chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Nonspecific reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patient of unknown age and gender. Pertinent medical history and concomitant conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23, vial (SDV, MDV OR ADDITIVE) (EA) 25, (dose and route not reported). Concomitant therapies were unspecified. On an unknown date the patient developed unspecified systemic reaction and also unspecified injection site reaction. Treatment for the adverse event and lab diagnostic tests were unspecified. There was no intervention required to prevent the seriousness criteria. There was no significant disability, no hospitalization and event was not life threatening. The outcome of the events was recovered. The causality was unspecified. No PQC reported. The case has been linked with the cases (same reporter link) # 1407USA003898 and 1407USA004448. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer refers to his cousin, a now 9 year old patient. On an unknown date in the patient's 3 year old, the patient was vaccinated with a dose of MMR II (lot#, expiration date, dose, route, indication not reported). On an unknown date after receiving the MMR II the patient experienced autism. The outcome of the event was unknown. Additional information is not expected due to caller did not wish to provide his demographic information.
Sex: U
Vaccine: PPV
Symptoms: Injection site abscess
Clinical narrative: This spontaneous report was received from a pharmacist referring to one unspecified patient of unknown age and gender. Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23, vial (SDV, MDV OR ADDITIVE) (EA) 25, (dose and route not reported). Concomitant therapies were unspecified. On an unknown date the patient experienced abscess at injection site. Treatment for the adverse event and lab diagnostic tests were unspecified. There was no intervention required to prevent the seriousness criteria. There was no significant disability, no hospitalization and event was not life threatening. The outcome of abscess at injection site was recovered. The causality was unspecified. No PQC reported. The case has been linked with the cases (same reporter link) # 1407USA003898 and 1407USA004450. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a unspecified number of patients of unknown age. Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with PNEUMOVAX 23, vial (SDV, MDV OR ADDITIVE) (EA) 25, subcutaneous for prophylaxis (dose not reported). Concomitant therapies were unspecified. On an unknown date the patients experienced unspecified injection site reaction. Treatment for the adverse event and lab diagnostic tests were unspecified. There was no intervention required to prevent the seriousness criteria. There was no significant disability, no hospitalization and event was not life threatening. The outcome of injection site reaction was recovered. The causality was unspecified. No PQC reported. The case has been linked with the cases (same reporter link) # 1407USA004448 and 1407USA004450. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Dehydration, Diarrhoea, Inflammation, Mucous stools
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 3 months, 12 days old male patient. There were none concurrent conditions or medical history. On 23-MAY-2014, the patient was vaccinated with the first dose of ROTATEQ 2 ml, orally (lot#, expiry date unspecified). None concomitant medications were reported. On 22-JUN-2014, the patient developed diarrhea. The patient was evaluated in an unspecified emergency room on 28-JUN-2014 and was then admitted to an unspecified hospital on 29-JUN-2014 for the treatment of dehydration. The patient was rehydrated and was discharged from the hospital on 30-JUN-2014. The patient was evaluated in the office on 07-JUL-2014 and was found to have "slimy stool without blood". The patient had also developed vomiting and was prescribed PEDIALYTE. On 07-JUL-2014, a stool culture was ordered which revealed "lactoferrin positive", indicating inflammation. Further stool culture results were pending at the time of report. The outcome of events was reported as not recovered/not resolved. The relatedness between all the events and ROTATEQ was not reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 3 months, 12 days old male patient. There were none concurrent conditions or medical history. On 23-MAY-2014, the patient was vaccinated with the first dose of ROTATEQ 2 ml, orally (lot#, expiry date unspecified). None concomitant medications were reported. On 22-JUN-2014, the patient developed diarrhea. The patient was evaluated in an unspecified emergency room on 28-JUN-2014 and was then admitted to an unspecified hospital on 29-JUN-2014 for the treatment of dehydration. The patient was rehydrated and was discharged from the hospital on 30-JUN-2014. The patient was evaluated in the office on 07-JUL-2014 and was found to have "slimy stool