chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided. This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 14-JAN-2014 after noon (also reported as 27-FEB-2014). It was reported that this dose was spoiled since the refrigerator was too cold. The parents of the patient were going to talk with physician and declined to repeat the dose. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Axillary mass, Purulent discharge
Clinical narrative: Patient received a series of immunizations for deployment. He reported after receiving Typhoid vaccination that he felt a lump under left armpit, he broke it open, pus/blood came out. Patient was sent to urgent care for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swelling, redness, warm to touch day after injection 9/25/2014. Increased in size. Pt came into urgent care. BENADRYL and OMNICEF prescribed.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site anaesthesia, Malaise
Clinical narrative: Numbness in left arm to elbow that resolved in a day. General malaise. Achy joints.
Age: 6.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Tdap given at too young of age.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 1 day (reported as 0 months) old male patient. On 11-JUL-2014 at 14:32, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # J012520, Expiration date:30-JAN-2016), dose 1, intramuscular (dose was not reported). It was reported that the vaccine storage temperature dropped to 0-1 degree (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). No adverse symptoms were reported. Thi sis one of several reports received from the same source. Additional information is not expected due to all follow ups requested to complete the case were received.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, pain redness, itch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with ZOSTAVAX subcutaneously (dose and lot # were not reported). It was reported that the patient received ZOSTAVAX on 30-SEP-2013 and 16-SEP-2014. No adverse effects were reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus
Clinical narrative: Received mandatory vaccine noticed redness and itching that haven't resolved; placed warm compress without relief.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: Generalized hives - started 12 hrs after injections was taken to the ER. Given IV and oral steroids in ER.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray normal, Culture urine, Differential white blood cell count, Electroencephalogram, Febrile convulsion
Clinical narrative: Fever 103.1 - likely febrile seizure witnessed by grandmother. Child brought to primary care PNP and was sent to ER - Dx: Fever of unknown cause.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Liver function test, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Fever 103.1 - likely febrile seizure witnessed by grandmother. Child brought to primary care PNP and was sent to ER - Dx: Fever of unknown cause.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Lip swelling
Clinical narrative: Moderate severe swelling of upper and lower lips approx 45 minutes after adm. of both meningococcal vax #2 and HPV #3.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Left thigh with warm 4cm x 1.5cm lesion slightly indurated, nontender, erythematous. Treatment: hydrocortisone, MOTRIN Q 6 hrs, BENADRYL Q 6 hrs, KEFLEX if erythema spreading beyond outline.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 1 day old female patient. On 14-JUN-2014 he patient was vaccinated with an improperly stored RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse symptoms reported. The patient did not seek medical attention. Also it was reported that vaccine storage temperature dipped to 0 to 1 grade in 18 different episodes according to min/max. All recorded temperatures were within 2 to 8 grade. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a neonate female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 06-JUN-2014 at 10:23 AM, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscular, Lot # J012520 and expiration date on 30-JUN-2016. Co-suspect therapy and concomitant medications were not provided. It was reported that vaccine storage temperature dipped to 0-1 degrees for eighteen different episodes between 14-MAY-2014 and 21-JUL-2014 according to minimal/maximal measures (the reporter was not able to identify how long the temperatures were down because it was not documented accordingly). The reporter did not know that when the temperatures were checked each AM and each PM, all recorded temperatures were within 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports received from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: MCV4 given in 8/18/14. Patient called office on 8/19/14 complaining of fever to 105, vomiting, and headache. Fever lasted 5 d with vomiting and headache the first 3 days. He had no known ill contacts prior to onset of symptoms. Recovered with supportive care at home. Follow up in office 8/27/14.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Red, blotchy rash and itching on ankles, feet and legs.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Swelling of upper arm with erythema extending to upper 3rd of left arm with itching. (Local reaction). No fever.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis
Clinical narrative: Ecchymosis - checked in on 9/26/14 and it is resolving on its own.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse concerning a neonate male patient. On 17-JUL-2014 at 22:39 the patient was vaccinated with the first dose of RECOMBIVAX HB lot # J012520, expiration date: 30-JAN-2016, intramuscular. The storage temperature of RECOMBIVAX HB was between 0 and 1 degrees, on 18 different episodes between 14-MAY-2014 and 21-JUL-2014. The registered nurse reported that it was no possible to identify how long the temperatures were down because it was not documented accordingly, since all recorded temperatures by morning and by night were within 2 and 8 degrees. It was reported that the vaccine was removed once the problem was identified and it had not been used after 21-JUL-2014. There were no adverse events reported since all follow ups requested to complete the case were received. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse concerning a neonate of unknown gender. The patient was vaccinated on 02-JUL-2014 at 11:11 AM, the same day that the patient was born, with the first dose of an improperly stored RECOMBIVAX HB lot number J012520, expiration date: 30-JUN-2016, (dose was not reported). It was reported that the vaccine storage temp dipped to 0-1 degrees for 18 different episodes from 14-MAY-2014 to 21-JUL-2014 according to minimum/maximum. It was not possible to identify how long the temps were down. All recorded temps, before midday and after midday were the normal within 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local reaction, Pruritus, Swelling
Clinical narrative: Significant local reaction 2 days post vaccination reddened, hot, swollen and itchy.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Asthenia, Dizziness, Malaise, Pain, Rash erythematous
Clinical narrative: Pt received MENACTRA, flu and GARDASIL on 9-23-14. Mom states she woke in the night at 10:00 pm on 9-23-14 with red dots on her trunk and woke in the middle of the night with body aches and felt hot to the touch. Felt "weak", dizzy with malaise. Wheezing (per pt) on Wed. night rx with VENTOLIN.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Skin warm, Wheezing
Clinical narrative: Pt received MENACTRA, flu and GARDASIL on 9-23-14. Mom states she woke in the night at 10:00 pm on 9-23-14 with red dots on her trunk and woke in the middle of the night with body aches and felt hot to the touch. Felt "weak", dizzy with malaise. Wheezing (per pt) on Wed. night rx with VENTOLIN.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea, Urinary tract infection, Vertigo
Clinical narrative: Patient states that beginning 9/8/14 she experienced significant dizziness, tiredness. On 9/9/14, she also began to have severe nausea. She went to an urgent care on 9/10/14 and then to the ER the night of 9/10/14.
Age: 0.61
Sex: F
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Muscular weakness, Periorbital oedema, Pruritus, Throat tightness
Clinical narrative: Developed throat tightness, periorbital edema, lower extremity weakness, pruritus and diaphoresis approximately 30-40 minutes after the vaccine - flu vaccine. EMS called and given IV access of NS; BENADRYL 50mg IV, given; EPIPEN on right thigh given; 50mg CORTEF 100mg IV given.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 0 day old neonate female patient. On 20-MAY-2014 at 3:00 AM the patient was vaccinated on a public clinic with public founds with an improperly stored of RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse symptoms reported. The storage temperature of RECOMBIVAX HB was between 0 and 1 degrees, on 18 different episodes between 14-MAY-2014 and 21-JUL-2014. The registered nurse reported that it was no possible to identify how long the temperatures were down because it was not documented accordingly, since all recorded temperatures by morning and by night were within 2 and 8 degrees. It was reported that the vaccine was removed once the problem was identified and it had not been used after 21-JUL-2014. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (medical assistant) refers to ten unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, ten unspecified patients were vaccinated with GARDASIL (dose, route and lot number were not provided. On an unknown date, GARDASIL were exposed to temperatures outside of the proper storage range and no adverse effect was reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 28 year old female patient without drug allergies. On 02-SEP-2014 the patient was vaccinated with GARDASIL, dose 4 (dose, lot # and route of administration were not reported). There was no concomitant medication. The patient became pregnant with last menstrual period (LMP) of 08-FEB-2014 and estimated date of delivery (EDD) of 15-NOV-2014. Initial exposure to GARDASIL was at 29 week(s). The pregnancy outcome was outcome pending. It was reported that on 02-SEP-2014 the pregnant patient received GARDASIL during pregnancy instead of Tdap. On 02-SEP-2014 the patient received Tdap after it was realized that patient received GARDASIL instead of Tdap on the same day (02-SEP-2014). The patient stated that she completed a 3 doses series of GARDASIL on specified dates in 2008. The patient did not receive any treatment. There were not laboratory diagnostics performed. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Fatigue, Headache, Heart rate increased, Influenza like illness
Clinical narrative: Patient complained of rapid heartbeat, flu like symptoms, fatigue, insomnia and headache. Pt said she was also experiencing an anxiety attack at this time.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia
