chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant (MA)) refers to a 6 month old patient. It was reported that the patient had received the first dose of HIB vaccine (manufacturer unknown), 0.5 ml intramuscularly on 15-OCT-2014 and received the second dose of PEDVAXHIB (lot #, expiration date were not provided) on 16-DEC-2014. On 16-FEB-2015, the patient was vaccinated with PEDVAXHIB dose 3 (0.5 ml, intramuscular, lot # and expiration date were not provided) and PENTACEL (dose and route of administration were not provided). No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site rash, Swelling face
Clinical narrative: Rash over injection site and also facial swelling with redness.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with the first dose of VAQTA, 25/0.5 injection, lot# and expiration date not reported, 0.5ml/ 1 dose, intramuscular. Nurse reported that the patient inadvertently received their second dose of VAQTA on 05-MAR-2015, thirteen days earlier than the recommended schedule. No adverse effects reported. 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 registered nurse refers to an unknown number of patients of unspecified demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with RECOMBIVAX HB, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Right after tetanus vaccine administered, donor felt nauseous, warm, and later sweaty. Donor was instructed to lay down and feet elevated, and ice packs applied to forehead, back and chest. After nausea went away, water by mouth was given to donor.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 29-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: Whole body ache. Shoulder pain. Tingle in extremities. No redness/discoloration at injection site.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to an adult female patient in her 50's. The concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 in the left deltoid (route and dose unspecified). The concomitant medications were not reported. On an unknown date the patient experienced severe pain in the left deltoid after the injection. The outcome of the event and the causality was unknown. 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 registered nurse refers to an unknown number of patients of unspecified demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with VAQTA, intramuscular which underwent a supported temperature excursion (incorrect product storage). The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a 50 years old male patient, as part of a marketing research program. The current condition included pneumonia. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown). On an unknown date the patient 'got sick' (malaise). The outcome of the event and the causality was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unspecified demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with GARDASIL, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the 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: Information has been received from a licensed vocational nurse referring to an unspecified number of patients of unknown age. The nurse reported that the unspecified number of patients received improperly stored VARIVAX (Merck) (dose, route and lot# not reported) on unspecified days (incorrect storage of drug). No adverse effects were reported. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 05-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcome of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 26-FEB-2015 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J014568, expiration date 18-FEB-2015, (dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Information about concurrent conditions and medical history were not provided. The patient reported that she received one dose of VARIVAX (Merck) (lot#, dose and route not reported) as a child on an unspecified date and had titers drawn. The results revealed that she was not immune to Varicella (date unspecified). The patient was administered the VARIVAX (Merck) (lot#, dose and route not reported) series, this time completing two doses on 02-SEP-2014 and 16-OCT-2014 respectively. No information regarding concomitant therapy was provided. However, as of 10-MAR-2015 titers were still showing her not being immune to Varicella. The patient sought for medical attention via visiting physician. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 20-JAN-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dysphonia, Erythema, Myalgia, Peripheral swelling
Clinical narrative: Information has been received from a 61 year old female patient with restless legs concerning herself via Pfizer (manufacturer# 2015095450). On 10-FEB-2015, the patient was vaccinated with a dose of PREVNAR 13. On 09-MAR-2015 at 09:30 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, dose, frequency and lot# were not reported) intramuscularly in the left upper arm for immunological deficiency. Concomitant therapies included gabapentin, trazodone (manufacturer unknown) and vitamins. The patient had sore shoulder at injection site prior vaccination. 10 or 15 minutes before the vaccination, the patient had a tickle in her throat. On 09-MAR-2015 a large area from her elbow to the top of her shoulder was swollen. Swelling started pretty quickly after the shot. By 01:00 in the morning on 10-MAR-2015, her arm was quite big. The swelling was down at the time of report but was still present. The patient developed a hoarse voice within two hours after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And sensitivity was down at the time of report. The muscles hurt in her left arm, on the first day but the worst was on 10-MAR-2015. She stated she was able to move it at the time of report. She had prickly redness near her elbow where the bottom of the worst of the swelling was. It developed during the second day, on 10-MAR-2015. This area looked more like bruising and had a deep, deep, deep, red color at the time of the report. The outcome of these events was reported as recovering/resolving. The patient sent an image to her doctor but did not visit doctor. No lab tests were performed. The relationship between these events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a 61 year old female patient with restless legs concerning herself via Pfizer (manufacturer# 2015095450). On 10-FEB-2015, the patient was vaccinated with a dose of PREVNAR 13. On 09-MAR-2015 at 09:30 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, dose, frequency and lot# were not reported) intramuscularly in the left upper arm for immunological deficiency. Concomitant therapies included gabapentin, trazodone (manufacturer unknown) and vitamins. The patient had sore shoulder at injection site prior vaccination. 