without blood". The patient had also developed vomiting and was prescribed PEDIALYTE. On 07-JUL-2014, a stool culture was ordered which revealed "lactoferrin positive", indicating inflammation. Further stool culture results were pending at the time of report. The outcome of events was reported as not recovered/not resolved. The relatedness between all the events and ROTATEQ was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 67 year old female patient with allergy to cortizone (manufacturer unknown) and allergy to PREDNISONE refers to herself. No other pertinent medical history was provided. In approximately 2010 (reported as "about 4 years ago"; also reported as "over three years ago") the patient was vaccinated in pharmacy with a dose of ZOSTAVAX injection in the left arm (dose, route, lot#, expiry date unspecified). Concomitant therapies included benzethonium chloride, diphenhydramine hydrochloride, CALAGEL lotion. On 01-APR-2014 (also reported as "3 weeks ago"), the patient developed shingles: she had severe pain in her back, and about four days later she broke out into the rash. She went to the doctor and the doctor diagnosed her with shingles and she received the treatment (also reported as she did not seek the medical attention). The outcome of shingles was reported as recovered on 13-MAY-2014. The relatedness between event and ZOSTAVAX was not reported. This is one of several reports for the same patient (linked report # 1406USA013901 & # 1406USA013902). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical History was not reported. The reporter informed that an unspecified dates since 22-MAY-2014, the patients received ROTATEQ (lot # J012518, expiration date 24-APR-2015) oral, dosage and strength were not reported. Concomitant therapy was not reported. The reporter stated that from 22-MAY-2014 until 27-MAY-2014 the ROTATEQ was improperly stored at 66 F (the total duration of exposure was 5 days). No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a child patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a 1 dose of GARDASIL injection intramuscularly (dose, lot#, expiry date unspecified). No concomitant medications were reported. The patient's mother was concerned that her child experienced a three day headache after receiving the GARDASIL vaccine (date unspecified). The patient's mother sought medical attention and was enquired if the headache her child was experiencing was from the injection. There was no treatment given. The doctor asked the patient's mother to bring the patient to the office for a follow-up appointment. The outcome of headache was unknown. The relatedness between event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot/batch number, expiration date, dose, route, dose number and indication not provided) that were improperly stored. No adverse effects were reported. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11 year old male patient. On 08-JUL-2014, the patient was vaccinated with an inadvertent dose of ZOSTAVAX (lot#, expiration date, dose, route, strength and indication not reported). The pharmacist also stated that the patient should had received his first dose of (Oka/Merck) VARIVAX (lot#, expiration date, dose, route, strength and indication not reported). No adverse effects was reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count abnormal, Lymphocyte count increased, Monocyte count increased, Rash generalised, Rash vesicular
Clinical narrative: Pt received MMR and varicella vaccines on 6/12/14 on 6/30/14 pt was seen in office for rash all over body x 1 day. Pt had blood drawn and showed positive for varicella and MMR. Pt symptoms lasted 3-4 days and resolved. No treatment. Rash was vesicular lesions and MD determined was active varicella.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rubella antibody positive, Varicella virus test positive
Clinical narrative: Pt received MMR and varicella vaccines on 6/12/14 on 6/30/14 pt was seen in office for rash all over body x 1 day. Pt had blood drawn and showed positive for varicella and MMR. Pt symptoms lasted 3-4 days and resolved. No treatment. Rash was vesicular lesions and MD determined was active varicella.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reported that the patient was administered a second dose of PROQUAD (lot # reported a H015601, 0.5 ml, subcutaneous) after the labeled expiration date(reported as 06-JAN-2014) that had been properly stored on 19-FEB-2014. No adverse events were reported. The outcome was unknown. This was one of the three reports that received from the same reporter (linked with MARRS#1407USA003926 and MARRS#1407USA004510). Lot H015601 is not a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reported that the patient was administered a second dose of PROQUAD (Merck) (lot# reported as H015601, 0.5 ml, subcutaneous) after the labeled expiration date (reported as 06-JAN-2014) that had been properly stored on 30-JAN-2014. No