chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients (no patient information known). On an unknown date, the unspecified number of patients were vaccinated with ZOSTAVAX, 19400 PFU (plaque forming units) (dose, route of administration and indication were not provided), that was improperly stored outside the prescribing information. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further adverse event was information available. 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 nurse practitioners refers to a patient of unknown age and gender. No information provided regarding concurrent conditions, medical history and drug reactions/allergies reported. On 21-MAY-2014 the patient was vaccinated with GARDASIL dose 2 (dosage, route, lot# not reported). Prior to this the patient also was administered with first dose of GARDASIL on 31-JAN-2014. No concomitant medications reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to 2 patients of unknown age. On unknown dates the 2 patients were vaccinated with ZOSTAVAX (lot# not reported) (start date, route, dose# and dosage not reported). On unknown dates the 2 patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 22-MAY-2014 the patient was inadvertently vaccinated with unspecified dose of ZOSTAVAX intramuscularly rather than subcutaneously (lot#, expiration date, anatomical location not reported). Concomitant medications were not reported. No adverse effects reported. Product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot # J010966 expiration date 20-MAR-2015 and lot # J010140 expiration 26-APR-2015). Strength, dose and route were not provided. ROTATEQ was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from the registered nurse and reported the ROTATEQ stability cut off date was 02-MAY-2014. The registered nurse stated that anyone who was vaccinated with vaccine after these dates needed to be contacted for re-vaccination. The registered nurse refused to share patient identifiers on these patients, per Health Insurance Portability and Accountability Act (HIPAA). Health Insurance Portability and Accountability Act (HIPAA) was reviewed with the nurse and she stated she would need to get that information from her supervisor. The phone call was transferred to her Supervisor. The follow-up information provided the primary reporter's occupation as a medical assistant. She reported that 3 unspecified patients were vaccinated with the improperly stored ROTATEQ. This case refers to a one patient vaccinated with the second dose of ROTATEQ. No demographics, medical history, concurrent conditions or concomitant drugs were reported. There were two other patients vaccinated with dose number 3 (case# 1405USA004216). The patient received the vaccine on 02-MAY-2014. Lot# and expiration date for all patients vaccinated with ROTATEQ was J010966, 20-MAR-2015 (previously it was reported that also lot# J010140 with expiration date 26-APR-2015 was used). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (Dose/Frequency: Unspecified, Therapy Route: Unspecified). Concomitant medications were unspecified. On an unknown date the patient experienced welt at the injection site after the administration of ZOSTAVAX. The patient sought medical attention by contacting the pharmacist. The pharmacist advised the patient to use ice compresses on the site and to take BENADRYL. The outcome of injection site reaction was reported as resolved in 1 day. The causality was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Convulsion, Death, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: 11/14/2007 - Seizure. Confirmed by EEG. Begun using DEPAKOTE. CBC and LFT's - within nml limits.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Liver function test normal, Nuclear magnetic resonance imaging brain abnormal, Pineal gland cyst
Clinical narrative: 11/14/2007 - Seizure. Confirmed by EEG. Begun using DEPAKOTE. CBC and LFT's - within nml limits.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site dryness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling from shoulder to mid-arm, hot, itchy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness/swelling shoulder to elbow, itchy, hot.