Clinical narrative: Patient complained of rapid heartbeat, flu like symptoms, fatigue, insomnia and headache. Pt said she was also experiencing an anxiety attack at this time.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Malaise
Clinical narrative: Patient described a 24 hr of complete malaise requiring bed rest directly following vaccine administration. "Complete lack of energy".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm sore, red and hot area below area of inj.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site reaction, Local reaction, Pain
Clinical narrative: Local reaction at the injection site. Very very painful and redness.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site discomfort, Injection site swelling
Clinical narrative: Patient had discomfort, swelling at site of ZOSTAVAX injection. A localized cellulitis was diagnosed - pt rec'd antibiotic injection and oral antibiotic.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Pt came back to pharmacy on 9/26/14 after receiving shots on 9/22 to report fever of 102 degrees and arm is red from shoulder to elbow and hot to touch.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a approximately 16 year old male patient. The patient's drug allergies and pertinent medical history was none. On 19-SEP-2014 the patient was vaccinated with second dose of GARDASIL  (dose, frequency and route were not reported) (lot # K001500 and expiry date: 06-NOV-2016). Concomitant medications were none. On an unkonwn date in September 2014 (reported as over the weekend) the patient experienced sunburn type rash. Nurse reported that the patient sought medical attention on 22-SEP-2014, physician stated it as medication reaction. The physician gave the patient 40mg Triamcinolone Acetonide intramuscular as treatment. The patient further took BENADRYL and applied cool compress as treatment. Nurse reported physician told the patient to come back after 2 days to re-evaluate the rash. Nurse reported when patient received his first dose of GARDASIL on an unknown date, the patient experienced soreness at the injection site. The outcome of sunburn type rash, medication reaction and soreness at injection site was unknown. The causality of the events was not provided. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Adverse drug reaction, Injection site pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a approximately 16 year old male patient. The patient's drug allergies and pertinent medical history was none. On 19-SEP-2014 the patient was vaccinated with second dose of GARDASIL  (dose, frequency and route were not reported) (lot # K001500 and expiry date: 06-NOV-2016). Concomitant medications were none. On an unkonwn date in September 2014 (reported as over the weekend) the patient experienced sunburn type rash. Nurse reported that the patient sought medical attention on 22-SEP-2014, physician stated it as medication reaction. The physician gave the patient 40mg Triamcinolone Acetonide intramuscular as treatment. The patient further took BENADRYL and applied cool compress as treatment. Nurse reported physician told the patient to come back after 2 days to re-evaluate the rash. Nurse reported when patient received his first dose of GARDASIL on an unknown date, the patient experienced soreness at the injection site. The outcome of sunburn type rash, medication reaction and soreness at injection site was unknown. The causality of the events was not provided. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Blood uric acid normal, Exposure during pregnancy, Foetal disorder, Full blood count
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypertension, Injection site erythema, Injection site swelling, Metabolic function test normal
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Neutrophil percentage increased, Tachycardia, Tachycardia foetal, Ultrasound antenatal screen normal, Ultrasound biliary tract normal
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ultrasound scan normal, White blood cell count increased
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal discomfort, Blood lactate dehydrogenase normal, Blood pressure increased, Blood uric acid normal, Body temperature increased
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Chills, Exposure during pregnancy, Full blood count normal, Headache
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Injection site erythema, Injection site inflammation, Laboratory test normal, Palpitations
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Specific gravity urine normal, Ultrasound abdomen normal, Ultrasound antenatal screen normal
Clinical narrative: On Wednesday 9/24/2014 I started to feel what felt like a tight band under by breast line that stayed, on 9/25/2014 at 0300 I awakened with constant pressure to my chest and abdomin area that felt like a tight binder that would not release, felt like my heart was racing and was chilled.  I took a Tylenol and Motrin and a gas reliever called Cripe water with no relief.  Symptoms got worse through out the day and at 5:30pm I went to the hospital because of the severe abdominal and chest pressure that felt like a tight band that would not ease, rapid heart rate 120's-140's and increased blood pressure.  Low grade temp of 99.4 oral, constant headache fetal heart rate was present as well on arrival to the hospital. Tdap site was red and inflammed to right upper arm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache outside of left eye, radiated to left side of head. Fairly severe pain, I don't usually get headaches.