adverse events were reported. The outcome was unknown. This was one of the three reports that received from the same reporter (linked with MARRS#1407USA004509 and MARRS#1407USA004510). Lot H015601 is not a valid lot number for PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reported that the patient was administered a second dose of PROQUAD (Merck) (lot# reported as H015601, 0.5 ml, subcutaneous) after the labeled expiration date (reported as 06-JAN-2014) that had been properly stored on 01-JUL-2014. No adverse events were reported. The outcome was unknown. This was one of the three reports that received from the same reporter (linked with MARRS#1407USA003926 and MARRS#1407USA004509). Lot H015601 is not a valid lot number for PROQUAD (Merck). Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hypophagia, Influenza like illness, Malaise, Nausea
Clinical narrative: Up until the time I went to bed, on July 6, 2014, around 9:00 p.m., I felt perfectly well - all day long and for the past several weeks. I enjoy excellent health. However, on July 6, around 11:30 p.m., I woke up feeling ill, with flu-like symptoms (chills, ague, feverish). Felt sick to my stomach but didn't vomit. Tossed and turned all night long until morning. Felt ill all the rest of the day; took sick leave from work. Couldn't eat any food all day and night (was able to swallow a protein drink). Felt better the next morning (July 7) and went to work, but I still felt queasy. By noon, I felt better but still not hungry. As of this morning, 7/10, I still feel some adverse reaction (a bit queasy; no interest in food), but have managed to get back to a normal work schedule. This illness came out of the blue and was totally unexpected. The only thing I can conclude is that my sickness resulted from the Shingles vaccine I had on the afternoon of July 6. I'm not upset and don't mean to blame anyone for my illness - just an adverse reaction from which I recovered - but thoght I should report it. I was not aware I could get so ill from such a vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Up until the time I went to bed, on July 6, 2014, around 9:00 p.m., I felt perfectly well - all day long and for the past several weeks. I enjoy excellent health. However, on July 6, around 11:30 p.m., I woke up feeling ill, with flu-like symptoms (chills, ague, feverish). Felt sick to my stomach but didn't vomit. Tossed and turned all night long until morning. Felt ill all the rest of the day; took sick leave from work. Couldn't eat any food all day and night (was able to swallow a protein drink). Felt better the next morning (July 7) and went to work, but I still felt queasy. By noon, I felt better but still not hungry. As of this morning, 7/10, I still feel some adverse reaction (a bit queasy; no interest in food), but have managed to get back to a normal work schedule. This illness came out of the blue and was totally unexpected. The only thing I can conclude is that my sickness resulted from the Shingles vaccine I had on the afternoon of July 6. I'm not upset and don't mean to blame anyone for my illness - just an adverse reaction from which I recovered - but thoght I should report it. I was not aware I could get so ill from such a vaccine.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Injection site movement impairment, Injection site swelling
Clinical narrative: The leg where immunization was given was "stiff", he won't bend the knee, and he couldn't walk straight. There's a little swelling noted by grandother. This has persisted for 2 full days.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Skin discolouration, Urticaria
Clinical narrative: Acute annular, polycyclic erythematous wheals with central duskiness on face and extremities that flared and resolved within <24 hours.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Child with fever to 102, varicella like rash on arms and legs consistant with chicken pox.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from an officer manager refers to a now 21 year old female patient. On 13-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot # J013324, expiration date: 12-FEB-2016, dose reported as 0.5, intramuscular). The second dose was requested by the patient. The first dose administered in 2010, date unspecified. After second dose was administered on 13-JUN-2014, patient asked for pregnancy test, which was positive. Gestational date or Late Menstrual Period (LMP) was unknown at that time, as patient had irregular menstrual cycle. The Expected Delivery Date (EDD) was unknown. The pregnancy outcome was not reported. No (other) adverse effects noted by patient. The patient did not seek medical attention. The outcome of irregular menstrual cycle was unknown. The causality of irregular menstrual cycle and GARDASIL was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Rash, Tenderness
Clinical narrative: Patient experienced localized rash, tenderness, calor.
