chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, UNK
Symptoms: Abdominal discomfort, Chills, Cough, Dyspnoea, Headache
Clinical narrative: sick to stomach; sick; headaches; chills; coughing; sputum; breathing difficult; feeling of tooth pain; heart rate was very high; she is denture wearer no means of dental pain; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA VACCINE, the patient experienced stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort. The patient was treated with azithromycin and prednisone. On an unknown date, the outcome of the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort were unknown.   It was unknown if the reporter considered the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and pneumonia 26 vaccine on the same day. After receiving the two vaccines, the patient experienced a lot worse. The patient was sick to her stomach and had chills. She also felt like her mouth was full of teeth that needed to be pulled, but she wears dentures and does not actually have teeth. The patient experienced coughing up a lot of sputum, and also experienced short of breathe when doing any activity like going to the mailbox. The patient received Azithromycin and prednisone and while taking those medications her heart rate was very high, running around 111-112. The patient stopped prednisone 2 days before her taper was supposed to end and at the time of reporting she finished her course of azithromycin.      Lab Comments: on an unknown date heart rate was measured
Sex: F
Vaccine: PPV, UNK
Symptoms: Heart rate increased, Malaise, Nausea, Oral discomfort, Productive cough
Clinical narrative: sick to stomach; sick; headaches; chills; coughing; sputum; breathing difficult; feeling of tooth pain; heart rate was very high; she is denture wearer no means of dental pain; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA VACCINE, the patient experienced stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort. The patient was treated with azithromycin and prednisone. On an unknown date, the outcome of the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort were unknown.   It was unknown if the reporter considered the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and pneumonia 26 vaccine on the same day. After receiving the two vaccines, the patient experienced a lot worse. The patient was sick to her stomach and had chills. She also felt like her mouth was full of teeth that needed to be pulled, but she wears dentures and does not actually have teeth. The patient experienced coughing up a lot of sputum, and also experienced short of breathe when doing any activity like going to the mailbox. The patient received Azithromycin and prednisone and while taking those medications her heart rate was very high, running around 111-112. The patient stopped prednisone 2 days before her taper was supposed to end and at the time of reporting she finished her course of azithromycin.      Lab Comments: on an unknown date heart rate was measured
Sex: F
Vaccine: PPV, UNK
Symptoms: Toothache
Clinical narrative: sick to stomach; sick; headaches; chills; coughing; sputum; breathing difficult; feeling of tooth pain; heart rate was very high; she is denture wearer no means of dental pain; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA VACCINE, the patient experienced stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort. The patient was treated with azithromycin and prednisone. On an unknown date, the outcome of the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort were unknown.   It was unknown if the reporter considered the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and pneumonia 26 vaccine on the same day. After receiving the two vaccines, the patient experienced a lot worse. The patient was sick to her stomach and had chills. She also felt like her mouth was full of teeth that needed to be pulled, but she wears dentures and does not actually have teeth. The patient experienced coughing up a lot of sputum, and also experienced short of breathe when doing any activity like going to the mailbox. The patient received Azithromycin and prednisone and while taking those medications her heart rate was very high, running around 111-112. The patient stopped prednisone 2 days before her taper was supposed to end and at the time of reporting she finished her course of azithromycin.      Lab Comments: on an unknown date heart rate was measured
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Malaise, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: generalized Malaise/significant pain in arms; significant leg pain; Unable to walk; Unable to lift; Weakness; This case was reported by a physician via call center representative and described the occurrence of general malaise in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced general malaise, leg pain, unable to walk, mobility decreased and weakness of arms. On an unknown date, the outcome of the general malaise, leg pain, unable to walk, mobility decreased and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the general malaise, leg pain, unable to walk, mobility decreased and weakness of arms to be related to Shingrix.  Additional details were received as follows: It was reported that, few days after receiving Shingrix, the patient experienced generlaized malaise, significant leg pain to the point that she was unable to walk and significant pain or weakness of her arms that she was unable to do lifting. The reporter consented to follow up. The outcome reported for all AES in the structured field of XML is "recovering" instead of "not resolved" (outcome uploaded)
