chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers and expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 15-SEP-201, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-NOV-2014 the patient was inadvertently vaccinated with ZOSTAVAX (lot # K006439, expiry: 05-AUG-2015), single dose, subcutaneous for prophylaxis that had been improperly stored. No adverse effects were reported. No product quality complaint was involved. No further information provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route of administration, anatomical location and lot number was unknown) that were improperly stored. Concomitant medications were unspecified by reporter. No adverse events were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number was not reported). The physician stated, that on an unknown date, had something happened to the patient, after the patient was administered a dose of PNEUMOVAX 23. The outcome of event was not reported. The relatedness between event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. In 2013 (exact date unspecified, reported as about one year ago) the patient was vaccinated with a first dose of PNEUMOVAX 23 (intramuscular, dose, units, anatomical location, lot number was not reported). On 10-NOV-2014, the patient was inadvertently vaccinated with a second dose of PNEUMOVAX 23 (intramuscular, dose, units, anatomical location, lot number was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: This spontaneous report was received from a nurse refers to a patient (reported as one of the 3 patients) of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 25/0.5 (unspecified units) (lot # K007262 and expiration date was 25-NOV-2015) dose 0.5 ml, intramuscular injection. Concomitant therapy was not reported. On an unknown date, the patient experienced severe muscle weakness, pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla, difficulty moving the injection site arm after receiving PNEUMOVAX 23. Patient was given ice to site. Patient sought medical attention by a physician visit. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse refers to a patient (reported as one of the 3 patients) of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 25/0.5 (unspecified units) (lot # K007262 and expiration date was 25-NOV-2015) dose 0.5 ml, intramuscular injection. Concomitant therapy was not reported. On an unknown date, the patient experienced severe muscle weakness, pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla, difficulty moving the injection site arm after receiving PNEUMOVAX 23. Patient was given ice to site. Patient sought medical attention by a physician visit. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a female patient of unknown age. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with second dose of GARDASIL (dose/frequency was reported as "1 single shot", route of administration, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient fainted while she was in the office. IT was reported that no adverse effects were reported with the patient's first dose of GARDASIL (dose, route of administration and anatomical location was unknown) on an unknown date. The patient sought medical attention but no treatment was given for the event. The action taken with GARDASIL was not reported. The outcome of the event was reported as recovered/resolved on an unspecified date. The causality was unknown. No further adverse event information was provided.  Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Apnoea, Breath holding, Breath sounds abnormal, Crying, Dyspnoea
Clinical narrative: PREVNAR was administered first IM to the left thigh. Pt crying, being held by Mom. HAVRIX administered IM to the right thigh. Pt continues crying, holding breath. Mom attempting to comfort. Pt. then became flaccid, pale and without respirations. Dr called to room. Pt. placed to exam table, stimulated. Spontaneous respiration resumed after approx 30-40 seconds of apnea. Pt gasping and wheezing. Skin color became red and blotchy from face down. Epinephrine 0.15 mg SC administered. Redness resolved. Respirations easier. Albuterol 0.021 administered via nebulizer. O2 sats >95 %. Observed x 20 min. Stable vital signs, no further wheezing, alert. Discharged to home with Mother. After discharge from our office it was reported to us by pt's grandmother that pt was lethargic and had coarse lung sounds. Advised by dr to take pt to Emergency room. He was prescribed BENADRYL and ORAPRED and discharged to home.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Erythema, Hypotonia, Lethargy, Pallor, Rash macular
Clinical narrative: PREVNAR was administered first IM to the left thigh. Pt crying, being held by Mom. HAVRIX administered IM to the right thigh. Pt continues crying, holding breath. Mom attempting to comfort. Pt. then became flaccid, pale and without respirations. Dr called to room. Pt. placed to exam table, stimulated. Spontaneous respiration resumed after approx 30-40 seconds of apnea. Pt gasping and wheezing. Skin color became red and blotchy from face down. Epinephrine 0.15 mg SC administered. Redness resolved. Respirations easier. Albuterol 0.021 administered via nebulizer. O2 sats >95 %. Observed x 20 min. Stable vital signs, no further wheezing, alert. Discharged to home with Mother. After discharge from our office it was reported to us by pt's grandmother that pt was lethargic and had coarse lung sounds. Advised by dr to take pt to Emergency room. He was prescribed BENADRYL and ORAPRED and discharged to home.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Respiratory arrest, Wheezing
