chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood pressure abnormal, Confusional state, Dizziness, Dyskinesia, Electrocardiogram normal
Clinical narrative: B/P prior to vaccine 100/70 temp. 97.4 oral 1105 B/P recheck 52/40. 1111 B/P recheck 80/50. 1103 GARDASIL 0.5ml given IM as ordered by dr. Pt immediately became pale and lightheaded statina. "I'm going to pass out". Immediately had pt lay back on the exam table, feet elevated, cold paper towel to head. Pt began jerking movements of her extremities and became confused thinking I was her mom. Immediately called out for a code. Out physician's both responded along with office nursing staff and w/i seconds dr and other nursing staff were present. Ammonia to nares, pt continued to be confused and pale for approx 1 min at which time she then became alert to name and location, pt says she had eaten breakfast today. B/P was checked x 2 as recorded. Per RN-pulse did not feel tachy during this episode. Stretcher was brought to the exam room and pt was taken to the ER for observation. Pt was accompanied by her mother and sister, report called to ER triage.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: B/P prior to vaccine 100/70 temp. 97.4 oral 1105 B/P recheck 52/40. 1111 B/P recheck 80/50. 1103 GARDASIL 0.5ml given IM as ordered by dr. Pt immediately became pale and lightheaded statina. "I'm going to pass out". Immediately had pt lay back on the exam table, feet elevated, cold paper towel to head. Pt began jerking movements of her extremities and became confused thinking I was her mom. Immediately called out for a code. Out physician's both responded along with office nursing staff and w/i seconds dr and other nursing staff were present. Ammonia to nares, pt continued to be confused and pale for approx 1 min at which time she then became alert to name and location, pt says she had eaten breakfast today. B/P was checked x 2 as recorded. Per RN-pulse did not feel tachy during this episode. Stretcher was brought to the exam room and pt was taken to the ER for observation. Pt was accompanied by her mother and sister, report called to ER triage.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: B/P prior to vaccine 100/70 temp. 97.4 oral 1105 B/P recheck 52/40. 1111 B/P recheck 80/50. 1103 GARDASIL 0.5ml given IM as ordered by dr. Pt immediately became pale and lightheaded statina. "I'm going to pass out". Immediately had pt lay back on the exam table, feet elevated, cold paper towel to head. Pt began jerking movements of her extremities and became confused thinking I was her mom. Immediately called out for a code. Out physician's both responded along with office nursing staff and w/i seconds dr and other nursing staff were present. Ammonia to nares, pt continued to be confused and pale for approx 1 min at which time she then became alert to name and location, pt says she had eaten breakfast today. B/P was checked x 2 as recorded. Per RN-pulse did not feel tachy during this episode. Stretcher was brought to the exam room and pt was taken to the ER for observation. Pt was accompanied by her mother and sister, report called to ER triage.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adverse event
Clinical narrative: B/P prior to vaccine 100/70 temp. 97.4 oral 1105 B/P recheck 52/40. 1111 B/P recheck 80/50. 1103 GARDASIL 0.5ml given IM as ordered by dr. Pt immediately became pale and lightheaded statina. "I'm going to pass out". Immediately had pt lay back on the exam table, feet elevated, cold paper towel to head. Pt began jerking movements of her extremities and became confused thinking I was her mom. Immediately called out for a code. Out physician's both responded along with office nursing staff and w/i seconds dr and other nursing staff were present. Ammonia to nares, pt continued to be confused and pale for approx 1 min at which time she then became alert to name and location, pt says she had eaten breakfast today. B/P was checked x 2 as recorded. Per RN-pulse did not feel tachy during this episode. Stretcher was brought to the exam room and pt was taken to the ER for observation. Pt was accompanied by her mother and sister, report called to ER triage.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 31 year old female pregnant patient with no drug reactions or allergies. The patient's medical history included positive tuberculosis skin test (date was not reported). On 06-FEB-2015, the pregnant patient was inadvertently vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subdermal. There was no concomitant medications. No adverse effects were reported. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention-visited the office. At the time of the report the fetus was 6 weeks gestation. LMP was calculated to be 31-DEC-2014. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Tuberculin test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 31 year old female pregnant patient with no drug reactions or allergies. The patient's medical history included positive tuberculosis skin test (date was not reported). On 06-FEB-2015, the pregnant patient was inadvertently vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subdermal. There was no concomitant medications. No adverse effects were reported. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention-visited the office. At the time of the report the fetus was 6 weeks gestation. LMP was calculated to be 31-DEC-2014. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Abortion induced, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 31 year old female pregnant patient with no drug reactions or allergies. The patient's medical history included positive tuberculosis skin test (date was not reported). On 06-FEB-2015, the pregnant patient was inadvertently vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subdermal. There was no concomitant medications. No adverse effects were reported. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention-visited the office. At the time of the report the fetus was 6 weeks gestation. LMP was calculated to be 31-DEC-2014. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Ultrasound antenatal screen, Varicella virus test negative
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 31 year old female pregnant patient with no drug reactions or allergies. The patient's medical history included positive tuberculosis skin test (date was not reported). On 06-FEB-2015, the pregnant patient was inadvertently vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subdermal. There was no concomitant medications. No adverse effects were reported. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention-visited the office. At the time of the report the fetus was 6 weeks gestation. LMP was calculated to be 31-DEC-2014. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from the patient's sister refers to a female patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (albumin status, lot#, expiration date, dose, route and site of vaccination were not reported). There was no concomitant medication. On an unknown date, the patient experienced high fever. The patient had an office visit on an unspecified date. The outcome of high fever was reported as recovered/resolved on an unspecified date. The relatedness between the event and M-M-R II was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J004058, expiration date 22-JUN-2014 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site swelling, Pain in extremity
Clinical narrative: Swelling at injection site left arm pain in joints of left hand.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient. The patient medical history and concurrent conditions were not provided. On 11-FEB-2015, the patient was vaccinated with VARIVAX (Merck), lot # K008819, expiration date 19-JUN-2016 (route was not provided). Concomitant medication information was not provided. It was reported that on 11-FEB-2015, a dose of VARIVAX (Merck) which was exposed to an unsupported temperature excursion, was administered to the patient. No adverse experience had been reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None known yet.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Dizziness, Injection site discomfort, Loss of consciousness, Musculoskeletal pain
Clinical narrative: Injection did not sting but noticed that the needle felt like if it was 3 or 4 times larger than usual. Shoulder felt stiff. After vax doctor took blood for testing. By noon, shoulder started hurting. By bedtime, could hardly touch it or turn over. Pain was intense. Felt like kidneys were working extra to clean body so was going to the bathroom repeatedly until 2 am. Then shoulder quit hurting. Next day while eating breakfast passed out on the floor from a minute to the next with no warning. Got up to go rest on couch and passed out again on the way there. When got up rested on couch and did not get dizzy spells again since.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pollakiuria, Tenderness
