chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Exposure during pregnancy, Uterine contractions during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015 the patient was inadvertently received a dose of GARDASIL (lot # K009482, expiration date; 06-MAR-2017, 0.5 ml, intramuscular) instead of Tdap, while pregnant at 27 weeks and 5 days. The last menstrual period (LMP) was 19-SEP-2014 and the estimated date of delivery (EDD) was 26-JUN-2015. Concomitant therapies included RHOGAM and Tdap. The patient visited the office, it was determined that the patient was having contractions and she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on 31-MAR-2015. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified). At the time of the report the outcome of adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Blood group A, Breech presentation, Caesarean section, Complication of delivery, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015 the patient was inadvertently received a dose of GARDASIL (lot # K009482, expiration date; 06-MAR-2017, 0.5 ml, intramuscular) instead of Tdap, while pregnant at 27 weeks and 5 days. The last menstrual period (LMP) was 19-SEP-2014 and the estimated date of delivery (EDD) was 26-JUN-2015. Concomitant therapies included RHOGAM and Tdap. The patient visited the office, it was determined that the patient was having contractions and she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on 31-MAR-2015. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified). At the time of the report the outcome of adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Foetal disorder, Pre-eclampsia, Pregnancy test urine, Premature rupture of membranes, Streptococcus test negative
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015 the patient was inadvertently received a dose of GARDASIL (lot # K009482, expiration date; 06-MAR-2017, 0.5 ml, intramuscular) instead of Tdap, while pregnant at 27 weeks and 5 days. The last menstrual period (LMP) was 19-SEP-2014 and the estimated date of delivery (EDD) was 26-JUN-2015. Concomitant therapies included RHOGAM and Tdap. The patient visited the office, it was determined that the patient was having contractions and she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on 31-MAR-2015. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified). At the time of the report the outcome of adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Transfusion, Ultrasound antenatal screen normal, Uterine atony
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015 the patient was inadvertently received a dose of GARDASIL (lot # K009482, expiration date; 06-MAR-2017, 0.5 ml, intramuscular) instead of Tdap, while pregnant at 27 weeks and 5 days. The last menstrual period (LMP) was 19-SEP-2014 and the estimated date of delivery (EDD) was 26-JUN-2015. Concomitant therapies included RHOGAM and Tdap. The patient visited the office, it was determined that the patient was having contractions and she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on 31-MAR-2015. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified). At the time of the report the outcome of adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Vaccination complication
Clinical narrative: Pt. had 1 1/2-2 inches red raised bump on her (R) arm SQ adverse reaction to injection. Varicella VIS 3/13/08.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Generalised tonic-clonic seizure, Pyrexia, Seizure, Tremor
Clinical narrative: Received vaccines documented below at approximately 1400. At 1700 the same day the patient developed fever to 104 F. Was taken to an ED, where he was documented to have an 8 minute generalized tonic-clonic seizure and then a second seizure with left sided shaking (unknown duration).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure, fever 103.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: MMR given on 3/26/15. Rash started 4/6/15, widespread by 4/7/15. No treatment needed.
Age: 1.02
Sex: M
Vaccine: UNK
Symptoms: Rash generalised
Clinical narrative: Rash started 4/6/15-spread all over 4/7/15.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular
Clinical narrative: Mac papular mild erythematous rash on upper thighs bilaterally; fine erythematous macules on back and scattered on face and chest.
Age: 40.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On the evening of 3-25-15, patient experienced redness, swelling and itching and pain with the feeling of heat on (R) upper arm at injection site. This lasted about a week. She applied lotion (BENADRYL) a couple of times for the itching.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown ages and genders who were vaccinated with an improperly stored doses of ROTATEQ (lot # reported as K007247, expiration date 30-MAR-2016 or Lot # K008140, expiration date 28-APR-2016, oral) (dose not reported) on either 29-MAR-2015 or 30-MAR-2015. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. No current or historical conditions were reported. On 25-MAR-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscular (lot # J011799 and expiration date 09-FEB-2015) by the reporting nurse. No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. No current or historical conditions were reported. On 26-MAR-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J011882, expiration date 04-JAN-2015, dose and route were unknown. No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. No current or historical conditions were reported. On 01-DEC-2014 the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX subcutaneous (lot# K007981 and expiration date 03-JUN-2016). No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Adverse reaction, Local reaction, Peripheral swelling, Tenderness
Clinical narrative: Pt. in HD for vaccines (HIB, MENACTRA, PNEUMOVAX 23) per her Dr's orders on 4-1-15. Pt called Friday 4-3-15, having swollen arm (R), told her to make appt with primary Dr, Dr.'s office called said she was having adverse reaction, swollen arm, lg local reaction, tender and swollen. (PNEUMOVAX 23 and HIB) given in this arm.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of COMVAX (route, dose, Lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, Lot# and expiration date were not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction, red swollen raised, the size of two quarters.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Had new pneumonia shot on 03/23/2015 night I had whole body (muscle and joint) ache. 03/24/15 felt better but very weak. 03/26/15 my arm had site redness and itching until now. No redness but itching arm still feels itching.