10 or 15 minutes before the vaccination, the patient had a tickle in her throat. On 09-MAR-2015 a large area from her elbow to the top of her shoulder was swollen. Swelling started pretty quickly after the shot. By 01:00 in the morning on 10-MAR-2015, her arm was quite big. The swelling was down at the time of report but was still present. The patient developed a hoarse voice within two hours after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And sensitivity was down at the time of report. The muscles hurt in her left arm, on the first day but the worst was on 10-MAR-2015. She stated she was able to move it at the time of report. She had prickly redness near her elbow where the bottom of the worst of the swelling was. It developed during the second day, on 10-MAR-2015. This area looked more like bruising and had a deep, deep, deep, red color at the time of the report. The outcome of these events was reported as recovering/resolving. The patient sent an image to her doctor but did not visit doctor. No lab tests were performed. The relationship between these events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The pertinent medical history was not reported. On 09-MAR-2015, the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscularly which underwent a supported temperature excursion. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-MAR-2015, one dose of improperly stored ZOSTAVAX (0.65 ml, subcutaneous (SQ), lot# and expiration date not reported) was administered to the patient. No adverse effects were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a 57 year old female patient with penicillin and sulfa drug allergy reporting on herself. The patient did not have pertinent medical history. On 16-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapies included spironolactone, losartan potassium (manufacturer unknown), pravastatin, paroxetine, famotidine (manufacturer unknown) and aspirin. On the same date, after receiving the vaccination, the patient experienced pruritus generalised as she was having itching all over her body, swollen lips and tongue. The patient also experienced throat tightness referred as "throat closed" and she was unable to speak. The patient sought medical attention by going to the urgent care clinic and was later admitted to the hospital on an unspecified date in 2015. An unspecified blood work was performed but the results were not provided. Treatment with EPIPEN, BENADRYL and another unspecified medication was given for the adverse events. At the time of the report, the outcome of aphasia, throat tightness, swollen tongue, lip swelling and pruritus generalised was unknown. Upon internal review the event of aphasia was considered to be medically significant. Additional information is not expected because the patient refused additional contact.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Blood test, Lip swelling, Pruritus generalised, Swollen tongue
Clinical narrative: This spontaneous report as received from a 57 year old female patient with penicillin and sulfa drug allergy reporting on herself. The patient did not have pertinent medical history. On 16-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapies included spironolactone, losartan potassium (manufacturer unknown), pravastatin, paroxetine, famotidine (manufacturer unknown) and aspirin. On the same date, after receiving the vaccination, the patient experienced pruritus generalised as she was having itching all over her body, swollen lips and tongue. The patient also experienced throat tightness referred as "throat closed" and she was unable to speak. The patient sought medical attention by going to the urgent care clinic and was later admitted to the hospital on an unspecified date in 2015. An unspecified blood work was performed but the results were not provided. Treatment with EPIPEN, BENADRYL and another unspecified medication was given for the adverse events. At the time of the report, the outcome of aphasia, throat tightness, swollen tongue, lip swelling and pruritus generalised was unknown. Upon internal review the event of aphasia was considered to be medically significant. Additional information is not expected because the patient refused additional contact.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: This spontaneous report as received from a 57 year old female patient with penicillin and sulfa drug allergy reporting on herself. The patient did not have pertinent medical history. On 16-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapies included spironolactone, losartan potassium (manufacturer unknown), pravastatin, paroxetine, famotidine (manufacturer unknown) and aspirin. On the same date, after receiving the vaccination, the patient experienced pruritus generalised as she was having itching all over her body, swollen lips and tongue. The patient also experienced throat tightness referred as "throat closed" and she was unable to speak. The patient sought medical attention by going to the urgent care clinic and was later admitted to the hospital on an unspecified date in 2015. An unspecified blood work was performed but the results were not provided. Treatment with EPIPEN, BENADRYL and another unspecified medication was given for the adverse events. At the time of the report, the outcome of aphasia, throat tightness, swollen tongue, lip swelling and pruritus generalised was unknown. Upon internal review the event of aphasia was considered to be medically significant. Additional information is not expected because the patient refused additional contact.