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles located on the top of his head; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 29th October 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 72 or 73 years. The patient received the 1st and 2nd dose of Shingrix in 2018.  Couple of days before the date of reporting, the patient was diagnosed with shingles  and his doctor gave him cream.  The shingles were located on the top of his head. No additional details were available. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer
Clinical narrative: Patient diagnosed with Breast Cancer within the year; This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix a year before the date of reporting. The pharmacist asked how to proceed with 2nd dose of Shingrix. It was reported that, within the year after receiving Shingrix, the patient was diagnosed with breast cancer . The health care professional (HCP) was unable to provide full details. The reporter did not consent to follow-up.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 8 years old male patient was given an expired dose of Ipol vaccine/No AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an eight years old male patient who was given an expired 0.5 ml dose of (VERO) [IPOL] lot N1J451M, expiry date: 05-Oct-2019via subcutaneous route in the left arm on 29-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error due to expired vaccine used.  There were no side effects observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: exposed to temperatures out of the recommended storage temperature range / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA301600 and 2019SA301601.  This case involves a 27 years old male patient who received 0.5 ml dose of suspect IPV (VERO) lot N1J45 (Expiry date 18-Nov-2019) via unknown route in unknown administration site on 24-SEP-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; HEPATITIS A VACCINE INACT, HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) ; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE)  and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) .  It was a actual medication error case due to incorrect product storage.  It was reported that temperatures out of the recommended storage temperature range.  At a time of reporting no adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: syringe leaked at hub of syringe when plunger was pushed / no AE; syringe leaked at hub of syringe when plunger was pushed down. Vaccine ran down the patient's arm during injection / no AE; syringe leaked at hub of syringe when plunger was pushed down. Vaccine ran down the patient's arm during injection / no AE; syringe leaked at hub of syringe when plunger was pushed / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6695LA (Expiry date 02-Jun-2020) via intramuscular route in the left deltoid on 25-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to vaccine underdose and Accidental exposure while administering drug .  It was also a case of syringe leak and Exposure via skin contact.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Headache, Product storage error
Clinical narrative: headache; a 64 year old female inadvertently received a dose of Flublok QIV that had been expired on  30Jun2019; a 64 year old female inadvertently received a dose of Flublok QIV that had been involved in a temperature excursion as shipment took too long in transit; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on 30 -Oct-2019 from nurse.  This case involves a 64 years old female patient who experienced headache (headache) after receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which was expired and exposed to temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient was postmenopausal.   On 29-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1952 expiry date: 30-Jun-2019, via intramuscular route in the right deltoid.  On an unknown date, patient experienced a non-serious headache (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.as shipment took too long in transit  It was reported that Flublok QIV involved in a temperature excursion and expired on 30-Jun-2019.  It was an actual medication error due to expired vaccine used and incorrect product storage.  Final diagnosis was headache.  No corrective treatment was not reported.  The patient outcome is reported as Unknown for headache.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient was given Fluzone Quadrivalent, no advesre event; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old female patient who was vaccinated with a 0.5 ml  first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U6648CA and Exp. Date 30-Jun-2020) via intramuscular route in the left thigh on 24-Sep-2019.  The patient's medical history not reported and no concomitant medications received.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  The patient did not received any treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Muscle spasms, Pregnancy
