chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route of administration were not provided), Lot # L016427, expiry 13-APR-2017; L018500, expiry date 13-APR-2017; L025738, expiry date 14-AUG-2017; L029631, expiry date 14-AUG-2017; and L027733, expiry date 13-SEP-2017. No adverse effects were reported. No additional information was provided. This is one of six reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route of administration were not provided), Lot # J007097, expiry date 14-MAR-2016. No adverse effects were reported. No additional information was provided. This is one of six reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route of administration were not provided), Lot # L004014, exp. 04-MAR-2017; L013429, exp. 21-JUL-2017; L014415, exp. 25-JUL-2017; L025733, exp. 28-JUL-2017; L019297, exp. 18-AUG-2017; and L017407, exp. 15-AUG-2017. No adverse effects were reported. No additional information was provided. This is one of six reports received 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 was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose and route of administration were not provided), Lot # L007559, expiry date 01-JUN-2017; L018499, expiry date 25-FEB-2017; L023936, expiry date 15-MAR-2017; L039659, expiry date 15-MAR-2017; K018181, expiry date 04-JUN-2017; L036300, expiry date; and L015460, expiry date 20-JUL-2017. No adverse effects were reported. No additional information was provided. This is one of six 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 an unspecified number of patients of unknown demographics. No medical histories, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L001334, expiration date: 13-JAN-2017 and lot # L034367, expiration date: 08-SEP-2017; doses and route were not provided). No adverse effects were reported. This is one of several 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 as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 20-NOV-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and refers to a 8051 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced unspecified adverse events. The outcome of adverse events was reported as not recovered/not resolved. The relatedness between the events and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 14-JAN-2016, the patient was vaccinated with one improperly stored dose of MMR II injection, albumin status recombinant human albumin (rHA) (lot# K024036, expiration date 26-NOV-2016 or lot# L01479, expiration date 10-APR-2017, dose, anatomical locations and route of administration were not reported). No adverse experiences were reported. Temperature 60.5 F, time frame 9 hours and there was no temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and refers to a 606 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced an abnormal Papanicolaou smear (Pap Smear) test result. The outcome of the events was unknown. The relatedness between the events and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same source. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPVX
Symptoms: Cervical dysplasia
Clinical narrative: This spontaneous report was received from an unspecified via an online article and refers to a 268 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced a cervical dysplasia. The outcome of cervical dysplasia was unknown. The relatedness between the cervical dysplasia and HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ (dose and route of administration were not provided), Lot # L008054, exp. 30-NOV-2016; L008057, exp. 01-DEC-2016; L013197, exp. 26-JAN-2017; L010837, exp. 16-FEB-2017; L013192, exp. 19-JAN-2017; L020861, exp. 25-JAN-2017. No adverse effects were reported. No additional information was provided. This is one of six 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 Certified Medical Assistant refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose and strength unknown, oral). Batch of lot# K011947 with expiration date of 07-JUN-2016 was stored at 13.2 Celsius degree for one hour and 42 minutes. Batch of lot# L020861 with expiration date of 25-JAN-2017 was stored at 14.1 Celsius degree for 2 hours and 18 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash - face, trunk and legs.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Swelling 4.5 inches in length, Oval shaped 2.75 inches at widest part, about 2/16th's raised from surface of rest of arm, red radiating from center of injection in an uneven shape taking up 2/3ds of swelling, warm to touch.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Papule, Rash papular
Clinical narrative: Fine papular rash on trunk and extremities. Right leg: Erythema and two papules, 1 cm in diameter.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Hyperhidrosis, Hypotonia, Loss of consciousness, Presyncope
