chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Nausea
Clinical narrative: Headaches daily, swollen lymph and neck, loss of appetite, nausea, tender belly. Blood tests reveal nothing. Chiropractic and lymph massage provides temporary relief. Can't afford neuro feedback treatment.
Age: 10.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Cyanosis, Immediate post-injection reaction, Lip discolouration, Muscle rigidity, Pallor
Clinical narrative: Pt given Tdap in (R) arm and immediately after IPV in (L) arm. Pt became pale with cyanotic lips, became rigid and unresponsive for approx. 10 sec. Pt. became responsive but pallor and lip discoloration remained for approx. 1/2 minute.
Age: 10.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt given Tdap in (R) arm and immediately after IPV in (L) arm. Pt became pale with cyanotic lips, became rigid and unresponsive for approx. 10 sec. Pt. became responsive but pallor and lip discoloration remained for approx. 1/2 minute.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu like symptoms-onset day of vaccine. Site swollen, hot to touch, knot at site, sore-next day after vaccine.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: Unnecessary. Tdap administered at 0935. Had received dose of Tdap on 04/24/2015.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Approximately 10-15 mins after vaccination pt reports feeling nauseous, then dizzy and weak, when she attempted to stand she fainted. After approximately 10 min. symptoms resolved. Pt was diaphoretic A and O x 3 during possible reaction no LOC.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Altered state of consciousness, Dizziness, Pallor
Clinical narrative: Patient felt like he was go to pass out. Patient turned pale white and said he felt lightheaded.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm. Acetaminophen/Hydrocodone one tab PRN.
Age: 1.62
Sex: F
Vaccine: HEPA
Symptoms: Balance disorder, Blood alkaline phosphatase increased, Somnolence, White blood cell count increased
Clinical narrative: Pt very sleepy 3 d. after vaccine Hep A. Also was off balance at home.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Erythema, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Received BOOSTRIX Tdap IM (L) deltoid on 6/24/15. Returned to office today. Stated within 24 h after injection his arm became painful, swollen, and red to 1-2 inches below elbow. ROM with elbow limited. today arm appeared normal on exam with no swelling or tenderness. However, he still has 15-20% deficit with inability to straighten arm at elbow.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Received BOOSTRIX Tdap IM (L) deltoid on 6/24/15. Returned to office today. Stated within 24 h after injection his arm became painful, swollen, and red to 1-2 inches below elbow. ROM with elbow limited. today arm appeared normal on exam with no swelling or tenderness. However, he still has 15-20% deficit with inability to straighten arm at elbow.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Received BOOSTRIX Tdap IM (L) deltoid on 6/24/15. Returned to office today. Stated within 24 h after injection his arm became painful, swollen, and red to 1-2 inches below elbow. ROM with elbow limited. today arm appeared normal on exam with no swelling or tenderness. However, he still has 15-20% deficit with inability to straighten arm at elbow.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TD
Symptoms: Malaise, Pallor, Staring, Syncope
Clinical narrative: Vaccine given and child sitting, looking at coloring book for approximately 10 min. Stood from chair and immediately fainted. Eyes with blank stare for approximately 30 sec. Awoke with amm, but continued to be pale and feel ill.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Not to touch. Swollen. Painful to move arm.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Rash
Clinical narrative: Temp. of 100, rash started on (R) leg, and spread to (B) legs and diaper area.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Localized swellinng, redness, and tenderness.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: 07/16/2015 Moderate other. Infant has experienced diarrhea and vomiting since 7/17/15. Started with runny nose on 7/16/15. Febrile with highest temperature 101 degrees F (Ax) on 7/17/15.
