chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Skin papilloma
Clinical narrative: Pain and swelling Right arm with redness and warmth along with knot size of an apple.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Alopecia
Clinical narrative: On April 28th I noticed a bald patch on patient's head. I had previously found several of his hairs in the bathroom but thought they were my husbands. I am applying a cortisone cream to his now 7 bald patches with no improvement.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On 17-FEB-2016 the patient was vaccinated with ZOSTAVAX (vial, dosing regimen unspecified) lot #K020801, expiry date 31-JAN-2016 (expired product administered). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 09-MAY-2016, the patient was inadvertently vaccinated with VARIVAX, lot # L046885, expiry date 23-NOV-2017, 0.5 ml subcutaneous instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The concomitant therapy, medical history and concurrent condition were not provided. The patient was vaccinated with the first dose of GARDASIL (unspecified lot#, expiration date and route) 8 years ago (in approximately 2008) and then received the second dose of GARDASIL (lot # L038135, expiration date 27-MAY-2017, route unknown) on 10-MAY-2016 (inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ lot #L008996, expiry date 01-DEC-2016, lot #L023870, expiry date 20-APR-2017, L008054, 30-NOV-2016, K020182, 25-JUN-2016. Temperature excursion of 52 degrees Fahrenheit for 182 days, no data logger and there was no previous excursion. There was no adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker reported the following dates of administration for doses of VAQTA (lot # L043209, expiration date 17-SEP-2017, dose and frequency unknown) that were improperly stored (incorrect product storage). The vaccines were exposed at 30 Fahrenheit (F) for 13 hours on 01-APR-2016 due to digital data logger and back in store range after that. There was no previous temperature excursion. No adverse effects reported. Dates doses were administered: 13-APR-2016 one dose, 18-APR-2016 two doses, 19-APR-2016 one dose, 20-APR-2016 one dose, 27-APR-2016 one dose, 28-APR-2016 one dose, 02-MAY-2016 two doses, 03-MAY-2016 one dose, 04-MAY-2016 one dose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Vaccination complication
Clinical narrative: Information has been received from a consumer regarding her husband, a 76 year old male patient, enrolled in a Market Research Program. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date in 2006, the patient and his wife were vaccinated with ZOSTAVAX (dose, strength, total daily dose and therapy route were not reported). The patient's wife reported that their doctor ordered another shingles shot even when the doctor knew that they had had a shingles shot. They trusted that the doctor knew what he was doing and received another shot on 27-APR-2016 from a nurse, who informed them that shingles vaccine shot was given only once in lifetime. The patient and his wife were having bad side effects, as of the time of the report. They were 72 and 76 years and the patient's wife asked about what they might need to know regarding this issue. No further information was reported. The action taken with ZOSTAVAX was not applicable. The outcome of the event, very bad side effects was not recovered. The causality of the event, very bad side effects to ZOSTAVAX and study procedure was not reported. The reporter considered the event very bad side effects to be serious (details unknown, considered as medically significant). The case is linked to MARRS# 1605USA003796 via same reporter link.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot number L004740, expiration date: 16-NOV-2017 and lot number L009649, expiration date: 29-NOV-2017, (dose, route of administration and injection site were not reported). Thee were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection, lot # L029306, expiration date: 26-MAR-2017, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot number L019989, expiration date: 01-JUN-2017, lot number L024268, expiration date: 01-JUL-2017 and lot number M001200, expiration date: 28-AUG-2016, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 18 year old patient. On 25-APR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L051101 with expiration date of 17-JUN-2017, strength, frequency, dose and route unspecified) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age and gender. No medical history and concurrent conditions were reported. On 10-MAY-2016 the patients were vaccinated with an improperly stored dose of ZOSTAVAX (incorrect product storage) (lot #L048452, expiry date 01-MAR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (L021210 with expiration date 10-JUN-2017, lot# was reported as L045955 with expiration date 17-NOV-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #K014548, 27-AUG-2016. No adverse effects were reported. Temperature 31 Fahrenheit for 712 hours and it was administered. There was no temperature excursion. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPVX, TD
Symptoms: Exposure during pregnancy, Product origin unknown
