chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient received a mixed regimen of GARDASIL and GARDASIL 9. He received his first two doses of GARDASIL on 09-MAY-2014 and on 18-JUL-2014 (dose, route, lot# and expiration date were not reported) and dose #3 with GARDASIL 9 (dose, route, lot# and expiration date were not reported) on 27-MAY-2015. No adverse experiences reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information as received from a nurse referring to multiple different unspecified patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, strength, dose and route unknown). There was no concomitant medication reported. After being administered GARDASIL, the patients experienced feeling faint. The outcome of the event was unknown. The causality between this event and GARDASIL was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored oral, (ROTATEQ) lot # K005273, expiration date 23-FEB-2016. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, lot#, expiration date, dose and route were unknown) (Incorrect product storage). The temperature excursion for RECOMBIVAX HB was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports 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 as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. ON 29-APR-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a 72 year old female consumer concerning herself. The patient had no pertinent medical history or drug reaction/allergies. On 16-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L006382 (expiration date not provided), 1 injection/ once (1 dosage form, exact dose not reported, route via injection). Concomitant therapies included LIPITOR, SYNTHROID, EVISTA and unspecified eyedrops. On approximately 19-MAY-2015 (reported as two weeks ago), the patient experienced a rash and itching after receiving ZOSTAVAX. She also had patches near her shoulder to mid-upper arm which were also red and itchy. This area was on the opposite side of her body from the injection site. The patient did not seek medical attention. No treatment was given for adverse events and no lab diagnostics studies were performed. The patient was not recovered from the events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from medical assistant refers to a 67 years old male patient. The patient's pertinent medical history included impaired fasting glucose, hypercholesterolaemia, hypertension and sleep apnea and was allergic to angiotensin-converting enzyme (ACE) inhibitors. On 04-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency were not reported) (lot # K020214 and expiry date: 25-MAR-2016) intramuscularly. Concomitant therapies included losartan potassium (manufacturer unknown) and COREG. On 04-JUN-2015, the patient experienced pain in the injection site as well as not being able to lift the arm, fever, chills and nausea. The patient developed decreased range in arm motion. The patient sought medical attention and was treated with MEDROL dose pack/diclofenac. No lab data was reported. The outcome of the events was reported as not recovered. The relatedness of the events with PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. The reporting medical assistant considered the event, not being able to lift the arm to be serious as disability, as the event resulted in decreased range in arm motion. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Antinuclear antibody positive, Aspiration pleural cavity, C-reactive protein increased, Pericardial drainage, Pericardial effusion
Clinical narrative: Worsening respiratory symptoms developed pleural effusion/pericardial effusion requiring thoracentesis and pericardiocentesis.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pleural effusion, Red blood cell sedimentation rate increased, Respiratory symptom
Clinical narrative: Worsening respiratory symptoms developed pleural effusion/pericardial effusion requiring thoracentesis and pericardiocentesis.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: 2 episodes of shaking with fever within 24 hours of vaccination that sound like may have been febrile seizure.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Amnesia, Asthenia, Asthma, Back pain
Clinical narrative: Had a seizure in the waiting room 15 minutes after being given the shot. Started immediately having memory loss, dizziness, headaches, weakness, stomach issues/pain, numbness/tingling in extremities, seizures, breathing difficulties, chest pain, back pain, brain fog, extreme fatigue, shortness of breath.  (Probably has more symptoms). These symptoms have not stopped at all just gradually getting worse.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Chest pain, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Had a seizure in the waiting room 15 minutes after being given the shot. Started immediately having memory loss, dizziness, headaches, weakness, stomach issues/pain, numbness/tingling in extremities, seizures, breathing difficulties, chest pain, back pain, brain fog, extreme fatigue, shortness of breath.  (Probably has more symptoms). These symptoms have not stopped at all just gradually getting worse.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Had a seizure in the waiting room 15 minutes after being given the shot. Started immediately having memory loss, dizziness, headaches, weakness, stomach issues/pain, numbness/tingling in extremities, seizures, breathing difficulties, chest pain, back pain, brain fog, extreme fatigue, shortness of breath.  (Probably has more symptoms). These symptoms have not stopped at all just gradually getting worse.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Panic attack, Paraesthesia, Seizure, Ultrasound scan
Clinical narrative: Had a seizure in the waiting room 15 minutes after being given the shot. Started immediately having memory loss, dizziness, headaches, weakness, stomach issues/pain, numbness/tingling in extremities, seizures, breathing difficulties, chest pain, back pain, brain fog, extreme fatigue, shortness of breath.  (Probably has more symptoms). These symptoms have not stopped at all just gradually getting worse.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at injection site with slight redness and swelling.  The Emergency Department physician was notified.  Benadryl 25mg was given by mouth at 12:25 AM.  Dr. then reported decreased swelling, no itching and that all symptoms were resolved.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Breast mass, Contusion, Erythema, Nodule, Pain in extremity
Clinical narrative: Spoke to patient. TDaP was given right upper arm on 5/31/15. Arm became sore that night. Redness "just noticed yesterday." "3 pea sized nodules" two above elbow, one facing the axillary (none at the injection site). Associated pain and the one on the axillary side of arm looks "bruised." Nodules appeared 3 days ago.  Also complained about a lump on left breast, concern over whether this is associated vs a clogged milk duct.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on injection site slightly larger than quarter.
