chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event, Product expiration date issue, Product quality issue
Clinical narrative: Information has been received from a pharmacist via Center referring to a 48 year old female patient. The patient did not have any relevant medical or drug history. On 06-FEB-2015 the patient was vaccinated with a dose of MMR II, lot# was reported as H018945 that expired on 18-OCT-2014 (dose, dose number, application site and route were not reported). The patient did not take any concomitant medications. The patient did not report any problems and no tests had been done. As of 06-FEB-2015 it was unknown if the patient would get another MMR II vaccine and the outcome of receiving an expired vaccine was unknown. This pharmacist stated that the lot number and expiration dates on the cartons were very hard to read and she did not known if the lot number and expiration date given was accurate. Product quality complaint (PQC) involved (also reported as "emergency PQD: No"). This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Dizziness, Nausea
Clinical narrative: On 2/12/15-Early evening-developed soreness left arm and loss of appetite, fatigue on 2/13/15-Noon (approx) developed nausea (Took ZOFRAN) but it didn't help). By evening had uncontrollable vomiting, diarrhea, severe abdominal pain, weakness. Taken to ER/Hosp-was shaking/chills, rapid breathing and bad dehydration. Got IV fluids, pain and nausea meds, rest etc. Still has some loss of appetite/fatigue//adverse reaction/side effects and blood labs etc requiring stool culture et and IV fluids clear liquid while in ER at hospital etc: diet and rest etc.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Vomiting
Clinical narrative: On 2/12/15-Early evening-developed soreness left arm and loss of appetite, fatigue on 2/13/15-Noon (approx) developed nausea (Took ZOFRAN) but it didn't help). By evening had uncontrollable vomiting, diarrhea, severe abdominal pain, weakness. Taken to ER/Hosp-was shaking/chills, rapid breathing and bad dehydration. Got IV fluids, pain and nausea meds, rest etc. Still has some loss of appetite/fatigue//adverse reaction/side effects and blood labs etc requiring stool culture et and IV fluids clear liquid while in ER at hospital etc: diet and rest etc.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Asthenia, Chills, Decreased appetite, Dehydration
Clinical narrative: On 2/12/15-Early evening-developed soreness left arm and loss of appetite, fatigue on 2/13/15-Noon (approx) developed nausea (Took ZOFRAN) but it didn't help). By evening had uncontrollable vomiting, diarrhea, severe abdominal pain, weakness. Taken to ER/Hosp-was shaking/chills, rapid breathing and bad dehydration. Got IV fluids, pain and nausea meds, rest etc. Still has some loss of appetite/fatigue//adverse reaction/side effects and blood labs etc requiring stool culture et and IV fluids clear liquid while in ER at hospital etc: diet and rest etc.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Respiratory rate increased
Clinical narrative: On 2/12/15-Early evening-developed soreness left arm and loss of appetite, fatigue on 2/13/15-Noon (approx) developed nausea (Took ZOFRAN) but it didn't help). By evening had uncontrollable vomiting, diarrhea, severe abdominal pain, weakness. Taken to ER/Hosp-was shaking/chills, rapid breathing and bad dehydration. Got IV fluids, pain and nausea meds, rest etc. Still has some loss of appetite/fatigue//adverse reaction/side effects and blood labs etc requiring stool culture et and IV fluids clear liquid while in ER at hospital etc: diet and rest etc.
