chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site swelling, Joint stiffness, Myalgia
Clinical narrative: Injection site swelling and severe pain began at 3:00 PM 07/01/14. At 1:00 AM 07/02/14 nausea, fever, chills, shaking, muscle pain, joint stiffness and severe headache began. All symptoms lasting in intensity until 10:00 PM 07/02/14. Symptoms still present in less severity 07/03/14.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Injection site swelling and severe pain began at 3:00 PM 07/01/14. At 1:00 AM 07/02/14 nausea, fever, chills, shaking, muscle pain, joint stiffness and severe headache began. All symptoms lasting in intensity until 10:00 PM 07/02/14. Symptoms still present in less severity 07/03/14.
Sex: U
Vaccine: MMR
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This spontaneous report as received from the patients mother, concerning her child of unknown age and gender. On an unknown date the patient ws vaccinated with a dose of M-M-R II (lot E, dose, and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serious side effects after receiving M-M-R II. The patient had severe hives and shortness of breath. On an unknown date the patient had to be taken to the emergency room (ER). The outcome of severe hives and shortness of breath was unknown.  This is one of several reports received from the same reporter: MARRS 1407USSA000434 and 1407USA000509. Additional formation is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 2 year old male patient. Patient had no previous medical history. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX injection (dose number, dose unit, route, lot # and expiry date unknown). No concomitant medications were reported. ON an unknown date the patient experienced mild to moderate chicken pox under the fee, on the ands and truck of his body after received (Oka/Merck) VARIVAX. On an unknown date, patient visited office for medical attention. On an unknown date patient recovered from the event. The outcome of mild to moderate chicken pox under the feet, on the hands and trunk of his body was reported as recovered/resolved. The reporter did not provide the causality of (Oka/Merck) VARIVAX. to mild to moderate chicken pox under the fee, on the hands and truck of his body. No further AE information provided.  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 nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, patients were vaccinated with (Oka/Merck) VARIVAX, 05. ml, once, subcutaneous (lot number was not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received (Oka/Merck) VARIVAX (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 30-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 weeks old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (lot # J016185, expiry date: 02-OCT-2016, dose and route of administration were not reported) that was exposed to temperatures our of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning of 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects were reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: Redness around site of injection around 1 inch diameter. Pustule at site of needle entry aprrox. 3/8 inches in diameter.
Sex: U
Vaccine: MMR
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This spontaneous report as received from the patient's mother, concerning her child of unknown age and gender. On an unknown date the patient ws vaccinated with a dose of M-M-R II (lot #, dose, and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serious side effects after receiving M-M-R II. The patient had severe hives and shortness of breath. The outcome of severe hives and shortness of breath was unknown. This is one of several reports received from the same reporter: MARRS 1407USA000508 and MARRS 1407USA000434. Additional information is not expected.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown type reporter refers to a 15 years old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of GARDASIL (lot#batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Full blood count normal, Grand mal convulsion
Clinical narrative: 2 minute seizure (tonic-clonic) with neg. CT/labs, or any other reasons for seizure, self resolving.