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 patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route or administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Heart rate increased, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: She woke up with a high fever. She would fall asleep for short periods of time and whimper when she was awake. She would not eat or drink. She was very crabby and cried a lot. Her breathing was very fast and so was her heart rate. When I took her in to the doctor she has ulcers in the back of her throat from the fever. She had a seizure at 10:15 pm. Her high fever continued until mid day on 06/06/2015.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Seizure, Ulcer
Clinical narrative: She woke up with a high fever. She would fall asleep for short periods of time and whimper when she was awake. She would not eat or drink. She was very crabby and cried a lot. Her breathing was very fast and so was her heart rate. When I took her in to the doctor she has ulcers in the back of her throat from the fever. She had a seizure at 10:15 pm. Her high fever continued until mid day on 06/06/2015.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two patients of unknown demographics. Information about patients' medical histories were not provided. On an unknown date, the patients were inadvertently vaccinated with doses of MMR II (lot # K000255, expiration date: 08-JAN-2016) (therapy type was not specified) which had been improperly stored. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, VAQTA (lot # K005958, expiration date: 12-FEB-2017) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive Hep A vaccine (dose, route of administration and anatomical location was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, dose and route were not reported). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, RECOMBIVAX HB (lot # K014548, expiration date: 27-AUG-2016) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive RECOMBIVAX HB (dose, route of administration and anatomical location was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. In 2015 (reported as since 13-MAY-2015), the patients were vaccinated with doses of PNEUMOVAX23 batch/lot # K008410, expiration date 25-FEB-2016 (also reported as 26-FEB-2016), batch/lot # K020214, expiration date 25-MAR-2016, batch/lot # K019561, expiration date 20-APR-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 13 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unspecified dates the patient was vaccinated with first and second dose of GARDASIL (intramuscular, dose, anatomical location and lot numbers was not reported). Concomitant medications were unspecified by reporter. On an unknown date, following administration of first and second doses, the patient developed redness and swelling around the injection site. The reporting physician had continued to administer the third dose in "quarter increments'. The initial "quarter increment" had been administered on an unknown date. The outcome of the events was reported as recovered/resolved. The causal relationship between the events and GARDASIL was not reported. Additional informaton has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, oral, ROTATEQ (lot # K010224, expiration date: 13-MAY-2016) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive oral, ROATTEQ (dose was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, dose and route were not reported). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13, RV5
Symptoms: Drug administration error
Clinical narrative: Vials very similar so VAQTA was administered in error. Checked with patient this afternoon and there was no AEs to vaccine.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Feeling tired the evening of vaccine. Started with fever 101.8 next day, along with headache, weakness, nausea. Injection site red and tender to touch. 5/28 started with fatigue and on 5/30 felt well.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: Feeling tired the evening of vaccine. Started with fever 101.8 next day, along with headache, weakness, nausea. Injection site red and tender to touch. 5/28 started with fatigue and on 5/30 felt well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth to (L) arm area where vaccine was given. Advised ice, Ibuprofen and BENADRYL. Swelling extended from shoulder to elbow-local hypersensitivity reaction.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Hypotonia, Irritability, Somnolence
Clinical narrative: Irritable, floppy, sleepiness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Swollen, hot, red 6 x 7 cm. Recommended OTC BENADRYL, Ibuprofen, ice.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Ageusia, Anosmia, Lethargy, Pyrexia
Clinical narrative: Pt reports within a couple hours he developed a fever and became lethargic; pt took a nap; when he awoke he noticed his sense of smell & taste were gone.