Age: 0.18
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Crying, Dysphonia, Erythema, Pyrexia
Clinical narrative: After yesterday's vaccines patient cried almost non stop for 3-4 hrs. We tried cold compress but did not work. She kept crying a lot. Few times she was crying in a hoarse voice with face becoming very red. After we gave warm water bath she was better and stopped crying. Later she was smiling, cooing etc. She had fever at night and we gave her infant Tylenol and she was fine.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Activated partial thromboplastin time, Bladder catheterisation, Culture stool, Diarrhoea
Clinical narrative: Bloody mucus noted in stool, diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Escherichia test, Full blood count normal, Haematochezia, Liver function test abnormal, Metabolic function test
Clinical narrative: Bloody mucus noted in stool, diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Mucous stools, Occult blood positive, Prothrombin time, Ultrasound abdomen normal, Urine analysis normal
Clinical narrative: Bloody mucus noted in stool, diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: X-ray normal
Clinical narrative: Bloody mucus noted in stool, diarrhea.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with GARDASIL that were stored improperly. No adverse effects reported. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available for the vaccines that were improperly stored: GARDASIL lot # J013324, expiration date: 12-FEB-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 23 year old female patient. In approximately 2004 (reported as over 7 to 10 years ago) the patient was vaccinated with the first and second dose of GARDASIL (lot#, dose and route not reported). According to pharmacist, as per patient's physician (name unspecified) report, the patient had the first two doses as per prescribing information schedule, but office was not able to provide any specific vaccine information, including dates of administration. The pharmacist was asking for alternate dosing schedule for GARDASIL for the patient, who presented at pharmacy asking for third dose of GARDASIL. The patient was not receiving her third dose on 16-MAY-2014, but pharmacist was providing professional information processed in this case to patient's physician (name unspecified), for their use. The patient did not seek medical attention. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date 15-DEC-2014, dose single dose, route SQ for vaccination. On an unknown date in May 2014, patient the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teach was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no Lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from health care worker refers to approximately 2 year old female patient. No information provided regarding concurrent conditions and medical history reported. On 11-JAN-2012 the patient was vaccinated with GARDASIL dose 2 (dosage, route, lot # not reported). Prior to this the patient was vaccinated with GARDASIL on 26-OCT-2011. No concomitant medications reported. The health care professional reported that the patient was at teh office to receive third dose of GARDASIL at the time of the report and no adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no known drug allergies. The patient's pertinent medical history was none. On an unknown date the patient was vaccinated with ZOSTAVAX (Dose/Frequency: Unspecified, Therapy Route: Unspecified). Concomitant medications were none. On an unknown date the patient had flare ups of eczema that come and go. The pharmacist stated that the patient saw an unspecified physician, on an unspecified date who prescribed TOPICORT. The pharmacist reported that they filled TOPICORT around the beginning of April 2014. The pharmacist stated that the patient was in the pharmacy on 29-MAY-2014 asking if ZOSTAVAX was the cause of flare ups of eczema. Lab diagnostics studies performed were none. The outcome of flare ups of eczema was unknown. The relatedness of eczema with ZOSTAVAX was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old female patient. The patient's pertinent medical history reported as irritable bowel syndrome. Drug reactions/allergies were reported as none. On 18-SEP-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular (lot# not reported). It was also reported that patient had also vaccinated with first 2 doses of GARDASIL on an unknown date. No concomitant medications were reported. On 17-MAY-2014, the patient experienced diarrhea, hives and a rash after the third dose of GARDASIL. Nurse reported that the patient never had any side effects after receiving the first 2 doses of GARDASIL. Lab diagnostics studies are not performed. At the time of reporting the diarrhea is still occurring but the rash and hives are getting better and are just behind patient's ears now (date is unspecified of when rash and hives started getting better). It was also reported that patient was using hydrocortisone cream for the rash and hives. The patient was not hospitalized due to experience. The experience was not life threatening. There was not a persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 year old female patient with no pertinent medical history or drug reactions/allergies. In April 2014 (reported as 1 month ago) the patient was vaccinated with the first dose of M-M-R II (dose, route and lot # not reported). There was no concomitant medication reported. The pharmacist reported the patient developed a red rash around her mouth and on her abdomen 7 days after administration of the first dose of M-M-R II 1 month ago. The rash resolved after an unspecified length of time without requiring medical treatment. Two weeks ago, the rash returned. There was no lab diagnostics studies performed. Patient sought medical attention by calling the pharmacy. There was no treatment given. At the time of report, the patient did not recovered from event. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Symptoms started about 1-2 minutes after injection. Dizzy, sweating, passed out while sitting in chair. Pt placed head between legs, cool pack applied to back of neck and cold water to drink given. Informed Dr. lasted for 5 minutes.