chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: MNQ, YF
Symptoms: Crying, Drooling, Formication, Irritability, Pruritus
Clinical narrative: Drooling, hives, sensory issues like something crawling on the skin lead to excessive scratching, fussiness, crying, and irritability. Patient was given 1/2 teaspoon of BENADRYL in office at 4:26 pm.
Age: 2.0
Sex: U
Vaccine: MNQ, YF
Symptoms: Sensory disturbance, Urticaria
Clinical narrative: Drooling, hives, sensory issues like something crawling on the skin lead to excessive scratching, fussiness, crying, and irritability. Patient was given 1/2 teaspoon of BENADRYL in office at 4:26 pm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (Lot # K007799, expiration date 29-NOV-2015), (dose number, route, dosage and frequency were not provided). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Disorientation, Dizziness, Headache, Vomiting
Clinical narrative: Dizzines, headache, and vomiting x5 3 hours after HPV vaccine was given. Looked disoriented.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cough, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Surrounding immunization site with induration, edema, erythema over (L) deltoid and separate area over (L) bicep lower. No evidence of cellulitis, non tender. Pt c/o muscle aches, chills, cough starting 2 days after shot.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Surrounding immunization site with induration, edema, erythema over (L) deltoid and separate area over (L) bicep lower. No evidence of cellulitis, non tender. Pt c/o muscle aches, chills, cough starting 2 days after shot.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA, PPV, TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: 5/14-pt reports numbness to right hand, weakness and severe pain to right arm (site 3 injections). Sent to hospital, from which she was discharged with analgesics and muscle relaxers.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On 15-MAY-2015 the patient was inadvertently administered with an expired dose of PNEUMOVAX23 (lot # J004387, expiry date: 04-JAN-2015) .5ml, intramuscular. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL, orally (lot number and expiration date and dosage not provided). No adverse effects were 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: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 14-MAY-2015 the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L004007, expiration date 05-AUG-2016; dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ, orally (lot number and expiration date and dosage not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB, lot number and expiration date and dosage not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored dose of (Merck) VARIVAX (lot number K002931, expiration date 26-FEB-2016, dose and route were unknown). No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot # K011077, expiration date: 30-MAR-2017, (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports 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 an unspecified number of patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored (incorrect product storage) M-M-R II (dose, frequency and route were not provided). No symptoms were reported with regard to the medication error. 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 physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K007828, expiration date: 02-MAR-2017 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # J013394, expiration date: 25-AUG-2016 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare professional refers to 2 patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medication was not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route and lot number not provided). Subsequently on an unknown date, the patients experienced syncope and recovered on their own on an unspecified date. Both of them were observed for 15 minutes after fainting and released. It was reported that neither of them sought for medical attention or required more interventions. 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 physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K004619, expiration date: 20-MAY-2016, oral. No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: JEVX, TD, 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 labeling 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). 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 labeling documents. Additional information received on 30-APR-1999. Additional reference numbers were added to the case: SBV010, VIV9813 and VARES 119281.
