chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Body temperature increased, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Temperature of 103, Chills, scrambled speech, Irritable, Problems breathing.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Disorganised speech, Dysarthria, Dyspnoea, Echocardiogram, Irritability
Clinical narrative: Temperature of 103, Chills, scrambled speech, Irritable, Problems breathing.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Cough, Crying, Lethargy, Moaning, Pain
Clinical narrative: Fever - 100.8 and kept rising to 103.9 - continued through out day and into the night of 06/06/15. Gave Ibuprofen for fever. Inconsolable crying. Moaning- Lethargic- crying out in pain. Throwing up. Coughing. 06/06/15- Went to Doctor on 06/06/15- Recommended to just manage fever.  Fever-and pain still present 06/07/15.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever - 100.8 and kept rising to 103.9 - continued through out day and into the night of 06/06/15. Gave Ibuprofen for fever. Inconsolable crying. Moaning- Lethargic- crying out in pain. Throwing up. Coughing. 06/06/15- Went to Doctor on 06/06/15- Recommended to just manage fever.  Fever-and pain still present 06/07/15.
Age: 40.0
Sex: F
Vaccine: DTP
Symptoms: Lymphadenopathy, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Very sore muscle for 4 day straight.  Could not touch it, it was so painful.  5 days after shot developed swollen supraclavicular lymph node and shoulder and neck pain.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site after one day.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chest pain, Nausea
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 23 year old female patient. The information was reported to the physician by the patient's mother who was also a nurse. The patient's medical history and concurrent conditions were unspecified by reporter. On an unknown date the patient was vaccinated with first dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown). It was reported that the patient completed all the 3 doses of GARDASIL. Concomitant medications were not reported. On an unknown date, between the patient's second and third dose, the patient began to experience abdominal cramping, nausea and chest pain. No product quality complaint was reported. The patient sought medical attention by visiting to an unspecified neurologist and gastrointestinal specialist. The outcome of abdominal cramping, nausea and chest pain was unknown. The causal relationship between the events and GARDASIL was unknown. Additional information is not expected as reporter was not willing to be contacted.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: Information has been received from a pharmacist referring to a about 45 years old male patient. The patient had no drug reactions/allergies and no pertinent medical history. On unspecified dates in 2014, the patient was vaccinated with 2 doses of VARIVAX (Merck) (lot# and dose unknown) subcutaneously. No concomitant medication was reported. The patient had titers drawn on an unspecified date in February 2015 which were negative for immunity to varicella. As a result, patient was administered a third dose of VARIVAX (Merck) subcutaneously (extra dose administered) on an unspecified date in February 2015. The reporter considered the events as non-serious. Outcome and causality were not provided. No product quality issue (PQC) was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Mononucleosis heterophile test positive
Clinical narrative: Information has been received from a healthcare worker referring to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 27-APR-2015 the patient was vaccinated with her first dose of GARDASIL (lot # K014891, expiration date: 10-MAY-2017, 0.5 ml, intramuscular). On an unspecified date in 2015, the patient had a mononucleosis spot test. On 29-MAY-2015, the patient was diagnosed with mononucleosis by an unspecified physician located at a different office than where the healthcare worker worked. The outcome of mononucleosis was reported as not recovered/not resolved. The relationship of the adverse event and GARDASIL was not 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 pharmacy technician (also reported as a healthcare worker) referring to an unspecified number of patients of unknown age and gender. There was no information about pertinent medical history and drug reactions/drug allergies. On unknown dates the patients were vaccinated with GARDASIL (lot # K006960, expiration date 19-FEB-2017, dose and route were not reported). These vaccines were improperly stored. Information about concomitant medication was not provided. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 556078. A 31-year-old male patient received the first dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm on 17 November 2014 (route was reported as unknown). The patient's history was reported as "CECLOR" and his current illnesses was reported as not applicable. Patient's prior vaccinations were not reported and other medication was reported as PAXIL that was discontinued approximately 1.5 weeks before receiving vaccine. On 27 November 2014, ten days post-vaccination, the patient had mild pain, swelling and redness at the injection site (on left arm) and red streaks that went into the armpit on the left arm which was later diagnosed as cellulitis. The patient required an emergency room visit. Laboratory investigation was not reported. The patient received Vancomycin intravenously and Doxycycline 100 mg two times a day (BID) for ten days as corrective treatment. The events resolved on an unspecified date. Upon internal review, the company assessed the event of injection site cellulitis as serious and an important medical event. List of Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 556078. A 31-year-old male patient received the first dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm on 17 November 2014 (route was reported as unknown). The patient's history was reported as "CECLOR" and his current illnesses was reported as not applicable. Patient's prior vaccinations were not reported and other medication was reported as PAXIL that was discontinued approximately 1.5 weeks before receiving vaccine. On 27 November 2014, ten days post-vaccination, the patient had mild pain, swelling and redness at the injection site (on left arm) and red streaks that went into the armpit on the left arm which was later diagnosed as cellulitis. The patient required an emergency room visit. Laboratory investigation was not reported. The patient received Vancomycin intravenously and Doxycycline 100 mg two times a day (BID) for ten days as corrective treatment. The events resolved on an unspecified date. Upon internal review, the company assessed the event of injection site cellulitis as serious and an important medical event. List of Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient received varicella immunization not knowing she was pregnant. On 12/22/2014 she learned that she was pregnant. In Jan, 2015 she miscarried. An initial VAERS was submitted when she learned of the pregnancy (559344-1). Call to VAERS and they recommended a 2nd VAERS instead of addendum. The patient wants Merck to learn of the AEFI.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Apnoea, Hypotension, Pallor