Age: 18.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: Pt given influenza vaccination intranasally and immediately developed a bloody nose.  Bleeding controlled with direct pressure after 10 minutes.  Per patient this is his intranasal immunization.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Aphagia, Headache, Mobility decreased, Nausea, Oropharyngeal pain
Clinical narrative: Couldn't eat or stay awake, high fever couldn't lift arm, throwing up, sore throat, headache severe. 09/27/2004, arm still cant lift, and nauseous.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: Couldn't eat or stay awake, high fever couldn't lift arm, throwing up, sore throat, headache severe. 09/27/2004, arm still cant lift, and nauseous.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Back pain, Chest pain, Dyskinesia, Dyspnoea, Feeling abnormal
Clinical narrative: Around 9:00 pm, possibly later, patient's pulse was very high (around 95), chest pain, felt like she was having trouble breathing, low back pain and said she just felt really strange and jerking.  Could not rest or relax.  Next morning was fine and back to normal except for the low back pain above and across the buttocks.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Heart rate increased, Restlessness
Clinical narrative: Around 9:00 pm, possibly later, patient's pulse was very high (around 95), chest pain, felt like she was having trouble breathing, low back pain and said she just felt really strange and jerking.  Could not rest or relax.  Next morning was fine and back to normal except for the low back pain above and across the buttocks.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abasia, Abdominal pain upper, Activities of daily living impaired, Asthenia, Blood test
Clinical narrative: Vaccine Thurs. am, mild stuffiness Sat. Monday student attended classes. Developed severe headache from base skull to front head around eyes, associated with severe dizziness, weakness, severe nausea, left arm cold, numb, with moderate left arm pain from the elbow down. Patient went to ER at around midnight. She was given IV fluids, compazine, Benadryl & sent back to her dormitory @ 04:30 Tues the 23rd. She saw an MD at the health office Wed. afternoon & received Motrin. Her headache remained on & off & she was unable to return to classes. Her dizziness, nausea, weakness, & confusion remained. Thursday the 25th, I, (pt's mother & RN ), came to see her but before I arrived, she called crying asking what was wrong with her. She said she could not walk, was extremely dizzy, nauseated, & had fallen & was "crunching." She was taken via ambulance to Hospital. She was given IV fluids, compazine, which she had been prescribed at the first ER on Mon/Tues. She had only taken 2 oral doses that day for nausea. I arrived 3pm Thurs. She started having what they called "dystonic" movements. She appeared to be having seizure like movements. The staff gave her Benadryl IV. A cpl hrs later the episode occurred again & they repeated Benadryl. They released her 1:30 Fri we had to return less than an hour because she had 2 seizure like episodes in her room. They admitted her to ED for short time just watched her. Only saw neurologist once & routine bloodwork. No CT, no LP, no CT. I brought her home & as of now she still has severe stomach pain, weakness, stiffness, glossy eyes, is "clammy" feeling, states she feels confused/foggy. We are returning to the ED now. Our PCP since the start & his PA has felt this is a severe reaction to the vaccine with the symptoms including the hemipelegia & all the other symptoms & the timing & length of symptoms.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Cold sweat, Confusional state, Crying, Dizziness, Dystonia
Clinical narrative: Vaccine Thurs. am, mild stuffiness Sat. Monday student attended classes. Developed severe headache from base skull to front head around eyes, associated with severe dizziness, weakness, severe nausea, left arm cold, numb, with moderate left arm pain from the elbow down. Patient went to ER at around midnight. She was given IV fluids, compazine, Benadryl & sent back to her dormitory @ 04:30 Tues the 23rd. She saw an MD at the health office Wed. afternoon & received Motrin. Her headache remained on & off & she was unable to return to classes. Her dizziness, nausea, weakness, & confusion remained. Thursday the 25th, I, (pt's mother & RN ), came to see her but before I arrived, she called crying asking what was wrong with her. She said she could not walk, was extremely dizzy, nauseated, & had fallen & was "crunching." She was taken via ambulance