chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   On an unspecified date the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  The subject was 4 weeks gestational age when she received the vaccine.  No further information was provided.  Follow-up received from a healthcare professional on 07 July 2011: The subject was 36 years-old.  Her last menstrual period was on 16 February 2011.  She received Boostrix intramuscularly at 4 weeks gestation, before she knew she was pregnant.  The estimated delivery date was reported as 21 November 2011.  The conception was reported as normal and not in-vitro fertilization.  The pregnancy was a single foetus.  At the time of reporting, the subject had no adverse events or complications.  03 April 2012:  Reporter indicated follow-up information was forthcoming.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Glucose tolerance test abnormal, Prenatal screening test
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included ectopic pregnancy and three normal full-term live births.      On 1 September 2011 the subject received a dose of Boostrix (.5 unknown units, intramuscular, unknown route), and experienced vaccine exposure during pregnancy.  The subejct was vaccinated at approximately 37 weeks gestation.  Date of last menstrual period was 09 December 2010 and estimated delivery date was 22 September 2011.  The subject had not been using contraception prior to becoming pregnant.  The conception was normal.  Prenatal testing revealed no evidence of a defect, including 4 ultrasounds.  Maternal serum alfa-fetoprotein was positive on 07 April 2011.  Quad screen was positive, but scans revealed normal anatomy.  The subject declined an amniocentesis.  The subject had one abnormal value on 3 hour glucose tolerance test, but was negative for gestational diabetes mellitus.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 07 April, 22 April, 08 June and 17 August 2011, with no evidence of fetal defect. Amniocentesis was not performed. One abnormal value on 3 hour glucose tolerance test (not gestational diabetes mellitus). Quad screen positive; normal anatomy scan.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  Prior to becoming pregnant the subject had not been using contraception.  On 29 August 2011 at 13:30 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 24 weeks gestation at the time of vaccination.  Date of last menstrual period was 24 February 2011 and estimated delivery date was 16 December 2011.  Prenatal testing including ultrasound on 31 August 2011 had revealed no evidence of a defect.  There were no adverse events at the time of reporting.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound performed on 31 August 2011 revealed no evidence of a defect.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in a normal birth of a full-term infant with no defects.  The subject had not been using contraception before becoming pregnant.  On 29 August 2011 at 14:55 the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during her third trimester of pregnancy.  The conception was reported to be normal.  The subject was approximately 38 weeks pregnant at the time of vaccination.  Date of last menstrual period was 26 November 2010 and estimated delivery date was 10 September 2011.  Ultrasound on 22 April 2011 and maternal serum alpha-fetoprotein on 30 March 2011 had revealed no evidence of a defect.  There were no adverse events at the time of reporting.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 22 April 2011 and maternal serum alpha-fetoprotein on 30 March 2011 revealed no evidence of a defect.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.  Past medical history included no previous pregnancies.  The subject and the father of the baby were smokers.  Prior to becoming pregnant the subject did not use contraception.  On 29 August 2011 at 15:00 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The subject was approximately 37 weeks gestation at the time of vaccination.  The conception was reported to be normal.  Date of last menstrual period was 07 December 2010 and estimated delivery date was 13 September 2011.  Prenatal testing including ultrasounds on 25 April 2011 and 11 July 2011, and maternal serum alpha-fetoprotein on 28 March 2011 had revealed no evidence of a defect.  There were no adverse events at the time of reporting.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 25 April 2011 and 11 July 2011, and maternal serum alpha-fetoprotein on 28 March 2011 revealed no evidence of a defect.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  Prior to becoming pregnant she had not been using contraception.  On 31 August 2011 at 08:40 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 32 weeks gestation at the time of vaccination.  Date of last menstrual period was 19 January 2011 and estimated delivery date was 26 October 2011.  Prenatal testing including ultrasounds performed on 11 March 2011 and 03 June 2011 had revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds on 11 March 2011 and 03 June 2011 revealed no evidence of a defect.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.  The subject's past medical history included two previous pregnancies resulting in normal births of two full-term infants with no defects.  Concurrent medical conditions included gestational diabetes mellitus under diet control.  The subject had not been using contraception before becoming pregnant.  On 31 August 2011, the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during her third trimester of pregnancy.  The conception was reported to be normal.  