Sex: U
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist via Pfizer (manufacturer control# 2015058208) referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot#, dose and frequency were unknown). On an unknown date the patient experienced allergic reaction after being administered PNEUMOVAX 23. The symptoms of the allergic reaction were unknown. The outcome of allergic reaction was unknown. The relationship between the adverse event and PNEUMOVAX 23 was not reported. Follow-up was received via telephone call with the pharmacist on 17-MAR-2015. The pharmacist stated that she was unfamiliar with the details of the reported event of hypersensitivity. Additional information has been requested. This is a corrected and downgraded report. The event of allergic reaction should not be considered as medically significant.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: After receiving third Gardasil booster shot, was covered in itchy light-pink bumps all over my body for 2-3 days.
Age: 1.14
Sex: M
Vaccine: DTAP
Symptoms: Crying, Insomnia, Pyrexia
Clinical narrative: High Fever. Non stop crying. Unable to sleep.
Age: 0.51
Sex: F
Vaccine: DTPIHI, RVX
Symptoms: Crying, Decreased appetite, Mobility decreased, Oral administration complication, Somnolence
Clinical narrative: She threw up while taking vaccine, then threw up twice at home, hardly ate at night, and was very sleepy, even when awake she hardly moved, frequent crying all night.
Age: 0.51
Sex: F
Vaccine: DTPIHI, RVX
Symptoms: Vomiting
Clinical narrative: She threw up while taking vaccine, then threw up twice at home, hardly ate at night, and was very sleepy, even when awake she hardly moved, frequent crying all night.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red area at injection site about 3 inches diameter that was raised about 0.25" and felt painful. Next day this area remained and a swollen area 6 inches in diameter had developed around the original read area that was not red, but area still painful.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Surgery
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history or concurrent condition were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Other suspect therapies included Tdap (lot number, expiry date, dose, route were not reported). No concomitant medications were reported. On an unknown date (reported as "couple of weeks post administration of vaccine products"), the patient was hospitalized for an unspecified emergency surgical procedure. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event was considered to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Impaired work ability, Pain in jaw, Swelling
Clinical narrative: Patient received vaccine on 3-4-15 due to hospital employee policy change. Patient had titers drawn and were negative. Patient woke up in the middle of the night of 3-11-15 with right jaw pain and swelling. Patient was seen at medical clinic on 3-12-15. Trimethoprim 100mg was given to patient. Patient was required to stay home from work due to working in a health care facility. Patient was then seen again on 3-14-15 to follow up. At that time, the patient's symptoms had resolved.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Aspiration, Death
Clinical narrative: Received call from wife. Approx. 3AM pt. aspirated and 911 was called. Pt. expired in transport. Due to close proximity of vaccine administration we are reporting the event.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Woke up with fever under 100 degrees, nausea, dizziness and headache. Woke up 3/20/15 with stiff neck as well. By 10 AM on 3/20/15 symptoms resolved.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Chills, body aches, headaches, congestion and runny nose.