to Hospital. She was given IV fluids, compazine, which she had been prescribed at the first ER on Mon/Tues. She had only taken 2 oral doses that day for nausea. I arrived 3pm Thurs. She started having what they called "dystonic" movements. She appeared to be having seizure like movements. The staff gave her Benadryl IV. A cpl hrs later the episode occurred again & they repeated Benadryl. They released her 1:30 Fri we had to return less than an hour because she had 2 seizure like episodes in her room. They admitted her to ED for short time just watched her. Only saw neurologist once & routine bloodwork. No CT, no LP, no CT. I brought her home & as of now she still has severe stomach pain, weakness, stiffness, glossy eyes, is "clammy" feeling, states she feels confused/foggy. We are returning to the ED now. Our PCP since the start & his PA has felt this is a severe reaction to the vaccine with the symptoms including the hemipelegia & all the other symptoms & the timing & length of symptoms.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Fall, Feeling abnormal, Glassy eyes, Headache, Hemiplegia
Clinical narrative: Vaccine Thurs. am, mild stuffiness Sat. Monday student attended classes. Developed severe headache from base skull to front head around eyes, associated with severe dizziness, weakness, severe nausea, left arm cold, numb, with moderate left arm pain from the elbow down. Patient went to ER at around midnight. She was given IV fluids, compazine, Benadryl & sent back to her dormitory @ 04:30 Tues the 23rd. She saw an MD at the health office Wed. afternoon & received Motrin. Her headache remained on & off & she was unable to return to classes. Her dizziness, nausea, weakness, & confusion remained. Thursday the 25th, I, (pt's mother & RN ), came to see her but before I arrived, she called crying asking what was wrong with her. She said she could not walk, was extremely dizzy, nauseated, & had fallen & was "crunching." She was taken via ambulance to Hospital. She was given IV fluids, compazine, which she had been prescribed at the first ER on Mon/Tues. She had only taken 2 oral doses that day for nausea. I arrived 3pm Thurs. She started having what they called "dystonic" movements. She appeared to be having seizure like movements. The staff gave her Benadryl IV. A cpl hrs later the episode occurred again & they repeated Benadryl. They released her 1:30 Fri we had to return less than an hour because she had 2 seizure like episodes in her room. They admitted her to ED for short time just watched her. Only saw neurologist once & routine bloodwork. No CT, no LP, no CT. I brought her home & as of now she still has severe stomach pain, weakness, stiffness, glossy eyes, is "clammy" feeling, states she feels confused/foggy. We are returning to the ED now. Our PCP since the start & his PA has felt this is a severe reaction to the vaccine with the symptoms including the hemipelegia & all the other symptoms & the timing & length of symptoms.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Nasal congestion, Nausea, Pain in extremity
Clinical narrative: Vaccine Thurs. am, mild stuffiness Sat. Monday student attended classes. Developed severe headache from base skull to front head around eyes, associated with severe dizziness, weakness, severe nausea, left arm cold, numb, with moderate left arm pain from the elbow down. Patient went to ER at around midnight. She was given IV fluids, compazine, Benadryl & sent back to her dormitory @ 04:30 Tues the 23rd. She saw an MD at the health office Wed. afternoon & received Motrin. Her headache remained on & off & she was unable to return to classes. Her dizziness, nausea, weakness, & confusion remained. Thursday the 25th, I, (pt's mother & RN ), came to see her but before I arrived, she called crying asking what was wrong with her. She said she could not walk, was extremely dizzy, nauseated, & had fallen & was "crunching." She was taken via ambulance to Hospital. She was given IV fluids, compazine, which she had been prescribed at the first ER on Mon/Tues. She had only taken 2 oral doses that day for nausea. I arrived 3pm Thurs. She started having what they called "dystonic" movements. She appeared to be having seizure like movements. The staff gave her Benadryl IV. A cpl hrs later the episode occurred again & they repeated Benadryl. They released her 1:30 Fri we had to return less than an hour because she had 2 seizure like episodes in her room. They admitted her to ED for short time just watched her. Only saw neurologist once & routine bloodwork. No CT, no LP, no CT. I brought her home & as of now she still has severe stomach pain, weakness, stiffness, glossy eyes, is "clammy" feeling, states she feels confused/foggy. We are returning to the ED now. Our PCP since the start & his PA has felt this is a severe reaction to the vaccine with the symptoms including the hemipelegia & all the other symptoms & the timing & length of symptoms.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Peripheral coldness, Seizure like phenomena