Clinical narrative: Dtap and IPV were given in the left arm.  The mother was holding the child and another nurse assisted in restraining. The child cried but held still. The child was turned around for the other arm to be vaccinated with Hepatitis B and MMRV. The child knew what was going to happen so she was really tense and trying to move. Appeared to have held her breath while being vaccinated. After immunization the child went limp and appeared to have passed out. The child became sweaty. The mother held her up and splashed water on her face. Mother was instructed to lay the child down so the blood could return to her brain. Mother reassured and asked when the child had last eaten. Child recovered within a few minutes. Mother stated at breakfast. Mother instructed to come back for immunizations in March and make sure the child eats and drinks right before immunizations. Mother gave child a banana to eat.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Syncope
Clinical narrative: Nausea, then 1 week later had episode of fainting.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperhidrosis, Injection site mass, Injection site reaction, Rash macular, Syncope
Clinical narrative: Nausea, then 1 week later had episode of fainting.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Visual impairment
Clinical narrative: Nausea, then 1 week later had episode of fainting.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Hypotension, Vision blurred
Clinical narrative: 2nd dose of HPV vaccine administered to patient, 3 minutes after vaccine- the patient had blurry vision, hypotension (BP 62/40 on L arm and BP 70/46 on R arm, HR 73, RR 18).  No additional medication was given.  Patient returned to "normal (according to patient)" 10 minutes later.  Patient was observed for more than 45 minutes.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L025738 with expiration date 14-AUG-2017, lot # L044707 with expiration date 06-OCT-201, lot # L025738 with expiration date 14-AUG-2017, dose and route were unknown). No adverse effect 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: Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of M-M-R II (lot # L004656 with expiration date 11-FEB-2017, lot # LL007216 with expiration date 03-MAR_2017, lot # L024267 with expiration date 01-JUL-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Pt developed hives and rash at injection site and on her torso.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Typical redness, swelling, itching at the site of injection noticed after 24 hours of vaccination.
Age: 48.0
Sex: F
Vaccine: HEPAB, MEN, TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Localized reaction consisting of redness, tenderness, and itching of shoulder at site of injection.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blister, Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: SHINGLES/ZOSTAVAX SEVERE REACTION. RED SWOLLEN AREA ABOUT THE SIZE OF A BASEBALL.  HOT, TENDER AND WHITE AREA IN THE MIDDLE.  TRAVELED FROM A LITTLE PAST MY ELBOW TO MY UNDERARMS.  MANY BLISTERS. I HAVE SEVERAL PHOTOS THAT I CAN SEND IF NEEDED.  WE MARKED THE AREA WITH A MARKER TO OBSERVE HOW FAST IT WAS SPREADING.  I'M ON DAY 3, AND IT'S STILL BAD. WENT TO DR. TO GET ANTIBIOTICS AND TOPICAL. 2ND DAY OF ANTIBIOTICS AND HAVE NOT SEEN A CHANGE YET.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: SHINGLES/ZOSTAVAX SEVERE REACTION. RED SWOLLEN AREA ABOUT THE SIZE OF A BASEBALL.  HOT, TENDER AND WHITE AREA IN THE MIDDLE.  TRAVELED FROM A LITTLE PAST MY ELBOW TO MY UNDERARMS.  MANY BLISTERS. I HAVE SEVERAL PHOTOS THAT I CAN SEND IF NEEDED.  WE MARKED THE AREA WITH A MARKER TO OBSERVE HOW FAST IT WAS SPREADING.  I'M ON DAY 3, AND IT'S STILL BAD. WENT TO DR. TO GET ANTIBIOTICS AND TOPICAL. 2ND DAY OF ANTIBIOTICS AND HAVE NOT SEEN A CHANGE YET.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint movement impairment, Pain
Clinical narrative: Pain and limited ROM in left arm following Flu vaccine inection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint manipulation, Nuclear magnetic resonance imaging
Clinical narrative: Pain and limited ROM in left arm following Flu vaccine inection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Discomfort, Headache
Clinical narrative: Slight headache.  Following mid-day on 01/16/2016 hard stomach ache followed by diahrrea which has continued through 01/20/2016.  Not sufficient diahrrea to cause me to seek medical attention, but many bathroom attempts each day plus stomach ache making me uncomfortable.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain upon injection in shoulder and upper arm. Pain continued for several weeks then went to see physician and had cortisone injection in shoulder plus physical therapy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus
Clinical narrative: PATIENT PRESENTED TO PHARMACY WITH 6 INCH ROUND RED SWOLLEN AREA ACCOMPANIED WITH ITCHING, BURNING AND REDNESS CONTINUING AROUND THE ARM. SHE SAID IT FELT RAW.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Eyelid rash, Rash, Swelling, Urticaria
Clinical narrative: At 3:30 I noticed a small rash on my daughter's chin and a small rash with hives on her forehead.  I spoke with the nurse at our PCP's office to report the symptoms and requested the doctor be notified and a non-urgent call back to discuss.  I gave my daughter 25 mg Benadryl around 4:00.  Between 3:30 and 4:30, the rash and hives were more spotty on other areas of the face so I administered another dose of 25 mg Benadryl (the highest recommended dosage for her age).  I then phoned my PCP again because the rash had spread to the eye area and looked swollen. I spoke with my PCP who recommended we go to the ER for further assessment.  However, as I prepared the family to leave for the ER, around 4:45, the rash appeared to be diminishing.  I did not feel an ER visit was indicated. My daughter had no difficulty breathing nor any other symptoms during the event.  By 5:30, the rash had decreased at least 90% and was 100% cleared by 6:30.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Mass, Pain, Skin warm
Clinical narrative: "Golf ball size lump, red, hot and painful". Dx: Cellulitis 12/17/15 in ER.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: 10-13-15, PM - sudden onset of seizures clonazepam 0.125 mg PO, for seizures lasting greater than 3 minutes.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Oral discharge, Respiratory arrest, Rhinorrhoea
Clinical narrative: Parents called on 1/15/16 and reported that on the morning of 1/11/16, the family found her in her crib, not breathing with congestion around nose and mouth. Taken by ambulance to hospital. Autopsy report pending per mom.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013202 with expiration date 27-JAN-2017, lot # L013206 with expiration date 29-JAN-2017, lot # L020865 with expiration date 09-FEB-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428 with expiration date 30-JUL-2017, lot # L036245 with expiration date 09-FEB-2017, dose and route were unknown). No adverse effect reported. This is one of several 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 other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of VAQTA (lot # was reported as "L034381" with expiration date 21-DEC-2016, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Malaise, Post-traumatic stress disorder, Rash vesicular
Clinical narrative: Information has been received from a physician referring to a 60 year old patient of unspecified gender. The patient's medical history included chickenpox in childhood. The patient had no history of herpes zoster and herpes zoster ophthalmicus. The patient had no allergies or prior immunodeficiency. The patient's history drug included oral antivirals VALTREX (full treatment). On 28-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported) in left shoulder. There was no concomitant medication. On 29-DEC-2015 the patient experienced malaise, zoster like rash in penis, "scalene" and left medial thigh (25 lesions). The patient also experienced outbreak of shingles ( "L2-L3 middle left (L) dermatome") and had severe post-traumatic stress disorder (PTSD) from the shingles on 29-DEC-2015. The maximum temperature was reported as 99.6 (unit not provided). It was also reported that there was possible secondary transmission (onset date: 29-DEC-2015). It was mentioned that the specimen from healed rash in "SCAV" beyond vesicle was obtained. "14 days later", on 12-JAN-2016 the patient recovered from the above adverse events. The causality was not provided. 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 Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: This literature study report was received from a literature article. The author stated that newly diagnosed HIV-positive individuals are 35 to 100-fold more susceptible to Streptococcus pneumoniae infection compared to non-infected individuals. Therefore, the PPV23 has previously been recommended, though efficacy and effectiveness of vaccination remains controversial. Early severe B cell dysfunction is a central feature of HIV infection. The specific nature of the immune cells involved in the production of protective antigen-specific antibodies in HIV-positive individuals remains to be elucidated. There were three goals in this study. First, to elucidate the immunogenic response to PPV23 in newly diagnosed