Age: 69.0
Sex: M
Vaccine: MMR
Symptoms: Joint swelling, Miliaria, Rash
Clinical narrative: 5/20/15-"heat rash" on legs for 2 days. 6/4/15-swelling (R) knee x 24 hrs-resolved. 6/5/15-swelling (L) knee-almost fully resolved as on 6/9/15. Has taken ALEVE x 3d.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen and warm to the touch. Upper arm painful.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) upper arm w/redness, swelling, no fluctuance, Nl to touch. No lymphangitis or fever. Pt taken to ER.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Otitis media, Upper respiratory tract infection
Clinical narrative: Fussy, irritability starting 6/3/15. Now URI, (L) OM.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Half dollar size inflamed hard area sensitive to touch at site of injection (DTAP).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Redness and hard lumps from injection site down arm to wrist. Cephalexin given by MD. Pt presented to pharmacy on Day 4 and arm showed only small amount of redness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper extremity mass
Clinical narrative: Redness and hard lumps from injection site down arm to wrist. Cephalexin given by MD. Pt presented to pharmacy on Day 4 and arm showed only small amount of redness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Hyporesponsive to stimuli, Listless, Staring
Clinical narrative: When he woke up 10 days after shots, he was listless/less responsive, seem to be staring. He never had fever/rash/other signs of illness. He remained less active/responsive all day, though it did gradually improve over the day. By next day he was normal again.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 05-JUN-2015, the patient was vaccinated with an expired dose (3 months past expiry date) of ZOSTAVAX 0.65 ml, subcutaneously in the left deltoid (lot # J016257, expiration date: 20-FEB-2015) (strength was not reported). No concomitant medications were reported. No adverse experience was reported. The outcome of the event was unknown. The patient did not seek any medical attention. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vitiligo
Clinical narrative: This spontaneous report was received from the patient mother refers to her son as a 12 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose and lot# were not reported) intramuscular. Other suspect therapies included GARDASIL (dose, route and lot# were not reported) as the product GARDASIL or GARDASIL 9 was unspecified. The sequence of GARDASIL shots was unspecified. On an unknown date, the patient developed autoimmune disease called vitiligo. Patient sought medical attention. The reporter reported that the pediatrician referred the patient to a dermatologist for treatment. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of vitiligo was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Excessive eye blinking, Somnolence, Syncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Approx 5-10 min following receipt of the first Gardasil 4 vaccine patient had several seconds of eye blinking and generalized tonic clonic activity, at which point she was unresponsive. She then had syncopal episode and was layed on the exam table at which time she was arousable but remained groggy for approx 10 min. Her vital signs were stable. She became more alert after 10 min and left the office without assistance and with normal mental status.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever to 101.5, nausea, dizziness, myalgias, and headache.
Age: 1.23
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Vaccines given 5/18/15. Rotavirus given to baby 14 months old. KINRIX given instead of PEDIARIX. No advers effects.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Pyrexia
Clinical narrative: Patient received herpes zoster vaccine and had a fever spike two hours later. Acetaminophen 650 mg PRN.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face
Clinical narrative: Facial swelling.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Muscular weakness, Rash
Clinical narrative: AE of muscle weakness and moderate discomfort (of arm) started 6/2/15 after injection with rash onset of 6/3/15 progressively worsening until today's visit with rash measuring 9.5 x 4.5 inches.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Induration, Localised oedema
Clinical narrative: 6/15/15 7 pm (L) arm redness, warmth, edema 14 cm x 15.5 cm. Redness and induration to (L) helix. Treated with BENADRYL and cool compress.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Oropharyngeal pain, Paraesthesia, Speech disorder
Clinical narrative: 11:46: 0.5 ml yellow fever vaccine administered SC right tricep. 11:51: Pt stated throat feeling sore, not feeling like this earlier - denied throat closing. Described as tingling. Kept touching her throat. 11:53: Administered 0.3 ml EPIPEN. 11:55: Vitals BP 107/69 R 20 P 63. 12:00: BENADRYL 50 mg IM left deltoid by RN - ordered by MD - examined by MD. 12:02: BP 111/74, R 20, P 68 - pt c/o throat sore difficulty speaking, tingling. Breathing good. 12:06 transported to ER.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Swelling , erythema, warmth within 24 hours and persist for 48 hours.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling , erythema, warmth within 24 hours and persist for 48 hours.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Peripheral swelling
Clinical narrative: Patient complains of tenderness and inflammation of left upper arm since PNEUMOVAX on 4/18/12. Complains of tenderness to touch only. Swollen arm. Sulfamethoxazole/trimethoprim 1 tab BID, diphenhydramine 25 mg once
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at the site and pain at the site. 2.5cm diameter with tenderness over the area and minimal induration. No signs of infection.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration
Clinical narrative: Round hardened are at inj site
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia
Clinical narrative: Myalgia.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Rhinorrhoea
Clinical narrative: Sore muscles, especially legs; headache; extreme tiredness; labored breathing; runny nose.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Outdated vaccine dated 6/4/2015 was given to pt.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: Red raised rash on arm that continued to increase in size over next few days to approximately 6 inches long and 2 inches wide. Red area has not decreased in size for over a week now.