Clinical narrative: Injection did not sting but noticed that the needle felt like if it was 3 or 4 times larger than usual. Shoulder felt stiff. After vax doctor took blood for testing. By noon, shoulder started hurting. By bedtime, could hardly touch it or turn over. Pain was intense. Felt like kidneys were working extra to clean body so was going to the bathroom repeatedly until 2 am. Then shoulder quit hurting. Next day while eating breakfast passed out on the floor from a minute to the next with no warning. Got up to go rest on couch and passed out again on the way there. When got up rested on couch and did not get dizzy spells again since.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L)/(R) upper arm swelling nontender with redness. LSQ/RD.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age an unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 11-FEB-2015 the patient was vaccinated with expired dose of GARDASIL (lot number: H010123 with expiry date of 16-JAN-2015) (third dose) (dose, frequency and route unspecified) (expired product administered). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 11-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency and route unspecified) (lot number: K020187 with expiry date 27-JAN-2016) which had been exposed to a supported temperature excursion. Concomitant medications were not reported. No adverse experience has been reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 4 x 2 3/4 inches area of warmth, redness and tender (L) thigh around injection site. KEFLEX (250/5) 2 ml PO TID x 10 days.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a non-pregnant female patient of unknown age refers to herself. The patient's medical history included an allergic reaction to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTAP), the patient experienced a high fever and swelling in her legs. On an unknown date, the patient was vaccinated with a dose of M-M-R II (albumin status, lot#, expiration date, dose, route and site of vaccination were not reported). There was no concomitant medication. On an unknown date, the patient experienced high fever. The patient had an office visit on an unspecified date. The outcome of high fever was reported as recovered/resolved on an unspecified date. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster
Clinical narrative: This spontaneous report was received from a health care worker and refers to a 71 year old female patient. The patient's concurrent conditions included allergy to penicillin and sulfa. The patient's historical drugs included ZETIA, MICARDIS, PATANOL which the patient was taking during vaccination. On 28-JUL-2009 the patient was vaccinated with ZOSTAVAX (19400 plaque-forming unit (PFU) 0.65 ml, subcutaneous (lot number was not reported). His concomitant medication included ALLEGRA. On 04-FEB-2015, the patient experienced shingles. The patient was diagnosed with shingles on 06-FEB-2015. The patient sought medical attention by consulting physician and was treated with ZOVIRAX from 06-FEB-2015. There were no lab diagnostics studies performed. There was no product quality complaint (PQC) involved. The patient reported that she was very uncomfortable and believed that her shingles was spreading. The outcome of shingles was reported as not recovered at the time of the report. The causality of the event was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Pyrexia, Rash maculo-papular, Rash pruritic, Rash pustular
Clinical narrative: 2/9/15- H/O URI sx and fever x 4-5 days the start with maculo, papular rash on face, scalp and spreading to trunk, arm and legs including hands and feet. Rash itching. Pt has fever on days of the rash with macular, papular, pustules/vesicles and one crush lesion. Dx Varicella O2.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Skin lesion, Upper respiratory tract infection, Varicella, Varicella virus test positive
Clinical narrative: 2/9/15- H/O URI sx and fever x 4-5 days the start with maculo, papular rash on face, scalp and spreading to trunk, arm and legs including hands and feet. Rash itching. Pt has fever on days of the rash with macular, papular, pustules/vesicles and one crush lesion. Dx Varicella O2.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema multiforme, Hypersensitivity, Otitis media acute, Rash
Clinical narrative: Received routine immunizations at 4 yr check up 1/30/15 was on d9 of amoxicillin for (R) otitis media, Amox ended 1/31/15. Onset rash 2/1/15, seen at hospital ER 2/1/15 and diagnosed allergic reaction to Amox. Treated BENADRYL and ORAPRED. Seen in office 2/2/15 and diagnosed erythema multiforme minor.
Age: 1.05
Sex: F
Vaccine: MMRV, MMR, MMRV
Symptoms: Unevaluable event
Clinical narrative: No symptoms noted.