Age: 1.19
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Abasia, Inability to crawl, Mobility decreased, Pyrexia, Tremor
Clinical narrative: Baby could not lift head or extremities; fever 101.2; legs shook in evening; next day still would not walk or crawl; recommend ER visit.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Cough, Crying, Hypersensitivity, Rhinorrhoea
Clinical narrative: Immediate allergic reaction consisting of lots of sneezing, runny nose and mucus, tight coughing, complaining of stomach discomfort and crying
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Secretion discharge, Sneezing
Clinical narrative: Immediate allergic reaction consisting of lots of sneezing, runny nose and mucus, tight coughing, complaining of stomach discomfort and crying
Age: 1.11
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 105.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 2 month old patient. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 5 microgram/0.5 ml, 0.5 ml dose, intramuscular (lot/batch number, exp. date and indication not reported) and with a dose of PEDIARIX (dose, route, lot/batch number, exp. date and indication not reported) on the same day. No adverse effect reported. 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot/batch number, expiration date, dose, route, dose number and indication not provided) that were improperly stored. No adverse effects were reported. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old female patient. On 05-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J014810, .65 ml, subcutaneous, for the prevention of shingles. On 06-JUL-2014, the patient experienced erythema, two inches in diameter, around the injection site, and an injection site that was itchy and sore. No information regarding concomitant medications, concurrent medical conditions, or other pertinent medical history was not provided. Treatment was not given (but it was reported that the patient saw the pharmacist). The outcome of erythema, two inches in diameter, around injection site, and an injection site that was itchy and sore is unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Palpitations, Pyrexia, Vision blurred
Clinical narrative: This spontaneous report was received from a physician refers to a 14 year old female patient. No medical history or concurrent conditions were reported. On 06-JUN-2013, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular route, (lot# H020005; Exp. Date: 08-AUG-2015). No co-suspect or concomitant therapies were reported. On 06-JUN-2013, reported as one hour after she received the first dose, the patient experienced blurred vision, a fever greater than 102 F, lethargy and racing heart. The symptoms lasted 24 hours and then resolved. The patient took ADVIL to control the fever. On 12-SEP-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscular route, (lot # J006850: Exp. Date: 31-MAR-2016). On 12-SEP-2013, reported as one hour after she received the second dose, the patient again experienced blurred vision, a fever greater than 102 F, lethargy and racing heart. The symptoms only lasted a few hours and then resolved. Lab diagnostics studies were not performed. There was no intervention to prevent serious criteria. At the time of the report, the outcome of all events was reported as recovered. The causal relationship between the events and GARDASIL was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Child had vaccine. sibling was also in the room and getting vaccines. Patient hopped off the exam table to let her sister get on the table for her vaccines, and sat in a chair. Shortly after she looked pale and felt dizzy and fainted. Mom was at her side and no fall occurred. B/P 100/54 HR 82, cool packs, water given, eventually placed onto exam table to lay down. Rested and observed for over 30 min. Eventually was able to stand and walk without dizziness. Recommended to go home and rest, no driving.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Paraesthesia
Clinical narrative: Off balance, tingling and numbness of feet, complete numbness from the waist down.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Off balance, tingling and numbness of feet, complete numbness from the waist down.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Injection site reaction, Myalgia, Pyrexia
Clinical narrative: Fever of 103 for 36 hours.  Dizziness, fatigue, muscle pain at site, and muscle pain throughout body.  Slight wheezing of chest throughout 2 nights.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Fever of 103 for 36 hours.  Dizziness, fatigue, muscle pain at site, and muscle pain throughout body.  Slight wheezing of chest throughout 2 nights.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Local swelling, Skin warm
Clinical narrative: 24 hours post vaccine patient's arm started to swell increasingly and felt hot to the touch. She also experienced headache, and felt under the weather. On 7/4/14 went to urgent care and received diphenhydramine and TORADOL, monitored for 3 hours.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was given Dtap injection on 6-23-14 in left leg. Mother called on 6-25-14 stating that pt's left leg at injection site is red and swollen about 3 1/2 inches around site. Denies warmth and fever. 6-26-still red, smaller - recovering.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash generalised
