chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 31-AUG-2010, the patient was vaccinated with RECOMBIVAX HB injection dose 1, (lot number and dosage not reported) "soon after their birth". Then was administered with the second and third doses of RECOMBIVAX HB on 12-MAY-2015 and 29-JUN-2015, respectively. This was outside the labeled recommendations in the RECOMBIVAX HB prescribing information. No adverse effect reported. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date in March of 2015, the patient was administered the first dose of ZOSTAVAX (dosing details, lot# and expiry were unknown) and the second dose of ZOSTAVAX was administered on 09-MAR-2016. No adverse effects were reported. There were no product quality complains (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of GARDASIL 9 (lot # L016429, expiration date: 09-AUG-2017, dose, route of administration and injection site were not reported). Administered doses of  GARDASIL 9 underwent temperature excursions at 32.7 Fahrenheit degrees for 9 hours. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, only 22 days after the first dose was administered, the patient was inadvertently administered the second dose in the GARDASIL series (lot#, expiration date, exact dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested. The pharmacist wished to be contacted via email.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiration date 20-JUL-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 10.5C for 32 hours, 8 minutes and to temperature of 0.6C for 16 hours. No previous temperature excursions was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013203 and expiration date 28-JAN-2017, lot # L027067 and expiration date 06-APR-2017, exact doses were not reported, orally). The vaccines were exposed to temperature of 10.5C for 32 hours, 8 minutes and to temperature of 0.6C for 16 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-<AY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L019989 and expiration date 01-JUN-2017, lot # L020189 and expiration date 03-JUN-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 105C for 32 hours, 8 minutes and to temperature of 0.6C for 16 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle spasms
Clinical narrative: Pain at injection site persisting 16 days afterwards - resulting in avoidance of use/spasms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # reported as L031068 and expiration date 18-AUG-2017, lot # L036830 and expiration date 24-SEP-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of -2.6C for 59 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 30-DEC-2015, the patient was vaccinated with improperly stored dose of MMR II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). 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 product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 20-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 31-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 13-JAN-2016, the patient was vaccinated with an improperly stored dose of MMR II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient received extra dose of HPV.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 24-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Anxiety, Cold sweat, Dizziness, Pallor, Syncope
Clinical narrative: Patient was instructed to wait 15" post vaccination because he seemed anxious. Upon leaving he said he fell dizzy and was moved to a chair where he continued to have a syncopal episode. His face was pale, skin clammy and was not verbally responsive for 30 seconds to 1 minute. Episode began at 1610. After he responded to ice pack on neck hew was transferred to the table. At 1615 BP 88/47 P 45. At 1625 BP 203/54 p. 52. Ambulated to bathroom, said felt better. 1645 BP 2200/55 p65. color returned. Said he wanted to leave. Ambulated with supervision to vehicle. (mother drove. Instructed to rest and call physicians if symptoms do not subside.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was instructed to wait 15" post vaccination because he seemed anxious. Upon leaving he said he fell dizzy and was moved to a chair where he continued to have a syncopal episode. His face was pale, skin clammy and was not verbally responsive for 30 seconds to 1 minute. Episode began at 1610. After he responded to ice pack on neck hew was transferred to the table. At 1615 BP 88/47 P 45. At 1625 BP 203/54 p. 52. Ambulated to bathroom, said felt better. 1645 BP 2200/55 p65. color returned. Said he wanted to leave. Ambulated with supervision to vehicle. (mother drove. Instructed to rest and call physicians if symptoms do not subside.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 24-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 28-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 20-APR-2017, dose and route of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 11-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a male patient of unknown age, was reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date one month after the vaccination, the patient experienced pruritus. The outcome of pruritus was reported as not recovered by the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there were no contact details provided.
Age: 1.43
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hepatitis A vaccine administered 1 month too early.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 22-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose od M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received for the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 18-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Erythematous, warm 5.5 cm x 6.5 cm oval at vaccine site that is tender. Subjective fever.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. 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 product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with PROQUAD (Merck) (Lot # L023114, expiry: 24-DEC-2016; Lot# L016394, expiry: 08-NOV-2016; Lot3 L007229, expiry: 03-SEP-2016) (route, dose and strength were not reported), which was improperly stored at -12.7 degree centigrade for 9 hours and 58 minutes. No adverse effects were reported. There was no prior temperature excursions and data logger was involved. This is one of the several cases from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Burning sensation, Erythema, Induration, Injection site pain, Pain
Clinical narrative: Spreading redness and induration. Tenderness hot to touch pain, itching, burning. Pain radiating from site up to shoulder and down forearm.