Clinical narrative: Two successive episodes of pallor, loss of tone and apnea lasted 20 seconds. Responded to back blow. Admitted overnight to hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Apnoea, Blood electrolytes normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Two successive episodes of pallor, loss of tone and apnea lasted 20 seconds. Responded to back blow. Admitted overnight to hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Hypotonia, Pallor, Urine analysis normal
Clinical narrative: Two successive episodes of pallor, loss of tone and apnea lasted 20 seconds. Responded to back blow. Admitted overnight to hospital.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: this spontaneous report as received from a pharmacist refers to a 50 years old female patient. No concomitant medication and no pertinent medical history was reported. On 03-MAY-2015, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot#, expiration date were not reported). On 13-MAY-2015, the patient experienced redness, warmth, and tenderness at the injection site following administration. The pharmacist also reported that, on 13-MAY-2015, following the administration of ZOSTAVAX, the patient experienced neck and shoulder pain. The patient sought medical attention by seeing in pharmacy. The outcome of events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: this spontaneous report as received from a pharmacist refers to a 50 years old female patient. No concomitant medication and no pertinent medical history was reported. On 03-MAY-2015, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot#, expiration date were not reported). On 13-MAY-2015, the patient experienced redness, warmth, and tenderness at the injection site following administration. The pharmacist also reported that, on 13-MAY-2015, following the administration of ZOSTAVAX, the patient experienced neck and shoulder pain. The patient sought medical attention by seeing in pharmacy. The outcome of events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 76 year old female patient, reporting on herself. The patient had none pertinent medical history, none drug reactions or allergies and did not take any concomitant medications. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX dose reported as "one shot", lot # K021953, (route of administration and expiration date - not reported). On 04-MAR-2015, the patient experienced injection site reactions of redness and swelling after receiving ZOSTAVAX. The patient treated the reaction by applying ice to the injection site. She reported that she did not experience a rash. The redness and swelling had lessened, but they were still present and have not seemed to improve much lately. No lab diagnostics studies were performed. The patient sought medical attention by speaking with an unspecified pharmacist. The outcome of event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a 76 year old female patient, reporting on herself. The patient had none pertinent medical history, none drug reactions or allergies and did not take any concomitant medications. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX dose reported as "one shot", lot # K021953, (route of administration and expiration date - not reported). On 04-MAR-2015, the patient experienced injection site reactions of redness and swelling after receiving ZOSTAVAX. The patient treated the reaction by applying ice to the injection site. She reported that she did not experience a rash. The redness and swelling had lessened, but they were still present and have not seemed to improve much lately. No lab diagnostics studies were performed. The patient sought medical attention by speaking with an unspecified pharmacist. The outcome of event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Blood test, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Shaking episodes with eye rolling x3 episodes after the vaccine was administered.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Electroencephalogram, Eye movement disorder, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Shaking episodes with eye rolling x3 episodes after the vaccine was administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Patient had no pertinent medical history and no drug reactions or allergies. On 27-MAY-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown). On 02-JUN-2015, the patient experienced a rash on her abdomen (disability), after receiving a dose of ZOSTAVAX. The patient felt the rash was an outbreak of shingles, but this had not been officially diagnosed at the time of report. No treatment was provided for the rash. No laboratory tests were performed. The patient sought medical attention-she called the pharmacist. The pharmacist felt this was a significant disability for the patient since she was "very concerned" about the rash and did not go to work because of it. The outcome of rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling to (L) thigh. BENADRYL OTC and Orapred x 3days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Administered ZOSTAVAX approx 3 inches above elbow Sq. On 5/27/15 was swollen and red for 3-4 days. On Thursday June 4th 8 days later had pain and swelling on to of shoulder and pain in shoulder blade. On June 7th - 11 days later all symptoms gone. She did not go to her MD or any MD.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen and warm to touch.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Injection site induration, Peripheral swelling, Skin warm
Clinical narrative: Denies SOB, warm to touch, red, swollen shoulder to elbow, firmness at injection site. Antibiotics, prednisone and loratidine to treat.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at injection site noted ~2 months after injection. Injection done appropriately.