Clinical narrative: Vaccine Thurs. am, mild stuffiness Sat. Monday student attended classes. Developed severe headache from base skull to front head around eyes, associated with severe dizziness, weakness, severe nausea, left arm cold, numb, with moderate left arm pain from the elbow down. Patient went to ER at around midnight. She was given IV fluids, compazine, Benadryl & sent back to her dormitory @ 04:30 Tues the 23rd. She saw an MD at the health office Wed. afternoon & received Motrin. Her headache remained on & off & she was unable to return to classes. Her dizziness, nausea, weakness, & confusion remained. Thursday the 25th, I, (pt's mother & RN ), came to see her but before I arrived, she called crying asking what was wrong with her. She said she could not walk, was extremely dizzy, nauseated, & had fallen & was "crunching." She was taken via ambulance to Hospital. She was given IV fluids, compazine, which she had been prescribed at the first ER on Mon/Tues. She had only taken 2 oral doses that day for nausea. I arrived 3pm Thurs. She started having what they called "dystonic" movements. She appeared to be having seizure like movements. The staff gave her Benadryl IV. A cpl hrs later the episode occurred again & they repeated Benadryl. They released her 1:30 Fri we had to return less than an hour because she had 2 seizure like episodes in her room. They admitted her to ED for short time just watched her. Only saw neurologist once & routine bloodwork. No CT, no LP, no CT. I brought her home & as of now she still has severe stomach pain, weakness, stiffness, glossy eyes, is "clammy" feeling, states she feels confused/foggy. We are returning to the ED now. Our PCP since the start & his PA has felt this is a severe reaction to the vaccine with the symptoms including the hemipelegia & all the other symptoms & the timing & length of symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vitreous floaters
Clinical narrative: Left eye became engulfed with floaters.  Will see eye MD on Monday.  Unable to see correctly.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Dizziness, Ear, nose and throat examination
Clinical narrative: Severe dizziness and vomiting vertigo continues.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Vertigo, Vomiting
Clinical narrative: Severe dizziness and vomiting vertigo continues.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Injection site pain, Lacrimation increased, Muscular weakness
Clinical narrative: Weakness in legs and arms, pain at injection site, hot, clammy, wheezy, shaky, sneezy, eyes watering, fever, nauseous.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Sneezing, Tremor, Wheezing
Clinical narrative: Weakness in legs and arms, pain at injection site, hot, clammy, wheezy, shaky, sneezy, eyes watering, fever, nauseous.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Influenza, Nausea
Clinical narrative: Headache, Aches and Pains, Sore Throat, Cough, nausea and Chills.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Headache, Aches and Pains, Sore Throat, Cough, nausea and Chills.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia, Sensation of heaviness
Clinical narrative: Felt fine directly after and started to feel numb around area and feeling tingling around area and tingling spread down arm over night.  Patients reports limb as feeling heavy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling, Pain
Clinical narrative: Patient's arm swelled when the injection was given and began to bleed immediately after the needle was pulled out of the arm.  The patient was called later and he said he was sore, but otherwise he was fine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Lightheadedness, rapid pulse.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Within 30 minutes patient developed nickle-sized red bump. By next day it was the size of a 50 cent piece. The next day if was larger and warm and sore to touch. She also had a low-grade fever. Visited family doctor on 9/25/14 and was diagnosed with local cellulitis and prescribed Augmentin 875mg twice a day for 10 days. By 9/27/14 the bump was resolving but not yet gone.