HIV-positive individuals. Second, to evaluate whether is it potentially beneficial to provide 6-12 months of HAART (highly active anti-retroviral therapy) to suppress viral load and potentially improve immune function before PPV23 vaccination in newly diagnosed HIV-positive individuals with CD4<200. Third, to elucidate the phenotypic distribution of PPS-selected B cells in newly diagnosed HIV-positive individuals, dependent on CD4 count, compared to HIV-negative individuals. This case concerns a patient of unknown age and gender. Forty-three pneumococcal polysaccharide vaccine naïve newly diagnosed HIV-positive volunteers participated in the open observational study. HIV-positive individuals were stratified according to CD4 counts. Twenty two HIV-negative volunteers participated in this study. All volunteers were vaccinated with PNEUMOVAX 23 (dose and route of administration not provided) on day 0. All adverse events to vaccination were recorded. On an unknown date one patient experienced Arthus-type reaction. The outcome of the events was unknown. The authors considered the event to be related to PNEUMOVAX 23. The authors concluded that despite CD4-dependent pneumococcal polysaccharide-specific deficiencies in newly diagnosed HIV-positive patients, vaccination was beneficial based on opsonophagocytic titers for all newly diagnosed HIV-positive groups. In HIV-positive patients with CD4<200 cells/microL, 6-12 months of HAART did not improve opsonophagocytic titers or antibody concentrations. Based on these findings, immunization with the PNEUMOVAX 23 should not be delayed in newly diagnosed HIV-positive patients with CD4<200 cells/microL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Extra dose administered
Clinical narrative: He received FLUARIX QUAD 2015-2016 vaccine in 9/10/15, We did not realize this and he got FLUZONE HIGH DOSE 2015-16 vaccine today 1/20/2016.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ. No adverse event was reported. The outcome of the event was unknown. 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 physician and refers to multiple unspecified patients of unknown age and gender. There was no concurrent condition, medical history or concomitant medication reported for the patients. On an unknown date, improperly stored diluent (manufacturer unknown) (dose, frequency, route, lot #, expiration date and indication were not reported) was used to reconstitute unspecified vaccines which were then administered to multiple unspecified patients. No adverse effects were reported. Follow up information has been received from the physician on 19-JAN-2016. The reporter stated that, on unknown dates, improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017, (dose, frequency and route were not reported) were administered to an unspecified number of patients. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.46
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Swelling, redness, and bruising.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report has been received from a licensed practical nurse concerning to a 66 years old male patient with rash and shingles. Patient's medical history was not reported. The reported stated that the patient told the physician that he might have already had shingles at the time of vaccination but he did not seek medical treatment at that time. The reporter also stated that, the patient had a rash which developed "a few days" prior to receiving ZOSTAVAX (unspecified onset date of the rash) and the rash was still present when he was vaccinated. The patient thought the rash might possibly have been the early stages of shingles. On 22-DEC-2015 reported as 8 days before 29-DEC-2015, the patient was vaccinated with unknown dose of ZOSTAVAX (lot number and expiration date were not provided). On unknown date in December 2015 the patient's rash developed into blisters on his body (unspecified part of his body). So on 29-DEC-2015, the patient went to the physician once where he was diagnosed with shingles and treated with acyclovir (manufacturer unknown). At the time of the report, the patient was recovering of the herpes zoster. The causality between the herpes zoster and the vaccination with ZOSTAVAX was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unspecified and separate dates, the patient was vaccinated with two doses of M-M-R II (strength, frequency, route, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, after receiving both doses of the vaccine, the patient had a M-M-R II titer drawn which resulted negative (measles antibody negative, mumps antibody negative and rubella antibody negative). The outcome of rubella antibody negative, mumps antibody negative and measles antibody negative were unknown and the relatedness between the events and the suspect therapy was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Bradycardia, Contusion, Face injury, Fall, Heart rate decreased