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot# unknown, 0.5ml) intramuscularly. The reporter reported that PNEUMOVAX 23 were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored PNEUMOVAX 23 were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# unknown, 0.5 ml) intramuscularly. The reporter reported GARDASIL were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored GARDASIL were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA (lot#, 0.5 ml) intramuscularly. The reporter reported that VAQTA were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored VAQTA were administered to an unspecified amount of patients. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot#, 0.5ml) intramuscularly. The reporter reported that RECOMBIVAX HB were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored RECOMBIVAX HB were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (lot# and route unknown, 0.5 ml). The reporter reported that VARIVAX were exposed to 8F for "10 minutes or less" and the improperly stored VARIVAX were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Eye swelling
Clinical narrative: 13 yrs o female was given immunizations on 5/13/14 HAV#2 an HPV#2 at 12:05 pm, she returns to the clinic at 4:35 pm with a report that her eyes got swollen at 1 pm while in school/that day no other symptoms. She was given 1 dose of BENADRYL p.o. and 1 dose of prednisolone as well, She was then discharged home on ATARAX syr. P.O., follow-up 24 hrs after child was well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5 cm red swelling of (L) upper arm with pain and no itching and no warmth.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Patient called today complaining her arm was red, sore, and hard. I told her to contact her doctor and inform him. Doctor called in fluocinonide 0.05% cream.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Aphasia, Dysphagia, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: This 51 y/o male with sudden onset left arm tingling/numbness 5 hours after flu shot. Felt jaw quivering, unable to talk. Was eating and unable to get food out of mouth -> used hard to remove. Awake/alert throughout; lasted approximately 5 minutes. Presented for eval 2 days after episode.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: This 51 y/o male with sudden onset left arm tingling/numbness 5 hours after flu shot. Felt jaw quivering, unable to talk. Was eating and unable to get food out of mouth -> used hard to remove. Awake/alert throughout; lasted approximately 5 minutes. Presented for eval 2 days after episode.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash erythematous, Upper respiratory tract infection
Clinical narrative: Had MMR-V on 5/2/2014 (no other prior immunizations) - a couple days later broke out in a red, raised, pinpoint rash circumferential at base of neck. Approx 1 wk. after rash and immun. had caught URI sx.; on 5/27/14 rash still present. Not spreading - mom stated it had "come and gone" during past few weeks.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Patient, 10 days after vaccines given, developed febrile seizure, and fever for seven days.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site bruising, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swollen bruised bump on right leg with 5 cm diameter of tenderness and induration.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Nausea, Syncope, Vomiting
Clinical narrative: Faint, nausea, vomiting, hypotensive.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site warmth
Clinical narrative: Clinic nurse reports high pitched cry, warmth and redness (R) VL site/s and unconsolable since about 11:30 AM - vaccines given about 9:30 AM - seen at pediatrician's office in afternoon for observation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Paraesthesia, Throat irritation
Clinical narrative: Painful, hot rash at injection site; raspy throat; tingling feeling on skin all over body; patient was prescribed MEDROL dose pak, alprazolam and hydrocodone/APAP for pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling, redness and pain in arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bruise at injection site Left Deltoid Swelling, Redness, and warmth 3-4 inches from injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient came to pharmacy around 2:00 PM on 6/3/2014 to report that she had an adverse reaction from the vaccine. Her arm was bruised red and purple at the injection site. The diameter is about the size of a golf ball and the bruise was not raised. She reported that she had a mild headache, denied having a fever, and stated she had some pain at the injection site. After receiving the vaccine on 6/2/14 very light bleeding was noticed at the injection site. The patient denied using any aspirin or blood thinners since receiving the vaccine and was instructed to follow up with her primary care physician who prescrived the vaccine. Receptionist at her primary care physician's office was notified of the adverse event via telephone at 2:22 PM on 6/3/14.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenopia, Dystonia, Eyelid function disorder, Laboratory test normal, Muscle spasms
Clinical narrative: It first started with my right eye feeling heavy as if it was going to close on its own.  This went on for weeks and progressed down the right side of my face and jaw.  My jaw was completely moving to the right side of my face which made it difficult to talk.  This then progressed to the closure of my right eye and then progressed to the left side of my face. Spasms of my face muscles made it hard to talk and keep my eyes open. About a few months later I got spasms throughout my entire body.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: It first started with my right eye feeling heavy as if it was going to close on its own.  This went on for weeks and progressed down the right side of my face and jaw.  My jaw was completely moving to the right side of my face which made it difficult to talk.  This then progressed to the closure of my right eye and then progressed to the left side of my face. Spasms of my face muscles made it hard to talk and keep my eyes open. About a few months later I got spasms throughout my entire body.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Chills, Flushing, Myalgia, Nausea