Age: 0.43
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. 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 has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified numbers of improperly stored doses of GARDASIL (lot number J010668 - expiration date 29-APR-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010881, 1507USA010882, 1507USA010883, 1507USA010884). Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Breath holding, Crying, Erythema, Pallor
Clinical narrative: Appeared to have breath holding spell after imms. Cried intensely sudden silence went red-> pale, Leaned head against mom went very still with eyes shut no seizure like movement. By time MD arrives (approximately 1 min) waking up & typical then asleep/napping by time of departure.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Pt had shots mid morning and awoke from nap mid to late afternoon with inconsolable crying and a red swollen left thigh. Would not breastfeed, take a bottle or a pacifier. TYLENOL 50mg PO given as well as diphenhydramine 6 mg PO given. Also cold pack applied to leg.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. Concurrent conditions and medical history were not reported. On 05-JUN-2015, the patients were vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. 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: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. Concurrent conditions and medical history were not reported. On 10-JUN-2015, the patients were vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016) (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. 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: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 12-JUN-2015, the patient was vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.44
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reports erythema and pain at injection site 2 days after immunization. Was treated with oral diphenhydramine and ice compress.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative, referring to two unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was reported that on an unspecified date, the patients were vaccinated with a dose of (Merck) VARIVAX solution for injection (does, route of administration and frequency were not reported). Later on an unknown date, the patients received a second dose of (Merck) VARIVAX solution for injection (dose, route of administration and frequency were not reported). The healthcare worker stated that (Merck) VARIVAX "did not work after a couple of years" (vaccination failure) because these two patients who received the vaccine "got the disease". It was reported that this occurred recently on an unspecified date within this past year, approximately in 2014. At the time of the report, the outcome of adverse event and vaccination failure was unknown. The relatedness of (Merck) VARIVAX with the varicella and vaccination failure was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness & swelling at site of both injections approximately 2 1/2 weeks post injection. No fever-diameter of swelling-3 cm of firmness. Pt instructed to take ibuprofen & apply ice packs if no better or sxs worsen notify MD.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 18 months old. The patient demographics were updated. On 04-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 10-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 05-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot# H021861 and expiration date 09-OCT-2015, strength, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Patient experienced redness, swelling, heat around injection site and large area on back of arm and broke out in a rash all over. Patient claims MD confirmed it was shingles. Method of confirmation unknown.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site haemorrhage, Injection site swelling, International normalised ratio, Prothrombin time
Clinical narrative: Pt developed swelling/ecchymosis at injection site approximately 2 wks after initial injection. No treatment--ecchymosis gradually resolved over next 2 weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Headache, Hypersomnia, Lethargy, Nausea
Clinical narrative: Stomach ache, nausea, throbbing head pain that increased when going from sitting to standing orllay in to standing, fever of 100.4, lethargic- slept more then usual.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Stomach ache, nausea, throbbing head pain that increased when going from sitting to standing orllay in to standing, fever of 100.4, lethargic- slept more then usual.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal pain, Abnormal behaviour, Arthralgia, Asthenia, Chills
Clinical narrative: Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Discomfort, Dizziness, Gait disturbance, Headache, Impaired driving ability
Clinical narrative: Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Injection site swelling, Insomnia, Mobility decreased, Mood altered
Clinical narrative: Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Nausea, Neck pain, Pain in jaw, Palpitations, Pyrexia
Clinical narrative: Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Spinal pain, Vision blurred, Vomiting, Walking aid user
Clinical narrative: Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, slight pain to injection site.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Computerised tomogram head, Defaecation urgency, Fall, Laceration
Clinical narrative: Approximately 5 minutes after administration of vaccine client c/o stomach pain and urge to have a BM. In the rest room client experienced syncopal episode, regained full consciousness after ~ 30 seconds to a minute. BP supine 90/55 P 52  and sitting 91/54 P 62, skin warm and dry.  Approximately 15 minutes after client continued to c/o stomach pain and urge to have BM and vomit, however did not. Client taken to Emergency Dept. for further evaluation. When falling client hit chin on toilet seat and sustained superficial laceration to chin. No c/o SOB, no hive, no swelling.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Syncope
Clinical narrative: Approximately 5 minutes after administration of vaccine client c/o stomach pain and urge to have a BM. In the rest room client experienced syncopal episode, regained full consciousness after ~ 30 seconds to a minute. BP supine 90/55 P 52  and sitting 91/54 P 62, skin warm and dry.  Approximately 15 minutes after client continued to c/o stomach pain and urge to have BM and vomit, however did not. Client taken to Emergency Dept. for further evaluation. When falling client hit chin on toilet seat and sustained superficial laceration to chin. No c/o SOB, no hive, no swelling.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Swelling face
Clinical narrative: After she went to bed she felt like she might have had a slight bit of swelling in the lower lip area and upon awaking in the morning she noticed her whole face was puffy.  No problems with swallowing, speaking, reading, no chest pain, or shortness of breath.  She called Dr's. office and she was brought into the clinic for an appointment.  Dr. prescribed a Medrol dose pak, told her to take Claritin, Allegra or Zyrtec and also Ranitidine daily to help with the reaction.  If she noticed any difficulty with breathing or symptoms get worse she was directed to go directly to the Emergency Room.