Clinical narrative: PREVNAR was administered first IM to the left thigh. Pt crying, being held by Mom. HAVRIX administered IM to the right thigh. Pt continues crying, holding breath. Mom attempting to comfort. Pt. then became flaccid, pale and without respirations. Dr called to room. Pt. placed to exam table, stimulated. Spontaneous respiration resumed after approx 30-40 seconds of apnea. Pt gasping and wheezing. Skin color became red and blotchy from face down. Epinephrine 0.15 mg SC administered. Redness resolved. Respirations easier. Albuterol 0.021 administered via nebulizer. O2 sats >95 %. Observed x 20 min. Stable vital signs, no further wheezing, alert. Discharged to home with Mother. After discharge from our office it was reported to us by pt's grandmother that pt was lethargic and had coarse lung sounds. Advised by dr to take pt to Emergency room. He was prescribed BENADRYL and ORAPRED and discharged to home.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 5 years old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a dose of an improperly stored (Oka/Merck) PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint wsa involved. This is one of several reports received from the same source. Additional informiton has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration, Skin warm
Clinical narrative: Day after: started with 2 inch radius of hot, red skin; enlarged to 7 inches; changed to purple in color.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt awoke without reaction, however this afternoon c/o redness, warmth, and raised area at injection site. 2.25 in x 1.5 in.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Local reaction, Nasopharyngitis
Clinical narrative: Baseball sized localized reaction, developed "cold-like" symptoms, lethargy. Treated in Emergency Dept 8/9/14.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Condition aggravated, Joint instability, Nausea, Pain in extremity
Clinical narrative: Nausea, pain that continues in UE and unusual joint instability at shlds and hips. Paraesthesias that begin distal and move proximal in UE and LE, randomly. Recent adversions to sensory inputs to exteme of immobilization to smells. Continued since date of injection. Stomach pain.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Paraesthesia, Parosmia, Sensory disturbance
Clinical narrative: Nausea, pain that continues in UE and unusual joint instability at shlds and hips. Paraesthesias that begin distal and move proximal in UE and LE, randomly. Recent adversions to sensory inputs to exteme of immobilization to smells. Continued since date of injection. Stomach pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 62 year old female patient. Patient concurrent and medical history was unspecified. On 30-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot # J011333, expiry: 13-DEC-2014) (strength, route of administration, frequency and dose unknown). Concomitant medications were unspecified. On an unknown date in 2014 the patient experienced shingles post vaccination. Patient's husband (name unspecified) came in for a visit to the physician's office on unspecified date and mentioned that his wife came down with shingles despite receiving ZOSTAVAX. No additional information was provided. The outcome of event was unknown. Action taken was not applicable. Causality was unknown. No PQC was involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: I gave 4 yr. old immunizations to this child that were meant for her brother by mistake. She had already had them July 31, 2012 at another clinic but I had no record of them.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Local swelling
Clinical narrative: 2 days after MMRV (PROQUAD and VZ) on (L) thigh developed progressively increasing redness at inj. site with local swelling. No itching, pain, inflammation, fever. Also had limp x 1 day. Final size 16 cm x 11.5 cm area of redness and fullness. Resolved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 05-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 18-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered GARDASIL (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered RECOMBIVAX HB (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting. Mild fever. Headache within 24 hrs. Several others in the class, girls and boys.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Eye movement disorder, Hypotonia, Loss of consciousness, Malaise
Clinical narrative: My daughter who is 11 years old was give the HPV vaccine (GARDASIL). After receiving the shot we walked out of the exam room and by the time we got to the front desk she told me she did not feel well. I had her sit on my lap and before she could sit down her eyes rolled back, her body went completely stiff, her arms became bent and started to shake uncontrollably and she went into a seizure for about 10 or more seconds then suddenly her body went totally limp and she passed out. When she awoke the doctor took her to the exam room and had us stay in the doctors office for an hour. The doctor called the Neurologist and we went to see the pediatric Neurologist the next day.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle contractions involuntary, Musculoskeletal stiffness, Tremor
Clinical narrative: My daughter who is 11 years old was give the HPV vaccine (GARDASIL). After receiving the shot we walked out of the exam room and by the time we got to the front desk she told me she did not feel well. I had her sit on my lap and before she could sit down her eyes rolled back, her body went completely stiff, her arms became bent and started to shake uncontrollably and she went into a seizure for about 10 or more seconds then suddenly her body went totally limp and she passed out. When she awoke the doctor took her to the exam room and had us stay in the doctors office for an hour. The doctor called the Neurologist and we went to see the pediatric Neurologist the next day.