Age: 1.05
Sex: F
Vaccine: MMRV, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms noted.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site reaction, Urticaria
Clinical narrative: Immediate small welph at site (R) T increased in size measurements:2-2 1/2 BENADRYL given 1/4 tsp.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Hyperaesthesia, Injection site pruritus, Injection site swelling, Muscle twitching
Clinical narrative: Two days after the injection on 9-11-14 I experienced a mild swelling and itching of the injection site on my left arm, approx. 3 days after I felt very mild tingling sensation in my fingers on my left hand. Several days after that tingling started in my left toe. A week later, I noticed that I was hypersensitive to hot and cold water while I was washing my hands or taking a shower. A week later, I experienced confusion, minor muscle aches, twitching in my arms and legs. I experienced sleep tremors, approximately 1 month later, then other neuropathy symptoms which progressed. Question: I've noticed on the pharmacy sheet attached that most of the adverse reactions or side effects seem to suggest an immediate reaction after the shot. I do not know what arthralgia or myalgia are? Could these medical terms suggest neuropathy? And could they be a delayed reaction to a shingles shot? Please do not contact anyone from the medical profession concerning this letter. And please answer the question above concerning neuropathy. I can be reached if you have any additional questions.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Paraesthesia, Tremor
Clinical narrative: Two days after the injection on 9-11-14 I experienced a mild swelling and itching of the injection site on my left arm, approx. 3 days after I felt very mild tingling sensation in my fingers on my left hand. Several days after that tingling started in my left toe. A week later, I noticed that I was hypersensitive to hot and cold water while I was washing my hands or taking a shower. A week later, I experienced confusion, minor muscle aches, twitching in my arms and legs. I experienced sleep tremors, approximately 1 month later, then other neuropathy symptoms which progressed. Question: I've noticed on the pharmacy sheet attached that most of the adverse reactions or side effects seem to suggest an immediate reaction after the shot. I do not know what arthralgia or myalgia are? Could these medical terms suggest neuropathy? And could they be a delayed reaction to a shingles shot? Please do not contact anyone from the medical profession concerning this letter. And please answer the question above concerning neuropathy. I can be reached if you have any additional questions.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown gender and their age range was from 1 year to 18 years old. The patients' relevant medical history was not reported. On unknown dates, the patients were vaccinated with M-M-R II (lot# K000174, expiration date 08-JAN-2015) (dose, dose number and route not reported) which were improperly stored. Information about concomitant medication was not reported. The temperature excursion for M-M-R II was not supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. The registered nurse provided that there had been no adverse events reported following the administration of the vaccinations and on need for revaccination. PQC (product quality complaint) was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: This spontaneous report was received from an approximately 63 years old female patient regarding herself. The concurrent condition included the gastrooesophageal reflux disease. The patient stated that she has suffered from the herpes simplex virus for over 45 years. It was reported that on an unknown date in 1970 (reported as 45 years ago) the patient received a special Smallpox vaccine to provide immunity for the herpes simplex virus and after the injection of the smallpox virus (45 years ago) she has suffered mild and manageable symptoms of sores on the mouth as a result of herpes simplex virus. The patient had no known drug allergies. On an unknown date in February 2014 (approximately 1 year ago) the patient was vaccinated with ZOSTAVAX 1 injection. Concomitant therapies included ESTRATEST, VIROXIN and unspecified stomach medication. On an unknown date in October 2014, (also reported as in the last 4 months i.e. October 2014, November 2014, December 2014 and January 2015) the symptoms of the sores from herpes simplex virus certainly worsened possibly as a result of the ZOSTAVAX. The patient had no other symptoms or new symptoms appeared but simply the fact that the symptoms ha gotten worse after receiving the ZOSTAVAX to the point where it was becoming unmanageable. The patient did not seek any medical attention. The patient took over the counter medications, BLISTEX and others. No lab tests were performed. The patient enquired if this was possibly caused by the fact that she vaccinated with smallpox vaccine and then received ZOSTAVAX. The outcome of symptoms of the sores from herpes simplex virus certainly worsened was reported as not recovered/not resolved (reported as not improved). The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were intramuscularly vaccinated with GARDASIL (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were intramuscularly vaccinated with RECOMBIVAX HB (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient were intramuscularly vaccinated with VAQTA (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 33 year old female patient. On 05-FEB-2015 the patient was vaccinated with a dose of GARDASIL  injection, 0.5 ml, intramuscularly. The patient was 36 weeks pregnant at the time of reporting on 06-FEB-2015. The patient was pregnant with Last Menstrual Period (LMP) of 29-MAY-2014 and Estimated date of delivery (EDD) of 05-Mar-2015. No adverse effect reported. The pregnancy outcome was pending. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 4x4 area at injection site w/ redness, swelling and itching w/duration of 7 days. Tx: Aveeno anti-itch lotion.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Large localized reaction with swelling, induration and erythema at the site, no fevers, chills, SOB, pain, or respiratory distress.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, Injection site reaction, Myalgia, Pain