Clinical narrative: This spontaneous prospective pregnancy report has been received from a consumer refers to his wife of unknown age, who received numerous vaccines as part of a refugee vaccination program. On 11-DEC-2015, the patient was vaccinated with a dose of HPV vaccine (manufacturer unknown) (product origin unknown) and a dose of hepatitis A vaccine (manufacturer unknown) (dose, route and lot were unknown for the both vaccines). On 06-FEB-2016 the patient was vaccinated with another dose of HPV vaccine (manufacturer unknown) (product origin unknown). Concomitant therapies included DTAP and TENIVAC. It was reported that they now discovered the patient was pregnant (exposure during pregnancy). The last menstrual period (LMP) and Estimated date of delivery (EDD) were not given. The pregnancy outcome was unknown. Additional information is not expected as no contact information was provided.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 13 year old patient. The patient had parasympathetic tingling sensations. There was no concomitant medications or drug allergies reported. On 10-DEC-2015, the patient was vaccinated with GARDASIL, dose 1 lot # K006960, 19-FEB-2017 and on 11-FEB-2016, the patient was vaccinated with GARDASIL K005881, 14-JAN-2017, dose 2 right leg intramuscular. On an unknown date, the patient experienced increased tingling sensations in the right leg after the first and second dose. The patient was referred to a specialist in pain management for unspecified treatment. Therapy with GARDASIL was discontinued. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On 18-APR-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J009788, Expiry: 17-MAR-2016). It did not had any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 14-year-old non-pregnant female patient with no pertinent medical history and no drug reaction or allergies. On 28-APR-2016 at approximately 10:00, the patient was vaccinated with the first dose of GARDASIL 9 lot # L045711, expiration date reported as 08-MAY-2017, 1 shot, intramuscular. There were no concomitant medications. On the same day at about 16:00 (6 hours after vaccination), the patient's parents called the office, because the patient experienced swelling in the hand on the same side she was administered the injection. The nurse practitioner recommended the patient ice and to elevate the hand that is swollen as treatment. The patient was to be seen in the office at the day of report. The outcome of swelling was reported as not recovered/not resolved. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Interchange of vaccine products, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a 16 year old female patient with asthma, bipolar disorder, blindness unilateral and drug allergies to DEPO-PROVERA. Concomitant therapies included albuterol. On 21-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot#, dose and route not reported) and on 04-NOV-2015 (inappropriate schedule of drug administration) with the second dose of GARDASIL (lot# L016428 and expiration date: 30-JUL-2017; dose and route not reported). On 09-MAY-2016, the patient was in the office for her annual physical and was vaccinated with the third HPV vaccine dose with GARDASIL 9 (lot # L044475 and expiration date: 12-MAY-2017) (interchange of vaccine products) intramuscularly. Later in the day, after the third dose was administered an unspecified rapid urine pregnancy test was performed and was positive (vaccine exposure during pregnancy). No treatment was given. The LMP was reported as the first week of April 2016. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot number L013192, expiration date: 19-JAN-2017 and lot number K019372, expiration date: 16-JUL-2016, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL lot # L040459, expiry date 06-APR-2017 and lot # K010215, expiry dates 05-MAY-2017. Temperature excursion of 52 Fahrenheit for 182 days, no data logger and there was no previous excursion. There was no adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 79 year old female patient. The concurrent condition and medical history was not reported. The patient had no known drug allergies. On 16-DEC-2008, the patient was vaccinated with ZOSTAVAX (dose, route and lot details unspecified). The concomitant medication was not reported. On an unknown date in July 2015 the patient developed shingles. The patient sought medical attention by contacting the pharmacist. The event was treated with VALTREX and NEURONTIN. The outcome of herpes zoster was reported as resolved on an unknown date. The 'VZVIP' pack was faxed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On 27-APR-2016 the patient was vaccinated with ZOSTAVAX (vial, dosing regimen unspecified) lot # K020801, expiry date-31-JAN-2016. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 30 degrees Fahrenheit for 334 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Had pain right away but not as severe as next day. Next day had severe pain on arm, not at vax site but directly on other side close to armpit. Had hot red spots in armpit no on. Went to doctor and was prescribed cephalexin (500 mg). Had improvement by 24 hours, on 3rd day still had pain during regular activities. By 5th day still had red mark by vaccine site but pain and everything else had subsided. Had received pneumonia vax before about 2-3 years ago had no problem.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Had pain right away but not as severe as next day. Next day had severe pain on arm, not at vax site but directly on other side close to armpit. Had hot red spots in armpit no on. Went to doctor and was prescribed cephalexin (500 mg). Had improvement by 24 hours, on 3rd day still had pain during regular activities. By 5th day still had red mark by vaccine site but pain and everything else had subsided. Had received pneumonia vax before about 2-3 years ago had no problem.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site reaction, Injection site swelling, Injection site warmth, Purpura
