chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain, Swelling, Upper extremity mass
Clinical narrative: Redness, soreness, swelling reported 10/6/14 - applied ice - as day progressed extreme swelling down to elbow area and lump in arm by 9 pm 10/16/14. Went to ER for steroid/antibiotic treatment.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: (10/6/14) Monday - swollen, red circle around it, itchy, burning. Low grade fever for a few days. Monday -> Friday it got smaller then gone by Saturday (10/11/14).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pruritus generalised, Pruritus genital
Clinical narrative: Pt. said entire body was itchy including eyeballs and between toes and private area. Took 2 BENADRYL pt took 2 caps at bedtime and has been better ever since.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Dysstasia, Vomiting
Clinical narrative: 10/16/14 at 13:25 - Patient received influenza vaccine. 10/16/14 at 16:30 - Dizziness, unable to stand or walk. 10/16/14 at 18:30 - Vomited x 1. 10/16/14 at 20:00 - Symptoms resolved without intervention. 10/21/14 at 14:45 - Adverse reaction reported to provider.
Age: 1.92
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Influenza live-intranasal given to 23 month old.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: (L) deltoid area shot given. Pain and limited range of motion 1 month later.
Age: 1.66
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Febrile siezure 20 hours after immunization; seen in ER; follow-up in PCP office.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Chest and arm rash, itchy skin, and sl SOB about 30 min after vaccine admin. No improvement and worsening SOB, w/o resp distress, 30 min after BENADRYL 25 mg at 12:25 pm. Epi 0.3 mg via Epi pen at 12:55 and transferred to ED. NKA.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: 2 cm diameter red, macular area (R) anterior thigh 5 days post injection of MMR/V - lasting > 4 days.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, induration and itch at site of injection (4 x 4 cm).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node in rt. axilla became swollen and tender.
Age: 0.76
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Rash
Clinical narrative: Child developed rash 1 day after influenza vaccine. Rash spread seen at ER. 10/12/14 diagnosed erythema multiforme : possible secondary to influenza vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder hurts and I can't move or lift my arm without pain.
Age: 61.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Family of four came in for flu vaccines. Gave FLUMIST to all four. The adult was over 49 yrs. old and ineligible for FLUMIST- phone call to client was made notifying of error - no adverse reports. E-mail to CDC who replied to count as valid dose.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: Immediately after withdrawing needle, patient's arm bled and formed a small bubble or whelp at injection site. Patient complained of soreness at site and tingling sensation. After patient took ADVIL, the small whelp seemed to actually decrease slightly in size. Patient was feeling ok when she left pharmacy. After calling her the next day, patient reported that she had a black/blue bruise at injection site, but otherwise was feeling ok. I also reported the side effect to her personal physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles, Paraesthesia, Urticaria
Clinical narrative: Immediately after withdrawing needle, patient's arm bled and formed a small bubble or whelp at injection site. Patient complained of soreness at site and tingling sensation. After patient took ADVIL, the small whelp seemed to actually decrease slightly in size. Patient was feeling ok when she left pharmacy. After calling her the next day, patient reported that she had a black/blue bruise at injection site, but otherwise was feeling ok. I also reported the side effect to her personal physician.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Mom called our office the day after pt received Flu vaccination 10/17/14 pt developed the following sx: pt arm was swollen from shoulder to hand. Arm felt warm/hard per mom. Pt developed hives all over her face; etc.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dehydration, Dysphagia, Hypoaesthesia oral, Nausea
Clinical narrative: Chills, nausea, vomiting -> dehydration, numbing around lips, trouble swallowing, tightness and redness of throat.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal erythema, Throat tightness, Vomiting
Clinical narrative: Chills, nausea, vomiting -> dehydration, numbing around lips, trouble swallowing, tightness and redness of throat.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness, Pain
Clinical narrative: Five days after flu adm, employee had inc. swelling, tenderness, and warmth at inj site. C/o of itching during the night. Painful to touch. Unequal hand grasps w/(L) hand weakness noted. No ecchymosis noted.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Five days after flu adm, employee had inc. swelling, tenderness, and warmth at inj site. C/o of itching during the night. Painful to touch. Unequal hand grasps w/(L) hand weakness noted. No ecchymosis noted.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Erythema, Headache, Local swelling, Nausea
Clinical narrative: Large local swelling and redness, headache, nausea, chills, fever.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: Large local swelling and redness, headache, nausea, chills, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patients arm unaffected where injection was given but at least 8 inches below this the patient developed cellulitis. Treatment with prednisone and doxycycline. Cellulitis of left arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: Pt. developed soreness at injection site following day. Said the pain continued. He is experiencing needle like pain in whole arm. Can not lift right arm as much as he can do on left arm. Fingers show weakness.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Injection site rash, Rash
Clinical narrative: Rash left thigh documented 10/21/14. Rash started about week ago with 2 blisters and now radiating lt buttock cheek, groin and back.