Age: 0.8
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (lot # J016185, expiry date: 02-OCT-2016, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects were reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker reported also as medical assistant (CMA) refers to a 2 months old patient of unknown gender. It was reported that on unknown date pediatric patient came in the office for immunization. The patient was supposed to received ROTATEQ (dose, lot # and route unspecified), PEDIARIX (dose, lot# and route unspecified) and PEDVAXHIB. It was reported that the patient was inadvertently administered ROTATEQ, RECOMBIVAX HB (dose, lot # and route unspecified); PEDVAX HIB has not yet been administered. No adverse effects were reported.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No therapeutic response
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The patient's pertinent medical history was not provided. On an unknown dates, the patient was vaccinated with RECOMBIVAX HB series twice (dose, frequency, route of administration, lot # and expiration date were not provided) and the patient non responded to RECOMBIVAX HB. The outcome of the event was unknown. The relatedness between the event and vaccination with RECOMBIVAX HB was unknown. Additional information is not expected because the reporter declined to participate in this report.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown type reporter refers to a 11 years old patient of unknown gender. On 06-MAY-2014 the patient was vaccinated with a dose of GARDASIL (lot#/batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an unknown type reporter refers to a 11 years old patient of unknown gender. On 06-MAY-2014 the patient was vaccinated with a dose of GARDASIL (lot#/batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. 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 nurse refers to an unknown number of patients of unknown age and gender. On 23-JUN-2013, patients were vaccinated with PROQUAD (dose, route and lot number were not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received PROQUAD (Merck) (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 23-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown type reporter refers to a 15 years old patient of unknown gender. On 22-MAY-2014 the patient was vaccinated with a GARDASIL (lot#/batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) and a nurse refers to a 4 years old patient of unknown age (gender unknown). On 27-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J0009990; expiration date 13-AUG-2015 (also reported as 12-AUG-2015), which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours (also reported as exposed to 16F for 120 hours), subcutaneously. No known adverse effects. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site dermatitis, Injection site pain
Clinical narrative: Patient had an injection site reaction w/some dermatitis and pain near site. Occurred the nite after injection and pain treated at hospital.
Age: 0.34
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. On 23-JUN-2014 the patient ws vaccinated with liquid PEDVAXHIB (lot # J016185, expiry date: 02-OCT-2016, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period, totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified dates, reported as prior to the morning 23-JUN-2014). that were not supported by Merck's stability data. No adverse effects were reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Swelling
Clinical narrative: Patient reportedly fell and hit his head as he and his mother were checking out. Our front desk staff called for a doctor. He was on the ground and conscious when we got to him. BP was checked in 15 minute intervals, pulse ox and pulse for an hour. He had a knot on the (R) side of head from falling.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) and a nurse refers to a 4 years old patient of unknown age (gender unknown). On 28-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J009990; expiration date 13-AUG-2015 (also reported as 12-AUG-2015), which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours (also reported as exposed to 16F for 120 hours), subcutaneously. No know adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient with actinic keratosis, diabetes, allergy to paraben's, milk and wheat. On 23-JUN-2014, the patient was vaccinated with ZOSTAVAX (lot # K0052621; expiration date 20-MAR-2015 , 0.65 ml, subcutaneous. Secondary and concomitant therapies were reported. Pharmacist reported that the patient came into the pharmacy on 25-JUN-2014 (reported as today) and showed her that she developed a large 3" x 3" oval shaped red patch below the injection site after receiving ZOSTAVAX. Pharmacist stated that the injection site was swollen, hot to touch, itchy, and she noted that a "knot" in the middle. Pharmacist sent her to her physician right away. Pharmacist stated that the patient was seen by the physician on 25-JUN-2014 (reported as today). The physician informed the patient to apply a cold compress to the injection site and to took BENDARYL. At the time of the report, the outcome of the adverse events was reported as not recovered. No labs diagnostics were performed.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of unspecified patients of unknown age and gender. On 23-JUN-2014 unspecified number of patients were vaccinated with ROTATEQ (dose, lot# and expiry date were not reported) that were exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date reported as prior to the morning 23-JUN-2014 that were supported by Merck's stability data. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, patients were vaccinated with (Oka/Merck) PROQUAD (dose, route and lot number were not reported). Concomitant medications were not reported. Nurse stated that an unspecified numbers of patients may had received PROQUAD (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 30-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with PROQUAD (subcutaneous injection, strength, dose number, lot #, expiration date not reported). The reporter stated that the patients were vaccinated with PROQUAD that was exposed to 15F intermittently throughout the day every day for an unknown period of time during the last. No adverse symptoms reported. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, strength, dose number, lot #, expiration date not reported). The reporter stated that the patients were vaccinated with (Oka/Merck) VARIVAX that was exposed to 15F intermittently throughout the day every day for an unknown period of time during the last. No adverse symptoms reported. This is one of several reports received from the same source. 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 register nurse, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-NOV-2013, the patient was vaccinated with a dose of GARDASIL (dose, lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported one patient received improperly stored GARDASIL on 12-NOV-2013. The register nurse did not reported if this was the patient's first dose or if the patient received previous doses of GARDASIL. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. Medical history was not reported. On30-JUN-2014 the patient was vaccinated with an expired dose of M-M-R II injection, 0.5 ml, subcutaneous, lot # H012142, expiration date 29-JUN-2014. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. Medical history was not reported. On 30-JUN-2014 the patient was vaccinated with an expired dose of M-M-R II, injection, 0.5ml subcutaneous, lot # H012142, expiration date 29-JUN-2014. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. 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 nurse refers to an unknown number of patients of unknown age and gender. On 17-JUN-2014 patients were vaccinated with PROQUAD (dose, route and lot number were not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received PROQUAD (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 17-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. 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 nurse refers to an unknown number of patients of unknown age and gender. On 17-JUN-2014 patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, once, subcutaneous (lot number was not reported). Concomitant medications were not reported. Nurse stated than an unspecified number of patients may had received (Oka/Merck) VARIVAX (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 17-JUN-2014. No adverse effects reported. This is one several reports received from the same source. 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 nurse refers to an unknown number of patients of unknown age and gender. On 23-JUN-2014, patients were vaccinated with (Oka/Merck) VARIVAX, 0.5ml, once, subcutaneous (lot number was not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received (Oka/Merck) VARIVAX (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minute each excursion). Nurse stated vaccines were administered on 23-JUN-2014. No adverse effects reported. This is one of several reports received from the same source.  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 a medical assistant refers to an unknown number (out of 6 patients) patients of unknown age and gender. The patient's medical history was not reported. On 03-JUN-2014, the patients were vaccinated with doses of improperly stored liquid PEDVAXHIB (lot #J013944, expiry date 13-AUG-2016, 0.5 milliliter(ml) intramuscular (IM) that had been exposed to 30 Fahrenheit (F) for less than one hour, rather than the 16 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old patient of unknown gender. On 23-JJN-2014 the patient was vaccinated with VAQTA (lot # J005010) expiry date 23-OCT-2015 (dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with VAQTA (lot # J005010, expiry date: 23-OCT-2015)(dose and route of administration were not reported). that was exposed to temperatures out of range (multiple excursion over 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous reports as received from an unknown type reporter refers to a 12 year old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of GARDASIL (lot#batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the events was unknown. This is one pf several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reports as received from an unknown type reporter refers to a 12 year old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of GARDASIL (lot#batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the events was unknown. This is one pf several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician as a part of a marketing research program conducted by a marketing research agency, refers to a 75 year old male patient. The patient medical history and current condition are not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (reported as shingles vaccine) of unknown dose and frequency (Lot # and expiry date not reported). Other concomitant drugs were not reported. On an unknown date the patient suffered from shingles in his eye (apparently the eye area was affected seriously a day after receiving shingles vaccine). The outcome of the event is unknown. The reporter considered the patient suffered from shingles in his eye (apparently the eye area was affected seriously a day after receiving shingles vaccine) to be related to ZOSTAVAX. Upon internal review the event of shingles in his eye was considered as medically significant since it was stated as the eye area was affected seriously a day after receiving shingles vaccine. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal discomfort, Nausea, Vision blurred
Clinical narrative: Employee experienced nausea and blurred vision. Employee was given ice pack for the back of her neck.
Age: 1.28
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Fever 103.0 F Day 7 06/30/2014. Rash 07/02/2014. Diarrhea x 1 episode 06/30/2014 (day 7). Treated with Acetaminophen and Ibuprofen.