Clinical narrative: Muscular soreness at site after receiving flu shot; difficulty raising right arm overhead. Mild discomfort, twinges and aching continuing since injection. Raising arm continues to be painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Red eye on side of body shot given (left). Hives/itchy legs.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site; rash on R and L thigh.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Injection site mass, Mass, Neck mass
Clinical narrative: Lump inside upper arm where shot was administered. Pain in joints and additional lumps showing up at several other areas, neck, wrist, and shoulder.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient states that she experienced dizziness after receiving Zostavax vaccine. No other symptoms reported.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Chills, Headache, Injection site swelling, Myalgia
Clinical narrative: Swelling around shot, painful, headache, back ache, chills, legs and muscle and leg pain.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Swelling around shot, painful, headache, back ache, chills, legs and muscle and leg pain.
Age: 0.56
Sex: F
Vaccine: DTAPH, IPV
Symptoms: Abnormal behaviour, Irritability, Pyrexia
Clinical narrative: Fever of 100.3 ongoing for 6-7 days. Fussy, cranky, not playful self. One call to on call nurses. Two trips to doctors office.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to patient of unknown age and gender. The nurse reported that on unspecified dates the patient received improperly stored ROTATEQ oral liquid (Lot#, strength, dose and frequency were unspecified), orally and LIQUID PEDVAXHIB intramuscular injection (Lot#, strength, dose, frequency and route were unspecified), which were exposured to 33.2 Fahrenheit for 37 minutes. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816  with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administered to an unspecified number of patients. No adverse effects were reported. Follow up information has been received from licensed practical nurse via telephone call on 12-FEB-2015. Total number of doses administered of PROQUAD (Merck) were 20. This report refers to a 6 year old patient. On an unknown date patient was vaccinated with inappropriately stored PROQUAD (Merck) (batch/lot: lot no. K011968, expiry: 21-FEB-2016). There was no need for revaccination. The outcome of incorrect product storage and no adverse event were unknown. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administered to an unspecified number of patients. No adverse effects were reported. Follow up information has been received from licensed practical nurse via telephone call on 12-FEB-2015 refers to a 2-5 year old patient. Total number of doses administered of VARIVAX (Merck) was 13. On an unknown date patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K006136, expiry: 29-APR-2016). There was no need for revaccination. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K02816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administered to an unspecified number of patients. No adverse effects were reported. Follow up information has been received from licensed practical nurse via telephone call on 12-FEB-2015. Total number of doses administered of VARIVAX (Merck) was 13. On an unknown date 12 patients were vaccinated with improperly stored VARIVAX (Merck) (lot #K006136, expiry: 29-APR-2016). There was no need for revaccination. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: KK007828 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: KK007828 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effect (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with the GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and  route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse referring to a 3 year old White male patient. On 24-JAN-2015 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, Subcutaneous injection (Lot# was reported as K007977, expired date, strength, dose and frequency were unspecified). On 04-FEB-2015 at 11:00 AM the patient experienced hard, red, itching, knot at the injection site, the area of erythema was 3 cm. patient was given clod cloth, BENADRYL. The patient had seen the doctor. The outcome of all the events was recovered on unspecified date in FEB-2015. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient requested this vaccine, PNEUMOVAX-23 eight weeks after receiving PREVNAR-13 in preparation for a cochlear implant. She developed redness, swelling and pain around and radiating from inj. site. Advised to use cold, BENADRYL, ADVIL on 2/10. She is planning to see MD 2/11/15.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: Swelling, redness, pain, headache.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.