Age: 1.92
Sex: M
Vaccine: DTAPHEPBIP, MMRV, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No adverse reaction noted at this time. Child is still under monitor for eventual adverse event.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Injection site erythema, Injection site rash, Irritability, Pruritus
Clinical narrative: +diffuse maculopapular rash s/p vaccines on Tuesday 03/17/2015. Mild fever 1st day followed by diffuse rash yesterday slight decreased appetite but good UOP (10x/day) and normal stools. +fussy per parents-->seeming itchy. Rash worse over site of injections in thighs (patch-like erythema) and present on trunk as well as arms/legs, elbows. Discussed with Pediatrics (per PCP, + mild rash seen around umbilicus prior to vaccines-->looked at rash today and notes now significantly more diffuse c/w exacerbation). May give decadron for severe rash (do not feel necessary in this case). Cautioned against Benadryl as under 6 month of age-->but may be okay to trial topical Benadyl (small quantities-->encouraged to avoid for now-->trial emollients only for now such as Aquaphor and rash should be self-limited. Precautions given to seek med attention if any worsening symptoms, shortness of breath. Voice understanding and agree with plan.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Rash generalised, Rash maculo-papular
Clinical narrative: +diffuse maculopapular rash s/p vaccines on Tuesday 03/17/2015. Mild fever 1st day followed by diffuse rash yesterday slight decreased appetite but good UOP (10x/day) and normal stools. +fussy per parents-->seeming itchy. Rash worse over site of injections in thighs (patch-like erythema) and present on trunk as well as arms/legs, elbows. Discussed with Pediatrics (per PCP, + mild rash seen around umbilicus prior to vaccines-->looked at rash today and notes now significantly more diffuse c/w exacerbation). May give decadron for severe rash (do not feel necessary in this case). Cautioned against Benadryl as under 6 month of age-->but may be okay to trial topical Benadyl (small quantities-->encouraged to avoid for now-->trial emollients only for now such as Aquaphor and rash should be self-limited. Precautions given to seek med attention if any worsening symptoms, shortness of breath. Voice understanding and agree with plan.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Extreme vomiting, vomiting bile.
Age: 21.0
Sex: F
Vaccine: FLU3, IPV, RAB, TYP
Symptoms: Burning sensation, Fear, Heart rate increased, Limb discomfort, Pain in extremity
Clinical narrative: In the Patients words "THE LEGS BEGAN TO BURN IN BOTH THIGHS AT FIRST. I FELT HEAT WHEN I PUT MY HAND ON THEM. AFTER FALLING ASLEEP, I WOKE UP AT 4 AM AND MY LEGS FELT LIKE A DEAD WEIGHT. I FELT TINGLING IN MY FEET. IT SCARED ME. I ALSO BEGAN TO HAVE AN INCREASE HEART RATE, AS I FELT MY HEART BEAT FASTER. THE PAIN FROM ALL THE SHOTS WAS STILL IN MY ARMS, BUT I NOTICED MORE TINGLING IN MY HANDS THAN IN MY ARMS. "
Age: 21.0
Sex: F
Vaccine: FLU3, IPV, RAB, TYP
Symptoms: Paraesthesia, Skin warm
Clinical narrative: In the Patients words "THE LEGS BEGAN TO BURN IN BOTH THIGHS AT FIRST. I FELT HEAT WHEN I PUT MY HAND ON THEM. AFTER FALLING ASLEEP, I WOKE UP AT 4 AM AND MY LEGS FELT LIKE A DEAD WEIGHT. I FELT TINGLING IN MY FEET. IT SCARED ME. I ALSO BEGAN TO HAVE AN INCREASE HEART RATE, AS I FELT MY HEART BEAT FASTER. THE PAIN FROM ALL THE SHOTS WAS STILL IN MY ARMS, BUT I NOTICED MORE TINGLING IN MY HANDS THAN IN MY ARMS. "
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient developed a rash with itching at injection site approx 24 hours after injection. She reported the reaction 8 days afterwards, the rash was still present, measuring 12 inches up and down and 6 inches around her arm. No other symptoms were mentioned.