Age: 1.63
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, seizure.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M increased, Pyrexia, Rash morbilliform
Clinical narrative: 103 degree fever on 6/14/14, rash not present at that time. No other symptoms with fever.  On 6/17/14, rash began and increased in severity. Presented to physician on 6/19/14 covered from head to toe, including palms and soles with a morbilliform rash.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Muscular weakness, Pain, Paraesthesia, Sensation of heaviness
Clinical narrative: Feeling of heaviness all over then leg weakness, then pins and needles hands and feet and lastly and chronically prickling, shooting pains and weakness in arms and legs including hands and feet.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Ring of erythema approximately 3 inches, warm, tender.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Abdominal X-ray, Hypotonia, Peripheral coldness, Pyrexia, Urine analysis normal
Clinical narrative: He arrived to the ER after being found at home limp, cyanotic (possibly) and cold the day after receiving his vaccines. He had a fever Tm 101.3 sometime prior to arriving at ER - He was transported from home via ambulance and was stable on arrival to ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: (L) arm cellulitis at site of injection.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted, fell off exam table.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid region with 5cm x 4cm erythematous, warm, indurated, tender area. No fever. Treated with KEFLEX and topical steroid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis on (L) vastus lateralis noted 24-48 hours after admin. No tenderness 5cm x 6cm. Warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm swollen. 5 in x 5 in area of warmth, erythema. No induration.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site mass
Clinical narrative: Patient came in w/mom secondary to concerns of localized superficial swelling lumps (bilateral thighs). Seen for 4 month well child visit and had vaccines on 6/17/14. She was seen by RN 6/26 and MD 6/27.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Muscle spasms, Throat tightness
Clinical narrative: Legs cramp - tiredness - throat closed up.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 20 cm painful red resolved 1 wk. induration around injxn site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Shot was administered on Tues 7/1, noticed increased redness, soreness as of 7/2, warmness did not take oral med or use topical treatment. Pt went to urgent care MD who prescribed KEFLEX and NORCO.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Dyspnoea, Fontanelle bulging, Pyrexia
Clinical narrative: She had a fever all night long and the soft spot on her head was very swollen this morning. Difficult breathing also.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (route, dose, lot number and expiration date not reported) that was exposed to temperatures outside of the recommended range. No adverse effect reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to 44 year old female pharmacist who is the patient also. There was not medical history, drug reactions or allergies. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX vial 19400, plaque forming unit (PFU) in the arm, strength, lot number and expiration date were not reported. Because her mother came down with a case of shingles. Concomitant therapy was not reported. The reporter informed that on 25-JUN-2014 the patient presented to the pharmacy with what appeared to be a silver dollar sized wheal at the injection site, also informed he advised to apply ice to the injection site and administered BENDADRYL and CLARITIN (unspecified forms strengths) to treat the symptom. The reporter informed that on 26-JUN-2014 (also reported as today) that wheal has moved from the injection site down to the patient's elbow. The pharmacist believed that the patient my have developed cellulitis. None laboratories studies were performed. The patient sought medical attention by a pharmacist visit. The outcome of the events was not recovered. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Body temperature, Cellulitis, Swelling
Clinical narrative: Temperature, swelling, sore. Cellulitis - cephalexin 500 #20 1 capsule twice a day for 10 days.
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 age and gender. The nurse reported that on 30-JUN-2014 (administration between "yesterday and today") unspecified number of patients might have received an unspecified number of doses of PNEUMOVAX23 single dose vial (SDV) 0.5 ml once (route, lot number and expiration date not reported that were improperly stored at 31F for 24 hours. No adverse effects reported. 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 Certified Medical Assistant (CMA) refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J003359, exp date: 21-JUN-2014 (strength, dose, frequency, route unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 16-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H010559 (which was expired on 24-MAY-2014), 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash and pain.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Allergic urticaria and all over body including the upper lip. Patient was given KENALOG 40mg IM and BENADRYL 25mg IM. She is also to take BENADRYL OTC. Patient waited 15mns post injection and had no adverse reactions.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Leukocytoclastic vasculitis, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with unspecified allergies and no pertinent medical history. On approximately 29-MAY-2014 (reported as about two weeks ago), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot#, expiry date unspecified). No concomitant medications were reported. On approximately 08-JUN-2014 (reported as 3 or 4 days ago), the patient developed a rash and he was seen by an unspecified primary care physician. The patient was put on oral and injectable steroids, which had little effect on the rash at that time. The physician stated that he had not yet seen the patient, but the patient had a diagnosis of "urticarial vasculitis". No laboratory tests were performed. The outcome of urticarial vasculitis was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Follow up information has been received from the physician concerning the patient with no prior drug allergy. The patient's concurrent condition included chronic asthma which was stable. The patient's medical history included prior history of less severe urticaria. On 27-MAY-2014 the patient was administered a dose of ZOSTAVAX. Concomitant therapy included SINGULAIR, RHINOCORT and ROGAINE. On 08-JUN-2014, the patient experienced urticarial vasculitis. On 24-JUN-2014 the patient was recovered (also reported as still be with urticarial, no vasculitis more). The event urticarial vasculitis was considered as medical significant by the reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients (reported as "a couple of patients") of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, route and lot number not reported) for prevention to HPV. On an unknown date the patients passed out after receipt of GARDASIL. The outcome of the event and relatedness between the event and GARDASIL were not reported. Upon internal review the event of passing out was determined to be medically significant. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. This case has been downgraded. The adverse event was incorrectly assessed as medically significant. This is a non-serious case.
