 13 Mar for chest pain w/ troponin elevation (NSTEMI) found to have pericarditis, likely secondary to Smallpox vaccination. Strongly advised patient to take Aspirin and MOTRIN as directed. Keep Cardiology appt 27 March. Fitness, Mobility and Duty restricted x 31 days. Profile entered in immunization tracking system. NO travel!!! RTC in 3weeks for reassessment and labs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Reddish, raised, hard, hot area surrounding the injection site. 11 cm wide by 8 cm in length.  Symptoms appeared slowly, with inflamed site increasing in size. Patient visited Care facility due to the spread of the affected area.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting, persistent headache.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting, persistent headache.
Age: 37.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Borrelia test negative, Computerised tomogram head, Facial paralysis, Immunology test
Clinical narrative: Severe episode of Bell's palsy started 4 days after administration of Tdap and Influenza vaccine. Treated with prednisone, valacyclovir, gabapetin. Symptoms are improved but unresolved after 5 weeks.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came into the Immunization Clinic on 3/13/18 at 3:45pm complaining of pain to left shoulder and the inability to lift arm without "assistance."  No redness, bruising, or swelling was noted at that time. She stated that the pain and weakness had been ongoing since a little while after receiving the vaccine. She denied any known trauma to the area, and denied taking any pain medication or treatment of any kind. Advised patient to try pain relievers and offered MD appointment which she declined. No pain medication was administered at that time.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed rash a few minutes after receiving influenza vaccine. Treated with triamcinolone 40mg IN x1. Sent home with RX for diphenhydramine 50mg Q6H PRN .
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Decreased appetite, Erythema, Fatigue, Myalgia
Clinical narrative: Severe fatigue, loss of appetite, muscle and arm soreness, spreading redness on arm in a map shaped pattern, spread to neck and chest. Diagnosed in urgent care with cellulitis.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Severe fatigue, loss of appetite, muscle and arm soreness, spreading redness on arm in a map shaped pattern, spread to neck and chest. Diagnosed in urgent care with cellulitis.
Age: 21.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling, redness at injection site, pain.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Severe, debilitating arm/shoulder pain. Slight fever. Shaking for one evening. Pain 10/10 at onset still lasting after 4 days and continues now at about 8/10.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac pacemaker insertion, Injection site erythema, Injection site mass, Injection site warmth, Oral herpes
Clinical narrative: Developed a cold sore within 5 hours of receiving shot. No tingle or itch to warn of impending cold sore which is unheard of with cold sores. Right arm extremely sore with large warm red lump extending beyond the site of the shot which lasted for four days.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Insomnia, Rash, Streptococcus test negative, Viral infection
Clinical narrative: Pt. rec'd 12 mo immunizations in office on 03/02/18. Mom reported rash (x 1 day) on 3/12/18; Afebrile, seen in office that day. Dx with viral illness. Seen again 3/14/18 with s/s increased rash and decreased sleeping. Afebrile possible dx - 5th's disease - vs - MMR reaction. No tx - parent to monitor and call if s/s increase.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Rec'd. routine imm. on 3/13/18. Seen 3/14/18 for S/S - (LT) arm with erythema and edema; non-painful. Have decreased at time of visit, afebrile. Tx with BENADRYL at H.S.; Ibuprofen every 6 hours prn. Return if S/S worsen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Eye pain, Headache, Pain
Clinical narrative: 3/6/18 - High fever, chills, aches at beginning and continued plus rash next day 3/7/18 and continued. Fever, chills, aches (ear, eye and headache excruciating!) continued for 3 days. Headache for 6 days, rash for 7 (still).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: 3/6/18 - High fever, chills, aches at beginning and continued plus rash next day 3/7/18 and continued. Fever, chills, aches (ear, eye and headache excruciating!) continued for 3 days. Headache for 6 days, rash for 7 (still).
Age: 64.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Feeling abnormal, Peripheral swelling, Pyrexia
Clinical narrative: After getting the vaccination later that evening started to get a fever of 102, arm started to swell and get red. Felt just miserable.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site swelling
Clinical narrative: Patient returned to the pharmacy morning of 3/19/18 stating that her arm was still red and swollen and itching beyond just the vaccine site. Upon examination, confirmed redness, swelling and a bit warm to the touch extending almost to the elbow. Patient states that it is still spreading. Slight bruising at injection site noted. Recommended patient see primary care physician to assess reaction.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a unspecified first year pediatric resident via a field representative and refers to a 2 month old patient on an unknown gender. No information regarding the patient's cconcurrent conditions, medical history and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of ROTATEQ oral liquid, vial, orally (lot #, expiration date were not reported) for prophylaxis. On an unknown date, the patient was hospitalized due to unknown reason. The outcome of adverse event was reported as not recovered/not resolved. The treatment was received for adverse event. Product quality complaint was not reported. The causality between the event and suspect therapy was not reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Antibody test negative, Gastrointestinal disorder, Irritability, Polymerase chain reaction positive
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 2 month old female patient. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose, frequency, lot # and expiry date were not reported) orally for prophylaxis (reported as pediatric schedule) along with "other unspecified vaccines". On an unknown date the patient experienced irritability and unspecified gastrointestinal symptoms and the patient was hospitalized twice at an unknown location on unknown dates for the events. On an unknown date (reported as after 11 days) the patient's polymerase chain reaction (PCR) was only detectable for ROTATEQ (Antibody test negative). It was reported that the patient received unspecified treatment for the events. The outcome of the events was unknown. The relationship between the events and ROTATEQ was not provided. No product quality complaint was involved.