Age: 66.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: 5/22/15- Developed hives on right side upper body and trunk area. Cortisone 10 cream applied and oral Benadryl. Resolved in 2-3 days. Taking Tylenol every 4-6 hours for pain relief. 5/23/15- "Deep strong pain" in right shoulder area; top of shoulder into deltoid area. Did not notice any redness, swelling or bruising. Heat applied to shoulder area with heating pad, also used hot shower to relieve some discomfort. Reports that shoulder area very sensitive to pressure, could not wear bra strap. 5/30/15- Saw Chiropractor for adjustment. Slight improvement of symptoms. Continues to take Tylenol q 8-10 hours for pain relief. 6/1/15- Went to PCP. MD reports that slight redness in right deltoid area w/minimal swelling. Call to HD. Recommended to continue heat and Tylenol and if no improvement to seek care with PCP. 6/9/15- Continues to feel deep aching pain in right shoulder area. Continues to take Tylenol q 10 hours for pain relief.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to two patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On an unknown date the two patients were vaccinated with a dose of ZOSTAVAX, subcutaneous, once (dose, dose number, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified. On an unknown date the two patient experienced injection site swelling and injection site erythema and sought medical attention by visiting the reporter's office. Treatment given for the adverse events and laboratory diagnostic studies performed were unspecified. The outcome of injection site swelling and injection site erythema was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Crying
Clinical narrative: Skin prepped with alcohol. Given band aid applied. Pt cried; tolerated well. Double checked by LPN.
Age: 55.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: Pt started noticing little bumps (painful to touch / itchy-fluid filled-several), A LOT more on Friday 6/5/15...went to ER (MD didn't think it was chicken pox).
Age: 55.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Pt started noticing little bumps (painful to touch / itchy-fluid filled-several), A LOT more on Friday 6/5/15...went to ER (MD didn't think it was chicken pox).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Influenza like illness, Pain in extremity, Peripheral swelling, Retinal detachment
Clinical narrative: Flu shot received on 9/15/2014 and patient returned to the pharmacy on 6/03/15 to let us know that he thought he had a reaction to the flu shot he received 9 months before.  He said that the night the shot was given to him that his arm was sore and a little swollen, but he was still able to bike 40 miles that evening.  He said the next day he experienced "flu-like" symptoms including dizziness.  He has been going to eye movement training the past few months (not related to the dizziness) and recently (within the last month) has discovered he has a detached retina in his right eye.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Gastrointestinal pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, severe stomach ache. Vomited from about 3:00 AM off and on until about 5:00 AM 06/09/2015. Severe intestinal pain.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Chromaturia, Dry mouth
Clinical narrative: Patient was feeling great prior to the vaccine (given ~9 am), but right about 2:00-2:30 felt joint pain (hands, knees, ankles, etc) and rapidly developed chills, shakes.  Husband had to pick her up from work.  She was unable to get out of the car on her own.  She developed skin pain/sensitivity that felt like needles poking her skin.  Was running a temp of 104.7 F and had extreme thirst.  The diet coke she drank had a metallic taste (which has persisted since).  Also had a "headache from hell".  Took some Advil.  Wasn't able to eat, was nauseated, fatigued.  Tried to throw up but wasn't able to do so.  Was able to eat some french fries and an English muffin.  Saturday the fever was 103.  Sunday stayed in bed until mid-day.  Ate something on Sunday night which made her feel really sick to her stomach and nauseated.  Still had a fever Sunday night.  Woke up yesterday (Mon) w/ a metallic taste in her mouth but w/o a fever.  Stomach is still bothering her and food isn't tasting normal.  Had an intense HA last night w/ a dry mouth and dark urine.  Urine has been looking quite dark, but it's getting better.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Fatigue, Feeding disorder, Headache, Hyperaesthesia