Sex: U
Vaccine: MMRV
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. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD, lot # K001854, expiration date 06-AUG-2015. On an unknown date, the patient received (Oka/Merck) PROQUAD that underwent an unsupported temperature excursion. No adverse experience was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 12-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: 4 x 4 area red, warm. No pain or burning. Not getting any larger. More red area w/in 4 x 4 area about size of 1/2 dollar. No other symptoms. Pt instructed: if increase in size or severity to go in.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Headache, Injection site erythema, Injection site induration
Clinical narrative: Severe headache, joint pain, weakness, redness and hardness at injection site.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Local reaction at injection site - swelling/tenderness/redness. Myalgias and fever to 101 degrees F - lasted approximately 48 hrs. Local reaction improved in 5-7 days.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 24-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Erythema, Injection site erythema, Rash macular
Clinical narrative: Patient developed redness and splotches to bilateral cheeks. Redness behind left ear and slight redness to injection sites on both arms. BENADRYL (12.5mg/5ml) 1 tsp (5ml) given, and patient observed for 30 minutes in office.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella disease - vaccine strain.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient came in on 11/20/14 to ask if "pain near the inject site is normally after 1 month?". Patient states he has pain where BOOSTRIX was given. The pain is the size of a dime. Pain ranges from zero to seven on a 10 scale. On his right arm deltoid. Patient also states he's right handed and he's been more physical with a home remodel and outdoor chores. Referred patient to MD 11/22/14. I called pt today 11/24/14. Patient states he has not contacted MD. Pain is better.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture, Headache, Injection site reaction, Laboratory test, Night sweats
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a 61 year old male patient with allergy to adenosine. Pertinent medical history was unspecified by the reporter. On 11-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were unspecified. On 16-SEP-2014, 6 days after onset of therapy the patient experienced hives spread to his head, both arms and now all over his body, having night sweats, head and body have been in pain (also reported as since September), rash spread to his head, both arms and now all over his body, and injection site reaction. The patient was on emergency room (ER) due to the events; the ER physician referred him to a dermatologist who performed a culture (unspecified) and unspecified lab/diagnostics tests (no results were provided for the tests). The patient received an unspecified treatment for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reproted. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash generalised, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a 61 year old male patient with allergy to adenosine. Pertinent medical history was unspecified by the reporter. On 11-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were unspecified. On 16-SEP-2014, 6 days after onset of therapy the patient experienced hives spread to his head, both arms and now all over his body, having night sweats, head and body have been in pain (also reported as since September), rash spread to his head, both arms and now all over his body, and injection site reaction. The patient was on emergency room (ER) due to the events; the ER physician referred him to a dermatologist who performed a culture (unspecified) and unspecified lab/diagnostics tests (no results were provided for the tests). The patient received an unspecified treatment for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reproted. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 25-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX in the arm (dose, route, lot number expiry date were not provided). Other suspect therapies included a dose of Influenza virus vaccine (unspecified)(manufacturer unknown) in the same arm (dose and route were not provided). Concomitant medication was not provided. On an unknown date, the patient developed swelling and erythema in that same arm in the general area of the immunizations. The outcome of developed swelling and erythema in that same arm in the general area of the immunizations was reported as recovered (date not reported in 2014). Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: TYP
Symptoms: Arthropathy
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a subject, via a company representative and concerns a 38 year old male: US-9327. The subject's weight and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) on 20-JUL-1993 at 12:00 hours as a prophylactic vaccination. Concomitant medications included diphtheria and tetanus toxoids and prednisone. On 10-AUG-1993, 21 days after treatment with typhoid vaccine oral ty21a the subject developed acute arthropathy. Action taken with typhoid vaccine oral ty21a was unknown. The subject had not recovered from acute arthropathy on an unspecified date. This report was serious (medically significant).