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain in extremity, Pruritus, Skin warm, Tenderness
Clinical narrative: Spreading redness and induration. Tenderness hot to touch pain, itching, burning. Pain radiating from site up to shoulder and down forearm.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: High fever up to 104.9 lasting for 3-days. Then again on 03/08/2016 red spots appeared randomly all over her body.  They resemble a bug bite but after a doctor visit, it cannot be confirmed that it isn't related to the vaccines.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Computerised tomogram, Faecal incontinence, Mobility decreased, Musculoskeletal disorder
Clinical narrative: Neurological deficit, progressive. Limited use of extremities. Now loss of bowel/bladder. Unable to ambulate or transfer.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging, Spinal fusion surgery, Urinary incontinence
Clinical narrative: Neurological deficit, progressive. Limited use of extremities. Now loss of bowel/bladder. Unable to ambulate or transfer.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Gastrointestinal pain, Gastrointestinal viral infection
Clinical narrative: First intestinal cramping and diarrhea that lasted for 5 days, on 4th day my left arm broke out in a rash with welts, and to this date I still have bouts of my stomach aching, loose stool, and having bouts of feeling bad and then feeling better then feeling bad again.  I still feel like I have the intestinal flu.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: First intestinal cramping and diarrhea that lasted for 5 days, on 4th day my left arm broke out in a rash with welts, and to this date I still have bouts of my stomach aching, loose stool, and having bouts of feeling bad and then feeling better then feeling bad again.  I still feel like I have the intestinal flu.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV, MNQ, UNK
Symptoms: Pyrexia, Seizure
Clinical narrative: My son developed a high temperature & then went into his 1st seizure of many.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, redness with extreme temperature, redness spread to whole upper arm by 8:00 PM. On 3/11/16 Dr. diagnosed a bacterial infection and prescribed Clindamycin.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Joint and muscle pain extreme fatigue headache sore throat.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pustule
Clinical narrative: Patient reported hardness around site of injection and yellow pus when bandaid was removed.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient complained about redness at injection site, neck stiffness, and soreness on left hand between thumb and forefinger.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Mass, Pruritus, Rash macular, Swelling
Clinical narrative: Itching, swelling, red blotch, marble-sized lump.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discomfort, Urticaria
Clinical narrative: PATIENT CAME IN ON 3/8/16 AND COMPLAINED OF A RED WELT (HIVE) ON HER LEFT ARM AFTER GETTING ZOSTAVAX SHOT. THIS WAS ALMOST UNDERNEATH HER ARMPIT AND WAS NOT WHERE THE SHOT WAS GIVEN. PATIENT HAD DR APPT FOR THE NEXT DAY FOR A REGULAR CHECKUP AND WOULD CHECK WITH THE DOCTOR ABOUT IT. I TOLD HER TO TAKE SOME BENADRYL AND APPLY ICE PACKS TO THE SITE FOR COMFORT/RELIEF.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. called on 03/11/2016 and complained of pain and redness around the injection site, but it was not itchy. The pt. was advised to seek medical attention if the redness doesn't go away.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cough, Eye swelling, Generalised erythema, Immediate post-injection reaction, Injection site urticaria
Clinical narrative: After reviewing vaccine ingredient lists on CDC website, parent requested to stay in office for observation post vaccine administration as DTaP listed bovine casein (a milk protein) in ingredients. Immediate hives at injection site, progressed to wide spread hives within minutes and total body redness, frequent coughing, complaint of itchy throat, eyes/facial swelling (still in pediatricians office for observation after vaccine).  Administered Benadryl and epinephrine with physician present and went to nearest emergency room for anaphylaxis.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Swelling face, Throat irritation, Urticaria
Clinical narrative: After reviewing vaccine ingredient lists on CDC website, parent requested to stay in office for observation post vaccine administration as DTaP listed bovine casein (a milk protein) in ingredients. Immediate hives at injection site, progressed to wide spread hives within minutes and total body redness, frequent coughing, complaint of itchy throat, eyes/facial swelling (still in pediatricians office for observation after vaccine).  Administered Benadryl and epinephrine with physician present and went to nearest emergency room for anaphylaxis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Raised red area at site of injection radiating outward down arm about 5-6 inches, itching.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Pain, Poor quality sleep
Clinical narrative: Very sore upper arm and shoulder. Hurts to use arm and wakes me up while trying to sleep. Took ibuprofen and used ice bag but still very sore and painful.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Very sore upper arm and shoulder. Hurts to use arm and wakes me up while trying to sleep. Took ibuprofen and used ice bag but still very sore and painful.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Red, swollen at injection site, rash, hard at injection site. Taken to urgent care- prescribed steroid- Prednisone 3ml for 5 days 2x a day.