Age: 60.0
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Dizziness, Euphoric mood, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered refers to a 60 year old patient of unknown gender. The reporter stated that on 26-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (route of administration, anatomical location, dose number, lot number were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered refers to a 60 year old patient of unknown gender. The reporter stated that on 26-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (route of administration, anatomical location, dose number, lot number were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphonia, Asthenia, Dyspnoea
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 80 year old female patient. Historical drug included aspirin. Current condition include aspirin allergy. On 21-JUN-2014 (at 4:40 pm) the patient was vaccinated with ZOSTAVAX vial, one dose (dosage not specified), in the left arm, (lot number J013452, expiry date 24-JAN-2015). No concomitant medications were reported. On 22-JUN-2014 (at approximately 8 am), with ZOSTAVAX the patient experienced minor shortness of breath (SOB), no energy and lost her voice (medically significant). The adverse events were previously reported to the doctor. The outcome of the events was unknown. Causality of the event was unknown. Upon internal review lost her voice was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash, Rash papular
Clinical narrative: This spontaneous report as received from a pharmacist via a nurse regarding a 66 year old female patient. The patient's concurrent condition included arthritis. On 21-JUN-2014, the patient was vaccinated with ZOSTAVAX (lot # J013453, expiration date 24-JAN-2015) 0.65 ml in the left deltoid. On 23-JUN-2014, the patient developed lesions on her right flank and she was assessed by another nurse practitioner who diagnosed with herpes zoster (disability) on 25-JUN-2014. She was treated with VALTREX. The patient reported that the lesions were painful. She was then referred to dermatologist. The outcome of the events were reported as not recovered. The patient sought medical attention. The reporter considered the event to be serious due to disability. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist via a nurse regarding a 66 year old female patient. The patient's concurrent condition included arthritis. On 21-JUN-2014, the patient was vaccinated with ZOSTAVAX (lot # J013453, expiration date 24-JAN-2015) 0.65 ml in the left deltoid. On 23-JUN-2014, the patient developed lesions on her right flank and she was assessed by another nurse practitioner who diagnosed with herpes zoster (disability) on 25-JUN-2014. She was treated with VALTREX. The patient reported that the lesions were painful. She was then referred to dermatologist. The outcome of the events were reported as not recovered. The patient sought medical attention. The reporter considered the event to be serious due to disability. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site cellulitis
Clinical narrative: This spontaneous report as received from a female patient (patient's age reported as 60) refers on herself. The patient's concurrent condition included thyroid (unspecified disorder) and arthritis. It was reported that the patient's drug reaction/allergy included reaction/allergy to LEVAQUIN and sulfonamides (reported as sulfa). On 23-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX in the right arm (dose, dose number, lot/batch number, expiration date not reported). 1 time vaccine. Concomitant therapies included diclofenac and unspecified thyroid medications. On 23-JUN-2014, the patient experienced irritation and temperatures of 101 (units not provided) after getting the ZOSTAVAX vaccine. The patient questioned if the vaccine was given correctly and if it was infected (also reported as product quality complain PQC not reported). The irritation was about 3 inches in diameter in the morning of 24-JUN-2014 and at the time of report (reported as now) spread up her right arm, shoulder and into her neck. The patient sought medical attention. She was given ice pace, CALFLEX, prednisone and probiotics for the treatment of the events. At the time of the report the patient was still under the doctor's care. The outcome of irritation was considered as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Injection site irritation, Skin irritation