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Adverse drug reaction, Arthralgia, Body temperature increased, Headache
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a 40 year old female subject, via a company representative, and concerns herself: US-9329. The subject's weight was not reported. The subject's concurrent conditions included diabetes. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 127994B) on 05-OCT-1993 as a prophylactic vaccination. Concomitant medications included yellow fever vaccine and meningococcal polysaccharide as a prophylactic vaccination. On 05-OCT-1993, the subject took 1 pill which had been out of the refrigerator for more than 48 hours. On the same date at 23:00, after one dose of typhoid vaccine oral ty21a the subject experienced bad stomach pains. She also experienced muscle soreness, joint ache, 101 degrees temperature, severe headache, nausea and developed an "insulin reaction". Action taken with typhoid vaccine oral ty21a was unknown. The subject had recovered from "insulin reaction", severe headache, nausea, 101 degrees temperature, muscle soreness, joint ache and stomach pains on an unknown date and outcome was unknown for took one pill stored outside recommended temperature. This report was serious (medically significant).
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect product storage, Myalgia, Nausea
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a 40 year old female subject, via a company representative, and concerns herself: US-9329. The subject's weight was not reported. The subject's concurrent conditions included diabetes. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 127994B) on 05-OCT-1993 as a prophylactic vaccination. Concomitant medications included yellow fever vaccine and meningococcal polysaccharide as a prophylactic vaccination. On 05-OCT-1993, the subject took 1 pill which had been out of the refrigerator for more than 48 hours. On the same date at 23:00, after one dose of typhoid vaccine oral ty21a the subject experienced bad stomach pains. She also experienced muscle soreness, joint ache, 101 degrees temperature, severe headache, nausea and developed an "insulin reaction". Action taken with typhoid vaccine oral ty21a was unknown. The subject had recovered from "insulin reaction", severe headache, nausea, 101 degrees temperature, muscle soreness, joint ache and stomach pains on an unknown date and outcome was unknown for took one pill stored outside recommended temperature. This report was serious (medically significant).
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Body temperature increased, Ear swelling, Erythema, Perichondritis
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative and concerns a 36 year old male subject; local ID: VIV-9704. The subject's weight and height was not reported. The subject's medical history included: seasonal allergy. On 15 and 17-SEP-1997, the subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 146123A), as prophylactic vaccination.  Concomitant medications included diphtheria and tetanus toxoids and Japanese encephalitis vaccine as prophylactic vaccination. On 16 and 17-SEP-1997, both the subject's ears were swollen and red like acute perichondritis. After receiving the second oral typhoid vaccine the subject's temperature was 99 degrees to 99.9 (units not provided). The subject received corrective treatment with astemizole and Benadryl orally and diprolene topically. Action taken with typhoid vaccine oral ty21a was not provided. The subject had recovered from perichondritis and fever on an unspecified date. This report was serious (medically important).
Age: 20.0
Sex: F
Vaccine: FLUX, HEPA, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from other healthcare professional and concerns a 20 year old female; local ID: SBV025. The subject's weight, height and medical history were not reported. On 07-DEC-1998 3:30pm, the subject received VIVOTIF (typhoid vaccine oral ty21a) (capsule, hard, oral, batch 0150891B) as prophylactic vaccination. Concomitant medications included hepatitis A vaccine and influenza vaccine as prophylactic vaccination. On 07-DEC-1998 9:30, the subject experienced severe dizziness and nausea. The subject was taken to the emergency room and treated at ER with intravenous fluids for three hours. Action taken with typhoid vaccine oral ty21a was unknown. The subject had recovered from severe dizziness and nausea on an unspecified date and discharged from the hospital. This report was serious (hospitalization).