Age: 5.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Activities of daily living impaired, Blood test normal, Computerised tomogram normal, Crying, Pruritus
Clinical narrative: Patient got a fever after getting hepatitis A and flu shot on 3/10/2016. I gave Motrin to control fever and kept him home from school on 3/11/2016. Fever continued all day on 3/11/16 and I gave Motrin around the clock. 3/12/16 at around 2:00 AM he started screaming and crying that he was itching. No rashes, hives, or marks are on his body but he keeps complaining of itching. Checked in to Hospital and patient was admitted. He continues to cry and complain of itching even after the medicines the hospital is giving him. Nothing is working. Please help. None of this happened until the shots.
Age: 5.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pyrexia, Screaming, Urine analysis normal
Clinical narrative: Patient got a fever after getting hepatitis A and flu shot on 3/10/2016. I gave Motrin to control fever and kept him home from school on 3/11/2016. Fever continued all day on 3/11/16 and I gave Motrin around the clock. 3/12/16 at around 2:00 AM he started screaming and crying that he was itching. No rashes, hives, or marks are on his body but he keeps complaining of itching. Checked in to Hospital and patient was admitted. He continues to cry and complain of itching even after the medicines the hospital is giving him. Nothing is working. Please help. None of this happened until the shots.
Age: 21.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Respiratory arrest, Seizure
Clinical narrative: Got my Tdap shot around 10 am on the 11th...the next morning I was awaken by cops and paramedics...I had a seizure and stopped breathing.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: She woke up and was in fever. Temp was 102 at highest point. Top half of arm swelled an remained red and hot to the touch.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged sore lymph node on clavicle on injection side after Tdap.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Woke up 10/01/15 could not raise arm above 90 degrees, upper arm swollen, next day redness of upper arm along with swelling, took about 5 days to resolve.
Age: 1.48
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: High Temperature of 103.8.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immune system disorder, Platelet count decreased, Rash
Clinical narrative: Patient developed rash, then was hospitalized for six days. Family member said his immune system was affected and therefore his platelet count was way down, but has rebounded and platelet count is approaching normal.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Platelet count decreased, Rash
Clinical narrative: Patient developed rash, then was hospitalized for six days. Family member said his immune system was affected and therefore his platelet count was way down, but has rebounded and platelet count is approaching normal.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Pt states rec'd flu shot in right arm. Next day arm sore. Pain never went away pain traveled from shoulder to elbow. Pt primary MD feels rotator cuff issue due to flu shot. Pt scheduled for MRI.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # L044055, expiration date 02-MAY_2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. 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 product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016 the patient was vaccinated with an improperly stored PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. 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 product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant  medication was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L015047, expiration date 29-APR-2017, dose and route unknown). The temperature of exposure was 6.8F and time frame was 8 hours. There was no previous temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Chest pain, Exposure during pregnancy, Neck pain, Pain in extremity
Clinical narrative: Severe nerve pain in hands, legs and back.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: Severe nerve pain in hands, legs and back.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with no pertinent medical history or drug reactions/allergies. Concomitant therapy was not reported. On 22-FEB-2016, the patient was admitted for an unspecified reason. On 23-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml once, route not reporter, lot # L036437 and Exp. date 18-MAY-2017) in the left arm, and the subject experienced a localized reaction with impressive swelling. The reporter reported this reaction occurred in the left upper deltoid region of the arm within 24 hours of administration of the vaccine (on approximately 23-FEB-2016). Cold packs were placed on the injection site as treatment for the swelling. No lab diagnostics studies performed. The patient had not recovered from the event at this time of reporting. Additional information has been requesting.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with no pertinent medical history or drug reactions/allergies. Concomitant therapy was not reported. On 22-FEB-2016, the patient was admitted for an unspecified reason. On 23-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml once, route not reporter, lot # L036437 and Exp. date 18-MAY-2017) in the left arm, and the subject experienced a localized reaction with impressive swelling. The reporter reported this reaction occurred in the left upper deltoid region of the arm within 24 hours of administration of the vaccine (on approximately 23-FEB-2016). Cold packs were placed on the injection site as treatment for the swelling. No lab diagnostics studies performed. The patient had not recovered from the event at this time of reporting. Additional information has been requesting.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Loss of muscle in the left arm, pain in neck and shoulders. Weakness in right arm. Also sore and weakness in upper thighs. Pain when getting up and down, weak muscles. Couldn't lift left arm or pick up a cup of coffee/swelling on left side. Neck and arm pain is affected, including muscle weakness.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Rheumatoid factor negative