Age: 23.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Tremor, Vomiting
Clinical narrative: On 2/12/15-Early evening-developed soreness left arm and loss of appetite, fatigue on 2/13/15-Noon (approx) developed nausea (Took ZOFRAN) but it didn't help). By evening had uncontrollable vomiting, diarrhea, severe abdominal pain, weakness. Taken to ER/Hosp-was shaking/chills, rapid breathing and bad dehydration. Got IV fluids, pain and nausea meds, rest etc. Still has some loss of appetite/fatigue//adverse reaction/side effects and blood labs etc requiring stool culture et and IV fluids clear liquid while in ER at hospital etc: diet and rest etc.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 17-FEB-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports 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 healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 26-FEB-2015, the patient received a dose of GARDASIL (0.5 ml, intramuscularly; lot#, exp. date and anatomical location were not reported) that was improperly stored. It was not specified which dose in GARDASIL series this was . No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a public health nursing supervisor on 23-FEB-2015 who indicated that there were 7 doses of PROQUAD (Merck) (lot # K005644, expiration date 17-OCT-2015) affected by temperature excursion and administered to unspecified patients of unknown ages and genders on unknown dates (dose and route were not reported). No Patient identification information provided for this specific lot number. The nurse also stated that there had been no reports of adverse events following administration of the vaccine and there was no need for revaccination. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On 23-FEB-2015 the patient was vaccinated with M-M-R II and PROQUAD (Merck) (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 18-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Scab, Skin lesion
Clinical narrative: Mother noticed scabbed lesions on the evening of 2/26/15. Denies fever. Presented to clinic with scabbed lesions on abdomen, leg, buttocks, and chest. Time of office visit 10:20 on 3-2-15.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Arm very very red swelled down to his elbow, 102 fever with nausea vomited 2 days and now diarrhea.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Arm very very red swelled down to his elbow, 102 fever with nausea vomited 2 days and now diarrhea.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 7 x 7.5 cm whelp in area that vaccine was given. Patient reported on 3/2/15.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Very swollen 1 min aft Injection cont to swell one w/e reddened, sore.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Trunkal to acral rash: systemic with raised pruritic maculo papular rash worst in pelvic distribution, no SOB rx with BENADRYL and prednisone.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 1 year old patient of unknown gender. On 24-FEB-2015 the patient was supposed to received first dose of M-M-R II and VARIVAX (Merck). On 24-FEB-2015, the patient was inadvertently administered VARIVAX (Merck) and PROQUAD (Merck) lot # K019101, expiration date unspecified, 0.5 ml, subcutaneous (Wrong vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-FEB-2015 the patient was vaccinated with expired ZOSTAVAX (0.65 ml, subcutaneous, lot # J014566, exp. date: 18-FEB-2015). No adverse event reported. The potency was supported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse via a company representative referring to a teenage female patient. Information about concurrent conditions and medical history were not provided. On an unknown date (reported as quite a while ago) the patient was vaccinated with a dose of GARDASIL (in the deltoid region of an unspecified arm, lot#, dose, dose# and route not reported). The nurse reported that as the injection of GARDASIL was being administered to the patient, "her eyes rolled back" and the patient collapsed and lost consciousness. The representative did not know if the dose of GARDASIL was the patient's first, second, or third dose of GARDASIL, nor did she know whether or not the GARDASIL series was continued to discontinued after this episode of loss of consciousness. The outcome of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with her first dose of ZOSTAVAX (lot #, dose and route were not reported). On 25-FEB-2015 the patient was vaccinated with her second dose of ZOSTAVAX (lot # was not reported), 0.65 ml, subcutaneously, which was considered as an extra dose. After the patient received the second dose of ZOSTAVAX she remembered that she already received the ZOSTAVAX in 2012. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Headache, Herpes zoster, Musculoskeletal pain