Sex: U
Vaccine: TTOX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a Pharmacist on 29 May 2015. A patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid (batch number, route of administration and site of administration were not reported) on unspecified date. On unspecified date, after vaccination patient experienced seizures. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: seizure. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: S/sx erythema, mild inflammation of (L) thigh, (4cm x 5cm) noted morning after injection provided. Tx: cool compress, antihistamine, hydrocortisone cream prn.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The day after the PREVNAR 13 injection, patient had swelling the size of an orange and it felt very hot at the injection site. Symptoms persisted for 2 days and swelling went down.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with COMVAX (dose, route of administration and anatomical location was unknown) that were improperly stored. Concurrent medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. No further informmation was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Merck) PROQUAD: lot# L004219 with expiration date 23-JUL-2016 or lot # reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with ROTATEQ (dose, route of administration and anatomical location was unknown) that were improperly stored. Concomitant medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. NO further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (dose, frequency, route of administration and indication were not specified) (lot # K019701, expiration date: 17-JUL-2017) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been requested. No product quality complaint (PQC) was involved. This is one of several reports received form 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 healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration and indication were not specified) (lot # H020901, expiration date: 05-JUL-2015) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (strength, dose, frequency, lot number and expiration date were not reported). The patients received a dose of RECOMBIVAX HB that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a 7 improperly stored doses of ZOSTAVAX lot # K018175, expiration date 10-JAN-2016, 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. On an unknown date in 2015 (reported as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product Quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated orally with an unspecified number of doses of improperly stored Oral, ROTATEQ (lot # K009753, expiration date: 29-APR-2016, doses were not reported and lot # K013861, expiration date: 18-MAY-2016, doses were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a 80 year old female patient refers to herself. Patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route were not reported). The patient stated that she still developed shingles (unknown date). At the time of the report the outcome of the event was reported as not recovered/not resolved. Additional information is not expected as no patient's or physician information was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several report received from the same reporter. Additional information has been requested,
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# K026385 exp: 15-DEC-2016, Lot: K011800 exp: 21-AUG-2016, Lot: reported as K018961 exp: 15-OCT-2016 respectively; strength, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. On an unknown date in 2015 (reported as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Erythema, Swelling
Clinical narrative: Tha day after vaccine given pt had redness, swelling temp 100.7, and getting worse. Was seen in the clinic on 6/1/15 - had cellulitis. treated with cephalexin for 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Computerised tomogram normal, Electroencephalogram, Full blood count abnormal, Injection site pain, Loss of consciousness
Clinical narrative: Child reported legs hurting night of shots and following day. Child had a seizure the following day and was sent to ER. Child vomited, lost consciousness and had convulsions.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Seizure, Urine analysis abnormal, Vomiting
Clinical narrative: Child reported legs hurting night of shots and following day. Child had a seizure the following day and was sent to ER. Child vomited, lost consciousness and had convulsions.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Cough, Haemoptysis, Pyrexia
Clinical narrative: Fever, bad cough. Chills-bleeding when coughing up. Weak, still have weakness when walking.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid/arm red and swollen, rash spreading to shoulder area, hot and tender to touch. Started two days ago.