Clinical narrative: PT EXPERIENCED "EXTREME MUSCLE AND BONE PAIN, CHILLS, NAUSEA, SLIGHT FEVER/FLUSHING" THAT LASTED FROM EVENING OF VACCINE UNTIL 06/01/2014.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: PT EXPERIENCED "EXTREME MUSCLE AND BONE PAIN, CHILLS, NAUSEA, SLIGHT FEVER/FLUSHING" THAT LASTED FROM EVENING OF VACCINE UNTIL 06/01/2014.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Pt c/o of irritation on left arm at injection site. Upper left arm slightly warm to touch with red raised area approx 1inch in diameter. No c/o itching or difficulty breathing.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Rash maculo-papular
Clinical narrative: Sore throat. Macularpapular rash on abdomen, neck, and back.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Leg became hard at injection site, redness, and hot to the touch.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event, administered Rotarix vaccine at 15 weeks and 4  days; recommendations not after 14 weeks and 6 days.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Pallor, Respiratory rate increased, Sluggishness, Syncope
Clinical narrative: Client fainted and was found laying outside in the parking area. When I was called he was already sitting inside his car. He looked sluggish and pale. A couple of ladies helped him walk to his car. Oxygen via mask was applied and BP was 80/40. Client was talking, pulse was regular at 60 bpm but client was breathing a litte fast. Ambulance arrived shortly and they took over. Client declined to go to hospital. He felt better and his color was back. Mother drove him home.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Bone marrow transplant, Contusion, Pallor
Clinical narrative: Paleness and bruising easily, thrombocytopenia, pancytopenia, severe aplastic anemia.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Pancytopenia, Thrombocytopenia
Clinical narrative: Paleness and bruising easily, thrombocytopenia, pancytopenia, severe aplastic anemia.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5
Symptoms: Allergy test, Barium swallow, Diarrhoea, Food allergy, Fructose intolerance
Clinical narrative: Extreme vomiting, explosive diarrhea. Patient had diarrhea for over a month. Patient now has fructose intolerance and is extremely sensitive to many foods.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5
Symptoms: Ultrasound scan, Vomiting, X-ray, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Extreme vomiting, explosive diarrhea. Patient had diarrhea for over a month. Patient now has fructose intolerance and is extremely sensitive to many foods.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: 12 cm hive and 25 cm erythema lasting 12 days required ice, NSAID's and antihistamines- did not see doctor as I am an MD.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Headache and sick to stomach for 1 day after recieving, swollen at site of injection 1 day later, quarter size redness and warm to touch 2 days later at site of injection, painful when touch site of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Headache and sick to stomach for 1 day after recieving, swollen at site of injection 1 day later, quarter size redness and warm to touch 2 days later at site of injection, painful when touch site of injection.
Age: 18.0
Sex: M
Vaccine: MEN, TD
Symptoms: Dysstasia, Gait disturbance, Heart rate decreased, Pyrexia, Speech disorder
Clinical narrative: Fever, Vomiting, Fainting, Speech Problems, Blurred Vision, Decreased Heart Rate, Trouble Walking and Standing.
Age: 18.0
Sex: M
Vaccine: MEN, TD
Symptoms: Syncope, Vision blurred, Vomiting
Clinical narrative: Fever, Vomiting, Fainting, Speech Problems, Blurred Vision, Decreased Heart Rate, Trouble Walking and Standing.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Breath holding, Crying, Hypotonia, Pallor, Presyncope
Clinical narrative: Child cried after shots, seemed to hold his breath briefly, but then became pale, limp, not responding normally. Stimulation helped a little but it took approximately 1 hour for him to recover. Sats 97% vitals normal. Possible seizure?
Age: 61.0
Sex: M
Vaccine: YF
Symptoms: Computerised tomogram, Contusion, Duodenal obstruction, Endoscopy abnormal, Endoscopy small intestine abnormal
Clinical narrative: Severe vomiting 6 days after vaccination. Groin and testicle bruising. More vomiting on May 9th. Patient did receive Hep A booster the day before symptoms.
Age: 61.0
Sex: M
Vaccine: YF
Symptoms: Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: Severe vomiting 6 days after vaccination. Groin and testicle bruising. More vomiting on May 9th. Patient did receive Hep A booster the day before symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients. On an unknown date the patients may had vaccinated with improperly stored VARIVAX (strength, route, lot number and expiration date not reported). The vaccines were transported in a brown bag. No adverse effects were reported. This is one of two reports from the same reporter (1405USA009182). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients. On an unknown date the patients may had vaccinated with improperly stored M-M-R II (strength, route, lot number and expiration date not reported). The vaccines were transported in a brown bag. No adverse effects were reported. This is one two reports received from the same reporter (1405USA015828). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with asthma who received a dose of PNEUMOVAX 23 "two years ago" (in approximately 2012) received a second dose of PNEUMOVAX 23 on 22-MAY-2014. The patient had a chronic pulmonary condition, and the pharmacist did not know if the patient was on any medication for her asthma. No adverse effect is currently known. The pharmacist did not have the patient's identifying information at the time of this call; he was inquiring about when the plan to revaccinate this patient of behalf of doctor. The outcome of chronic pulmonary condition was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age. The patient's pertinent medical history was not reported. Approximately in May 2013 (reported as a year ago) the patient was vaccinated with ZOSTAVAX. Concomitant medications were not reported. On an unknown date the patient experienced shingles. The outcome of shingles was unknown. The relatedness was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Contusion, Haematoma, Inflammation