Age: 85.0
Sex: U
Vaccine: PNC13
Symptoms: Cough, Diarrhoea, Speech disorder
Clinical narrative: On 3/19 Dr advised that I should have PCV 13 injection and I said I would get it done at a local pharmacy. I rec'd the shot at the market on 3/22. On 3/23 I started coughing and could hardly speak. On following days my condition was and is worse and as of 3/26, am unable to leave house because of coughing and diarrhea.
Age: 1.01
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: None stated.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to an adult (currently 39 year old) patient of unknown gender. The patient's medical history was not reported. In 2009 (exact dates were not reported), the patient was vaccinated with the first two doses of GARDASIL (lot #, dose, route and site of administration were not reported). In approximately 2015 (reported as "this past week"), the patient was vaccinated with a dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Patient described severe shoulder pain on the vaccinated side. He required steroid injections at the site to reduce inflammation. He described the same symptoms after a previous vaccine.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Arthralgia, Asthenia, Asthma, Back pain
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Bed rest, Blood pressure increased, Blood test, Blood uric acid abnormal, Cardiac stress test
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Cough, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Gout, Impaired driving ability, Joint stiffness, Joint swelling
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Middle insomnia, Muscular weakness, Pain in extremity, Peripheral swelling, Productive cough
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Ultrasound Doppler, Weight bearing difficulty
Clinical narrative: Feb. 11-2015-I went to Dr for a wellness check I was given pneumococcal conjugate vaccine-PCV-13. No effects that day. Feb.12-2015-I am tiring very easily but at 73-that come with life. Feb. 13-14-15-16-17-18-19-20-2015-I was very achy in legs, shoulder joints, lower back. My legs felt like they just couldn't hold me up. Very weak. Around the 16th I started getting shorter and shorter of breath and much more exhausted. Early Saturday morning, Feb. 21, around 3:30 a.m., two (2) very sharp chest pains shot down the middle of my chest-waking me up. Wasn't sure what to do. I called the telenurse, explained my situation. She suggested I call 911-call police department-they called ambulance. (I've lived here 44 years, small town). Feb. 21-2015-I was admitted to hospital-short of breath, gasping, blood pressure slightly elevated. Coughing constantly-small amount of phlegm. Feb. 22-2015-hospital drew many vials of blood-was not sure if I was having a heart attack. Feb. 23-2015-Had 2 heart tests-1 stress test and echogram. I started on prednisone and cough syrup. Also, an antibiotic was administered. Had the worst asthma attack in decades. Feb. 24-2015- I was released from hospital, told to see Dr, March 3, for follow up visit. I told the nurse my foot hurt really bad before I left the hospital. Feb. 25-2015-I returned home, very fatigued, even to drive. Foot pain unbearable, leg and ankle really swollen. Got an appointment with Dr at urgent care. Right leg was 5 inches larger than left. I was so weak, could not walk or drive. My leg and foot pain was very bad. Friend had to drive me to doctor, then to hospital for Doppler on Right leg for blood clot. Blood test showed uric acid-gout-never had gout that I can recall. I spent the next 2 weeks at home, in bed. Extremely exhausted and very weak. Only got out of bed to see Dr on March 3 for follow up visit from hospital. Returned home for more bed rest-so fatigued and no energy. March 3-2015-Follow up at Dr. March 10-2015-I am now pushing myself to stay up and out of bed. Had difficulty walking, lower back pain. I felt as if I was walking on stick-legs. Legs and shoulder joints still very achy. March 10-present day-2015-I exercise daily, sometimes 2 times a day. I ride a stationary bike and in a hot tub to keep joints moving. March 26-2015-Went to facility for follow up heart check up. The term Guillain-Barre Syndrome was mentioned. I am so thankful it isn't. My joints are still sore and stiff but I am getting better. Have a yearly check at facility. Present day-Getting better-still tired but not extremely fatigued or totally exhausted, exercise daily and keep moving. I do believe the vaccine was responsible for my illness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (route, dose, Lot# and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash, Rash macular