Clinical narrative: Patient came into clinic the morning after PNEUMOVAX inj with left upper arm swollen, hot to the touch and fevers. Fever, Erythema Multiforme, Purpura and hot to the touch near injection site. Acetaminophen 650 mg PRN.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient came into clinic the morning after PNEUMOVAX inj with left upper arm swollen, hot to the touch and fevers. Fever, Erythema Multiforme, Purpura and hot to the touch near injection site. Acetaminophen 650 mg PRN.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-APR-2016, the patient was vaccinated with an expired dose of GARDASIL injection, lot # J009243, expiration date 23-APR-2016 (dose and route were not reported). Concomitant therapies were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-APR-2016, the patient was vaccinated with an expired dose of GARDASIL injection, lot # J009243, expiration date 23-APR-2016 (dose and route were not reported). Concomitant therapies were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report concerning a patient of unknown age and gender was received from a pharmacist via Pfizer Inc. No medical history or concurrent conditions were reported. On unknown dates, the patient was vaccinated with a PNEUMOVAX 23 and a PREVNAR 13 (dose, dosage number, route of administration, anatomical location, lot # and expiration date for both the suspect vaccines were unknown). No concomitant medications were reported. On an unknown date, following the administration of PNEUMOVAX 23, the patient reported having a bright red arm. At the time of reporting, the outcome of the event was unknown. The reporter also failed to provide a causal relationship between the event and the vaccination with the suspect vaccines. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Injection site rash, Nausea, Swelling face
Clinical narrative: RASH AT INJECTION SIGHT, SWOLLEN FACE, NAUSEA AND DIARRHEA.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Arm pain, headache, fatigue, nausea, body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Secondary transmission
Clinical narrative: Patient reports 5 year old family member contracted Shingles. She was around him after she received Zostavax. She believes this is too coincidental and he contracted shingles because he was around her.
Age: 5.0
Sex: F
Vaccine: JEVX
Symptoms: Angioedema, Joint swelling
Clinical narrative: Angioedema of extremities. Both hands and fingers. Joint swelling.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Collapsed, loss of bladder control.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Blood test, Cardiac monitoring, Chest X-ray, Computerised tomogram
Clinical narrative: Started with a fever and flu-like symptoms; did not feel well; experienced intense stomach pains; went to Urgent Care; then another hospital later, then specialist, then to Hospital (over time).
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Echocardiogram, Electrocardiogram, Fibrin D dimer, Influenza like illness, Malaise
Clinical narrative: Started with a fever and flu-like symptoms; did not feel well; experienced intense stomach pains; went to Urgent Care; then another hospital later, then specialist, then to Hospital (over time).
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Started with a fever and flu-like symptoms; did not feel well; experienced intense stomach pains; went to Urgent Care; then another hospital later, then specialist, then to Hospital (over time).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Chest X-ray, Cough, Dyspnoea
Clinical narrative: Neck stiffness, muscle aches, joint pain, rapid heart beat, shortness of breath, cough with deep breathing, heat flashes.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram, Heart rate increased, Hot flush, Musculoskeletal stiffness, Myalgia
Clinical narrative: Neck stiffness, muscle aches, joint pain, rapid heart beat, shortness of breath, cough with deep breathing, heat flashes.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Pulmonary function test
Clinical narrative: Neck stiffness, muscle aches, joint pain, rapid heart beat, shortness of breath, cough with deep breathing, heat flashes.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient seen 5/7/16 for annual physical exam PREVNAR 13 administered. Patient seen on 5/10/16 for pain, tenderness, swelling, redness and warmth at injection site. Localized rash and decreased ROM (L) deltoid/shoulder.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient seen 5/7/16 for annual physical exam PREVNAR 13 administered. Patient seen on 5/10/16 for pain, tenderness, swelling, redness and warmth at injection site. Localized rash and decreased ROM (L) deltoid/shoulder.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Four little bumps near injection site. -Mom called office 5/11/16 at 6:30 pm. -Informed by doctor to monitor and follow up if any changes or concerns.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, TD
Symptoms: Syncope
Clinical narrative: Syncopal episode for less than 60 seconds after receiving 3 vaccines. Patient remained on exam table, did not hit his head. Patient assisted to supine position, legs elevated. Vital signs monitored. Patient was given a pedialyte pop, remained supine for 10 minutes, then sat up and stool up gradually. He was discharged home when vital signs remained stable and symptoms resolved.