Clinical narrative: Patient was feeling great prior to the vaccine (given ~9 am), but right about 2:00-2:30 felt joint pain (hands, knees, ankles, etc) and rapidly developed chills, shakes.  Husband had to pick her up from work.  She was unable to get out of the car on her own.  She developed skin pain/sensitivity that felt like needles poking her skin.  Was running a temp of 104.7 F and had extreme thirst.  The diet coke she drank had a metallic taste (which has persisted since).  Also had a "headache from hell".  Took some Advil.  Wasn't able to eat, was nauseated, fatigued.  Tried to throw up but wasn't able to do so.  Was able to eat some french fries and an English muffin.  Saturday the fever was 103.  Sunday stayed in bed until mid-day.  Ate something on Sunday night which made her feel really sick to her stomach and nauseated.  Still had a fever Sunday night.  Woke up yesterday (Mon) w/ a metallic taste in her mouth but w/o a fever.  Stomach is still bothering her and food isn't tasting normal.  Had an intense HA last night w/ a dry mouth and dark urine.  Urine has been looking quite dark, but it's getting better.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain of skin, Paraesthesia, Pyrexia, Thirst
Clinical narrative: Patient was feeling great prior to the vaccine (given ~9 am), but right about 2:00-2:30 felt joint pain (hands, knees, ankles, etc) and rapidly developed chills, shakes.  Husband had to pick her up from work.  She was unable to get out of the car on her own.  She developed skin pain/sensitivity that felt like needles poking her skin.  Was running a temp of 104.7 F and had extreme thirst.  The diet coke she drank had a metallic taste (which has persisted since).  Also had a "headache from hell".  Took some Advil.  Wasn't able to eat, was nauseated, fatigued.  Tried to throw up but wasn't able to do so.  Was able to eat some french fries and an English muffin.  Saturday the fever was 103.  Sunday stayed in bed until mid-day.  Ate something on Sunday night which made her feel really sick to her stomach and nauseated.  Still had a fever Sunday night.  Woke up yesterday (Mon) w/ a metallic taste in her mouth but w/o a fever.  Stomach is still bothering her and food isn't tasting normal.  Had an intense HA last night w/ a dry mouth and dark urine.  Urine has been looking quite dark, but it's getting better.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Patient was feeling great prior to the vaccine (given ~9 am), but right about 2:00-2:30 felt joint pain (hands, knees, ankles, etc) and rapidly developed chills, shakes.  Husband had to pick her up from work.  She was unable to get out of the car on her own.  She developed skin pain/sensitivity that felt like needles poking her skin.  Was running a temp of 104.7 F and had extreme thirst.  The diet coke she drank had a metallic taste (which has persisted since).  Also had a "headache from hell".  Took some Advil.  Wasn't able to eat, was nauseated, fatigued.  Tried to throw up but wasn't able to do so.  Was able to eat some french fries and an English muffin.  Saturday the fever was 103.  Sunday stayed in bed until mid-day.  Ate something on Sunday night which made her feel really sick to her stomach and nauseated.  Still had a fever Sunday night.  Woke up yesterday (Mon) w/ a metallic taste in her mouth but w/o a fever.  Stomach is still bothering her and food isn't tasting normal.  Had an intense HA last night w/ a dry mouth and dark urine.  Urine has been looking quite dark, but it's getting better.
Age: 0.58
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC13
Symptoms: Musculoskeletal stiffness, Pyrexia, Seizure, Staring, Vomiting
Clinical narrative: Low grade fever started around midnight, gave Tylenol at 5 AM when fever was 100.0F. Vomiting throughout the day, crying all day, when not crying, he was sleeping.  Had a suspected seizure about 2 pm (staring into space, stiff body, for 5-10 seconds.)
Sex: M
Vaccine: HEP
Symptoms: Crying, Dyskinesia, Eye movement disorder, Generalised erythema, Insomnia
Clinical narrative: Excessive high pitched crying, hives, throwing up, unusual body jolts and unusual body movements in pain, redness of skin all over body, eyes rolling up, not sleeping ...
Sex: M
Vaccine: HEP
Symptoms: Pain, Urticaria, Vomiting
Clinical narrative: Excessive high pitched crying, hives, throwing up, unusual body jolts and unusual body movements in pain, redness of skin all over body, eyes rolling up, not sleeping ...