Clinical narrative: Rash all over after getting shingles vaccine, burning sensation.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash
Clinical narrative: Pt developed a rash on her left lower leg approx 30-60 mins after receiving vaccines. Ret. to clinic to have rash checked. Pt given BENADRYL 25mg PO. Rash treated with hydrocortisone cream. Returned to clinic the next day; rash was resolved. Mother reported rash was gone by 10PM the evening before.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Pt developed a rash on her left lower leg approx 30-60 mins after receiving vaccines. Ret. to clinic to have rash checked. Pt given BENADRYL 25mg PO. Rash treated with hydrocortisone cream. Returned to clinic the next day; rash was resolved. Mother reported rash was gone by 10PM the evening before.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling, Urticaria
Clinical narrative: 2 inch in diameter red, swollen welt. Painful to the touch
Age: 39.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Expired drug administered, No adverse event
Clinical narrative: VACCINE ADMINISTERED 6/18 EXPIRED 6/14. NO ADVERSE EFFECTS NOTED
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fungal infection, Injection site rash, Rash, Swelling
Clinical narrative: Pt states rash breakout under breast and site of injection. There's also swelling and redness. Recommend pt to apply cold compress to area and try not to touch area with hand. Pt also states she had yeast infection. Pt will seek medical advice from PCP if symptoms persists.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age who on 09-JUL-2014, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # J003798) that was expired. The vaccine expired on 28-JUN-2014. No symptoms were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a 14 year old male patient. No pertinent medical history and drug allergies reported. On 03-JUL-2014 the patient received his first dose of GARDASIL (valid lot# K004204 expiration date: 12-JAN-2017). On 03-JUL-2014, few minutes after his first dose of GARDASIL the patient fainted. The patient was able to go home with his mother on 03-JUL-2014 (reported as today). Action taken with the suspect product was unknown. The reporter asked for a lot check. On 03-JUL-2014, the patient recovered from the event of fainting. Causality was not reported. The patient sought medical attention (details unknown). No product quality complaint reported. According to the healthcare worker, this is the second fainting of a patient within 6 days in her physician's office. The other syncope is documented in the related cases # 1406USA014097, 1407USA000892 and 1407USA000891. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Eye movement disorder, Febrile convulsion, Loss of consciousness, Tremor
Clinical narrative: Febrile seizure - 105.4 degrees. LOC completed - eyes roll back and shaking x 25-30 sec. at neck with family at incident.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Clonus, Eye movement disorder, Febrile convulsion, Full blood count, Loss of consciousness
Clinical narrative: Febrile seizure - 105.4 degrees. LOC completed - eyes roll back and shaking x 25-30 sec. at neck with family at incident.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Metabolic function test, Streptococcus test, Tremor, Urine analysis
Clinical narrative: Febrile seizure - 105.4 degrees. LOC completed - eyes roll back and shaking x 25-30 sec. at neck with family at incident.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Eye movement disorder, Febrile convulsion, Loss of consciousness, Tremor
Clinical narrative: Febrile seizure occurred while family was at the beach.  Complete loss of consciousness. Eyes rolled back and child started shaking.  Generalized clonic activity. Lasted 25- 30 seconds.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Clonus, Eye movement disorder, Febrile convulsion, Full blood count, Loss of consciousness
Clinical narrative: Febrile seizure occurred while family was at the beach.  Complete loss of consciousness. Eyes rolled back and child started shaking.  Generalized clonic activity. Lasted 25- 30 seconds.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Metabolic function test, Streptococcus test, Tremor, Urine analysis
Clinical narrative: Febrile seizure occurred while family was at the beach.  Complete loss of consciousness. Eyes rolled back and child started shaking.  Generalized clonic activity. Lasted 25- 30 seconds.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Parent reported itchy hives that worsened today, but dx ERYTHEMA MULTIFORME by me
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: FOCAL REACTION WITH SEVERE REDNESS, TENDERNESS AND WARMTH SURROUNDING THE INJECTION SITE L-TRICEP.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Dysphonia, Respiratory tract congestion, Wheezing
Clinical narrative: HOARSENESS, COUGHING, WHEEZING, CONGESTION.