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Neuralgia, Pain
Clinical narrative: Guillain-Barre Syndrome; weakness, paralysis, nerve pain. First treatment sought 9/13/13 due to pain and mild numbness, worsened until hospitalization on 9/21 when diagnosis was made.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Paralysis
Clinical narrative: Guillain-Barre Syndrome; weakness, paralysis, nerve pain. First treatment sought 9/13/13 due to pain and mild numbness, worsened until hospitalization on 9/21 when diagnosis was made.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Diplopia, Headache, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: Case number PHHY2014US150240, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 539961) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 20 Nov 2014. This report refers to a 57 year old male patient. He had penicillin allergy. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Oct 2011. On 06 Oct 2011, he developed headache, chills and jaw pain, followed by swollen sublingual gland, neck sensitivity, double vision, constant headache and neuropathy. He went to the emergency room and was hospitalized for 5 days for the events. Lab data was inconclusive. Outcome of the events was reported as condition unchanged as on 15 Aug 2014. Causality assessment was not reported. Events reported as serious (permanent disability). QA department stated that, the reported FLUVIRIN batch number: 540873 is not a valid batch number, hence no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 20 Nov 2014: Updated QA comments (no QA investigation would be performed).
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Neuropathy peripheral, Pain in jaw
Clinical narrative: Case number PHHY2014US150240, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 539961) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 20 Nov 2014. This report refers to a 57 year old male patient. He had penicillin allergy. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Oct 2011. On 06 Oct 2011, he developed headache, chills and jaw pain, followed by swollen sublingual gland, neck sensitivity, double vision, constant headache and neuropathy. He went to the emergency room and was hospitalized for 5 days for the events. Lab data was inconclusive. Outcome of the events was reported as condition unchanged as on 15 Aug 2014. Causality assessment was not reported. Events reported as serious (permanent disability). QA department stated that, the reported FLUVIRIN batch number: 540873 is not a valid batch number, hence no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 20 Nov 2014: Updated QA comments (no QA investigation would be performed).
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Diplopia, Headache, Laboratory test, Lymphadenopathy
Clinical narrative: Case number PHHY2014US150240, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 539961) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 20 Nov 2014. This report refers to a 57 year old male patient. He had penicillin allergy. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Oct 2011. On 06 Oct 2011, he developed headache, chills and jaw pain, followed by swollen sublingual gland, neck sensitivity, double vision, constant headache and neuropathy. He went to the emergency room and was hospitalized for 5 days for the events. Lab data was inconclusive. Outcome of the events was reported as condition unchanged as on 15 Aug 2014. Causality assessment was not reported. Events reported as serious (permanent disability). QA department stated that, the reported FLUVIRIN batch number: 540873 is not a valid batch number, hence no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 20 Nov 2014: Updated QA comments (no QA investigation would be performed).
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal discomfort, Neuropathy peripheral, Pain in jaw
Clinical narrative: Case number PHHY2014US150240, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 539961) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 20 Nov 2014. This report refers to a 57 year old male patient. He had penicillin allergy. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Oct 2011. On 06 Oct 2011, he developed headache, chills and jaw pain, followed by swollen sublingual gland, neck sensitivity, double vision, constant headache and neuropathy. He went to the emergency room and was hospitalized for 5 days for the events. Lab data was inconclusive. Outcome of the events was reported as condition unchanged as on 15 Aug 2014. Causality assessment was not reported. Events reported as serious (permanent disability). QA department stated that, the reported FLUVIRIN batch number: 540873 is not a valid batch number, hence no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 20 Nov 2014: Updated QA comments (no QA investigation would be performed).