The subject was approximately 36 weeks gestation at the time of vaccination.  Date of last menstrual period was 22 December 2010 and estimated delivery date was 28 September 2011.  Ultrasound on 10 May 2011 and maternal serum alpha-fetoprotein on 20 April 2011 had revealed no defects.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 10 May 2011 and maternal serum alpha-fetoprotein on 20 April 2011 had revealed no defects.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included three previous pregnancies resulting in one elective abortion and two normal full-term live births.  The subject had not been using contraception prior to becoming pregnant.  On 8 September 2011 the subject received a dose of Boostrix (.5 ml, intramuscular, unknown site), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal and date of last menstrual period was 22 December 2010.  Estimated date of delivery was 29 September 2011.  Prenatal testing, including ultrasounds performed on 11 May and 31 August 2011, and maternal serum alpha-fetoprotein on 07 April 2011 revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 11 May and 31 August 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 07 April 2011 revealed no evidence of a defect.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in normal birth of a full-term live infant with no defect.  The subject had not been using contraception before becoming pregnant.  On 7 September 2011 at 13:48 the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 34 weeks pregnant at the time of vaccination.  Date of last menstrual period was 12 January 2011 and estimated date of delivery was 19 October 2011.  Ultrasound on 18 May 2011 had revealed no evidence of a defect.  Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 18 May 2011 had revealed no evidence of a defect.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included two previous pregnancies resulting in normal births of two full-term live infants with no defects.  The subject had not been using contraception before becoming pregnant.  On 08 September 2011 the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 24 weeks gestation at the time of vaccination.  Date of last menstrual period was 15 March 2011 and estimated date of delivery was 20 December 2011.  Ultrasound on 02 September 2011 revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 02 September 2011 revealed no evidence of a defect.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden
Clinical narrative: Some patients are in bed for days; This case was reported by a physician via call center representative and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per vaccine indication. The physician stated that after receiving Shingrix, the patients were in bed for days.  No further details were provided. The reporter consented to follow up. The physician was in a hurry as patients were waiting, and she did not provide any further details after making this general statement, but she did give permission to follow up at the following address. This case has been linked with US2019162773, reported by the same reporter.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain, Product administered to patient of inappropriate age, Rash, Rash vesicular
Clinical narrative: Blistery-painful rash; Blistery-painful rash; Extremely painful arm at injection site; Armpit is swollen on injection site arm; Armpit is tender on injection site arm; Inappropriate age at vaccination; This case was reported by a consumer and described the occurrence of blistery rash in a 45-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the blistery rash, painful rash, injection site pain, local swelling and axillary pain to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, at 10:30 am, the patient received Shingrix. In the evening of the day before the reporting date, the patient experienced blistery-painful rash on side. The patient called the pharmacy who gave the vaccine to ask about side effects and they told the patient to call patient's MD. The patient was seeing MD in the afternoon but wonder if this was an expected reaction. The event was not listed in the common reactions. The patient also experienced extremely painful arm at injection site and my armpit was swollen and tender on injection site arm. The reporter thought that the longer needle was used thus she thought it was intramuscular. The NDC number was reported as 58160-0823-11.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Blistery-painful rash; Blistery-painful rash; Extremely painful arm at injection site; Armpit is swollen on injection site arm; Armpit is tender on injection site arm; Inappropriate age at vaccination; This case was reported by a consumer and described the occurrence of blistery rash in a 45-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the blistery rash, painful rash, injection site pain, local swelling and axillary pain to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, at 10:30 am, the patient received Shingrix. In the evening of the day before the reporting date, the patient experienced blistery-painful rash on side. The patient called the pharmacy who gave the vaccine to ask about side effects and they told the patient to call patient's MD. The patient was seeing MD in the afternoon but wonder if this was an expected reaction. The event was not listed in the common reactions. The patient also experienced extremely painful arm at injection site and my armpit was swollen and tender on injection site arm. The reporter thought that the longer needle was used thus she thought it was intramuscular. The NDC number was reported as 58160-0823-11.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Dermatitis acneiform, Rash, Rash papular