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no allergy or drug reactions. On 29-SEP-2014 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (lot # and expiration date not reported). On the same date (29-SEP-2014) within 30 minutes the patient began to experience  mild throat tightness and lip tingling which resolved within 30 minutes. No treatment was given. The patient did not seek medical attention. The outcome of mild throat tightness and lip tingling was reported as recovered/resolved on 29-SEP-2014. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain entire upper left arm. Given diphenhydramine and Tylenol.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-OCT-2014, the patient was vaccinated with ROTATEQ oral (dose, strength, lot number and expiration date were not reported). Physician reported that on 15-OCT-2014 a patient was administered ROTATEQ which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On approximately April 2013 (reported as about 18 months ago), the patient was vaccinated with ZOSTAVAX, first dose, 0.65 ml subcutaneous, (lot number reported). On 13-OCT-2014, the patient was a accidentally vaccinated with a second dose of ZOSTAVAX, 0.65  ml subcutaneous. Concomitant medication was not reported. The patient should have received an unspecified flu vaccine and not ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 71 year old patient of unknown gender. No pertinent medical history of drug reactions/allergies were provided. On 20-OCT-2014, the patient was vaccinated with (Oka/Merck) VARIVAX INJ, subcutaneous (dose and lot number not provided). The nurse reported that the patient received (Oka/Merck) VARIVAX outside of the recommended age range. No adverse effects were 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 health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in approximately September 2014, (reported as within the past week and half), the patients were vaccinated with improperly stored GARDASIL (route, dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of M-M-R II (HSA) which were improperly stored. No adverse effects were reported. This report is linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA009959 and 1410USA004588. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Lip swelling, Rash erythematous
Clinical narrative: this spontaneous report was received from a 68 year old female patient reporting on herself. Patient with allergy to tetracycline, penicillin and bixin.  On 18-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date not reported) subcutaneous injection. Concomitant therapies included omeprazole (manufacturer unknown), GLUCOTROL, raloxifene, and AVISTATIN. On 19-OCT-2014 the patient experienced red hot rash and swelling around the injection area of her ZOSTAVAX. Patient also reported that she experienced swelling of her lips. The patient sought for unspecified medical attention and was treated with loratadine (manufacturer unknown) and betamethasone (manufacturer unknown). Unspecified lab diagnostics studies were performed (results not provided). The outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 16-OCT-2014 the patient was vaccinated with expired dose of ZOSTAVAX (strength was reported as 19400 PFU), expiry date: 28-SEP-2014, lot number, route of administration, dose, anatomical location was unknown). No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female non-pregnant patient with hypercholesterolemia and thyroid (unspecified disorder). On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX23, 25/0.5 Y, injection (lot # K010522; Exp. Date: 25-FEB-2016) in the arm as routine administration (dose, route, and dose number not provided). Concomitant therapies included CRESTOR, levothyroxine sodium (manufacturer unknown) and PREMARIN.  On 15-OCT-2014, the patient experienced red, swelling and painful rash at and around the injection site after received with PNEUMOVAX23. Patient experienced bulbous swelling and nodule type thing that was a big hard lump described as the size of a tennis ball or racquetball at the injection site and going up to the shoulder. No treatment was given for the event. Labs diagnostics studies were not performed. The patient sought medical attention.  At the time of the report, the outcome of the events was unknown. The casual relationship between PNEUMOVAX23 and the events was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female non-pregnant patient with hypercholesterolemia and thyroid (unspecified disorder). On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX23, 25/0.5 Y, injection (lot # K010522; Exp. Date: 25-FEB-2016) in the arm as routine administration (dose, route, and dose number not provided). Concomitant therapies included CRESTOR, levothyroxine sodium (manufacturer unknown) and PREMARIN.  On 15-OCT-2014, the patient experienced red, swelling and painful rash at and around the injection site after received with PNEUMOVAX23. Patient experienced bulbous swelling and nodule type thing that was a big hard lump described as the size of a tennis ball or racquetball at the injection site and going up to the shoulder. No treatment was given for the event. Labs diagnostics studies were not performed. The patient sought medical attention.  At the time of the report, the outcome of the events was unknown. The casual relationship between PNEUMOVAX23 and the events was unknown. Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to 14 month old.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash pruritic
Clinical narrative: 5 days later patient experienced florid red blisters, rash on groin, thighs, to hips, below to knees, bilaterally, redness, very itchy rash. Used cortisone cream, took antihistamine, cleared in less than 12 hours. No S.O.B. No pain. No reaction at the injection site.