Age: 15.0
Sex: M
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging normal
Clinical narrative: Undiagnosed partial seizure 1 week after 1st round of travel vaccines. Partial seizure and extended grand mal seizure 1 week after last round of travel vaccines. Continued partial and grand mal seizures ongoing problem.
Age: 15.0
Sex: M
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Partial seizures
Clinical narrative: Undiagnosed partial seizure 1 week after 1st round of travel vaccines. Partial seizure and extended grand mal seizure 1 week after last round of travel vaccines. Continued partial and grand mal seizures ongoing problem.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: Patient received GARDASIL 9 vaccine at approximately 11:45 am on 5/29/15. Immediately after injection was given patient began to complain of dizziness then passed out. Per patient's mother, patient began to come to after a few seconds. Patient was monitored and vitals were taken. Patient reported that he was feeling better within a few minutes. Around 12:15 pm on 5/29/15 patient reported that he felt like "he might get lightheaded". EMS was contacted at that time and patient transported to the emergency room. Patient discharged from ER same day. Patient's mother contacted our office 5/30/15 advised staff patient was doing better.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: 8 x 9 cm area of eryth, warm, tender with palp, firm to touch. No streaking, AUGMENTIN 600/429 mg/5mL 5 mL BID.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # and expiration date were not reported). On an unknown date, within 24 hours of receiving the ZOSTAVAX, the patient experienced one-inch radius that was itching at the injection site. She went to the doctor and he told her to apply a hydrocortisone cream. The pharmacist contacted the patient about a week later and the patient stated that she had recovered from the event (reported as "oh I'm totally fine"). The outcome of itching at the injection site was recovered. The patient sought medical attention, she went to the doctor. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis in Left deltoid.
Age: 5.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Induration, Injection site mass, Pruritus, Skin warm, Swelling
Clinical narrative: Parent into the health dept on 6/1/15, 11:26 am for immunizations. Two vaccines were administered, Hep B and varicella. Mother states that when child woke up, she saw a lump on child's left arm. Back into the health dept today 6/2 at 3:45 pm. Assessed by clinic PHN child has an induration measuring 35 mm x 45 mm, raised, warm to touch and child states that induration is itchy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Mom of client called office at about 12:30 pm on 5-29-15 and stated her sons arm way swollen and red arm warm. Client presented if office and nurse assessed. Arm was swollen from top of shoulder to elbow. Red, tight and hot. RN called local PA, to make appointment to be seen right away. Client did not have a fever. Was treated at medical clinic.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid was warm and tender to touch. Red raised areas around administration site.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Ligament pain, Musculoskeletal stiffness, Myalgia, Ultrasound Doppler
Clinical narrative: Debilitating pain in all ligaments, muscles beginning morning after vaccines and continuing stiffness-more on left side but all over body not much improved in 2 months, if at all-affects all joints. On April 4 unable to cross (R) leg over (L).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient said she felt pain almost immediately at the time of the flu vaccine. She mentioned pain and limited mobility of her arm to her doctor (no exam done) and they recommended therapy. Pain remains.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Oropharyngeal pain, Rash
Clinical narrative: This spontaneous report has been received from a 76 year old male patient and refers to himself. The patient had no drug reactions/allergies. There was no concomitant therapy. In May 2013 (reported as "two years ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (route of administration, lot#, expiration date not reported). On an unspecified date (reported as a few months ago) the patient had stents put. On 03-MAY-2015 (reported as "about ten days ago, May third or fourth"), the patient began feeling pain on "his head". The patient went to the doctor and was told he had shingles (the shingles rash was located on his head and ear) and his sore was throat. Approximately in May 2015, the patient had had headache for "six days, but it was letting up" at the time of the report. No lab diagnostics studies were performed and the patient was treated for adverse events with valacyclovir 500 mg and prednisone (manufacturer unknown). The outcome of shingles rash located on his head and ear, sore throat and stents put in was not reported. The patient sought medical attention. The relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Patient was given wrong vaccines in error. Was previously given MMR, Varicella and PCV13 on 4/16/2014. These vaccines were given again on 5/28/15 by error.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash macular
Clinical narrative: Inj 5/30-5 PM. 1st appearance of red splotches 6/1 (felt itchy 5/31); arms, neck, chest, foot; more outbreak, same areas as day progressed-nothing at injection site (no soreness, red circle, warmth), no fever, no chest pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Vaccine given 5/28/15. On 5/29/15 pt was at school. After nap he "got stiff and was lowered to the floor" with "full body shaking". Episode lasted approx 1 min. After episode pt noted to have fever 102.9.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Red blood cell sedimentation rate, Tremor, Urine analysis
Clinical narrative: Vaccine given 5/28/15. On 5/29/15 pt was at school. After nap he "got stiff and was lowered to the floor" with "full body shaking". Episode lasted approx 1 min. After episode pt noted to have fever 102.9.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Sl. raised, pink, warm area Lt upper arm 5cm central darker red area. Lt upper arm 2cm area, sore and itchy.