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count abnormal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. Medical history, drug reactions and allergies was not reported. On 05-MAY-2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). Concomitant therapy was not reported. On an unknown date the patient's mother noticed some bruising on the patient after administration of the first dose of GARDASIL date and site of bruising unspecified. On 11-JUL-2014 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). On an unknown date, patient platelets were currently in the 60's the reporter physician reported that the patient became sick at some point after the second dose of GARDASIL. On 18-AUG-2014 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) in 2014 she had treatment with Prednisone (manufacturer unknown) for treatment of ITP. (Duration of the treatment was not specified). The reporter physician stated that the treatment with Prednisone (manufacturer unknown) was discontinued, so the patient received intravenous immunoglobulin (IVIG) treatments. The reporter physician considered a significant disability/incapacity based on patient's medical concerns. The outcome of the reported events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Malaise, Platelet count decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. Medical history, drug reactions and allergies was not reported. On 05-MAY-2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). Concomitant therapy was not reported. On an unknown date the patient's mother noticed some bruising on the patient after administration of the first dose of GARDASIL date and site of bruising unspecified. On 11-JUL-2014 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). On an unknown date, patient platelets were currently in the 60's the reporter physician reported that the patient became sick at some point after the second dose of GARDASIL. On 18-AUG-2014 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) in 2014 she had treatment with Prednisone (manufacturer unknown) for treatment of ITP. (Duration of the treatment was not specified). The reporter physician stated that the treatment with Prednisone (manufacturer unknown) was discontinued, so the patient received intravenous immunoglobulin (IVIG) treatments. The reporter physician considered a significant disability/incapacity based on patient's medical concerns. The outcome of the reported events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. Medical history, drug reactions and allergies was not reported. On 05-MAY-2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). Concomitant therapy was not reported. On an unknown date the patient's mother noticed some bruising on the patient after administration of the first dose of GARDASIL date and site of bruising unspecified. On 11-JUL-2014 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscular. (Lot#, expiration date was not provided). On an unknown date, patient platelets were currently in the 60's the reporter physician reported that the patient became sick at some point after the second dose of GARDASIL. On 18-AUG-2014 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) in 2014 she had treatment with Prednisone (manufacturer unknown) for treatment of ITP. (Duration of the treatment was not specified). The reporter physician stated that the treatment with Prednisone (manufacturer unknown) was discontinued, so the patient received intravenous immunoglobulin (IVIG) treatments. The reporter physician considered a significant disability/incapacity based on patient's medical concerns. The outcome of the reported events was unknown. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Laboratory test normal
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65-year-old patient of unknown gender. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004930, single dose vial, intramuscular in the left deltoid. Concomitant therapies included FLUZONE in the right arm. On 23-SEP-2014 at 2:00 pm, 3 hrs 20 min after onset of therapy the patient called the physician's office complaining of left arm pain traveling upwards to neck and then a headache and finally full body aches and pain mainly towards left side of body. The symptoms resolved without medication treatment. The patient recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65-year-old patient of unknown gender. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004930, single dose vial, intramuscular in the left deltoid. Concomitant therapies included FLUZONE in the right arm. On 23-SEP-2014 at 2:00 pm, 3 hrs 20 min after onset of therapy the patient called the physician's office complaining of left arm pain traveling upwards to neck and then a headache and finally full body aches and pain mainly towards left side of body. The symptoms resolved without medication treatment. The patient recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65-year-old patient of unknown gender. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004930, single dose vial, intramuscular in the left deltoid. Concomitant therapies included FLUZONE in the right arm. On 23-SEP-2014 at 2:00 pm, 3 hrs 20 min after onset of therapy the patient called the physician's office complaining of left arm pain traveling upwards to neck and then a headache and finally full body aches and pain mainly towards left side of body. The symptoms resolved without medication treatment. The patient recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Day after vaccination whole body felt achy; rash/redness by injection site (Pneumonia shot); fatigued that night and felt dehydrated; went to ER on 2nd day after vaccination; increased HR, body aches and arm pain. Pt admitted to hospital for 5 days. Possible sepsis/cellulitis.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dehydration, Fatigue, Heart rate increased, Injection site erythema, Injection site rash
Clinical narrative: Day after vaccination whole body felt achy; rash/redness by injection site (Pneumonia shot); fatigued that night and felt dehydrated; went to ER on 2nd day after vaccination; increased HR, body aches and arm pain. Pt admitted to hospital for 5 days. Possible sepsis/cellulitis.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Day after vaccination whole body felt achy; rash/redness by injection site (Pneumonia shot); fatigued that night and felt dehydrated; went to ER on 2nd day after vaccination; increased HR, body aches and arm pain. Pt admitted to hospital for 5 days. Possible sepsis/cellulitis.