Age: 15.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to 15 year old.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a 65 year old male patient. Pertinent medical history, drug reactions or allergies were unspecified. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX23  (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 08-OCT-2014 (also reported as later that day), the patient experienced significant pain and swelling at the injection site. On 05-OCT-2014 (also reported as the next day), the patient went to reporter's office and the physician's assistant stated that the swelling was raised about 5" in diameter and was uncomfortable to the touch for the patient. The patient was prescribed with BENADRYL and instructed to apply an ice pack. The reporter stated that she thought the swelling  would resolve itself and expected the patients to recover. None laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Started sore at injection site progressed to red and warmth about 4-5 inches from injection site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of GARDASIL which were improperly stored. No adverse effects were reported. This report is linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA009959 and 1410USA009960. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of RECOMBIVAXHB which were improperly stored. No adverse effects were reported.  This report linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA004588 and 1410USA009960. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial swelling 3" by 6" (per patient) within hrs after receiving vaccine. When seen in office localized Rx 2" by 2 1/2" - red, warm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-OCT-2014 the patient was vaccinated with an improperly stored ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effect were reported. Additional information is not expected because the reporter refused to be contacted for follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. Concurrent condition includes allergy to an unknown medication. No relevant medical history reported. On 14-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K007987, 0.65 ml, subcutaneously. No concomitant therapies were reported. On 15-OCT-2014, the patient experienced injection site reaction consisting of arm pain, swelling and bright redness 4 to 5 inches. The patient received treatment with BENADRYL which made the events slightly better. The patient did not have any other symptom. The pharmacist stated that the patient was on other medications but declined to provide them since they were not related to the reaction. The outcome of injection site reaction consisting of ram pain, swelling and bright redness was reported as not recovered (as of 18-OCT-2014). The causality for injection site reaction was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of RECOMBIVAX HB (start date, dosage, route and lot # not reported), nine months after the first dose of RECOMBIVAX HB). No adverse effects were reported. 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 Registered Nurse refers to 2 patients of unknown demographics. The patient's medical history and current conditions were not reported. On 24-SEP-2014 the 2 patients were inadvertently administered improperly stored RECOMBIVAX HB injection 10Y (strength, dose and frequency not reported) (lot # and expiry date not reported. No adverse effects reported. Product quality complaint was not involved.  This is one of several reports received from the same source.  Follow up information has been received from the Registered Nurse refers to a 1 day old patient (previously reported as 2 patients). On 24-SEP-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K006682, expiry date 17-DEC-2015). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of ZOSTAVAX which were improperly stored. No adverse effects were reported. The report is linked to MARRS1410USA009955, 1410USA004588, 1410USA009957, 1410USA009958, 1410USA009959 and 1410USA009960.  Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot# was not reported) and RECOMBIVAX HB (lot# was not reported). The reporter reported GARDASIL and RECOMBIVAX HB were improperly stored. No adverse events were reported. This is one of the reports 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 was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and genders not reported) were vaccinated a dose of with (Oka/Merck) VARIVAX which were improperly stored. No adverse effects were reported. This report is linked to MARRS1410USA004588, 1410USA009956, 1410USA009957, 1410USA00958, 1410USA009959 and 1410USA009960. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Leukocytosis, Pyrexia
Clinical narrative: Fever; Leukocytosis; inoculation of arm R deltoid.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old female patient. On 21-JUL-2014 at 6:00 PM the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # J012773 with expiry date 09-OCT-2015, subcutaneous in the left arm. On the same day at 6:00 PM, the concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) DTap, poliovirus vaccine inactivated (unspecified) (IPV) and M-M-R II, VARIVAX was improperly stored. No adverse symptoms reported. Thi sis one of four reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of (Merck) PROQUAD which were improperly stored. No adverse effects were reported. This report is linked to MARRS 1410USA009955, 1410USA009956, 1410USA004588, 1410USA009958, 1410USA009959 and 1410USA009960. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site nodule, Rash