Clinical narrative: Information has been received from a 66 year old female patient with drug allergy to trimethoprim concerning herself. Patient's pertinent medical history included high blood pressure. On 09-JAN-2010 the patient was vaccinated with ZOSTAVAX (dose, strength, route were not reported). Concomitant medications included unspecified medications. On 20-JAN-2015, the consumer developed shingles and had symptoms resulting in chills, severe headaches, pain the left arm and shoulder and neck. 4 days after those symptoms, the patient broke out in "blisters" over her arms. VALTREX was given as treatment for the shingles. There was no lab diagnostics studies performed. The patient had called the doctor for medical attention. Outcome of the shingles was not reported. Causality between the shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Information has been received from a 66 year old female patient with drug allergy to trimethoprim concerning herself. Patient's pertinent medical history included high blood pressure. On 09-JAN-2010 the patient was vaccinated with ZOSTAVAX (dose, strength, route were not reported). Concomitant medications included unspecified medications. On 20-JAN-2015, the consumer developed shingles and had symptoms resulting in chills, severe headaches, pain the left arm and shoulder and neck. 4 days after those symptoms, the patient broke out in "blisters" over her arms. VALTREX was given as treatment for the shingles. There was no lab diagnostics studies performed. The patient had called the doctor for medical attention. Outcome of the shingles was not reported. Causality between the shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Extra dose administered, Headache, Peak expiratory flow rate, Rhinorrhoea
Clinical narrative: Information has been received from a registered nurse referring to a 22 year old female patient (non-pregnant) with asthma, seasonal allergy, psoriasis, eczema and seborrhoeic dermatitis and with no drug reactions/allergies. On an unspecified date in August 2014 the patient was vaccinated with an initial dose of PNEUMOVAX 23 (lot# and dose not reported, intramuscular). Concomitant therapies included FLONASE, PROAIR, PORTIA, fexofenadine and unspecified topical medications of eczema and psoriasis. On 11-FEB-2015 the patient developed a cough, runny nose, and headache. Given the patient's history of asthma, the physician decided to administer PNEUMOVAX 23, but both the patient and physician were unaware at the time that the patient had previously received PNEUNOVAX 23. As a result, patient inadvertently received a second dose of PNEUMOVAX 23 (lot# reported as K012424, expiration date 05-JUN-2016, intramuscular, dose not reported) on 13-FEB-2015. No additional adverse effect was noted as a result of the second dose. The patient sought for medical attention via office visit but no treatment was given for the events. "Peak flow" was performed on an unspecified date with no result provided. The outcome of the events cough, runny nose, and headache was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On an unknown date the patient was vaccinated with dose one and two of GARDASIL (dose, route, lot# and expiry date unknown) one year apart. No adverse experience reported. No product quality complaint (PQC) involved. Additional information is not expected as we are not permitted to contact the physician.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt. states it was sore after injection, but became red, hot, and swollen 2 days later. Used BENADRYL, BENADRYL cream, and ibuprofen as needed. Did not report to this RN until today, 2/23/15.
Age: 65.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Chills, Dizziness, Erythema, Fatigue, Peripheral swelling
Clinical narrative: Pt underwent cardiac cath with PCI and stents on 2/10/15. He came to office on 2/18/15 after discharge. At visit pt. was given PNEUMOVAX and PCV 13. The following morning he had severe chills, fatigue, red, swollen arm radiating to chest, rash over upper arm and dizziness. No fever.
Age: 65.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Rash
Clinical narrative: Pt underwent cardiac cath with PCI and stents on 2/10/15. He came to office on 2/18/15 after discharge. At visit pt. was given PNEUMOVAX and PCV 13. The following morning he had severe chills, fatigue, red, swollen arm radiating to chest, rash over upper arm and dizziness. No fever.
Age: 9.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Blood glucose normal, Erythema, Loss of consciousness, Peripheral swelling, Vomiting
Clinical narrative: Rt arm red and swollen 2 in x 2 in varicella/MMR that arm. Left arm red and swollen 6 in x 6 in. DTAP in this arm. Mom states child  was playing at park passed out and threw up. Providers don't feel related.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL, FLUX
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Back of arm red and swollen left arm.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Back of arm red and swollen left arm.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: DTaP received at local hospital E.R. I suffered pain, soreness and decreased use of left arm for several months. I now believe it was Deltoid Bursitis. It is still not completely resolved and still bothers me some.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Rash erythematous
Clinical narrative: Received 4th rabies vaccine at facility above. Reported itchy pink rash/bumps over abdomen/trunk few hours after. No respiratory illness.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Increased pain and swelling at injection site, pain with shoulder movement. Rx: MEDROL dose pack, pain meds.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: (R) leg swelling and redness, fever, fatigue.