Age: 68.0
Sex: M
Vaccine: PNC
Symptoms: Asthenia, Dizziness, Dry mouth, Myalgia
Clinical narrative: Morning following vaccine felt weak and dizzy. Later in the day had muscle pain and dry mouth.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Ear infection, Malaise, Nervousness, Pneumonia
Clinical narrative: After administering vaccine, about an hour later patient started feeling shaky but not seizure like. Patient went to ER and was diagnosed with pneumonia and double ear infection. Patient didn't let office know beforehand of not feeling well. ER stated no signs of allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Mom states noticed (R) deltoid warm to touch with red inflamed area. No fever or pain. Notified PCP - who instructed her to come to Health Department. Staff notified.
Age: 1.34
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash and fever, irritability.
Age: 1.34
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever and rash, irritability.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Nodule, Skin warm
Clinical narrative: Red, warm to touch, 3-4 cm hard knot.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site on (L) arm.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received pneumonia vaccine 23 on 5/2/16. On 5/3/16 pt called reported area where she got the injection was red, swollen, (size of golf ball) painful and itching (had tried ice on it). Instructed to continue ice and hydrocortisone for itching.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Throat tightness
Clinical narrative: Pt experienced throat tightness, site swelling up to baseball size; red inflamed tenderness. Swelling today, 05/12/16 8 cm wide X 5 cm high.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dystonia, Eye movement disorder, Fall, Hyperhidrosis
Clinical narrative: Pt received TRUMENBA in her left arm. Within 3 minutes she said she felt faint upon standing up. She wasn't dizzy. She had a syncopal episode and fell to the floor with her mother holding her. Her eyes rolled back. She was diaphoretic. She had a dystonic reaction where her arms, hands, legs, flexed and contorted. Within less than 1 minutes she was alert and coherent but pale and diaphoretic. Within 15 min was fully recovered.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Syncope
Clinical narrative: Pt received TRUMENBA in her left arm. Within 3 minutes she said she felt faint upon standing up. She wasn't dizzy. She had a syncopal episode and fell to the floor with her mother holding her. Her eyes rolled back. She was diaphoretic. She had a dystonic reaction where her arms, hands, legs, flexed and contorted. Within less than 1 minutes she was alert and coherent but pale and diaphoretic. Within 15 min was fully recovered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Nausea
Clinical narrative: (L) arm swelling, (11x10cm over injection site), nausea.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Had swelling of left arm blanchable erythematous warm swelling left deltoid.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Activated partial thromboplastin time normal, Differential white blood cell count, Full blood count normal, Injection site bruising, Injection site haemorrhage
Clinical narrative: Scattered bruising and petechiae noted on both lower legs approx. 6 hrs after IM injections received in each anterolateral thigh.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: International normalised ratio normal, Liver function test normal, Prothrombin time normal, Red blood cell sedimentation rate normal
Clinical narrative: Scattered bruising and petechiae noted on both lower legs approx. 6 hrs after IM injections received in each anterolateral thigh.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: MENACTRA was given to patient inadvertently with an expiration date of 24APR16. MENACTRA was ordered. LPN thought exp. date was April 16, 2024. No adverse effe cts reported.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Patient started with swollen left gland in neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction
Clinical narrative: Patient presented with small (less than 1 inch in diameter) patch that looked like an injection site reaction. Patient complained of itchiness at the site. Patient had received the vaccine 7 days ago. Patient mentioned she was allergic to benadryl so she was counseled to apply hydrocortisone 1% with aloe over the injection site and follow up in 2 days with the pharmacy.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Arthralgia, Blood test, Nuclear magnetic resonance imaging, Pain, Spinal pain
Clinical narrative: Being treated with methotrexate injections and no relief for 1 year. Pain is at a 9/10 daily and has spread to hips and spine.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Face oedema, Headache
Clinical narrative: Facial edema, redness, and headache. Started about 16 hours after injection no specific treatment indicated.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Vision blurred, Visual impairment
Clinical narrative: Pt started to feel nauseated a couple hours after the shot was given. Then she felt very dizzy and her vision became blurred. At one point everything went black with her vision. She had to lie down because she felt like she was going to faint. Her head then started to pound- continued with a horrible headache.