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Within 30 minutes patient developed nickle-sized red bump. By next day it was the size of a 50 cent piece. The next day if was larger and warm and sore to touch. She also had a low-grade fever. Visited family doctor on 9/25/14 and was diagnosed with local cellulitis and prescribed Augmentin 875mg twice a day for 10 days. By 9/27/14 the bump was resolving but not yet gone.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from approximately the shoulder to the elbow.  Appeared to be an allergic reaction.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Soreness at injection site-took ibuprofen for pain relief, applied arnicare natural cream neither gave relief from the soreness. Dizziness and nausea 1-2 days after the vaccine was administered--pt took dramamine but had no relief. Headache that comes and goes 1 day after the vaccine.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itching, hives.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Rash generalised, Rash macular
Clinical narrative: Rash on entire body from face (including scalp) to ankle. Rash began on torso - entire torso is red. Rash went down both legs getting more diffuse below knee. Neck and arms are blotchy.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash on entire body from face (including scalp) to ankle. Rash began on torso - entire torso is red. Rash went down both legs getting more diffuse below knee. Neck and arms are blotchy.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on left arm
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, fever greater than 102, light headed, weak, diarrhea, hives. Just resting at home and taking Tylenol cold and flu and drinking plenty of fluids.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria, Vomiting
Clinical narrative: Nausea, vomiting, fever greater than 102, light headed, weak, diarrhea, hives. Just resting at home and taking Tylenol cold and flu and drinking plenty of fluids.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Headache, tingling all over body, nausea, vision (dots) weak, loss of energy, really tired, everything just seems diffrent and weird he says.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: Headache, tingling all over body, nausea, vision (dots) weak, loss of energy, really tired, everything just seems diffrent and weird he says.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient called pharmacy 9/27/14 to ask if having a rash on his face was normal from the shingles vaccine. The rash started the day after he received the shingles immunization. I suggested he follow up w/ his primary doctor.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incorrect dose administered, Local swelling, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX 23 in fall 2013. Patient administered PNEUMOVAX 23 again on Sept. 25, 2014. Patient states that arm is now sore and swollen. Started morning of Sept. 27.
Age: 1.6
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 19 month old male patient. Pertinent medical history, drug reaction or allergies were not reported. On 11-SEP-2014 the 19 month old patient was scheduled to receive DTaP but was inadvertently vaccinated with GARDASIL, "1 single shot", (dose, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. The patient sought medical attention (unspecified). The outcome of the events was unknown. Additional information is not expected because the reporter details were not provided.
Age: 16.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. On an unknown date in 2014 (reported as within the last two weeks) the patient was inadvertently administered ZOSTAVAX instead of (Oka/Merck) VARIVAX (dose, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 22-SEP-2014 the patient was vaccinated with improperly transported and handled (Oka/Merck) VARIVAX (lot # K005185, expiration date 10-APR-2016, dose and route were not provided. The product was en route to the office for 5 days, received in the office outside of the allowable shipping time prior to vaccination. No adverse symptom was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old female patient. The patient's medical history was not reported. On 22-SEP-2014 (reported as yesterday) the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (Dose: 0.5 ml, Route: subcutaneous in the left arm) (lot # K002927 and expiry date: 16-FEB-2016) instead of ZOSTAVAX. Staff error only. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is lined to case # 1409USA012416 (same reporter link). Additional information is not expected as the reporter did not wish to contact.