Age: 1.46
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Abasia, Dysstasia, Irritability, Pyrexia
Clinical narrative: Mother called the day of the vaccines stating that she was fussy and would not stand on legs. Reassured this can be normal after vaccines no redness, no lumps or bumps. Okay to given MOTRIN. Mother call this morning stating child has fever of 103.1 and still won't stand on legs. Denies any redness, swelling or bumps at injection site. Asked her to MOTRIN and I would call her back. Called back 1 hr later fever down to 99.5. Still won't walk. Asked her to try giving her a warm bath to get her to play. Will call back to see how she is doing. Called mother back. Child is now walking around and playing.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Chest pain, Dysgeusia, Nausea
Clinical narrative: 2-3 hours after vaccine administration pt developed crushing chest pain, nausea and metallic taste in mouth. Symptoms resolved after several minutes.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Unresponsive to stimuli
Clinical narrative: After receiving vaccinations 2:28 pm patient felt dizzy and needed to lie down. Patient then appeared to be unresponsive. With altered level of consciousness, responds to tactile and verbal stimulation.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: DTaP vaccine was given w/ exp. date of 2/12/15. Given on 2/20/15.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Neck pain, Peripheral swelling, Pruritus
Clinical narrative: Red, swollen arm, little neck pain, diarrhea, headache. Patient used BENADRYL for itchy red swollen arm.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Vaccination complication
Clinical narrative: Pt has red/raised/warm reaction to VARIVAX injection.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient came to the pharmacy because he received a Pneumococcal shot on February 27, 2015 and the next day, he developed a cellulitis at the right arm where he received the vaccine.
Age: 23.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Chest pain, Haemoptysis, Throat tightness
Clinical narrative: Client received vaccines at 8:15 am. 13:00 experienced chest pain. Middle of the night he felt chest pain and throat felt close, coughed and spit up a little blood. Return to clinic 8:15 next day no local reaction noted no further symptoms.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: 2/27/215 Pt. had approx. 6" round area - slightly reddened with small egg sized (oval) area (within the 6" area) that was darker shade of red. Entire area warm to touch and smaller area firm to touch. Pt. states area is tender and feels "itchy".
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient experienced itching on 2-28-15. It started with mild itching. It got worse as time progressed. On 3-1-15 patient experienced severe itching on both extremities and chest. Patient also develop redness and rash on both arms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL that was improperly stored and administered with a lot # reported as L001442 and expiration date: 04-NOV-2016. No adverse effects reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash morbilliform, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to approximately an year old male patient. No medical history and drug allergy was reported. On 26-JAN-2012, the patient was vaccinated with M-M-R II (dose, strength, route and lot number were not reported). Other suspect therapies included VARIVAX (Merck) (dose, strength, route and lot number were not reported) and SINGULAIR 4 mg, chewable tablet (strength, route and lot number were not reported). On an unknown date the patient developed unspecified allergies for which patient was prescribed SINGULAIR on an unspecified date. On an unspecified date in November 2014, the patient experienced cough and congestion. For which patient was treated with ZITHROMAX (manufacturer unspecified). The outcome of cough and congestion was reported as recovered/resolved. The outcome of unspecified allergies (hypersensitivity) was unknown. Action taken with SINGULAIR was unknown. Causality assessment was not provided. The patient subsequently experienced fever (pyrexia) and measles type rash (rash morbilliform) while on therapy with PROQUAD (Merck) (case# 1502USA010492). This is one of several reports receivd from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old male patient. The patient's medical history included frequent ear infections ear tube insertion, cough and congestion. The patient had a history of unspecified allergies while on therapies with M-M-R II and VARIVAX (Merck) and cough and congestion while on therapy with SINGULAIR (case# 1503USA000578). Concurrent condition included eczema. On 20-FEB-2015 the patient was vaccinated with PROQUAD (strength and dose was not reported, lot # K019101 with the expiration date of 15-APR-2016, subcutaneous. Other suspect therapies included ELOCON (dose, formulation, route, lot number, frequency were not reported) for eczema. On 20-FEB-2015, 1 day after onset of therapy later in the day, the patient developed fever  of 102F. On 21-FEB-2015 the patient experienced measles-type rash on his face. Patient called the office and sought medical attention. No product quality complaint (PQC) was involved. The outcome of pyrexia was reported as resolved on an unspecified date. The outcome of measles-type rash on his face was reported as improving. Action taken with ELOCON was unknown. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified report refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX that had expired (dose, route, lot # not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative concerned to a female patient (Age not reported) with a negative papanicolaou (PAP) test. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose and site not reported). On an unknown date the patient had a positive PAP after the receipt of GARDASIL. Patient's outcome on smear cervix abnormal was not reported. Relationship between smear cervix abnormal and vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old patient of unknown gender. Patient's medical history and concurrent condition were not reported. On 24-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot 3 J004157 expiration date 09-MAY-2014 (dose and route not reported), which was improperly stored and expired. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Glassy eyes, Hyperhidrosis, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Mother was carrying patient after vaccinations. Within 5 minutes, he became stiff - whole body and arched back. Eyes glazed and he looked pale and sweaty. Lasted < 30 seconds. He was back to normal after 15 minutes.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypotonia, Seizure like phenomena
Clinical narrative: I administered Tdap vaccine to the (R) deltoid then walked around pt and administered MENVEO to (L) deltoid. Pt was alert and talking when he suddenly went limp and quiet. I layed pt down when he began to have seizure like activity for about 30 sec.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Aldolase increased, Anti-transglutaminase antibody negative, Antinuclear antibody negative, Atelectasis, Axonal neuropathy
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Blood copper normal, Blood lead normal, CSF oligoclonal band absent, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Coordination abnormal, Cough, Cytomegalovirus test negative, Dysgeusia, Dysphagia
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Dyspnoea, Dysstasia, Electromyogram abnormal, Endotracheal intubation, Enterovirus test negative
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Gait disturbance, HIV test negative, Hypoaesthesia, Intensive care, Lung infiltration
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia, Peripheral sensorimotor neuropathy, Pneumonia
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TD
Symptoms: Respiratory failure, Respiratory tract congestion, Scan with contrast abnormal, Varicella virus test negative, Viral test negative
Clinical narrative: On 9/25 patient presents to the ICU from another hospital with a complaint of b/l LE weakness with numbness and tingling of the b/l hands and feet. He first noticed tingling on 9/22 but mostly attributed it to the intesne LE exercises required. His symptoms worsened to the point that he had difficulty climbing a flight of stairs and getting up from a seated position on the floor. In addition to a continued cough, the patient endorsed dysphagia to solids, a widened gait, decreased hand coordination and dysgeusia (metallic taste). On 9/27 patient c/o of difficulty breathing (unable to clear secretions) and was intubated after rapid response was called.  A post intubation CXR revealed RUL collapse. CT of chest with contrast which revealed R sided infiltrate and was negative for PE. Patient was treated for pneumonia with antibiotics.  Patient underwent a series of testing to determine if infectious process was culprit of muscle weakness.
Age: 0.82
Sex: F
Vaccine: IPV
Symptoms: Agitation, Decreased appetite, Lethargy, Pyrexia, Restlessness
Clinical narrative: Fever, lethargic, vomiting, agitated, restless, loss of appetite.
Age: 0.82
Sex: F
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Fever, lethargic, vomiting, agitated, restless, loss of appetite.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Swelling and cellulitis of the extremity requiring IV antibiotics and hospital treatment.