Age: 18.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Mother of vaccine recipient called clinic 3/19/2015 @ 5:00 PM to report erythema and swelling to left upper arm radiating to left axilla. Client counseled to come into clinic to have provider examine area; offer was declined. Mother stated adult client would go to ER after work. Attempt was made to contact client on 3/20/2015 morning to follow-up with client; no answer. Message left by clinic FNP to call clinic with questions or concerns.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abasia, Areflexia, Asthenia, Back pain, CSF protein abnormal
Clinical narrative: 01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: CSF white blood cell count positive, Condition aggravated, Defaecation urgency, Electromyogram abnormal, Gout
Clinical narrative: 01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nephrolithiasis
Clinical narrative: 01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nerve injury, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Spinal X-ray normal, Ultrasound kidney normal
Clinical narrative: 01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Left deltoid swollen, red, warm to touch, with a hard knot underneath the redness, painful to touch. temp 99.5.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swollen, red, warm to touch, with a hard knot underneath the redness, painful to touch. temp 99.5.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Catheter placement, Fall, Limb injury, Malaise, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 24Feb2015 at 0.5 ml, single dose. Medical history included pain disorders. Concomitant medications included methadone 10 mg, oxycodone 30 mg, duloxetine 60 mg, Vitamin D 1000 IU, doxepin 100 mg, and gabapentin 300 mg. On unknown dates in 2015, the patient was not feeling well, fell down/could not get back up, and crumbled his leg. The events were serious for hospitalization. The clinical course was as follows: the patient said that he was not feeling well after the vaccine and he went to hospital. The hospital had sent him home. When he was at home, he fell and could not get back up. He was in hospital and they put a catheter in and he crumbled his leg. The patient stated that the hospital told him that this was due to PREVNAR 13. The clinical outcome of the events, patient was not feeling well, fell down/could not get back up, was not recovered. The clinical outcome of the event, crumbled his leg, was unknown. The pharmacist did not think the events, patient was not feeling well, fell down/could not get back up, and crumbled his leg, were related to the PREVNAR 13. The pharmacist mentioned that the patient was still in hospital.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 65 year-old female patient received, on an unspecified date, PREVNAR 13 intramuscularly in deltoid of unknown arm, at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, one day after the injection, the patient experienced cellulitis of deltoid. Clinical outcome of the event was unknown at time of this report.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Developed local reaction with pain / erythema and induration at vaccine site.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Ear pain, Neuralgia, Pain, Paraesthesia
Clinical narrative: Within 30 min of vaccine neuralgia in administered arm, Left, started occurring spreading to the fingertips including pins and needles, weakness and pain.  About one hour later spread to left leg.  Continues at this time 3/20/2015 at 11:00 AM.  Additionally, at about 11:30 pm 3/19/15 started with intermittent severe right ear pain that with each episode lasting less than 30 seconds.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Noted sore throat, malaise, fatigue, dizziness, pain in left arm, "tingling" in arms and legs.  Approximately 1 week later noted 1-2 day history of dyspnea and chest discomfort.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Laboratory test normal, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: Noted sore throat, malaise, fatigue, dizziness, pain in left arm, "tingling" in arms and legs.  Approximately 1 week later noted 1-2 day history of dyspnea and chest discomfort.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Noted sore throat, malaise, fatigue, dizziness, pain in left arm, "tingling" in arms and legs.  Approximately 1 week later noted 1-2 day history of dyspnea and chest discomfort.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary pain, Chills, Induration, Lethargy, Lymphadenopathy
Clinical narrative: Started with fever, body chills, pain in left armpit, progressed to hard swelling of lymph nodes around left collarbone, severe lethargy, nausea.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Started with fever, body chills, pain in left armpit, progressed to hard swelling of lymph nodes around left collarbone, severe lethargy, nausea.
Age: 25.0
Sex: M
Vaccine: JEV1, TDAP, TYP
Symptoms: Rash, Rash erythematous
Clinical narrative: Client states that he developed a "rash" on his neck on the morning of 3/19. The client described the rash as "red and puffy looking." Per client, the rash is a uniform red area with "no dots." States the rash has defined borders, is on both sides of neck and extends down to his collarbone. Client states he first thought it was "bad sunburn." Client denies any other symptoms. Since its development, client states the rash has gotten worse. He applied some hydrocortisone today. Client took first typhoid pill on the night of 3/16 and has taken 2 pills so far.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Adverse event, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with ROTATEQ (lot number and expiry date unknown) oral suspension (dosing regimen and frequency unknown). No concomitant therapy was reported. On an unknown date, 3 to 5 days after vaccination, the patient was taken to the emergency department for unspecified symptoms (adverse event). On an unknown date the patient tested positive for rotavirus while in emergency department (Rotavirus infection). It was unknown whether or not the patient was admitted to the hospital or if the patient was treated and released from the emergency department. The patient had sought medical attention (details unspecified). The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. The reporter did not provide the causality between the events and the therapy with ROTATEQ. There was no product quality issue reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test, Varicella post vaccine
Clinical narrative: Came down with chicken pox.  Docter submitted blood sample but actual results not yet received.  He indicated it appeared to be chicken pox.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: 101.8 F FEVER, FATIGUE, SHORTNESS OF BREATH, JOINT PAINS.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Myalgia, Pain, Pyrexia
Clinical narrative: Significant pain, fever up to 103, myalgias, later developed redness at site.