Clinical narrative: Pt fainted after injection, low blood pressure, low heart rate. After 15-20 min. pt was fine. When the patient received his HVP vaccination, he had an episode of syncope with brief LOC, fell and hit face with no lac/mild contusion only and vital signs following syncope showed bradycardia to the 50s and hypotension to 80s over 40s which persisted for approximately 8 minutes. Hypotension/bradycardia initially concerning for vaccination triggered anaphylaxis but given its full resolution within 10 minutes and blood pressures and heart rate increasing back to the 130s over 80s with heart rate in the 80s to 90s with none of the other accompanying features of anaphylaxis including no wheezing, no lip swelling, no vomiting, no rashes, we think that this is much more likely to be vasovagal reaction to a painful stimulus like vaccination. Patient had a similar episode of syncope when he had a splinter removal several years prior, lending further evidence to this being a vasovagal reaction. However given family concern we are happy to refer to Allergy and Immunology to see whether a skin test for HPV vaccine produces any local reaction that would indicate patient has an allergy to this important vaccine. We recommended that the patient have any painful procedures like splinter removal, vaccination, suturing etc done sitting or lying down in a safe position where syncope will not produce a fall. Patient sustain only mild left facial contusion which was improved by applying ice pack for 15 minutes. Neurologic exam following the incident indicated that the patient was articulate speaking in full sentences with normal facial neurologic exam, normal strength, normal gait and otherwise reassuring overall appearance following the episode.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Hypotension, Loss of consciousness, Neurological examination normal, Presyncope, Syncope
Clinical narrative: Pt fainted after injection, low blood pressure, low heart rate. After 15-20 min. pt was fine. When the patient received his HVP vaccination, he had an episode of syncope with brief LOC, fell and hit face with no lac/mild contusion only and vital signs following syncope showed bradycardia to the 50s and hypotension to 80s over 40s which persisted for approximately 8 minutes. Hypotension/bradycardia initially concerning for vaccination triggered anaphylaxis but given its full resolution within 10 minutes and blood pressures and heart rate increasing back to the 130s over 80s with heart rate in the 80s to 90s with none of the other accompanying features of anaphylaxis including no wheezing, no lip swelling, no vomiting, no rashes, we think that this is much more likely to be vasovagal reaction to a painful stimulus like vaccination. Patient had a similar episode of syncope when he had a splinter removal several years prior, lending further evidence to this being a vasovagal reaction. However given family concern we are happy to refer to Allergy and Immunology to see whether a skin test for HPV vaccine produces any local reaction that would indicate patient has an allergy to this important vaccine. We recommended that the patient have any painful procedures like splinter removal, vaccination, suturing etc done sitting or lying down in a safe position where syncope will not produce a fall. Patient sustain only mild left facial contusion which was improved by applying ice pack for 15 minutes. Neurologic exam following the incident indicated that the patient was articulate speaking in full sentences with normal facial neurologic exam, normal strength, normal gait and otherwise reassuring overall appearance following the episode.
Age: 0.12
Sex: M
Vaccine: DTPHEP, HEP, HIBV, RVX
Symptoms: Crying, Dyspnoea, Eye swelling, Pain, Pallor
Clinical narrative: Baby was sleeping in swing, all of the sudden screaming in pain. Eyes swelled first and he turned white. Then his whole face swelled up. All within 2-3 minutes. We got him in car to rush to hospital. He was having a hard time breathing and started to try to fall asleep. I kept tapping his face to keep him awake and breathing. It was about a 20 minute drive to hospital. The ER checked him in and sat us in surgery waiting room (closed) away from everyone. I held him and his crying lessened. He slowly got color back but was still grey. Breathing got a little better. We waited for over an hour, close to two and waiting room had only a few people. By the time the doctor actually came in to room and saw him he said he was fine and saw nothing wrong with him.