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Blood iron decreased, Blood test, Depression, Endocrine test
Clinical narrative: This spontaneous report as received from the patient's mother refers to a non-pregnant currently 17-year-old female patient with no drug allergy. The patient's medical history included low blood sugar and low iron level. Sometime in 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). The patient was concomitantly using an unspecified birth control and allergy medication. Sometime in 2012, the patient experienced suicidal thoughts and depression. The patient sought medical attention (office visit on an unspecified date). The patient was prescribed CELEXA as a treatment for the adverse events (10 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer within the last 6 months). On an unknown date, blood and hormone tests were performed (results were not provided). The patient did not recover from suicidal thoughts and depression. The relatedness between GARDASIL and the events was not reported. Upon internal review, suicidal thoughts were considered to be serious as an other important medical event. Additional information is not expected because there was no consent to contact the physician.
Sex: F
Vaccine: HPV4
Symptoms: Suicidal ideation
Clinical narrative: This spontaneous report as received from the patient's mother refers to a non-pregnant currently 17-year-old female patient with no drug allergy. The patient's medical history included low blood sugar and low iron level. Sometime in 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). The patient was concomitantly using an unspecified birth control and allergy medication. Sometime in 2012, the patient experienced suicidal thoughts and depression. The patient sought medical attention (office visit on an unspecified date). The patient was prescribed CELEXA as a treatment for the adverse events (10 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer within the last 6 months). On an unknown date, blood and hormone tests were performed (results were not provided). The patient did not recover from suicidal thoughts and depression. The relatedness between GARDASIL and the events was not reported. Upon internal review, suicidal thoughts were considered to be serious as an other important medical event. Additional information is not expected because there was no consent to contact the physician.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diabetes mellitus, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a Registered Nurse through a company representative refers to a 14 year old male patient. On 01-MAR-2012, the patient was vaccinated with the first dose of GARDASIL intramuscular in the left arm (dose not provided, lot # reported as: 1524AA, expiry: 23-AUG-2014). On 09-APR-2012, the patient sought medical attention and was admitted to the hospital for two days. During his stay he was diagnosed with diabetes. Apart from that unspecified tests were performed in the hospital and determined he had been probably pre-diabetic for 6 months prior to being diagnosed with diabetes (approximately since October 2011). The outcome of diabetes was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diabetes mellitus
Clinical narrative: This spontaneous report as received from a Registered Nurse through a company representative refers to a 14 year old male patient. On 01-MAR-2012, the patient was vaccinated with the first dose of GARDASIL intramuscular in the left arm (dose not provided, lot # reported as: 1524AA, expiry: 23-AUG-2014). On 09-APR-2012, the patient sought medical attention and was admitted to the hospital for two days. During his stay he was diagnosed with diabetes. Apart from that unspecified tests were performed in the hospital and determined he had been probably pre-diabetic for 6 months prior to being diagnosed with diabetes (approximately since October 2011). The outcome of diabetes was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from other, as part of a marketing research program, refers to a female patient of 33 year old. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced hypersensitivity. The outcome of hypersensitivity was unknown. Relatedness between the pneumococcal vaccine (manufacturer unknown) and the adverse event was not provided. Upon internal review, hypersensitivity determined to be medically significant since the seriousness of the case was reported as unknown. Clarification has been received on 23-FEB-2015. The primary reporter of this case was confirmed to be the patient. Additional information is not expected because there is no contact information. Reporter type has been updated.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Convulsion, Electroencephalogram, Staring
Clinical narrative: Had a seizure with staring episodes lasted about 4 minutes when she was staring blankly.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Administration site reaction, Burning sensation, Injection site pain, Local reaction, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. This 67 year old male consumer was administered with PREVNAR 13, (Lot Number: F80381) unknown dose prefilled syringe intramuscular injection as single dose on left arm at 10:15 AM as a pneumonia vaccination on 26Feb2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. Relevant past product history included an unspecified Flu shot vaccine for an unknown reason in Dec2012. On 26Feb2013 he experienced local reaction at the site of administration, pain at the site of injection, burning sensation and pain in muscles. It was unknown if he had any siblings. Relevant lab data was none. The patient had not recovered from the reported events at the time of the report. Follow-Up (01Mar2013): New information received from the same consumer includes: outcome of events (changed to not recovered for all the events). Follow-up (10-APR-2013) Follow-up attempts completed. No further information expected.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever (105) and seizure.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Ear infection, Febrile convulsion, Pneumonia, Seizure
Clinical narrative: Patient was transported to Medical Center via EMS with seizue activity.  Diagnosed with febrile seizures, pneumonia and ear infection.