Age: 20.0
Sex: F
Vaccine: FLUX, HEPA, TYP, 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 labeling 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). 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 labeling documents. Additional information was received on 09-DEC-1998 partner number VIV-9836 was added to the case.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Choreoathetosis, Decreased eye contact, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Posture abnormal, Somnolence, Visual impairment, White matter lesion
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Crying, Decreased activity, Decreased appetite, Depressed mood
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Dyskinesia, Gaze palsy, Hyperhidrosis, Irritability, Posture abnormal
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Somnolence
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Anti-NMDA antibody positive, Childhood disintegrative disorder, Encephalitis autoimmune, Hypophagia
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Irritability
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Anti-NMDA antibody positive, Dyskinesia, Encephalitis autoimmune, Encephalopathy
Clinical narrative: Within 2 days developed encephalopathy with movement abnormalities-Diag with anti-NMDA receptor antibody encephalitis.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chest pain, Herpes zoster, Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous report was received from a 61 year old female patient and was reporting on herself. The patient's pertinent medical history included hyperthyroidism. The patient did not have drug reactions/allergies. Concomitant therapies included thyroid (ARMOUR THYROID TABLETS). On 30-APR-2015, the patient was vaccinated with ZOSTAVAX (route subcutaneous, dose, lot # and expiration date were not reported). On 01-MAY-2015, the patient experienced a pain in a neck and shoulders and also developed blisters and a rash. The patient reported also the shingles rash and blisters were on her chest, neck, scalp and the shingles completely covered the right side of her body and her back. The patient sought medical attention and was diagnosed with shingles (in an unspecified clinic). There was no lab diagnostics and studies performed. The patient was treated with valacyclovir. The patient's outcome was not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin
Clinical narrative: This spontaneous report was received from a 61 year old female patient and was reporting on herself. The patient's pertinent medical history included hyperthyroidism. The patient did not have drug reactions/allergies. Concomitant therapies included thyroid (ARMOUR THYROID TABLETS). On 30-APR-2015, the patient was vaccinated with ZOSTAVAX (route subcutaneous, dose, lot # and expiration date were not reported). On 01-MAY-2015, the patient experienced a pain in a neck and shoulders and also developed blisters and a rash. The patient reported also the shingles rash and blisters were on her chest, neck, scalp and the shingles completely covered the right side of her body and her back. The patient sought medical attention and was diagnosed with shingles (in an unspecified clinic). There was no lab diagnostics and studies performed. The patient was treated with valacyclovir. The patient's outcome was not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Musculoskeletal pain, Neck pain, Rash
Clinical narrative: This spontaneous report was received from a 61 year old female patient and was reporting on herself. The patient's pertinent medical history included hyperthyroidism. The patient did not have drug reactions/allergies. Concomitant therapies included thyroid (ARMOUR THYROID TABLETS). On 30-APR-2015, the patient was vaccinated with ZOSTAVAX (route subcutaneous, dose, lot # and expiration date were not reported). On 01-MAY-2015, the patient experienced a pain in a neck and shoulders and also developed blisters and a rash. The patient reported also the shingles rash and blisters were on her chest, neck, scalp and the shingles completely covered the right side of her body and her back. The patient sought medical attention and was diagnosed with shingles (in an unspecified clinic). There was no lab diagnostics and studies performed. The patient was treated with valacyclovir. The patient's outcome was not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pruritus, Swollen tongue
Clinical narrative: On 5/18/15, 72 yo F was seen in clinic for follow-up visit. During this visit, pt was ordered to receive TDaP vaccine. At 1120, pt was administered 0.5 mL in right deltoid. After injection, pt developed abnormal swelling at the injection site. Nurse manager and MD were notified and ice was applied to the affected area. Pt was evaluated and reported itching and slight tongue swelling. Pt was ordered and administered diphenhydramine 50 mg IV. Pt was monitored with noted improvement in symptoms. Pt was then discharged in stable condition.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Incorrect route of drug administration
Clinical narrative: The initial case was missing the following criteria: unidentifiable patient. Upon receipt of FU information on 12May2015 this case is now considered valid. This is a spontaneous report from a contactable physician. A 75-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Batch/lot# L13518, expiration date 01Jul2016) subcutaneous at 0.5 ml, single at right deltoid on 23Mar2015 10:34. The patient's medical history was not reported. The patient's concomitant medications were not reported. This physician had inadvertently given PREVNAR-13 subcutaneously instead of intramuscularly on 23Mar2015 with outcome of recovered. The patient developed mild cellulitis on 24Mar2015, which responded to antibiotics. The patient was not admitted to hospital, but the event required a physician visit. The patient recovered from cellulitis on 30Mar2015. The physician considered there was not a reasonable possibility that the event was related to the suspect product, but due to incorrect administration. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Amnesia, Fatigue, Headache, Mental status changes
Clinical narrative: Multiple spells consisting of altered mental status, fatigue, headache, loss of memory.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: Tingling sensations in fingers Lt hand, bilateral upper anterior thighs started ? after injection and are continuing on and off; tingling of toes both feet on 5-18-15 but now resolved. Dizziness, nausea, headache, fatigue since injection. Vomited on 5-18-15 pm. Syncopal episode immediately after injection. No treatment given.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Syncope
Clinical narrative: Tingling sensations in fingers Lt hand, bilateral upper anterior thighs started ? after injection and are continuing on and off; tingling of toes both feet on 5-18-15 but now resolved. Dizziness, nausea, headache, fatigue since injection. Vomited on 5-18-15 pm. Syncopal episode immediately after injection. No treatment given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Flushing, Injection site urticaria, Tongue pruritus, Urticaria
Clinical narrative: Mother reported child complained of stomach hurting and tongue itching just after leaving clinic; waited in car in parking lot; became more flushed in face and neck; brought back into clinic and noted to have flushing of head and neck area, hives on arms, back, legs (scattered) given BENADRYL po, vital signs stable; observed for approx 2 hours - flushing and hives were improving.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood urine present, Chromaturia, Injection site pain, Protein urine absent, Pyrexia
Clinical narrative: R/O rhabdomyolysis. Orange urine with moderate blood, fever and painful (R) arm site of injection.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urine bilirubin increased
Clinical narrative: R/O rhabdomyolysis. Orange urine with moderate blood, fever and painful (R) arm site of injection.