Clinical narrative: Contusion hematoma inflammation.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia
Clinical narrative: Patient reports 2 to 4 days after vaccine was administered SQ on his left arm, he started experiencing muscle and nerve pain from left side of hip to down in the legs. As on today, pain is still persisting. Seen by Dr. Is taking FLEXERIL 10mg TID from 5/27. Prescribed MEDROL Dose pack today.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Redness and sever inflammation at the site of the injection appeared within the first 24 hrs. Dr. prescribed CIPRO 500 mg bid x 7 days.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Local swelling
Clinical narrative: My left arm swelling.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Headache, Local swelling, Nausea
Clinical narrative: Pt states on 5/28/14 got a Td vaccine, late at night. Presents general arthralgia, nausea, fever, headache and 1 day after pain, redness, swelling of left arm.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt states on 5/28/14 got a Td vaccine, late at night. Presents general arthralgia, nausea, fever, headache and 1 day after pain, redness, swelling of left arm.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Urticaria
Clinical narrative: 24 hours, (L) leg swollen. Thigh to knee. No acute redness. Facial hives, resolving. No fever.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Pain
Clinical narrative: I was in terrible, excruciating pain the evening of 3/14/2013. I couldn't even move my arm. The pain has continued, despite cortisone injection and physical therapy.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received vaccine in the office on 6/2/14 around 10:30am, patient called the office on 6/3/14 at 1:36pm stating that she was having fevers of 102.0 degrees, arm and neck pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema multiforme
Clinical narrative: 6/13/13 Erythema multiforme x 7 days trunk and extremities. 8/29/13 Erythema multiforme x 7 days trunk and extremities.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Band neutrophil percentage increased, Injection site erythema, Injection site pain, Injection site swelling, White blood cell count increased
Clinical narrative: Pt received PNEUMOVAX 4/9/14. 24 hours after administer developed severe pain at site, redness, swelling. Went to ER - required tx with antibiotic and oral steroid to recover took 10 days to improve.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Feeling cold, Gaze palsy, Hyperhidrosis, Loss of consciousness
Clinical narrative: Case number PHHY2014US046766 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519715) web site on 14 Apr 2014 and with a follow up information received from the quality assurance department (QA reference number: 295589) on 25 May 2014. This report refers to a 24 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13415P, Expiry date: 31 Mar 2014) via intramuscular route on 17 Jan 2014. After vaccination, she was passing out. She was very sweaty and cold and her eyes got rolled over. Emergency service was called, who confirmed a drop in blood pressure. She was recommended to visit a hospital but the patient denied. Later the patient stated that she passes out usually during vaccine and blood draw. The outcome was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the document review, it was stated that the FLUVIRIN vaccine batch number (13415P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 25 May 2014: Batch summary updated.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Eye movement disorder, Feeling cold, Hyperhidrosis, Loss of consciousness
Clinical narrative: Case number PHHY2014US046766 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519715) web site on 14 Apr 2014 and with a follow up information received from the quality assurance department (QA reference number: 295589) on 25 May 2014. This report refers to a 24 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13415P, Expiry date: 31 Mar 2014) via intramuscular route on 17 Jan 2014. After vaccination, she was passing out. She was very sweaty and cold and her eyes got rolled over. Emergency service was called, who confirmed a drop in blood pressure. She was recommended to visit a hospital but the patient denied. Later the patient stated that she passes out usually during vaccine and blood draw. The outcome was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the document review, it was stated that the FLUVIRIN vaccine batch number (13415P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 25 May 2014: Batch summary updated.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Dizziness, Nausea, Pain, Retching
Clinical narrative: Case number PHHY2014US047000 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 519718) web site on 14 Apr 2014 with a follow up report received from the Quality Assurance department (QA reference number: 295588) on 25 May 2014. This report refers to a 40 year old female patient. Her current condition included hypothyroidism, mild and well controlled asthma. Her concomitant medication included SYNTHROID at a dose of 137 mcg, VENTOLIN as per need and daily Multivitamin. She was vaccinated with FLUVIRIN (batch number: 1308301, expiry date: 31 Mar 2014) via intramuscular route into left arm on 22 Oct 2013. On 25 Oct 2013, she experienced the usual achiness which was of no concern. She also experienced significant chest pain, sensations of food being stuck in her throat, gagging with and without food or beverage being consumed, frequent and extreme nausea and dizziness. She was taken to emergency room for medical support. The final outcome of the event was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported. Based on the batch review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 295588) on 25 May 2014: The expiry date and batch review report were updated.