Clinical narrative: This spontaneous report as received from a female patient (patient's age reported as 60) refers on herself. The patient's concurrent condition included thyroid (unspecified disorder) and arthritis. It was reported that the patient's drug reaction/allergy included reaction/allergy to LEVAQUIN and sulfonamides (reported as sulfa). On 23-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX in the right arm (dose, dose number, lot/batch number, expiration date not reported). 1 time vaccine. Concomitant therapies included diclofenac and unspecified thyroid medications. On 23-JUN-2014, the patient experienced irritation and temperatures of 101 (units not provided) after getting the ZOSTAVAX vaccine. The patient questioned if the vaccine was given correctly and if it was infected (also reported as product quality complain PQC not reported). The irritation was about 3 inches in diameter in the morning of 24-JUN-2014 and at the time of report (reported as now) spread up her right arm, shoulder and into her neck. The patient sought medical attention. She was given ice pace, CALFLEX, prednisone and probiotics for the treatment of the events. At the time of the report the patient was still under the doctor's care. The outcome of irritation was considered as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Lip swelling, Pruritus, Urticaria
Clinical narrative: Itching, burning sensation bilateral ventral wrists approximately 12 hours after the vaccine was administered. Shortly thereafter, developed urticarial bilat ventral wrists. Within the next several hours, noted swelling at left lower lip then right upper lip. Swelling and itching around lips persisted for three days when patient sought medical care.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pruritus
Clinical narrative: Erythema, 2" red circle at injection site with white 3.5" white circle, hardness of area, itching at site. 10:p.m. itching of both arms & thighs. Benadryl 25 mg taken with resolution.
Age: 27.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Redness around site, pain with movement remaining steady, swelling, with swelling growing in diameter post-injection (on day three it's the size of 1.5 half-dollars).
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a medical assistant via a field employee regarding an older male patient of unknown age. Medical Assistant said that the patient had "multiple unspecified comorbidities" regarding his health. No information about drug reactions and allergies was specified. On an unknown date in October 2013, The patient received ZOSTAVAX vial (dosing regimen unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, the patient developed a rash 3 days after the ZOSTAVAX was given. The rash was diagnosed as a severe case of shingles on an unspecified date. Medical Assistant stated that the patient died a few weeks later on an unspecified date. There was no product quality complaint with ZOSTAVAX. Cause of death and autopsy details were not provided. The outcome of the event severe case of shingles is unknown. The causality of the events was not specified by the reporter. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Loss of consciousness, Photophobia
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as secretary) regarding a 25 year old female patient. The patient had a medical history of osteomyelitis of the hip at four years of age (approximately in 2002). The patient had a history of local reaction (unspecified) while on prior therapy with VARIVAX (Merck) (reported in MARRS # 1407USA000891). On 27-JUN-2014, the patient was vaccinated at the camp check up with GARDASIL (dose, frequency, route, product lot/ expiry date unknown) and shortly after passed out (Hospitalization). The secretary stated the patient "eventually came to but then she had a terrible headache and we had to keep the lights off". The secretary stated Emergency Medical Team (EMT) was called and the patient was taken Emergency Room. The secretary stated she did not know how the patient was currently doing or if she has been admitted to Medical Center. When asked if the patient had any drug reactions or allergies the secretary reported that the patient had an unspecified local reaction after receiving VARIVAX, on an unspecified date (reported in MARRS # 1407USA000891). No treatment was given. No lab diagnostic studies were performed. The patient's present status was unspecified by reporter. The outcome of event was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.