Age: 1.07
Sex: M
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: Blistering at site of injection.
Age: 93.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Injection site got red and hard. It decreased after some time.
Age: 76.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Lethargy, Rash
Clinical narrative: Felt lethargic and not up to par for one week. On 4-22-15 - big red spot appeared on arm on shot site. Itched. Got from doctor flucinonide 0.5% ointment. Didn't help. Took prednisone 10mg for six days. Took away rash.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Erythema, Rash erythematous
Clinical narrative: Had shot on left arm but a red rash with blisters developed on right arm. Doctor prescribed steroid and VALTREX.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Varicella ad PROQUAD, PROQUAD in error, should have been given MMR instead. Called mother 5-20-15 to check on patient and baby is doing fine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm where vaccine given turned red and edematous mother took to physician, who advised against continuing series. Mother reported to HD 5-20-15 when checking for immunizations that were due.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional regarding unknown number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, unknown number of patients were vaccinated with improperly stored (Merck) VARIVAX lot number K018964, expiration date- 15-OCT-2016 and lot # K011800, expiration date- 12-AUG-2016. No adverse event was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter did not want to get contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional regarding unknown number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, unknown number of patients were vaccinated with improperly stored PROQUAD lot # K019101, expiration date- 15-APR-2016 and lot # L002213, expiration date- 21-JUL-2016. No adverse event was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the vent was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter did not want to get contacted.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Injection site erythema, Injection site pruritus, Necrosis, Pyrexia
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 labeling documents. This spontaneous report from a physician concerns a 41 year old female: US-TEA 9306. The subject's concurrent conditions included: ear ache. The subject's height and weight was not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) administered on an unknown date for prophylactic vaccination and tetanus vaccine (unspecified, batch 12124-1, expiry AUG-1993) initiated on an unknown date for prophylactic vaccination. Concomitant medications were not reported. On 29-APR-1993, the subject experienced redness and itching around the injection site, chills and fever. On 05-MAY-1993 erythema was 1x2 centimeters with central necrosis 'with skin of dead tissue'. Action taken with typhoid vaccine oral ty21a and tetanus vaccine was unknown. The subject had not recovered from the events. This report was serious (medically significant).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, Tendonitis
Clinical narrative: Initial R arm pain.  Migrated to bicep and diagnosed with R bicep tendonitis.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: 10 days post MMR 101 fever and increased to 102.3 by 11 days post vaccine, back to normal after 48 hrs. Gave half dose of acetaminophen before bed on day 2 of fever. 10 days post MMR a mild rash developed on face/trunk/legs, more red on day 11, slightly fading day 12 and hardly visible on day 13, lasted 3.5 days total.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: The injection site became very red, inflamed, and itchy for 4 days, with a 3 inch diameter circle.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX lot # K015308, expiration date 17-DEC-2015 (route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to a 46 year old female patient. The patient's concurrent conditions included hypothyroidism and pulmonary valve stenosis. On an unspecified dates in 2006, the patient received 3 dose series of RECOMBIVAX HB lot# 653363/1063R (also reported as '1063R), expiration date: 21-SEP-2008, dose and route were not reported. Concomitant therapies included ATENOLOL, WELLBUTRIN ADN levothyroxine sodium (manufacturer unknown). The nurse reported, that the patient showed no immunity on her Hepatitis B surface antibody (HBsAg) titer test on 28-APR-2015. HBsAg titer was 1.9 mIU/ml. The patient sought medical attention - she saw a doctor. No treatment was given for the event. A booster dose of RECOMBIVAX HB (lot# reported as K018796, expiration date: 24-OCT-2016) was given on 06-MAY-2015. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Information regarding the patients' relevant medical history and concomitant medications was not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, strength and route were not reported, lot # L001442 and expiration date: 04-NOV-2016) that was improperly stored. No adverse events were reported. No PQC (product quality complaint) was involved. Follow up information has been received from a medical assistant via a phone call on 02-APR-2015. The medical assistant provided that vaccination information was not readily available at the time of the call. The medical assistant provided that patient identification information was not readily available at the time of the call. Follow up information has been received from the medical assistant on 01-MAY-2015, concerning a 24 year old female patient. On 26-FEB-2015 at 15:45 o'clock, the patient was vaccinated with the first dose of GARDASIL, that was improperly stored. This is one of several reports received from the same reporter. Additional information is not expected, an no more information was available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. On an unspecified date in 2007, the patient received first dose of GARDASIL 2007 and second dose in March 2015 (dose, route of administration and lot number were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding two patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on 13-MAY-2015, the two patients were vaccinated with improperly stored MMR II, .5 milliliter (ml), subcutaneous (product lot#, expiry date not reported). No adverse experiences reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. Approximately on 14-MAY-2015 (yesterday) the patient was vaccinated with improperly stored LIQUID PEDVAXHIB VIAL WET SD (lot# K025066 and expiration date 02-JUL-2017) 0.5 ml, intramuscular. No adverse events reported. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Irritability, Pyrexia
Clinical narrative: Patient received MMR II and VARIVAX vaccines, developed fever and fussiness, fever did not respond to antipyretics, fever climbed to over 103 degrees, patient experienced febrile seizure.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood magnesium, Chest X-ray, Computerised tomogram head, Electrocardiogram, Full blood count
Clinical narrative: Pt received PREVNAR 13 on 5-5-15 approx. 8:30 am. She later reported an episode of syncope which resulted in an MVA around 3PM. She was transported by ambulance to the ER.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: International normalised ratio, Metabolic function test, Prothrombin time, Road traffic accident, Syncope
Clinical narrative: Pt received PREVNAR 13 on 5-5-15 approx. 8:30 am. She later reported an episode of syncope which resulted in an MVA around 3PM. She was transported by ambulance to the ER.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Troponin
Clinical narrative: Pt received PREVNAR 13 on 5-5-15 approx. 8:30 am. She later reported an episode of syncope which resulted in an MVA around 3PM. She was transported by ambulance to the ER.
Age: 44.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, fatique, muscle aches, headache, abdominal pain. Was treated with Tylenol and resolved.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Fall, Feeding disorder, Gait disturbance
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2-year-old male patient who received HAVRIX (batch number 523T3, expiry date unknown). Concomitant products included vitamins nos (Multivitamin). On 10th April 2015 02:30, the patient received the 2nd dose of HAVRIX (injection). On 8th May 2015, 28 days after receiving HAVRIX, the patient experienced fever. On 9th May 2015, the patient experienced walking difficulty, strength loss of, feeding disorder, fall and dizziness. On an unknown date, the outcome of the fever, strength loss of and feeding disorder were recovered/resolved and the outcome of the walking difficulty and fall were unknown and the outcome of the dizziness was recovering/resolving. The reporter considered the fever, walking difficulty, strength loss of, feeding disorder, fall and dizziness to be possibly related to HAVRIX. Additional information provided: The reporter's son developed fever, and then had difficulty walking, falls over while sitting, was dizzy, and loss strength (could not feed himself anymore). She reported that the patient has recovered from some of these side effects and he may be on the road to recovery for the other side effects.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2-year-old male patient who received HAVRIX (batch number 523T3, expiry date unknown). Concomitant products included vitamins nos (Multivitamin). On 10th April 2015 02:30, the patient received the 2nd dose of HAVRIX (injection). On 8th May 2015, 28 days after receiving HAVRIX, the patient experienced fever. On 9th May 2015, the patient experienced walking difficulty, strength loss of, feeding disorder, fall and dizziness. On an unknown date, the outcome of the fever, strength loss of and feeding disorder were recovered/resolved and the outcome of the walking difficulty and fall were unknown and the outcome of the dizziness was recovering/resolving. The reporter considered the fever, walking difficulty, strength loss of, feeding disorder, fall and dizziness to be possibly related to HAVRIX. Additional information provided: The reporter's son developed fever, and then had difficulty walking, falls over while sitting, was dizzy, and loss strength (could not feed himself anymore). She reported that the patient has recovered from some of these side effects and he may be on the road to recovery for the other side effects.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash
Clinical narrative: Day of injection 5/18 12:15 in the afternoon upper left arm was sore, red and felt hot that evening developed rash left arm. on 5/19/15 in the morning the rash spread to her upper back/shoulder blade area. Took ZYRTEC (allergy med) in the morning. 5/19/15 rash spread to upper chest (afternoon) took BENADRYL at night. 5/20/15 MD office visit in the morning. Pt still has rash symptom persist.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date since 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of LIQUID PEDVAXHIB (lot # K016965, expiration date: 20-JUL-2017) (dose, route and indication were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient took all four doses everyday instead of skipping a day.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles, Skin hyperpigmentation
Clinical narrative: Hyperpigmentation, blisters distal to injection site.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring, Cardiac stress test, Dizziness, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a 23 year old female consumer referring to herself. The patient did not have any medical history or concurrent condition. On an unspecified date in October 2014, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route of administration were not reported) dose 1, one vaccine only, one time. Concomitant therapies included unspecified birth control medication. Suspect drugs were not reported. On that same date, in October 2014, immediately after vaccination, the patient experienced what her physician called a "medically induced seizure" (no further specifics were given about this event in the office which were considered as related by the patient's physician to GARDASIL; she stated that she felt dizzy for a month after receiving the vaccine, she also reported that she had experienced fainting at work and that she had been "experiencing syncope off and on, just about all the time since getting the vaccine". It was stated that on an unspecified date, the patient was taken to an unspecified emergency facility. On an unknown date, her physician told her to drink fluids with a lot of electrolytes and wear compression socks. On unknown dates, Tilt table test, Stress test, EKG (electrocardiogram) and 24 hour heart monitor were performed, but the results were not provided. At the time of the report, it was stated that the therapy with GARDASIL was discontinued; and the outcome of seizure, syncope and dizziness was reported as not recovered. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Seizure, Syncope, Tilt table test
Clinical narrative: This spontaneous report was received from a 23 year old female consumer referring to herself. The patient did not have any medical history or concurrent condition. On an unspecified date in October 2014, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route of administration were not reported) dose 1, one vaccine only, one time. Concomitant therapies included unspecified birth control medication. Suspect drugs were not reported. On that same date, in October 2014, immediately after vaccination, the patient experienced what her physician called a "medically induced seizure" (no further specifics were given about this event in the office which were considered as related by the patient's physician to GARDASIL; she stated that she felt dizzy for a month after receiving the vaccine, she also reported that she had experienced fainting at work and that she had been "experiencing syncope off and on, just about all the time since getting the vaccine". It was stated that on an unspecified date, the patient was taken to an unspecified emergency facility. On an unknown date, her physician told her to drink fluids with a lot of electrolytes and wear compression socks. On unknown dates, Tilt table test, Stress test, EKG (electrocardiogram) and 24 hour heart monitor were performed, but the results were not provided. At the time of the report, it was stated that the therapy with GARDASIL was discontinued; and the outcome of seizure, syncope and dizziness was reported as not recovered. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring, Cardiac stress test, Electrocardiogram, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a 23 year old female consumer referring to herself. The patient did not have any medical history or concurrent condition. On an unspecified date in October 2014, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route of administration were not reported) dose 1, one vaccine only, one time. Concomitant therapies included unspecified birth control medication. Suspect drugs were not reported. On that same date, in October 2014, immediately after vaccination, the patient experienced what her physician called a "medically induced seizure" (no further specifics were given about this event in the office which were considered as related by the patient's physician to GARDASIL; she stated that she felt dizzy for a month after receiving the vaccine, she also reported that she had experienced fainting at work and that she had been "experiencing syncope off and on, just about all the time since getting the vaccine". It was stated that on an unspecified date, the patient was taken to an unspecified emergency facility. On an unknown date, her physician told her to drink fluids with a lot of electrolytes and wear compression socks. On unknown dates, Tilt table test, Stress test, EKG (electrocardiogram) and 24 hour heart monitor were performed, but the results were not provided. At the time of the report, it was stated that the therapy with GARDASIL was discontinued; and the outcome of seizure, syncope and dizziness was reported as not recovered. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tilt table test