Age: 0.12
Sex: M
Vaccine: DTPHEP, HEP, HIBV, RVX
Symptoms: Screaming, Skin discolouration, Swelling face
Clinical narrative: Baby was sleeping in swing, all of the sudden screaming in pain. Eyes swelled first and he turned white. Then his whole face swelled up. All within 2-3 minutes. We got him in car to rush to hospital. He was having a hard time breathing and started to try to fall asleep. I kept tapping his face to keep him awake and breathing. It was about a 20 minute drive to hospital. The ER checked him in and sat us in surgery waiting room (closed) away from everyone. I held him and his crying lessened. He slowly got color back but was still grey. Breathing got a little better. We waited for over an hour, close to two and waiting room had only a few people. By the time the doctor actually came in to room and saw him he said he was fine and saw nothing wrong with him.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received on 23-DEC-2015 from the medical assistant concerning a 12 years old white female patient who is a student. The patient's concurrent conditions and medical history were not provided. On 22-JUL-2015 at 17:00, the patient was vaccinated with second dose of GARDASIL injection, intramuscular, lot# K006960, expiration date 19-FEB-2017 (dose and site of administration were not reported). No adverse events were reported. The reported stated that the patient was vaccinated at private doctor's office/hospital (also reported as public health clinic/hospital) with private founds (also reported as public founds). This is one of several reports received from the same reporter. Additional information will be requested if is available.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Dizziness, Dyspnoea, Exercise tolerance decreased, Heart rate increased, Local swelling
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Migraine, Muscle spasms, Nausea, Rash, Swelling face
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Temperature intolerance
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Activities of daily living impaired, Biopsy thyroid gland normal, Computerised tomogram thorax normal, Decreased activity, Dizziness
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Dyspnoea, Exercise tolerance decreased, Eye pain, Facial pain, Fatigue
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Gingival pain, Heart rate increased, Hyperacusis, Muscle spasms, Nausea
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Photophobia, Temperature intolerance, Toothache, Urticaria
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Biopsy thyroid gland normal, Blood cortisol abnormal, Blood pressure fluctuation, Cardiac monitoring, Chest X-ray
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Chest pain, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Exercise tolerance increased, Fatigue
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Fibrin D dimer increased, HIV test negative, Lymphadenopathy, Migraine, Mononucleosis heterophile test negative
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Muscle spasms, Nausea, Nodule, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Ophthalmological examination normal, Palpitations, Photophobia, Red blood cell count normal, Sleep disorder
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Swelling, Thyroiditis, Ultrasound thyroid abnormal, Urine analysis normal, Vomiting
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: White blood cell count normal
Clinical narrative: Migraines/facial migraines, pain across front of chest, thyroiditis/nodule, swollen glands in face/neck, extreme fatigue/exhaustion, extreme shortness of breath, racing heart, dizziness, muscle spasms, nausea/vomiting, change in blood pressure (has been 165/100 and 102/68), bad cough, exercise intolerance, extreme sensitivity to light, adrenal insufficiency, (has not laid down flat to sleep in over 4 months due to shortness of breath and swelling); no treatment.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blister, Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: Reaction site -> redness, blistering, heat and redness/hardness.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Reaction site -> redness, blistering, heat and redness/hardness.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Amylase normal, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Chills, Headache
Clinical narrative: Right testicle and perineal pain, fever/chills, myalgias, h/a.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Myalgia, Perineal pain, Prostatic specific antigen normal, Pyrexia, Testicular pain
Clinical narrative: Right testicle and perineal pain, fever/chills, myalgias, h/a.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: White blood cell count decreased
Clinical narrative: Right testicle and perineal pain, fever/chills, myalgias, h/a.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Her arm at the injection site was very swollen and painful. It was also very swollen and painful in the lymph nodes around her armpit.