Age: 32.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itch at site of administration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Seizure
Clinical narrative: Convulsion, diaphoretic, approximately 5 minutes. Client and mother were advised to follow up at nearest ED.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Eye movement disorder, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Seconds after administration, my son's eyes rolled back in his head and he became unresponsive, followed by seizure-like twitching.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Injection site discolouration
Clinical narrative: 9:30pm - Baseball size swelling. 7/10 pain. Unable to elevate arm above waist. Applied ice and took 400mg naprox sodium. 10:00pm - Began to feel burning sensation in skin across ENTIRE body. No difficulty breathing. Self administered 50mg Benadryl. 11:00pm - Dizziness. Temp normal. Extreme malaise. Swollen area in Left delt extremely hard to touch and white in color. Pain continues 8/10. 1am - Pain unchanged. No fever. Skin still burning and shivering. Administer 1g Tylenol. 7am - No sleep. Continue w/ ice. Naprox 400mg. Pain unchanged. 5pm - entire day in bed with severe flu-like (not just virus like) symptoms. Swelling is less localized and spreading in arm although less severe. Continue w/ ice and Tylenol. 8pm: Sleep for 12 hours. 8am: Swelling reduced by 50%. No fever. Pain 5/10. Color returning to area. Headache. 12pm: unchanged. continue ice + rotate naprox w/ Tylenol q3hrs. No signs if cellulitis.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Insomnia, Malaise, Mobility decreased
Clinical narrative: 9:30pm - Baseball size swelling. 7/10 pain. Unable to elevate arm above waist. Applied ice and took 400mg naprox sodium. 10:00pm - Began to feel burning sensation in skin across ENTIRE body. No difficulty breathing. Self administered 50mg Benadryl. 11:00pm - Dizziness. Temp normal. Extreme malaise. Swollen area in Left delt extremely hard to touch and white in color. Pain continues 8/10. 1am - Pain unchanged. No fever. Skin still burning and shivering. Administer 1g Tylenol. 7am - No sleep. Continue w/ ice. Naprox 400mg. Pain unchanged. 5pm - entire day in bed with severe flu-like (not just virus like) symptoms. Swelling is less localized and spreading in arm although less severe. Continue w/ ice and Tylenol. 8pm: Sleep for 12 hours. 8am: Swelling reduced by 50%. No fever. Pain 5/10. Color returning to area. Headache. 12pm: unchanged. continue ice + rotate naprox w/ Tylenol q3hrs. No signs if cellulitis.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Skin burning sensation, Swelling
Clinical narrative: 9:30pm - Baseball size swelling. 7/10 pain. Unable to elevate arm above waist. Applied ice and took 400mg naprox sodium. 10:00pm - Began to feel burning sensation in skin across ENTIRE body. No difficulty breathing. Self administered 50mg Benadryl. 11:00pm - Dizziness. Temp normal. Extreme malaise. Swollen area in Left delt extremely hard to touch and white in color. Pain continues 8/10. 1am - Pain unchanged. No fever. Skin still burning and shivering. Administer 1g Tylenol. 7am - No sleep. Continue w/ ice. Naprox 400mg. Pain unchanged. 5pm - entire day in bed with severe flu-like (not just virus like) symptoms. Swelling is less localized and spreading in arm although less severe. Continue w/ ice and Tylenol. 8pm: Sleep for 12 hours. 8am: Swelling reduced by 50%. No fever. Pain 5/10. Color returning to area. Headache. 12pm: unchanged. continue ice + rotate naprox w/ Tylenol q3hrs. No signs if cellulitis.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Pt returned to pharmacy on 7/29 complaining of injection site redness, itching, warmth on left arm (appeared a little swollen compared to opposite arm).  No report of trouble breathing.  Recommended ice pack, and antihistamines.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site induration, Injection site nodule, Injection site reaction, Injection site warmth
Clinical narrative: Vaccine was PPSV, 23 - valent. Large red rash that grew from quarter size to palm of hand size with hard knot and noticeable heat under injection site over 4 - 5 days.  Hard knot at injection sites still present on 07/29/15.  Fever of ~ 101 F on 7/21, 7/22 and 7/23. Fatigue, general aches in body finally gone 07/25/2015.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash erythematous
Clinical narrative: Vaccine was PPSV, 23 - valent. Large red rash that grew from quarter size to palm of hand size with hard knot and noticeable heat under injection site over 4 - 5 days.  Hard knot at injection sites still present on 07/29/15.  Fever of ~ 101 F on 7/21, 7/22 and 7/23. Fatigue, general aches in body finally gone 07/25/2015.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented on 7/29/2015 concerned about redness and itching at site of injection. Stated it was beginning to improve. Area was approximately the size of a palm. Counseled patient that redness at the reaction site was common with Zostavax and to monitor and report if it worsened.