Clinical narrative: This spontaneous report was received from a physician via field representative, refers to a 12 month old patient. On an unknown date the patient was vaccinated with M-M-R II (lot # J014875 and expiration date was 21-NOV-2015) subcutaneous . Concomitant therapies included (Oka/Merck) VARIVAX, PREVAR, hib conj vaccine (unspecified carrier) (manufacturer unknown) and influenza virus vaccine (manufacturer unknown). On 10-OCT-2014 the patient experienced node at the injection site "MMR-like" rash over the back and trunk area (not specified if the patiens rash resembled measles, mumps, or rubella specifically). Patient sought medical attention by visiting doctor. No Produce Quality Complaint (PQC) was involved. The outcome of events was reported as not recovered/not resolved. Causality was not provided by the reporter.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H014029, expiry date: 07-SEP-2014, dose, units, route of administration, anatomical location were not reported). The reporter stated that the dose of RECOMBIVAX HB had never been exposed to a temperature out of the recommended storage range. No adverse effects reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a administrator refers to a 34 year old female patient with no medical history and no drug reactions/allergies. On 17-OCT-2014 the patient was inadvertently vaccinated with a dose of GARDASIL (lot # K001500, expiration date: 06-NOV-2016), 0.5 ml, intramuscular. Concomitant therapies included unspecified prenatal vitamin. The patient was in 36 gestation week at the time of vaccination. Approximated date for last menstrual period (LMP) was 07-FEB-2014 and estimated delivery date (EDD) was 14-NOV-2014, pregnancy outcome pending. There was no treatment given for adverse event. No lab diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a administrator refers to a 34 year old female patient with no medical history and no drug reactions/allergies. On 17-OCT-2014 the patient was inadvertently vaccinated with a dose of GARDASIL (lot # K001500, expiration date: 06-NOV-2016), 0.5 ml, intramuscular. Concomitant therapies included unspecified prenatal vitamin. The patient was in 36 gestation week at the time of vaccination. Approximated date for last menstrual period (LMP) was 07-FEB-2014 and estimated delivery date (EDD) was 14-NOV-2014, pregnancy outcome pending. There was no treatment given for adverse event. No lab diagnostics studies were performed. The patient did not seek medical attention. 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 certified medical assistant refers to a patient of unknown age and gender. On 17-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports 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 certified medical assistant refers to a patient of unknown age and gender. On 16-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports 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 certified medical assistant refers to a patient of unknown age and gender. On 25-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions and allergies. On 31-JUL-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported) lot # K002912, expiry date 26-FEB-2016 for routine administration. Concomitant therapies included prenatal vitamins. The patient did not know that she was pregnant and she received (Merck) VARIVAX. Nurse reported that the patient was 10 weeks and 6 days pregnant (Merck) VARIVAX was in the first trimester. The patient became pregnant with Last Menstrual Period date (LMP) of approximately 16-MAY-2014 (calculated by subtracting 10 weeks and 6 days from 31-JUL-2014) and Estimated Delivery Date (EDD) of approximately 20-FEB-2015 (calculated by adding 40 weeks to 16-MAY-2014). There was no treatment given for the event. The pregnancy outcome was outcome pending. The fetus outcome was unknown. It was also reported that at the time of the report, the patient was 21 weeks and 2 days pregnant (LMP also estimated 17-MAY-2014, EDD estimated to 21-FEB-2105). Diagnostic studies included ultrasound scan for pregnancy and routine prenatal tests (dates and results not specified). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patients of unknown age. On an unkonwn date the patient was vaccinated with PEDVAXHIB (lot# was not reported). The reporter reported PEDVAXHIB was improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female (non pregnant) patient with no drug reactions or allergies. The patient's concurrent condition included diabetes. On 25-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administration at dose 0.65 ml subcutaneously (lot # K003604 with expiry date: 20-MAR-2015). Concomitant therapies included an unspecified insulin, NEXIUM. hydrochlorothiazide (manufacturer unspecified), ramipril (reported as "ramopril"), verapamil (reported as "verapimil") and CRESTOR. The pharmacist stated that the patient was also taking amoxicillin as treatment at the time of injection but not to treat injection site reaction. Reason for amoxicillin treatment