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Migraine, Pyrexia
Clinical narrative: Patient's father reports increase high fevers and migraine headaches in the past year stating he is not sure if it correlated with the vaccine.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, Migraine, Pyrexia
Clinical narrative: Patient's father reports increase high fevers and migraine headaches in the past year stating he is not sure if it correlated with the vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, frequency, lot# expire date, route were not reported). No concomitant medications reported. The physician stated that he had ben administering (confirmed not GARDASIL 9) to an unspecified number of patients greater than 26 years of age (Inappropriate schedule of vaccine administered). No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash generalised, Viral infection
Clinical narrative: Parents noted rash all over body, low grade fever. ER MD thought viral. No other symptoms. Reported per protocol.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Received varicella in RASQ 6/4/15. Noticed swelling at 12P on 6/5. Became very tender, red and hard and swollen by 2P- showed RN at work and was marked at 35mm. to urgent care at on 6/6/15. Started on cephalexin 500mg QID until resolved-6/9 approx 3mm reddened area afebrile (T-37.4). Recovering pt. states swelling much less and tenderness much improved.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Prolonged severe headache after MENACTRA.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor, Pulse abnormal
Clinical narrative: After receiving both vaccines pt went to her car in the parking lot felt nauseated. Mom returned to the office, pt. pale (diaphoresis) alert and oriented. Pulse 76 and thready, given juice-observed for 15 mins-color returned to face and discharged.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling noticed 6/3/15. By 6/4/15 almost entire upper arm hot and swollen. Patient states it felt like a bee sting. Went to MD 6/4; MD diagnosed local rxn and told pt to take BENADRYL. Improved over week as of 6/9, still itchy but swelling gone.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt came into store said arm started itching yesterday-also is red and swollen told her to go to walk in clinic if Dr could not see her.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling, Neck mass, Skin warm
Clinical narrative: Over weekend arm was hot and area of inj was raised. Pt used cool compress on arm and symptoms getting better. Patient noticed a lump last night 1" x 2" on neck. Also states (L) ear is hot and red. Has appt tomorrow AM for evaluation.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Red swollen arm at injection site, size of a baseball, feverish, hurt to touch or raise her arm. Ice packs and Ibuprofen.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This report was received from a pharmacist via Pfizer (manufacturer control number 201582322 and refer to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that patient was administered with the second dose of PNEUMOVAX23 and the patient developed adverse reaction that was redness around the area where it was administered. The outcome of redness around the area was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. The pharmacist reported that on 29-MAY-2015, the patient missed a dose of ZOSTAVAX via dry SD 19.4 m unit, subcutaneous due to not having enough diluent. The patient would received ZOSTAVAX when the replacement arrived. The patient did not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 01-JUN-2015, the patient was vaccinated with an expired dose (exp. date: 15-MAY-2015) of PNEUMOVAX 23 (lot number or batch number unspecified) 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, Incorrect product formulation administered, No adverse event
Clinical narrative: On June 1, 2015, M.A. mixed vaccines and administered to patient a MENVEO and Tdap vaccine. It was later discovered that she had mixed the powder component of the MENVEO with a Tdap vaccine and also administered and extra Tdap vaccine. Instead of pulling out the liquid portion of the MENVEO, she accidentally pulled out an extra Tdap vaccine. When notified of this error I immediately contacted the CDC information line at 1-800-CDC-INFO. Spoke with person and gave explanation of the error that was made. She explained that there were no serious side effects of the error but if given closely together then may have a more prominent local reaction. She advised that she would forward to the vaccine specialist to verify but was sure of her advice. Received an email on June 2, 2015 from MD which verified person's information. (Copy of this email is in scanned documents in the chart) -- Dr. was informed of the error and response from the CDC. On June 3, 2015, MA was given a written warning for her error and patient's mother was notified. --- There is a language barrier because mom does not speak English. Was asked to come to the office the next day because patient would have to be revaccinated for the MENVEO since only one component was received. --- On June 4, 2015, patient and her mother returned to the office. Dr., with an interpreter, explained the error in detail and MA apologized for her mistake. Mother of patient expressed to Dr that she trusted him and understood that mistakes happen. She was very appreciative of Dr explaining everything to her and that there was no serious side effects from this error. Patient was given another MENVEO vaccine with both power and liquid components to make sure she had maximum meningococcal coverage. Error was reported to VAERS as directed by the CDC.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Relevant medical history and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose, not number and expiration date unspecified) orally. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023159, expiration date 26-JUL-2016) (dose, strength and frequency were not reported) oral. Concomitant medication was not reported. No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.