Age: 0.1
Sex: M
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: Hives all over body for 3 days; parent did not bring to doctor for evaluation.
Age: 0.1
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives all over body for 3 days; parent did not bring to doctor for evaluation.
Age: 0.1
Sex: M
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: Hives low grade fever 100.1. Tylenol.
Age: 0.1
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives low grade fever 100.1. Tylenol.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented on 7/29/15 concerned about redness and itching at injection site. Stated it was improving. Area was approximately the size of the palm of the hand. Counseled patient that redness at the reaction site was common with Zostavax and to monitor and report if it worsened.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction L shoulder.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt says that arm was fine for a week when had shot administered but a week later her arm started to hurt.  Pts left arm hurts when lifting things.  She has not been to the doctor yet.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Vaccinated L deltoid. Developed redness, warmth, pain which extended down the arm, beyond injection side.  Resolved by day 5-6 after injection.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Vaccinated L deltoid. Developed redness, warmth, pain which extended down the arm, beyond injection side.  Resolved by day 5-6 after injection.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immune thrombocytopenic purpura, Increased tendency to bruise, Platelet count abnormal, Platelet count decreased
Clinical narrative: Presented to ER 6-28-15 was transferred to medical center for ITP. Platelet count was low, had unusually easy bruising. Received vaccine 6-15-15.
Age: 1.02
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot to touch at injection site.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain in upper left arm and joint pain in left shoulder.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient stated she developed a rash at the injection site. She received two vaccines at the same day and said the rash was at the bottom of the two injections. The Adacel was IM given on the upper arm and the Zostavax was the lower injection site. Patient stated on 7/29/15 that the rash was coin size with no blisters. Patient did not develop a fever, no trouble breathing or any signs of anaphylaxis.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, warm, swollen area on arm just under injection site.  It measured about 3 inches by 6 inches.  My doctor said she had never seen anything like it.  She said she did not think it was cellulitis, but gave me an antibiotic just in case.  It was three weeks before it completely faded.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm oval shaped patch on outer surface of upper left arm. No streaking.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dehydration, Exposure during pregnancy, Headache, Heart rate increased
Clinical narrative: Nausea, vomiting, chills/sweats, headache, 101.6 fever that caused dehydration, low blood pressure with high heart rate, passing out and a type two heart attack while pregnant.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Myocardial infarction, Nausea
Clinical narrative: Nausea, vomiting, chills/sweats, headache, 101.6 fever that caused dehydration, low blood pressure with high heart rate, passing out and a type two heart attack while pregnant.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, chills/sweats, headache, 101.6 fever that caused dehydration, low blood pressure with high heart rate, passing out and a type two heart attack while pregnant.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Abortion spontaneous, Exposure during pregnancy, Feeling cold, Hot flush, Mobility decreased
Clinical narrative: Woke up that morning to hot and cold flashes, extreme nausea and vaginal discharge.  Started having "joint seizures" to the point she couldn't move her hands.  Lost full function of the hands, but was systemic to all joints in body.  Lasted 2 hours.  Went to the ER.  They were vague, stated they couldn't link symptoms directly to vaccination.  Went to her PCP.  Patient didn't realize she was pregnant, but miscarried on 7/12/15.  Her PCP felt her symptoms and miscarriage were related to MMR vaccination.  "PCP drew MMR titer, and patient claims her Rubella titer returned with extremely high numbers.  The other components of the titer were in normal ranges.  My PCP feels I'm extremely susceptible to Rubella vaccination and should claim medical exemption".  Episode lasted 4 days total.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal disorder, Nausea, Rubella antibody positive, Seizure, Vaginal discharge
Clinical narrative: Woke up that morning to hot and cold flashes, extreme nausea and vaginal discharge.  Started having "joint seizures" to the point she couldn't move her hands.  Lost full function of the hands, but was systemic to all joints in body.  Lasted 2 hours.  Went to the ER.  They were vague, stated they couldn't link symptoms directly to vaccination.  Went to her PCP.  Patient didn't realize she was pregnant, but miscarried on 7/12/15.  Her PCP felt her symptoms and miscarriage were related to MMR vaccination.  "PCP drew MMR titer, and patient claims her Rubella titer returned with extremely high numbers.  The other components of the titer were in normal ranges.  My PCP feels I'm extremely susceptible to Rubella vaccination and should claim medical exemption".  Episode lasted 4 days total.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Blindness, Hypertension, Injection site mass, Seizure