was unspecified. On 26-AUG-2014, after receiving the vaccine, the patient had swelling at the injection site "about the size of a baseball" with redness. The patient did not seek medical attention. The outcome of the events was reported as recovered approximately on 02-SEP-2014 (reported as "about a week later"), without treatment. No laboratory test were performed. The relatedness between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to two patients of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # was not reported). The reporter reported PNEUMOVAX 23 was improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old male patient. On 21-JUL-2014 at 06:30 PM the patient was vaccinated with the first dose of VARIVAX (Merck) lot # J012773 expiry date 09-OCT-2015, subcutaneous in the left arm. On 21-JUL-2014 at 06:30 PM, concomitant vaccines included M-M-R II and PREVNAR. VARIVAX (Merck) was improperly stored. No adverse symptoms reported. This is one of four reports received from the same reporter. Additional information is not expected.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist who is also patient's mother refers to her 16 month old son. The patient's medical history and current conditions were not reported. On 08-SEP-2014 the patient was vaccinated with (Merck) VARIVAX, of dose 0.5 ml (lot # and expiration date were not provided). Other co-suspects and concomitant medication were not reported. It was reported that the patient experienced rash, after receiving (Merck) VARIVAX. The rash began with a few spots, on 10-OCT-2014, and progressed to a total body rash. Patient also experienced a fever (unknown degrees) on 11-10-2014. Fever resolved on 14-10-2014. Cancer and overdose was not reported. The outcome of the event total body rash is unknown and the event fever is recovered. The relatedness between the events and the therapy with (Merck) VARIVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Medical history and concurrent conditions were not reported. On 21-JUL-2014 at 5:00 pm the patient was vaccinated with the second dose of (Merck) VARIVAX (lot# J012973, expiration date 15-OCT-2015, subcutaneous in the left arm). The vaccine was improperly stored. No adverse symptoms reported. This is one of four reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-OCT-2014 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # J005661, expiry date: 26-SEP-2014, dose, units, route of administration, anatomical location were not reported). It was not clear if this was the patient's first dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during breast feeding
Clinical narrative: This spontaneous report was received from a pharmacist via another company refers to a female patient of unknown age. On an unknown date approximately in October 2014 (also reported as last week) the patient was vaccinated with MMR II via unknown route (dose and frequency was not reported. It was reported that the patient was breastfeeding at the time she received MMR II last week. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Grip strength decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 67 year old male patient refers to his own experiences. The patient had drug reactions or allergies to unspecified oral steroids, NORVASC, felodipine, TEKTURNA. The patient's medical history included flu-like symptoms and an incident where he broke two of his teeth. The patient concurrent conditions included the pain from breaking his teeth which was "far to great to notice other symptoms from the vaccination". On an unknown date in the end of October 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). Concomitant therapies included TOPROL XL, aspirin, doxazosin mesylate, lisinopril (manufacturer unknown) ZOCOR and unspecified antibiotics. On an unknown date in 2013 reported as "about 2 weeks after vaccination" the patient experienced joint pains and body aches. His aches were in knees, knuckles, fingers and hips. He explained that his knuckles ached "really badly" and complained that he experienced severe pain in his knees when he banded. Moreover he experienced (unknown date in 2013) "spiked blood pressure" as well and his blood pressure was high at "200 over 100" (units not provided) when he last visited physician. The patient mentioned also that on approximately 16-OCT-2014 (reported as "this morning") when he woke up he was not able to clinch his fist. The patient reported that the pains occurred all of the time (outcome: not recovered) and he could not take medications to help his pain due to other concurrent drugs. Therefore there was no treatment given for the events. On unknown date blood work was performed but the result was not provided. The patient sought medical attention and visited a doctor. The outcome of blood pressure was high at "200 over 100" and was not able to clinch his fist was unknown. The outcomes of aches in his knees, knuckles, fingers and hips were reported as not recovered. Relatedness between all events and ZOSTAVAX was not specified. 