Clinical narrative: RASH ON FACE/RASH ON BODY; rash is pimply; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number RO24271 ?, expiry date 8th May 2021) for prophylaxis and MENACTRA (batch number U6521AA, expiry date 26th January 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Bexsero, HPV vaccine and MENACTRA. In August 2019, less than a week after receiving Bexsero and HPV vaccine, the patient experienced generalized rash and papular rash. The patient was treated with doxycycline and prednisone. On an unknown date, the outcome of the generalized rash and papular rash were recovered/resolved.   It was unknown if the reporter considered the generalized rash and papular rash to be related to Bexsero and HPV vaccine.  Additional information received were as follows: The licensed vocational nurse stated that received Bexsero and Menactra a week before the reporting date and experienced a rash on their face and body that was not itchy. The reporter had had 3 patients that had experienced a rash after having Bexsero, not itchy, on the face and body. First they thought it was giving the menectra and bexsero together the other had them both. On the reporting date, the third person and she did not had any other vaccine called complaining of the same rash. The healthcare professional stated that they assumed the rash was due to Bexsero since one of the patients experienced the rash received no other vaccine.  All patients reported the rash appearing within 2 days of vaccination.  The rash was pimply in appearance on face, arms, and neck. The rash lasted for 3 weeks where she saw the doctor again on 4th September 2019 and was given doxycycline and prednisone. The patient was told to see the doctor again in 10 days. The MSL confirmed that patient had not yet been back to the office on the reporting date. For the other 2 patient's, it is unknown how long the rashes lasted and if they were treated because they only called in to report the adverse event. The reporter consented to follow up. No additional details regarding patients or product were available but licensed vocational nurse was agreeable to follow up recontact. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Rash, Rash papular
Clinical narrative: RASH ON FACE/RASH ON BODY; rash is pimply; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number RO24271 ?, expiry date 8th May 2021) for prophylaxis and MENACTRA (batch number U6521AA, expiry date 26th January 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Bexsero, HPV vaccine and MENACTRA. In August 2019, less than a week after receiving Bexsero and HPV vaccine, the patient experienced generalized rash and papular rash. The patient was treated with doxycycline and prednisone. On an unknown date, the outcome of the generalized rash and papular rash were recovered/resolved.   It was unknown if the reporter considered the generalized rash and papular rash to be related to Bexsero and HPV vaccine.  Additional information received were as follows: The licensed vocational nurse stated that received Bexsero and Menactra a week before the reporting date and experienced a rash on their face and body that was not itchy. The reporter had had 3 patients that had experienced a rash after having Bexsero, not itchy, on the face and body. First they thought it was giving the menectra and bexsero together the other had them both. On the reporting date, the third person and she did not had any other vaccine called complaining of the same rash. The healthcare professional stated that they assumed the rash was due to Bexsero since one of the patients experienced the rash received no other vaccine.  All patients reported the rash appearing within 2 days of vaccination.  The rash was pimply in appearance on face, arms, and neck. The rash lasted for 3 weeks where she saw the doctor again on 4th September 2019 and was given doxycycline and prednisone. The patient was told to see the doctor again in 10 days. The MSL confirmed that patient had not yet been back to the office on the reporting date. For the other 2 patient's, it is unknown how long the rashes lasted and if they were treated because they only called in to report the adverse event. The reporter consented to follow up. No additional details regarding patients or product were available but licensed vocational nurse was agreeable to follow up recontact. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: That evening (Wednesday) began experiencing fever and shaking chills, pain and swelling at the injection site. The next day (Thursday) the shaking chills had subsided, continued to have a fever and nerve/joint aches and sensitivity. Called Dr.'s office and was told "this happens" and to take Tylenol or Motrin.   By Friday afternoon, the fever and aches had subsided. Today, (Monday, 5 days after the shot) the injection area is painful, hot, and red, an area about the size of the palm of my hand. The rest of my arm and shoulder now also ache.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal pain, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: That evening (Wednesday) began experiencing fever and shaking chills, pain and swelling at the injection site. The next day (Thursday) the shaking chills had subsided, continued to have a fever and nerve/joint aches and sensitivity. Called Dr.'s office and was told "this happens" and to take Tylenol or Motrin.   By Friday afternoon, the fever and aches had subsided. Today, (Monday, 5 days after the shot) the injection area is painful, hot, and red, an area about the size of the palm of my hand. The rest of my arm and shoulder now also ache.