Age: 36.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular discrete lesions on face trunk and arm started 2-3 days after his uneventful Td and MMR shot at clinic. Started from face and reached to trunk and head. Seen on day 11.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown demographics. Parents medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with GARDASIL (dose, route of adminitraion and anatomical location was unknown) that were improperly stored (poor quality drug administered) (incorrect product storage). Concomitant medications were unspecified by reporter. No adverse effects and no product quality complaint was reported. The outcome of the events was unknown. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharamcist refers to a 66 year old patient. Historical drugs included PREVNAR 13 on 17-NOV-2014. On 02-JUN-2015, the patient was vaccainted with PNEUMOVAX23 lot # K010522, 0.5 ml, once, intramuscualr (indication reported as Pneumococcal). Four hours after injection the patient experienced redness below the injection site, the patient's arm became swollen to elbow, tender to touch and the patietn was barely able to move the arm. The patinet experienced these event for three days and then contacted the pharmacist. No treatment was given to the patient and no laboratories were performed. The pharmacist stated that the patients was feeling better on 04-JUN-2015 with less swelling, more mobility in arm and still some redness. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 23 year old female patient. On unknown dates "in the past" the patient was vaccinated with first and second dose of M-M-R II (dose and route not provided). the nurse reported that on an unspecified date titers were drawn and patient showed low titers for measles. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose and route were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a medical assistant concerning a 13 year old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 26-MAR-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route and anatomical location were not reported) (lot # K006124, expiration date: 02-FEB-2017) that was improperly stored. No adverse effects were reported. This is  one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 10-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (dose, route and lot # not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a medical assistant concerning an 18 year old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 30-MAR-2014, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route and anatomical location were not reported)(lot #K006124, expiration date: 02-FEB-2017) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure
Clinical narrative: Information has been received from a published literature, titled as stated below, referring to a 10 months old patient of unknown gender. On an unknown date the patient was vaccinated with rotavirus vaccine, oral, (manufacturer unknown) (strength, dose and lot # not reported). The patient had been fully immunized. On an unknown date in 2013, during the patients' February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilious vomiting and periumbilical abdominal pain. On arrival at the closest pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination (vaccination failure). Within 5 minutes of returning from the hospital, the patient's two old brothers vomited while attempting to reach the bath room. That night, the patient's two old brothers had vomiting and diarrhea, and missed the toilet. 6 of 6 family members of the patient had been ill within 2 weeks. The patient experienced looser-than-usual bowel movements in a single day (which would not meet criteria for gastroenteritis in many study). On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to Rotavirus vaccine, Oral (manufacturer unknown). This is one of the three reports regarding the same article. The patient's siblings adverse events were captured in 1506USA003700 and 1506USA002868. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a medical assistant concerning a 17 year old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 24-MAR-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route and anatomical location were not reported) (lot # K006124, expiration date 02-FEB-2017) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a medical assistant concerning a 11 year old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 26-MAR-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route and anatomical location were not reported) (lot # K006124, expiration date: 02-FEB-2017) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. The mother of the patient reported that the patient received the second dose of GARDASIL (dose, route, lot number and expiry date were not reported) in April of 2015, four months after receiving the initial dose in December 2014, which is other-than-indicated in the Prescribing information (intentional product use issue). No adverse effects reported. It was also reported that the therapy was no discontinued. The outcome of intentional product use issue was unknown at the time of the report. The relatedness between the event and GARDASIL was not provided. Additional information is not expected because no demographics were provided for the reporter, or the patient, or the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' relevant medical history and concomitant medication were not reported. On an unknown date in 2015 (reported as since 14-MAY-2015, which was the date the exucrsion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.