Clinical narrative: Large red area on right superolateral thigh. Warm to touch - splotchiness. Diagnosis exanthem.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling at injection site. Acetaminophen 650 mg prn, cetirizine 10 mg every day.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: Rash, urticaria pruritus and nausea vomiting. Diphenhydramine 50 mg once, epinephrine 0.3 mg once, prednisone 60 mg once.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and EDD of 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency and route were unknown) in error. The physician did not have access to the lot number and expiration date of the dose of VARIVAX (Merck), since it was not administered in her practice. No adverse effects had been observed or reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Alpha 1 foetoprotein normal, Blood glucose, Blood group O, Complication of delivery, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and EDD of 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency and route were unknown) in error. The physician did not have access to the lot number and expiration date of the dose of VARIVAX (Merck), since it was not administered in her practice. No adverse effects had been observed or reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Foetal disorder, Haemorrhage, Labour induction, Postpartum disorder, Rhesus antibodies positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and EDD of 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency and route were unknown) in error. The physician did not have access to the lot number and expiration date of the dose of VARIVAX (Merck), since it was not administered in her practice. No adverse effects had been observed or reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Streptococcus test negative, Transfusion, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and EDD of 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency and route were unknown) in error. The physician did not have access to the lot number and expiration date of the dose of VARIVAX (Merck), since it was not administered in her practice. No adverse effects had been observed or reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Describes painful, swelling to right arm injection site on 04/04/15 (date injection given) then on 04/05/15 developed bruising, pain, 04/06/15 area measures 1.74 x 1/25" with 04/06/15 dark purple bruising, swelling, itching, warm to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-APR-2015 the patient received an expired dose of ZOSTAVAX (lot # K000328, expiration date 06-MAR-2015, 0.65 ml, subcutaneously). No adverse experiences reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Dizziness, Lymphadenopathy, Pain, Sinus headache
Clinical narrative: 3 days after vaccines given noted swelling of lymph nodes under right arm. Occurring 4-6-15. This AM 4-7-15 noted right side pains and sinus pain. Dizziness that is improving over the morning. No fever.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (route, dose, Lot# and expiration date were not reported). No adverse effects were experiences. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Gait disturbance, Hyperreflexia, Immediate post-injection reaction
Clinical narrative: Immediately following the vaccine (HPV), the patient felt lightheaded and slouched over. 15 minutes later, he had an unsteady gait. On my exam, he was stumbling with decreased strength in upper extremities, lower extremities and hyper-reflexic DTRs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown ages and genders who on an unknown dates were vaccinated with an improperly stored (incorrect product storage) doses of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers two unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with an improperly stored (incorrect product storage) doses of GARDASIL (lot # K009482, expiration date 16-MAR-2017) (dose and route were not reported). No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 10-SEP-2014 the patient was vaccinated with a dose of MMR II (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received HAVRIX (batch number X9LB7, expiry date 10th February 2017). On an unknown date, the patient received HAVRIX (unknown). On an unknown date, an unkonwn time after receiving HAVRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: HCP reported that HAVRIX was given to a 2 month old patient by accident. They meant to give the patient a Hepatitis B vaccine.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Oropharyngeal discomfort, Pain, Pruritus
Clinical narrative: Had previous series 2001 of rabies vaccine. Woke up 4/3/15 with joint aches, sorenss and fatigue. Went to work ok. Work up 4/4/15 with hives on back of scalp, itchy-continued to spread 4/5/15-approx 3 am-covered in hives, felt funny in throat went to ER. D/C worse few hours later went back to ER. Saw allergist now on prednisone spread out instead of lump dose.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Had previous series 2001 of rabies vaccine. Woke up 4/3/15 with joint aches, sorenss and fatigue. Went to work ok. Work up 4/4/15 with hives on back of scalp, itchy-continued to spread 4/5/15-approx 3 am-covered in hives, felt funny in throat went to ER. D/C worse few hours later went back to ER. Saw allergist now on prednisone spread out instead of lump dose.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown ages and genders who on an unknown dates were vaccinated with an improperly stored doses of (Oka-Merck) PROQUAD (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pruritus, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Per 3/25/15 Nursing Outpt Progress Note: Pt wife called reporting that patient has a reaction from the PREVNAR given on 3/23/15. Yesterday patient has a fever, given TYLENOL 500mg with help. Has a rash over the face and back of ears. Wife using Hydrocortisone cream. She verbalized that she will just monitor him and if conditions worsen. She will bring him to the emergency room. Relayed to dr. Per 3/31/15 addendum by dr to 3/25/15 Nursing Outpt Progress Note: called to follow up got fevers/muscle ache and rash all over body-no doe per se itching resolved after 3-4 days feeling well now. Myalgia, Urticaria, pruritus.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Bedridden, Decreased appetite, Dizziness, Injection site pain, Malaise