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: That evening (Wednesday) began experiencing fever and shaking chills, pain and swelling at the injection site. The next day (Thursday) the shaking chills had subsided, continued to have a fever and nerve/joint aches and sensitivity. Called Dr.'s office and was told "this happens" and to take Tylenol or Motrin.   By Friday afternoon, the fever and aches had subsided. Today, (Monday, 5 days after the shot) the injection area is painful, hot, and red, an area about the size of the palm of my hand. The rest of my arm and shoulder now also ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child received DTP/IPV for wrong series.  No adverse reaction noted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt came back the day after vaccine administration and showed me a red, hot, swollen bruised place on her arm where the vaccine was administered
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hot flush
Clinical narrative: Patient described having a "Hot Flash" and then felt short of breath. Listened to patients breath sounds. They were clear to auscultation. Offered to call 911, she declined. Gave patient dose of benedryl and had her sit for approx 5-10 minutes. Patient then stated going back to her office. Checked back in with patient 30 minutes later, stated she felt better.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: After vaccination, arm was a bit sore and a bit bruised which was expected.  On 9/13, after lunchtime noticed huge welt mark, very hot, 2 inches wide by 4 inches long, area had irregular borders, and was oval.   Patient went to doctor specified that it related to a reaction and outlined area with a marker to observe changes. By 9/14, affected area grew outside of the line so doctor prescribed Cephalexin (500mg, 2xday, 10 days).  Medication helped, today, area not as red, small area with pinkness, still feels a little bruise especially if you touch from underneath, and feels pressure/heat in the area when raise arm. In terms of recovery, patient is 98% back to normal.  In the past has experienced soreness and a little redness on vaccine site but nothing like what happened this time.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: After vaccination, arm was a bit sore and a bit bruised which was expected.  On 9/13, after lunchtime noticed huge welt mark, very hot, 2 inches wide by 4 inches long, area had irregular borders, and was oval.   Patient went to doctor specified that it related to a reaction and outlined area with a marker to observe changes. By 9/14, affected area grew outside of the line so doctor prescribed Cephalexin (500mg, 2xday, 10 days).  Medication helped, today, area not as red, small area with pinkness, still feels a little bruise especially if you touch from underneath, and feels pressure/heat in the area when raise arm. In terms of recovery, patient is 98% back to normal.  In the past has experienced soreness and a little redness on vaccine site but nothing like what happened this time.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient came to pharmacy on 9/11/19 claiming flu shot was given too high on his arm that caused pain to radiate down his arm & up to his neck. He said he had bursitis. Patient was seen at urgent care 9/13/19 and mentioned he is going to orthopedist on 9/16/19
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Headache, Myalgia
Clinical narrative: Severe headache, muscle aches, chills. I'm bed-ridden.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MMRV and MMR was given at the same time , Mom was notified and given instructions on what to watch for.  No reports of any side effects or issues.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Since the 1st shot ( the 2nd was August 14,  I can no longer sleep on my left side , it is too painful..  I get a very sharp  pain from my shoulder to my wrist when strain to take a shirt over my head.  If I strain my left are to try to reach something, the pain shoots down my arm.  there has be no inprovement or change in almost 4 months
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was administered MMR instead of MMR-. Patient did not receive the Varicella portion as ordered/scheduled. Varicella was administered on 8/28/19 as a catch up dose. There was no Varicella outbreak.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Lip dry, Lip swelling
Clinical narrative: Patient reported feeling fatigue, chills, dry/puffy lips, bright red 3" red spot below the injection site that began 1-2 days after injection. Denies any difficulty breathing or shortness of breath.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient received MMR on 3/7/2019 instead of MMR-V as ordered. Patient not immunized with Varicella vaccine on this date. Varicella was given on 6/18/19 as the catch up dose. No Varicella outbreak reported during lack of coverage.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Decreased appetite, Fatigue
Clinical narrative: Approximately 14 hours after injection, experienced severe shivering with elevated temp 99.8, headache and muscle/joint aches. Took Ibuprofen 400 mg and shivering & fever subsided within 3 hours.  Muscle aches subsided in about 6 hours. Headache persisted for about 12 hours and required additional Ibuprofen. Experienced malaise, fatigue (which necessitated bed rest, sleep), loss of appetite until 8pm .....19 hours from onset. Also left arm, site of injection painful, seemed swollen, and was red/hot to touch a hands width below the injection site. The redness/hotness persists 48 hours later....slight cellulitis?