Age: 29.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, RAB, TDAP, YF
Symptoms: Dizziness, Pallor
Clinical narrative: Approximately 1 min. after receiving the Yellow Fever vaccine, which was the last of 6 vaccines given (Hep A, Flu, MENVEO, Rabies, Tdap.  )Pt started to become pale and stated he felt lightheaded.  Lowered pt. to supine, applied cool pack to the back of his neck.  He never lost consciousness.  He was able to speak coherently.  Remained supine for 10 min. then sat in a chair for 10 min.  His color returned to normal after about 3 min. in the supine position.  He drank 8 oz. of water during the 10 min. he sat in a chair.  He stated he felt fine and left the office.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain, Paraesthesia, X-ray limb
Clinical narrative: Severe Burning about 2 inches above elbow. 4/15/2016  went to Emergency and was given Gabapentin.  Didn't help-only put me to sleep.  Went to Primary Dr 04/20/2016 and given TYLENOL 3 and told to keep taking Ibuprofen.  Went to Chiropractor for month of April-no help. Severe tingling in lower arm and last 2 fingers numb. Hurting so bad took 3 TYLENOL 3 in 2 days and in total fog so went back to Emergency May/9/2016 and given Prednisone. Still hurting so back to Primary 05/12/2016 for arm x-ray.  All good and given Acylovir, Folic Acid and inflammation cream.  Waiting to see how this works!
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: SWELLING AT SIGHT OF IMMUNIZATION. REDNESS AND HEAT. PATIENT SAID ARM FELT HEAVY. PATIENT FELT HOT.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Injection site nodule, Injection site pain
Clinical narrative: Her arm got very red and started swelling immediately after the injection. She had a small knot in her arm at the site of the injection. I gave her 10 mls of Diphenhydramine 12.5mg/5ml. I monitored her for 30 minutes. During that time, she complained of burning and tingling down the entire left arm. I continued to monitor her. The redness dissipated and the swelling was reduced. She reported feeling fine the entire time. I spoke with her about 7 hours after the injection and she said she was feeling fine. She said the injection site was sore but the swelling, redness, tingling and burning were gone. She was able to resume normal work activities shortly after the injection.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site paraesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Her arm got very red and started swelling immediately after the injection. She had a small knot in her arm at the site of the injection. I gave her 10 mls of Diphenhydramine 12.5mg/5ml. I monitored her for 30 minutes. During that time, she complained of burning and tingling down the entire left arm. I continued to monitor her. The redness dissipated and the swelling was reduced. She reported feeling fine the entire time. I spoke with her about 7 hours after the injection and she said she was feeling fine. She said the injection site was sore but the swelling, redness, tingling and burning were gone. She was able to resume normal work activities shortly after the injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Entire upper arm from shoulder to elbow is swollen, red and warm to touch. Pt states very tender to touch. No itching. No fever or generalized symptoms. Temp = 98.6.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid area presented with, edematous, warm to touch, erythema to the skin area.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Redness-edema with secondary cellulitis at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Vaccination complication
Clinical narrative: This study report as received from a consumer, as part of a marketing research program, referring to herself a 72 years female. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date in 2006, the patient and her husband were vaccinated with ZOSTAVAX (dose, strength, total daily dose and therapy route were not reported). The patient reported that her doctor ordered another shingles shot even when the doctor knew that they had a shingles shot. They trusted that the doctor knew what he was doing and yet received another shot on 27-APR-2016 from a nurse, who informed them that shingles vaccine shot was given only once in lifetime. The patient and her husband were having very bad side effects, as of the time of the report and wanted to know regarding this issue. The action taken with ZOSTAVAX was not applicable. The outcome of the event, very bad side effects and overdose was unknown. The causality of the event, very bad side effects to ZOSTAVAX and study procedure was not reported. The reporter considered the event very bad side effects to be serious (details unknown, considered as medically significant). The case is linked to MARRS# 1605USA005707 via same reporter link.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of ROTATEQ, lot #K009900 with expiration date of 04-MAY-2016. The patient's concomitant medications were not reported. At the time of the report, the patient had no experienced any adverse event due to the vaccination. Furthermore, no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot #L034372, expiration date 08-SEP-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 17 degrees Fahrenheit for 52 minutes and 30 seconds. There were no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was also reported that the vaccines ZOSTAVAX, PROQUAD, M-M-R II were also improperly stored, however, those vaccines were not administered to patients. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection, lot #L034372, expiration date 08-SEP-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 17 degrees Fahrenheit for 52 minutes and 30 seconds. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was also reported that the vaccines ZOSTAVAX, PROQUAD (Merck) and M-M-R II were also improperly stored, however, those vaccines were not administered to patients. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount of patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and drug reactions/allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had lot # L008034 and expiration date 05-AUG-2016 and lot # L027726 and expiration date 10-MAY-2017 (dose was not reported). There were no concomitant medications provided. The reporter stated that there was a previously temperature excursion of 9 Celsius (C) for 10 hours. On an unspecified date, the ROTATEQ were exposed to 15 Celsius (C) for 120 hours. There was no data logger was used to capture the excursion. No adverse effects had been reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and drug reactions/allergies was not provided. On unspecified dates in 2016, the patients were vaccinated with improperly stored doses of VAQTA which had lot# L034381 and expiration date 21-DEC-2016; lot# K004856 and expiration date 07-DEC-2016; lot# L026600 and expiration date 15-MAR-2016 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The reporter stated that there was no previously temperature excursion. On 25 and 26-FEB-2016, the VAQTA were exposed to 9 Celsius (C) for 10 hours each day and a data logger was used to capture the excursion. No adverse effects reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 52 year old female patient, reporting on herself. The patient's medical history or concurrent conditions were not reported. On 11-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number and expiration date were not provided). Other suspect therapy included prednisone (manufacturer unknown) tablet, (strength, dose, route, indication, lot number and expiration date were not provided) started on 04-MAY-2016. Concomitant medication included FLONASE and CLARITIN. On 30-APR-2016, the patient developed a painful rash, which progressively got worse. On 03-MAY-2016, the patient went to her provider and was diagnosed with shingles. Therefore, the patient was given an unspecified antiviral for 7 days, the patient did not state how her treatment was working as she just started it. It was also reported that, there was not intervention to prevent serious criteria. There were not significant disability, incapacity, life threatening, hospitalization or prolonged. And there was not product quality complaint involved. At the time of reporting, the outcome of shingles was reported as recovering. The action taken with prednisone (manufacturer unknown) was unknown. Additionally, the patient stated that she did not know if prednisone (manufacturer unknown) contributed to her symptoms. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Rash, Sinusitis
Clinical narrative: This spontaneous report was received from a 52 year old female patient, reporting on herself. The patient's medical history or concurrent conditions were not reported. On 11-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number and expiration date were not provided). Other suspect therapy included prednisone (manufacturer unknown) tablet, (strength, dose, route, indication, lot number and expiration date were not provided) started on 04-MAY-2016. Concomitant medication included FLONASE and CLARITIN. On 30-APR-2016, the patient developed a painful rash, which progressively got worse. On 03-MAY-2016, the patient went to her provider and was diagnosed with shingles. Therefore, the patient was given an unspecified antiviral for 7 days, the patient did not state how her treatment was working as she just started it. It was also reported that, there was not intervention to prevent serious criteria. There were not significant disability, incapacity, life threatening, hospitalization or prolonged. And there was not product quality complaint involved. At the time of reporting, the outcome of shingles was reported as recovering. The action taken with prednisone (manufacturer unknown) was unknown. Additionally, the patient stated that she did not know if prednisone (manufacturer unknown) contributed to her symptoms. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Rash, Rash erythematous, Rash morbilliform, Rash pruritic
Clinical narrative: My son woke up on 5/3/16 with a red measles like rash to his trunk and neck. It spread to his arms and cheeks on 5/3 and 5/4/16. It had resolved by 5/6/16. Rash was itchy. BENADRYL used for symptom management.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently administered extra dose of DTAP, IPV, HIB, MMR, Hep B, PCV13.