Age: 32.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: CLIENT GIVEN HEPATITIS A DOSE 4 MONTHS AFTER FIRST DOSE. INTERVAL BETWEEN DOSES TOO SHORT. WILL HAVE TO REPEAT DOSE. CLIENT INFORMED OF ERROR. ERROR REPORTED.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Pyrexia
Clinical narrative: Patient developed fever of 103.5 F overnight associated with chills.
Age: 26.0
Sex: F
Vaccine: MENB
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Culture, Headache, Intensive care
Clinical narrative: This is a spontaneous report from a contactable physician. A 26-year-old female patient received TRUMENBA on 20Feb2015 at 9:30 am at 0.5 ml single dose via intra-articular route. Concomitant medications were none. Medical history included asthma when she was a child, now resolved. On 20Feb2015 the patient developed high fever, headaches, and a small rash on her leg as a reaction to the vaccine. She went to the emergency department after midnight on 21Feb2015 and was admitted to the ICU to rule out meningitis since there was currently an outbreak of meningitis in the community. The patient did not have meningitis. On 21Feb2015 chest X-ray was negative for meningitis, lumbar puncture was negative and showed no WBC, cultures are still pending, multiple laboratory tests showed no signs of infection. High fever recovered on 21Feb2015. Outcome of the events headache and rash was recovering. The rash was described as minimal at the time of reporting.
Age: 26.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test normal, Lumbar puncture normal, Pyrexia, Rash, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable physician. A 26-year-old female patient received TRUMENBA on 20Feb2015 at 9:30 am at 0.5 ml single dose via intra-articular route. Concomitant medications were none. Medical history included asthma when she was a child, now resolved. On 20Feb2015 the patient developed high fever, headaches, and a small rash on her leg as a reaction to the vaccine. She went to the emergency department after midnight on 21Feb2015 and was admitted to the ICU to rule out meningitis since there was currently an outbreak of meningitis in the community. The patient did not have meningitis. On 21Feb2015 chest X-ray was negative for meningitis, lumbar puncture was negative and showed no WBC, cultures are still pending, multiple laboratory tests showed no signs of infection. High fever recovered on 21Feb2015. Outcome of the events headache and rash was recovering. The rash was described as minimal at the time of reporting.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local injection site redness, warmth.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: Rash and low grade fever starting morning of 2/20/2015.  Fever reaching 105.4*F and still rising the evening of 2/21/2015.  No appetite.  Fever lowered with Ibuprofen.  Fever and rash started to subside on the morning of 2/22/1015.
Sex: U
Vaccine: HEP, PPV, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age. On unspecified dates, an unspecified number of unspecified patients received doses of GARDASIL, PNEUMOVAX 23, RECOMBIVAX HB, oral ROTATEQ and VARIVAX (Merck) that were improperly stored. The lot#, expiration date, dose and frequency for the vaccines were not provided. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of ROTATEQ orally (dose, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Axillary pain, Body temperature increased, Chills, Fatigue
Clinical narrative: Complained starting on Monday of arm pit pain....continued saying it bothered him on and off for the next 3-4 days---I did not notice anything apparent when I looked at it, but am suspecting swollen gland.  On March 2, 2014 patient started getting the chills and complained of fatigue.  On March 3 he complained that his legs ached and were sore. He felt warm to the touch and complained of the chills and was not playing as he normally does.  I checked his temperature at 1:00 PM and it was 100.4 F axillary.  At that point I called the doctor to report.