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 14 hours after injection, experienced severe shivering with elevated temp 99.8, headache and muscle/joint aches. Took Ibuprofen 400 mg and shivering & fever subsided within 3 hours.  Muscle aches subsided in about 6 hours. Headache persisted for about 12 hours and required additional Ibuprofen. Experienced malaise, fatigue (which necessitated bed rest, sleep), loss of appetite until 8pm .....19 hours from onset. Also left arm, site of injection painful, seemed swollen, and was red/hot to touch a hands width below the injection site. The redness/hotness persists 48 hours later....slight cellulitis?
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Approximately 14 hours after injection, experienced severe shivering with elevated temp 99.8, headache and muscle/joint aches. Took Ibuprofen 400 mg and shivering & fever subsided within 3 hours.  Muscle aches subsided in about 6 hours. Headache persisted for about 12 hours and required additional Ibuprofen. Experienced malaise, fatigue (which necessitated bed rest, sleep), loss of appetite until 8pm .....19 hours from onset. Also left arm, site of injection painful, seemed swollen, and was red/hot to touch a hands width below the injection site. The redness/hotness persists 48 hours later....slight cellulitis?
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient was nervous before shot was given Immediately after administration patient had an episode of syncope She lost conciousness but breathing was normal Patient was laid down horizontally and came by just before EMT arrived EMT  thought it might have been a panick attack
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Arthralgia, Back pain, Balance disorder, Chest discomfort
Clinical narrative: Immediately after the vaccine, I felt no symptoms, when I went to the check out desk approximately 3-4 minutes later, I felt a surge of tightness and flushing in my head, neck and arms.  I thought I had broken out in a rash on my arms, but it didn?t appear so. The feeling intensified and I felt I needed water or something for the throat constriction. After reporting to the desk clerks that something was wrong, I sat down before being escorted into a room. The constriction feeling continued along with a severe pulsating abdominal pain- feeling like deep bone pain. I couldn?t stand because of it and the weakness in my legs. I laid down. The nurse continued to monitor me and ask questions. I felt more numbness throughout my arms, hands and legs. The constriction subsided, but was followed by my upper lip feeling swollen and numb. I felt somewhat dizzy throughout.  After awhile I determined I could drive home. I did feel somewhat unsteady, but okay. The time when I left was about noon or a little after. I came home and took a benedryl and slept for a couple of hours. I still have what feels like soreness in the hip and back areas. I felt a little short of breath and had some chest discomfort off and on the remainder of the day and next. I wonder if it was an allergic reaction common to some Ehlers- Danlos patients.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Dysstasia, Flushing, Hypoaesthesia
Clinical narrative: Immediately after the vaccine, I felt no symptoms, when I went to the check out desk approximately 3-4 minutes later, I felt a surge of tightness and flushing in my head, neck and arms.  I thought I had broken out in a rash on my arms, but it didn?t appear so. The feeling intensified and I felt I needed water or something for the throat constriction. After reporting to the desk clerks that something was wrong, I sat down before being escorted into a room. The constriction feeling continued along with a severe pulsating abdominal pain- feeling like deep bone pain. I couldn?t stand because of it and the weakness in my legs. I laid down. The nurse continued to monitor me and ask questions. I felt more numbness throughout my arms, hands and legs. The constriction subsided, but was followed by my upper lip feeling swollen and numb. I felt somewhat dizzy throughout.  After awhile I determined I could drive home. I did feel somewhat unsteady, but okay. The time when I left was about noon or a little after. I came home and took a benedryl and slept for a couple of hours. I still have what feels like soreness in the hip and back areas. I felt a little short of breath and had some chest discomfort off and on the remainder of the day and next. I wonder if it was an allergic reaction common to some Ehlers- Danlos patients.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia oral, Lip swelling, Muscle tightness, Muscular weakness, Tension headache