Clinical narrative: Pt stated he felt crummy evening of 4-2-15 and by Friday 4-3-15 he was bedridden. C/o ringing in ears, dizziness, light headedness, injection site painful to touch, no appetite could only eat toast and water and lost 10 lbs., achy neck joints, low grade fever. Pt recovered by Sunday 4-5-15. Denied any previous vaccination reaction in the past.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain, Pyrexia, Tinnitus, Weight decreased
Clinical narrative: Pt stated he felt crummy evening of 4-2-15 and by Friday 4-3-15 he was bedridden. C/o ringing in ears, dizziness, light headedness, injection site painful to touch, no appetite could only eat toast and water and lost 10 lbs., achy neck joints, low grade fever. Pt recovered by Sunday 4-5-15. Denied any previous vaccination reaction in the past.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored PEDVAXHIB (dose, strength, route and lot# were not reported). No adverse effects reported. Follow up information has been received on 01-APR-2015 from the Licensed Practical Nurse via a telephone call. The lot number and expiration date for the PEDVAXHIB vaccination was provided: lot number: K002818, expiration date: 10-DEC-2016. The nurse reported that patient identification information was not readily available at the time of the call and there were no reported adverse events. This case was one of the 7 reports received from the same reporter (other two products were captured in case 1502USA005910, 1503USA003159, 1504USA002730 and 1504USA002731; the other two reports concerning the same product was captured in 1504USA003188 and 1503USA003160). Additional information has been requested. Product and narrative were updated.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored LIQUID PEDVAXHIB (dose, strength, route and lot# were not reported). No adverse effects reported. Follow up information has been received on 01-APR-2015 from the Licensed Practical Nurse via a telephone call. The lot number and expiration date for the LIQUID PEDVAXHIB vaccination was provided: lot number: K008877, expiration date: 24-FEB-2017. The nurse reported that patient identification information was not readily available at the time of the call and there were no reported adverse event. This case was one of the 7 reports from the same reporter (other two products were captured in case 1502USA005910, 1503USA003159, 1504USA002730 and 1504USA002731; the other two reports concerning the same product was captured in 1504USA003187 and 1503USA003160). Additional information has been requested. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to unspecified patients. On unknown dates the patient were vaccinated with improperly stored GARDASIL (lot # K007828, expiration date, route and dose unspecified). No adverse event. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Drug dose omission, Erythema, Malaise, Mouth swelling, Pruritus
Clinical narrative: Case previously recorded as EM2000-0003. Hives, swollen mouth: A female patient (age and past history unknown) was exposed to rabies by picking up a rabid animal. She was treated with three doses of RABAVERT, but developed systemic reactions (swollen mouth, hives) to RABAVERT 2 days after the third injection. The patient went to the emergency room to receive treatment. The company physician assessed that the event was possibly related to RABAVERT, and that the case was medically significant. Additional information received 07 Feb 00: On 14 Dec 99, the patient, a 25-year-old female, presented for rabies immunoglobulin (RIG) vaccine and RABAVERT for a cat bite to the middle finger of the left hand on 23 Nov 99. the animal had not been captured and status of animal is unknown. The patient was administered 14.7 ml of RIG in divided doses to the left and right of the gluteal muscle intramuscularly and 1 ml RABAVERT to the left deltoid on 14 Dec 99. The patient missed her fourth RABAVERT vaccine on 04 Jan 00 due to "not feeling well" and said she broke out in hives on 23 Dec 99, two days after the third RABAVERT dose. On 26 Dec 99, she was treated in a private clinic for urticarial rash on the arms, back of the neck, itching and redness to the hands, feet, and lips. The physician at the private clinic stated the hives were caused by something internal, not external. She was discharged in stable condition and advised to follow-up with her personal physician in two days. The patient had not informed the physician at the time that she was receiving post exposure rabies vaccination. On 13 Jan 00 and 27 Jan 00, she received her fourth and fifth vaccination.