Age: 50.0
Sex: M
Vaccine: MM
Symptoms: Arthralgia, Discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: 14 days post vaccination client had severe leg, hip and buttocks pain resulting in severe discomfort.  Pt reported taking Naproxen and within 24 hours situation resolved.  Pt reports brothers had similar reaction to vaccination.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: upper arm very swollen so that OT could not get her fingers under his short sleeve
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Local swelling, Pain, Pyrexia
Clinical narrative: He stated couple days after administration of vaccine he had pain and fever and had been taking Tylenol. Stated site was sore and redness and swelling around arm and rash. Cold compressor applied to affected arm.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: He stated couple days after administration of vaccine he had pain and fever and had been taking Tylenol. Stated site was sore and redness and swelling around arm and rash. Cold compressor applied to affected arm.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: syncope episode upon injection  - lasted 20-30 seconds
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Muscular weakness
Clinical narrative: Significant arm weakness for two days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Passed out and some seizure like activity after getting the Gardasil vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out 1/2 hr after receiving immunizations.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Pt received vaccine and felt light headed and dizzy immediately after. She kept nodding off. EMS was called and pt was in ER. Received fluids and was discharged.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "50 cent" size swelling, eryhtrema at site. Itching/tender.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with RECOMBIVAX HB (dose and route not provided). The reporter stated an unspecified number of patients may have received doses RECOMBIVAX HB (dose in series unspecified) that were exposed to 25 F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's medical history included headaches and arthritis with none drug reactions and allergies. On 09-DEC-2011 the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, dose schedule, route, lot number and expiration date were not reported). Concomitant therapies included methotrexate (manufacturer unknown) maintenance dose. In approximately June 2014 (reported as approximately three weeks ago) the patient experienced shingles on her forehead area and pain, and the patient stated that she was not immunosuppressed. The reporter stated that the patient consulted an emergency room physician who diagnosed the condition. The patient was prescribed with ACYCLOVIR on 18-JUN-2014. On an unknown date in 2014 the patient consulted her ophthalmologist, who prescribed an unspecified medication (not GABAPENTIN) for the pain that the patient was experiencing during her shingles outbreak. Performed laboratory diagnostic studies were unspecified. The outcome of shingles and pain was reported as recovering. The pharmacist did not believe that the patient was still experiencing fluid-filled vesicles. 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 Certified Medical Assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB (lot #, dose and route not reported) that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected (Reporter refused additional contact).
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of PNEUMOVAX (lot #, dose and route not reported) for prophylaxis that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected (Reporter refused additional contact).
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 06-JUL-2014 the patient was vaccinated with improperly stored MMRII, 0.5 ml, subcutaneous (lot number and expiration date not reported). The vaccine was exposed to 49F for 20 minutes. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, VAQTA was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients for prophylaxis (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored PNEUMOVAX 23 (MARRS # 1407USA002446) and GARDASIL (MARRS # 1407USA005269). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant via a representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# unknown, strength, dosage, route unknown) as directed for prevention of shingles. The patient developed a terrible case of shingles after vaccination with ZOSTAVAX. The patient contacted the practitioner for seeking medical attention. The outcome of the event was reported as not recovered. The causality between the event of ZOSTAVAX was not provided. 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 an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with VAQTA (dose and route not provided). The reporter stated an unspecified number of patients may have received doses of VAQTA (dose in series unspecified) that were exposed to 25 F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with GARDASIL (dose and route not provided). The reporter stated an unspecified number of patients may have received doses of GARDASIL (dose in series unspecified) that were exposed to 25 degrees F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified Medical Assistant refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with LIQUID PEDVAXHIB (lot #, dose and route not reported) that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected (Reporter refused additional contact).
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, PNEUMOVAX 23 was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored GARDASIL (MARRS # 1407USA005269) and VAQTA (MARRS # 1407USA05270). Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, redness/cellulitis, warmth still worsening, 5 days post injection burning sensation.