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 an other health professional (Registered Nurse) refers to patients of unknown age and demographics. Current conditions and medical history was not reported. On 07-OCT-2014, the patient was vaccinated with VARIVAX (Merck) injection, subcutaneous (dose and frequency was not reported). Concomitant medications were not reported. It was reported that doses of improperly stored VARIVAX (Merck) was administered to unspecified patients on 07-OCT-2014. This was supported. No adverse effects reported. Product quality complaint was not reported. This case is linked to 1410USA005725 (same reporter). Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, sore arm at injection site, red, raised swollen arm at injection site.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 years old female patient. No information about medical history, concurrent conditions was reported. The patient was not pregnant. On 01-OCT-2014 the patient was vaccinated with RECOMIVAX HB first dose and on 07-OCT-2014 with second dose (lot #, dose, route not specified for both doses). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. The outcome is unknown. 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 certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 12-OCT-2014 the patient was vaccinated with improperly stored ZOSTAVAX (lot number unknown), which exposed to 15 F for six hours, 0.65 ml, subcutaneous. No adverse effects were reported. The outcome was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 month old patient of unknown gender. On 13-OCT-2014 the patient was inadvertently vaccinated with the second dose of VAQTA (route and lot number not reported) 1 ml, adult dose. The patient was due to receive dose 2 of pediatric VAQTA on 13-OCT-2014. No symptoms were reported. 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 certified medical assistant refers to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports 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 certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported0 which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports 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 certified medical assistant refers to a patient of unkonwn age and gender. On 18-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiry date: August 2014, dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unspecified date in 2014 the patient was vaccinated with GARDASIL lot number, expiration date and dose not provided. On an unkonwn date in 2014, reported as two weeks later, the patient found out she was pregnant. The gestation age was reported as 7 weeks on 23-SEP-2014. Last Menstrual Period (LMP) was estimated as of 05-AUG-2014 (by subtracting the Gestational Age from the date of this report). Due Date was estimate das 12-MAY-2015. The patient was exposed to GARDASIL during the first trimester of pregnancy. The pregnancy outcome was pending. No adverse effects were reported. No further adverse event information was provided. Additional information is not expected, because the patient did not wish to provide specific information and contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received regarding a case in litigation for ZOSTAVAX (case # 1407USA011162) from a lawyer regarding an unspecified number of patients (demographics not provided). On unknown dates, "people of all ages ranging from 20 to 60 years old" were vaccinated with ZOSTAVAX (dosage and route of administration not provided). The outcome of the event was not provided. Additional information is not expected.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient in his 60's (years of age, exact age were unknown). The patient's medical history, concurrent conditions, drug reactions and allergies were unknown. On an unspecified date, approximately in April 2013 (reported as "approximately 18 months ago"), the patient received ZOSTAVAX dose, frequency, therapy route, lot # and expiration date were not reported. Concomitant medications were not reported. On an unspecified date, in October 2014 (reported as "last week"), the patient developed unspecified shingles symptoms. The patient sought medical attention and he was treated with acyclovir and prednisone. At the time of the report the patient did not recover from adverse event. The relatedness between vaccination with ZOSTAVAX and the event was not reported. 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 healthcare worker and certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 33 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 03-APR-2013 the patient was vaccinated with VARIVAX (Merck) (dose 1). The nurse reported that on 14-AUG-2014 the pregnant patient was vaccinated with VARIVAX (dose 2, subcutaneous, dosage 0.5 ml and lot number K002048, expiration date 10-FEB-2016). Concomitant medications included iron (unspecified), minerals (unspecified), vitamins (unspecified) (also reported as prenatal vitamins). No adverse effect reported. The nurse reported that for gestation or LMP, it was noted that on 17-JUL-2014 the patient had an intrauterine pregnancy of 3 months gestation with approximately calculated date of last menstrual period (LMP) 29-APR-2014 and Estimated date of delivery (EDD) of 03-FEB-2015. Initial exposure to VARIVAX (Merck) was at 15 week(s) of pregnancy. The pregnancy outcome was outcome pending and the fetal outcome is unknown. The outcome of the events reported was unknown. No product quality complaint was involved. Additional information has been requested.