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Blister, Macule, Papule, Skin lesion, Varicella post vaccine
Clinical narrative: Two-dose varicella vaccine recipient diagnosed with varicella at ED on 9/1/2014. Reported 400 lesions (macules, papules, and vesicles), no history of chickenpox. No exposures noted.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dizziness, Headache, Injection site swelling
Clinical narrative: Chills, fever, swelling at injection site, muscle aches, joint aches, dizziness, nausea, severe nasal congestion, headache, injected arm still painful when used.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nasal congestion, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, swelling at injection site, muscle aches, joint aches, dizziness, nausea, severe nasal congestion, headache, injected arm still painful when used.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Pruritus generalised
Clinical narrative: Large lump in arm at injection site. Painful, itchy; Has not yet gone away, though it has decreased some; from time to time will start itching all over again.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Rash, Swelling
Clinical narrative: Patient received Pneumovax 23 on 3/18/15, she has had swelling, redness, fever & chills since then.  Today she has developed a rash.  She is here to r/o cellulitis.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Huge red swelling and itching at vaccine site (right arm).
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Employee stated that she felt dizzy after the vaccination. Employee was put in the supine position with feet elevated. Vital signs was taken: BP was 125/83; Pulse was 79; and temp was 96.8 oral. Ice was placed at nape of neck.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria, Viral rash
Clinical narrative: Yesterday seen in ER for rash and hives, rash was dx as viral and urticaria. Pt was rx with Zyrtec.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Abdominal pain upper
Clinical narrative: Client complains of stomach pains for a few minutes in duration on and off through out day.
Age: 15.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain
Clinical narrative: Client reports sharp pains in abdomen area that last up to a few hours.  Reports approximately 3 times a day being in the morning, around dinner time and again in the evening before bed.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient note that she had no side effects until she was sleeping that night, and switched sides, and noted warm, puffy, painfully red arm. Tried Tylenol and ice on affected site with no help. Told patient to go seek care by PCP, or another medical doctor to assess site.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, VARCEL
Symptoms: Headache, Herpes zoster, Nausea, Rash
Clinical narrative: Herpes Zoster diagnosis in a two-dose variella vaccine recipient. Diagnosed at Health Center on 11/12/2014. Painful rash in one dermatome (left back). She has a history of eczema. Treated with unknown antiviral. Other symptoms included headache and nausea.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt nauseous and dizzy after received his Hepatitis A vaccine for several hours.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fatigue
Clinical narrative: Pt felt tired and dizzy for several hours after getting his Hepatitis A vaccine.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Pain
Clinical narrative: Pain present when sleeping and when playing racquetball approximately 0.5 inches distal to the acromion process.  Pain is focal and does not spread. Pain is not "achy." Pain may have started the day after vaccination and persists (24 days later) only when sleeping or "with activity."  Pain subsides when activity is stopped or when he is done rolling over while in bed. Pt has been encouraged to use OTC anti-inflammatory medications and heat applications; pt states he has not tried these.  Pt is encouraged to see his health care provide; pt states he has not scheduled an appointment to see his PCP.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient stated it started itching first then the redness came along with a little swelling in the area. He did not feel good! He went to his doctor office & he put neosporin/gauze/tape over area.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated it started itching first then the redness came along with a little swelling in the area. He did not feel good! He went to his doctor office & he put neosporin/gauze/tape over area.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Severe swelling, hot to the touch, body aches and fever.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: Pain all over body, especially arm. Difficulty breathing.
Age: 0.15
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site pain, Rash macular, Vaccination site reaction, Vaccination site swelling
Clinical narrative: At Site of Vaccination... Swelling, redness, huge blotchy patch about 2 inches by 3 inches wide. Extreme pain at the site.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Diagnostic procedure, Neovascular age-related macular degeneration, Rash, Rash vesicular, Visual field tests abnormal
Clinical narrative: Painful vesicular rash on trunk, right side, 4 weeks. Rapid onset of symptomatic wet macular degeneration, 2 days after vaccine. Noted visual field low - not present before. Recurrence of painful vesicular rash (R) trunk (March 2015).
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Hallucination, Memory impairment, Pharyngeal oedema, Urticaria
Clinical narrative: Patient experienced "crazy hallucinations" and didn't remember certain events throughout the evening. She had broken out in hives. Also had swelling of the throat.