Age: 25.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Hyperhidrosis, Pallor, Respiratory rate increased
Clinical narrative: Pt was sweating and turned pale after I administered TYPHIM. He was breathing heavily. He refused to go to ER.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm swollen, red, warm to touch.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's wife called 7/10/14 4:28 to notify us that her husband has a warm, puffy redness around the injection site. It does not itch or hurt. He has not treated the area (nor did he inform his wife about it). It started day of immunization. I notified primary care physician for follow-up with pt.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Erythema, Local swelling
Clinical narrative: 1 day after vaccines, patient had very large area of redness and swelling extending from shoulder to elbow and onto upper chest. Also low grade temp (100).
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Erythema, Pain
Clinical narrative: Pt received PNEUMOVAX in (R) deltoid on 7/1. Developed redness at shoulder to mid upper arm. C/o pain/weakness for 3 days. Improved by Monday 7/7. Redness almost completely gone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Area where she received vaccination was raised, hot, hard and she had headache.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, GARDASIL was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored PNEUMOVAX 23 (MARRS # 1407USA002446) and VAQTA (MARRS # 1407USA005270). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TDAP
Symptoms: Hypoaesthesia, Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: 50yo female with known history of DTH to neomycin ear drops, developed bilateral UE (L>R) erythematous/pustules exanthem within 24 hours of TWINRIX #1 (Left arm) and Tdap (right arm). Left arm also associated with significant swelling and tenderness. No systemic symptoms. No generalized urticaria, lip swelling, throat tightness or any airway or vascular compromise. Symptoms slowly resolved over the course of days. Medical attention was sought approximately 6 days later and started on topical steroids with significant clinical improvement.
Age: 50.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TDAP
Symptoms: Erythema, Rash, Rash pustular, Swelling, Tenderness
Clinical narrative: 50yo female with known history of DTH to neomycin ear drops, developed bilateral UE (L>R) erythematous/pustules exanthem within 24 hours of TWINRIX #1 (Left arm) and Tdap (right arm). Left arm also associated with significant swelling and tenderness. No systemic symptoms. No generalized urticaria, lip swelling, throat tightness or any airway or vascular compromise. Symptoms slowly resolved over the course of days. Medical attention was sought approximately 6 days later and started on topical steroids with significant clinical improvement.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Large raised, swollen are at injection site - appx size of 50-cent piece.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness at site of injection with sharp pain.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a field employee regarding a female patient of "around 50 years of age". No information about medical history, drug reactions and allergies was specified. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported) vial 19400 plaque forming unit (PFU). No concomitant medications were reported. The field employee reported that the pharmacist reported to her that the patient developed rash, redness, and swelling after ZOSTAVAX was administered. The patient sought medical attention with the pharmacist. There was no product quality complaint. VZVIP pack was faxed to pharmacist. Field employee reports that the pharmacist reported to her the patient has recovered from the above adverse events at an unspecified date. The causality of the event was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. In 2002, the patient was vaccinated with the first dose of VARIVAX (Merck) (injection, 0.5ml, lot# was unknown) subcutaneously. In March 2013, the patient was vaccinated with the second dose of VARIVAX (Merck). In May 2014, the patient was inadvertently vaccinated with the third dose of VARIVAX (Merck). No symptoms reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a 1 year old patient of unknown gender. There was no information on patient's medical history and drug reactions or allergies. On 09-JUL-2014, the patient was vaccinated with M-M-R II first dose (dose .5ml (millilitre). The concomitant medications was unknown. The patient had received an expired dose of M-M-R II and no adverse effects was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product label confusion
Clinical narrative: This spontaneous report as received from a nurse who at the physician's office via a company representative, stated that they would no longer order VAQTA pediatric doses, (Lot# unspecified) dose, frequency and route unspecified, because this vaccine's caps were the same color as SANOFI's flu vaccines, and the physician's office stated they were afraid of mixing the products up. No adverse effects occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: DIZZY, NAUSEA, FAINTING, VISION BLACKED OUT. LAID DOWN TO REST.
Age: 1.11
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Welt at site of injection with some redness.  Resolved within a few hours without any treatment.
Age: 1.11
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site induration, Injection site pustule, Injection site swelling
Clinical narrative: Welt at site of injection with some redness.  Resolved within a few hours without any treatment.