Clinical narrative: Lump in my arm at the injection site. Couldn't see. Seizure at home. Another seizure at ER. High blood pressure.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient had received his first dose of Gardasil and his second dose of Menactra approximately 6:40 PM, July 28, 2015.  He was sitting with his father at a table in the clinic.  All adolescents are requested to wait 15 minutes following immunizations for safety. At about 6:45 PM, I observed the pt. sitting in his chair and then falling from to the right onto the floor. I rushed to him and found him to be unconscious for a few seconds.  He was conscious again and seemed dazed, but said he was "fine".  Other nurses and I assisted him by applying a pillow under his head, a cold pack behind his neck and elevated his extremities.  His vital signs and neuro signs were monitored.  It is uncertain whether or not he bumped his head in the fall. He did not think he had. After approx. 10 minutes he was assisted to a sitting position and reported no dizziness.  Instructions were given to father for signs to watch for, to which he replied he was well versed in concussion care, as he is a local football coach.  Pt. left clinic in the company of his father.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash macular, Swelling
Clinical narrative: Soreness started on 07/28/2015. Quarter-sized swollen red splotches appeared on the skin about 3 inches from the injection site around 3PM on 07/29/2015.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to about 8 cm around injection site.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Borrelia test, Chest X-ray, Computerised tomogram head, Differential white blood cell count
Clinical narrative: Patient passed out twice within two minutes- looked like seizure activity. He could not walk and was helped to the car. Was taken to the Emergency room at the local hospital.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Drug screen, Electrocardiogram, Full blood count, Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient passed out twice within two minutes- looked like seizure activity. He could not walk and was helped to the car. Was taken to the Emergency room at the local hospital.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: Patient passed out twice within two minutes- looked like seizure activity. He could not walk and was helped to the car. Was taken to the Emergency room at the local hospital.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Impaired work ability, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a physician regarding a 43 year old female patient. The patient's concurrent conditions was not reported. The patient did not have any drug reaction or allergies, her pertinent medical history was not reported. On 13-JUL-2015 the patient was vaccinated with PNEUMOVAX23 (lot # L003227/ expiry date: 12-OCT-2016), (Dose 0.5 ml, intramuscular). Concomitant medications were not reported. On 13-JUL-2015, within about 5-6 hours of administration of PNEUMOVAX23 the patient experienced severe swelling and redness around injection site, high fever, stiff neck and cellulitis. The patient sought medical attention and went to emergency room (ER) twice on unspecified dates for symptoms that she had been experiencing but patient was not admitted to hospital. On an unknown date the patient  was treated with unspecified intravenous and oral antibiotics. On an unspecified date the patient also had a follow-up checkup with the reporting physician. The reporter stated that the patient had missed 2 days of work due to adverse event symptoms. A product quality complaint was not filed. The physician reported that as of 21-JUL-2015 patient's symptoms have resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician regarding a 43 year old female patient. The patient's concurrent conditions was not reported. The patient did not have any drug reaction or allergies, her pertinent medical history was not reported. On 13-JUL-2015 the patient was vaccinated with PNEUMOVAX23 (lot # L003227/ expiry date: 12-OCT-2016), (Dose 0.5 ml, intramuscular). Concomitant medications were not reported. On 13-JUL-2015, within about 5-6 hours of administration of PNEUMOVAX23 the patient experienced severe swelling and redness around injection site, high fever, stiff neck and cellulitis. The patient sought medical attention and went to emergency room (ER) twice on unspecified dates for symptoms that she had been experiencing but patient was not admitted to hospital. On an unknown date the patient  was treated with unspecified intravenous and oral antibiotics. On an unspecified date the patient also had a follow-up checkup with the reporting physician. The reporter stated that the patient had missed 2 days of work due to adverse event symptoms. A product quality complaint was not filed. The physician reported that as of 21-JUL-2015 patient's symptoms have resolved. The reporter did not provide the causality between the event and the suspect therapy. 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 unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (that were exposed to 9 degree celsius for 29 minutes) ROTATEQ suspension 2 (units unknown), 2 ml, orally (lot # K011948, expiry date: 07-JUN-2016) and (lot # K023534, expiry date: 22-MAY-2016). No concomitant medication were reported. No adverse effects were reported. The outcome of the event was unknown. There were not product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.