Clinical narrative: Loss of muscle in the left arm, pain in neck and shoulders. Weakness in right arm. Also sore and weakness in upper thighs. Pain when getting up and down, weak muscles. Couldn't lift left arm or pick up a cup of coffee/swelling on left side. Neck and arm pain is affected, including muscle weakness.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Electrocardiogram, Grip strength decreased, Mobility decreased, Muscular weakness
Clinical narrative: Loss of muscle in the left arm, pain in neck and shoulders. Weakness in right arm. Also sore and weakness in upper thighs. Pain when getting up and down, weak muscles. Couldn't lift left arm or pick up a cup of coffee/swelling on left side. Neck and arm pain is affected, including muscle weakness.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Swelling
Clinical narrative: Loss of muscle in the left arm, pain in neck and shoulders. Weakness in right arm. Also sore and weakness in upper thighs. Pain when getting up and down, weak muscles. Couldn't lift left arm or pick up a cup of coffee/swelling on left side. Neck and arm pain is affected, including muscle weakness.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: Loss of muscle in the left arm, pain in neck and shoulders. Weakness in right arm. Also sore and weakness in upper thighs. Pain when getting up and down, weak muscles. Couldn't lift left arm or pick up a cup of coffee/swelling on left side. Neck and arm pain is affected, including muscle weakness.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old female consumer of an unspecified ethnicity received PREVNAR 13 on 03Dec2015, at single dose. Medical history included cancer detected via a chest x-ray and resolved on unknown date and hip started hurting in June (year unspecified) and feeling shaky when she walked and her hands were shaking after taking XANAX and prednisone. She got a hip replacement. The patient's concomitant medications were not reported. On 08Dec2015, the consumer experienced joint pain, lack of appetite, shaking and fatigue. The events required hospitalization on the same date. The events were not resolved except the decreased appetite which resolved on an unknown date. The patient received unspecified treatment for the events decreased appetite, tremor and joint pain. Follow-up (01Mar2016): additional information received from a contactable consumer includes age of the patient, and outcome of the events. Hospitalization added as criteria of seriousness. Case upgraded to serious.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old female consumer of an unspecified ethnicity received PREVNAR 13 on 03Dec2015, at single dose. Medical history included cancer detected via a chest x-ray and resolved on unknown date and hip started hurting in June (year unspecified) and feeling shaky when she walked and her hands were shaking after taking XANAX and prednisone. She got a hip replacement. The patient's concomitant medications were not reported. On 08Dec2015, the consumer experienced joint pain, lack of appetite, shaking and fatigue. The events required hospitalization on the same date. The events were not resolved except the decreased appetite which resolved on an unknown date. The patient received unspecified treatment for the events decreased appetite, tremor and joint pain. Follow-up (01Mar2016): additional information received from a contactable consumer includes age of the patient, and outcome of the events. Hospitalization added as criteria of seriousness. Case upgraded to serious.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test normal, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old female consumer of an unspecified ethnicity received PREVNAR 13 on 03Dec2015, at single dose. Medical history included cancer detected via a chest x-ray and resolved on unknown date and hip started hurting in June (year unspecified) and feeling shaky when she walked and her hands were shaking after taking XANAX and prednisone. She got a hip replacement. The patient's concomitant medications were not reported. On 08Dec2015, the consumer experienced joint pain, lack of appetite, shaking and fatigue. The events required hospitalization on the same date. The events were not resolved except the decreased appetite which resolved on an unknown date. The patient received unspecified treatment for the events decreased appetite, tremor and joint pain. Follow-up (01Mar2016): additional information received from a contactable consumer includes age of the patient, and outcome of the events. Hospitalization added as criteria of seriousness. Case upgraded to serious.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine 2-28-16 and went to MD on 3-7-16. Patient had cellulitis of left upper extremity and will be treated with Cephalexin.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient received vaccine 2-28-16 and went to MD on 3-7-16. Patient had cellulitis of left upper extremity and will be treated with Cephalexin.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Abdominal pain, Chills, Cough, Decreased appetite, Disturbance in attention