Clinical narrative: This spontaneous report was received from a 23 year old female consumer referring to herself. The patient did not have any medical history or concurrent condition. On an unspecified date in October 2014, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route of administration were not reported) dose 1, one vaccine only, one time. Concomitant therapies included unspecified birth control medication. Suspect drugs were not reported. On that same date, in October 2014, immediately after vaccination, the patient experienced what her physician called a "medically induced seizure" (no further specifics were given about this event in the office which were considered as related by the patient's physician to GARDASIL; she stated that she felt dizzy for a month after receiving the vaccine, she also reported that she had experienced fainting at work and that she had been "experiencing syncope off and on, just about all the time since getting the vaccine". It was stated that on an unspecified date, the patient was taken to an unspecified emergency facility. On an unknown date, her physician told her to drink fluids with a lot of electrolytes and wear compression socks. On unknown dates, Tilt table test, Stress test, EKG (electrocardiogram) and 24 hour heart monitor were performed, but the results were not provided. At the time of the report, it was stated that the therapy with GARDASIL was discontinued; and the outcome of seizure, syncope and dizziness was reported as not recovered. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Pyrexia, Wheezing
Clinical narrative: Patient began to get a fever, she has been very tired, and a little bit of wising.
Age: 1.07
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse effects reported.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, myalgias.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthenia, Conversion disorder, Immobile, Mental disorder, Respiratory disorder
Clinical narrative: Respiratory problems, weakness in back and body. Completely immobile within 1 week.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Walking aid user
Clinical narrative: Respiratory problems, weakness in back and body. Completely immobile within 1 week.
Age: 53.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Local swelling
Clinical narrative: 14cm x 12cm area of erythema and swelling with pain.  Complaint of joint pain, muscles aches, fever, chills, nausea, diarrhea, and lymphedema of axilla on vaccination arm for several days.  Still having joint pain in various random joints.
Age: 53.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Lymphoedema, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: 14cm x 12cm area of erythema and swelling with pain.  Complaint of joint pain, muscles aches, fever, chills, nausea, diarrhea, and lymphedema of axilla on vaccination arm for several days.  Still having joint pain in various random joints.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Erythema 10mm in size, chills.  Treated with 7 day course of ABX.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Erythema 10mm in size, chills.  Treated with 7 day course of ABX.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt experienced immediate itching on left arm where injection was received and on her back.  Upon examination injection site was slightly red and warm to touch and slight rash was apparent.  Pt was advised to take Benadryl immediately and to go to er if any worsening symptoms.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Musculoskeletal pain
Clinical narrative: Pain in the shoulder and inflammation.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling (hardness), itching, and mild pain at injection site.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling/induration at site- thighs.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fever 100.1; arm very red and sore lump at injection site, then extreme headache and fatigue. Next day redness really increased to nearly all of upper arm. But fever HA gone.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever 100.1; arm very red and sore lump at injection site, then extreme headache and fatigue. Next day redness really increased to nearly all of upper arm. But fever HA gone.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Rash generalised, Rash pruritic
Clinical narrative: Itchy rash, started on legs, now all over body. Sx started 5/16/15.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient took one capsule every day for 3 days starting May 6, 7, 8.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Lumbar puncture, Nuclear magnetic resonance imaging, Pseudopapilloedema, Strabismus
Clinical narrative: Mom reports patient's eyes started crossing within an hour of receiving vaccine. She was seen in ED the next day and by ophthalmology on 5/11. They were concerned for papilledema so she was admitted to hospital, had MRI and LP. Dx pseudopapilledema.