Clinical narrative: Immediately after the vaccine, I felt no symptoms, when I went to the check out desk approximately 3-4 minutes later, I felt a surge of tightness and flushing in my head, neck and arms.  I thought I had broken out in a rash on my arms, but it didn?t appear so. The feeling intensified and I felt I needed water or something for the throat constriction. After reporting to the desk clerks that something was wrong, I sat down before being escorted into a room. The constriction feeling continued along with a severe pulsating abdominal pain- feeling like deep bone pain. I couldn?t stand because of it and the weakness in my legs. I laid down. The nurse continued to monitor me and ask questions. I felt more numbness throughout my arms, hands and legs. The constriction subsided, but was followed by my upper lip feeling swollen and numb. I felt somewhat dizzy throughout.  After awhile I determined I could drive home. I did feel somewhat unsteady, but okay. The time when I left was about noon or a little after. I came home and took a benedryl and slept for a couple of hours. I still have what feels like soreness in the hip and back areas. I felt a little short of breath and had some chest discomfort off and on the remainder of the day and next. I wonder if it was an allergic reaction common to some Ehlers- Danlos patients.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Throat tightness
Clinical narrative: Immediately after the vaccine, I felt no symptoms, when I went to the check out desk approximately 3-4 minutes later, I felt a surge of tightness and flushing in my head, neck and arms.  I thought I had broken out in a rash on my arms, but it didn?t appear so. The feeling intensified and I felt I needed water or something for the throat constriction. After reporting to the desk clerks that something was wrong, I sat down before being escorted into a room. The constriction feeling continued along with a severe pulsating abdominal pain- feeling like deep bone pain. I couldn?t stand because of it and the weakness in my legs. I laid down. The nurse continued to monitor me and ask questions. I felt more numbness throughout my arms, hands and legs. The constriction subsided, but was followed by my upper lip feeling swollen and numb. I felt somewhat dizzy throughout.  After awhile I determined I could drive home. I did feel somewhat unsteady, but okay. The time when I left was about noon or a little after. I came home and took a benedryl and slept for a couple of hours. I still have what feels like soreness in the hip and back areas. I felt a little short of breath and had some chest discomfort off and on the remainder of the day and next. I wonder if it was an allergic reaction common to some Ehlers- Danlos patients.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Sepsis
Clinical narrative: Pt was admitted to hospital with sepsis
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: development of crops of vesicles 10 days after vaccination
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient received MMR on 12/18/2018 instead of MMR-V as ordered. Patient not immunized with Varicella on this date. Varicella was given on 6/28/2019 as a catch up dose once error was discovered. No Varicella outbreak during lack of coverage.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to two adolescent patients at the age between 13 and 18 years old. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010526: US-009507513-1908USA004659: US-009507513-1908USA010528:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to an adult patient at the age between 19 and 24 years old. On an unknown date in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020. There was no reactions or problems with the patient. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010526: US-009507513-1908USA010527: US-009507513-1908USA004659:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored doses of PROQUAD and VARIVAX were administered to patient; This spontaneous report was received from a medical assistant and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: RHA) injection (lot # S003178, expiry date 30-JUL-2020) (strength, dose, route and site of administration were not reported) and with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R030487, expiry date 22-OCT-2020; also reported as: lot number R034398, expiry date 27-NOV-2020) (strength, dose, route and site of administration were not reported); both for prophylaxis. The sterile diluent used to reconstitute the vaccines was stored properly.   The suspect vaccines were stored in a temperature of 36 degrees Fahrenheit for 15 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received unspecified dose of Rotateq that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-AUG-2019, the patient was vaccinated with improperly stored unspecified dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 34.1 degrees Fahrenheit for 4 hours and 30 minutes. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced previous temperature excursion of 34.7 degrees Fahrenheit for 3 hours and 2 minutes. There was no adverse effects reported.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose ofV ARlV AX (lot: N022978; expiration: 08/23/2019).; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 04-SEP-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # N022978, expiration date 23-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with unexpired sterile diluent (lot # S003613, expiration date: 22-JUL-2021). No known adverse effects were reported.