Clinical narrative: Sensation of throat swelling and difficulty swallowing, mild wheezing and coughing, pounding headache, dizziness, fatigue and lethargy, abdominal cramps, extreme pain at site of injection, hard lump at site, fever of 100 degrees, chills, muscle pain, pounding of heart in her ears, watery eyes, difficulty concentrating because so lethargic, loss of appetite, muscle aches and pains.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Dizziness, Dysphagia, Fatigue, Headache, Injection site induration
Clinical narrative: Sensation of throat swelling and difficulty swallowing, mild wheezing and coughing, pounding headache, dizziness, fatigue and lethargy, abdominal cramps, extreme pain at site of injection, hard lump at site, fever of 100 degrees, chills, muscle pain, pounding of heart in her ears, watery eyes, difficulty concentrating because so lethargic, loss of appetite, muscle aches and pains.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site mass, Injection site pain, Lacrimation increased, Lethargy, Myalgia
Clinical narrative: Sensation of throat swelling and difficulty swallowing, mild wheezing and coughing, pounding headache, dizziness, fatigue and lethargy, abdominal cramps, extreme pain at site of injection, hard lump at site, fever of 100 degrees, chills, muscle pain, pounding of heart in her ears, watery eyes, difficulty concentrating because so lethargic, loss of appetite, muscle aches and pains.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Palpitations, Pharyngeal oedema, Wheezing
Clinical narrative: Sensation of throat swelling and difficulty swallowing, mild wheezing and coughing, pounding headache, dizziness, fatigue and lethargy, abdominal cramps, extreme pain at site of injection, hard lump at site, fever of 100 degrees, chills, muscle pain, pounding of heart in her ears, watery eyes, difficulty concentrating because so lethargic, loss of appetite, muscle aches and pains.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site rash, Rash
Clinical narrative: Rash located at site of administration, spreading down arm and across chest.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Mass, Skin warm, Tenderness
Clinical narrative: Large lump, warm to touch and tender to the patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Local reaction, Pruritus, Swelling
Clinical narrative: Patient with local reaction erythema, swelling and itching. Mild headache. Patient take two tablets of Tylenol and apply ice in area.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Headache, Polyuria
Clinical narrative: Patient reports chills, headache, and polyuria after receiving Prevnar 13 vaccine. Reports that theses issues had stopped by 3/11/16.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful sore arm at injection site.  Hot to touch large red ring around injection site.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after administering SQ MMR and Varicella, redness/warmth and hive noticed. Patient was not in any respiratory distress.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Asthenia, Blood test, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received on 04Dec2015 PREVNAR 13 at single dose and influenza vaccine (manufacturer unknown). Medical history included blood pressure (under control). The patient received an influenza vaccine in Sep2015. Concomitant medications were none. On an unspecified date, the patient experienced dehydration, loss of energy, appetite lost and diarrhea. Reactions were described as follows: The patient reported that she really had a hard time on vaccination. She had to go to ER because she had dehydration and they gave her some fluids there. Blood work was performed on an unspecified date at the hospital and on 01Mar2016, results were not available. Blood work was performed since she had dehydration due to a whole week of diarrhea. She had no energy and no appetite. She thinks too many toxins were there in her body at one time. The patient was not experiencing any side effects right now and on 01Mar2016 was the first day when she felt normal.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received on 04Dec2015 PREVNAR 13 at single dose and influenza vaccine (manufacturer unknown). Medical history included blood pressure (under control). The patient received an influenza vaccine in Sep2015. Concomitant medications were none. On an unspecified date, the patient experienced dehydration, loss of energy, appetite lost and diarrhea. Reactions were described as follows: The patient reported that she really had a hard time on vaccination. She had to go to ER because she had dehydration and they gave her some fluids there. Blood work was performed on an unspecified date at the hospital and on 01Mar2016, results were not available. Blood work was performed since she had dehydration due to a whole week of diarrhea. She had no energy and no appetite. She thinks too many toxins were there in her body at one time. The patient was not experiencing any side effects right now and on 01Mar2016 was the first day when she felt normal.