Clinical narrative: Slight cramping; Fluzone Quadrivalent recived by pregnant patient; miscarried; bleeding; Initial information received on 30-Oct-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 28 years old female patient who experienced bleeding (haemorrhage), miscarried (abortion spontaneous) and slight cramping (muscle spasms), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received Retrospective. The date of last menstrual period was reported as 22-Sep-2019.  The estimated due date was 28-Jun-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ231AA (30-Jun-2020) via intramuscular route in the right deltoid while she was pregnant.  On 28-Oct-2019, the patient developed a serious bleeding (haemorrhage) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On 29-Oct-2019, the patient had miscarried (abortion spontaneous) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, (Slight cramping on Sunday, then 28-OCT-2019 increased cramping) (muscle spasms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Final diagnosis was bleeding, miscarried and slight cramping.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.; Sender's Comments: This case involves a 28 years old female patient who experienced bleeding, miscarried and muscle spasms, while she received vaccine FLUZONE QUADRIVALENT and assessed as medically significant. The time to onset is compatible with the role of the vaccine. Moreover, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Pain, Swelling, Urticaria
Clinical narrative: Redness to the touch, swelling and painful; Hives; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old female patient who experienced redness to the touch, swelling and painful (inflammation) and hives(urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ223AB Expiry date: 30-Jun-2020 via unknown route and in unknown administration site.  On an unknown date, the patient developed a non-serious redness to the touch, swelling and painful (inflammation) one day (reported as next day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious hives(urticaria) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The patient had recovered from inflammation (reported as for 1 day) and outcome was not reported for hives.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Blood test, Chest X-ray, Chills
Clinical narrative: As I was leaving pharmacy after receiving vaccine I felt a little disoriented.  Went home and within one hour had chills and aching pain in lower back.  Chills continued to worsen, trouble breathing (used emergency inhaler - did not help),, felt weak and vomited.  911 called -  was getting more disoriented, confused.  I have no recollection of being put in ambulance or the ride to the ER.  became more aware while being put in bed in ER.  Had IV, tylenol for 104 degree temperature.  I was told my blood pressure was low.  Blood work was being done along with chest Xray and CT Scan. After blood pressure was stabilized I was admitted as in-patient.  Remained in hospital from 9/26/2019 discharged on 9/29/2019. I did hav I also received respiratory therapy, oxygen and more blood work and IV antibiotics while hospitalized.  It was a horrible and frightening experience.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Confusional state, Disorientation, Dyspnoea, Hypotension
Clinical narrative: As I was leaving pharmacy after receiving vaccine I felt a little disoriented.  Went home and within one hour had chills and aching pain in lower back.  Chills continued to worsen, trouble breathing (used emergency inhaler - did not help),, felt weak and vomited.  911 called -  was getting more disoriented, confused.  I have no recollection of being put in ambulance or the ride to the ER.  became more aware while being put in bed in ER.  Had IV, tylenol for 104 degree temperature.  I was told my blood pressure was low.  Blood work was being done along with chest Xray and CT Scan. After blood pressure was stabilized I was admitted as in-patient.  Remained in hospital from 9/26/2019 discharged on 9/29/2019. I did hav I also received respiratory therapy, oxygen and more blood work and IV antibiotics while hospitalized.  It was a horrible and frightening experience.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: As I was leaving pharmacy after receiving vaccine I felt a little disoriented.  Went home and within one hour had chills and aching pain in lower back.  Chills continued to worsen, trouble breathing (used emergency inhaler - did not help),, felt weak and vomited.  911 called -  was getting more disoriented, confused.  I have no recollection of being put in ambulance or the ride to the ER.  became more aware while being put in bed in ER.  Had IV, tylenol for 104 degree temperature.  I was told my blood pressure was low.  Blood work was being done along with chest Xray and CT Scan. After blood pressure was stabilized I was admitted as in-patient.  Remained in hospital from 9/26/2019 discharged on 9/29/2019. I did hav I also received respiratory therapy, oxygen and more blood work and IV antibiotics while hospitalized.  It was a horrible and frightening experience.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient came into pharmacy on 11/6/2019 to report pain in left arm and limited range of motion from 2 vaccines given on 10/8/2019.  She reported that at the time of the vaccine the injection resulted in more pain than expected and she has had difficulty with range of motion.  She has not yet seen a physician
Age: 59.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Excruciation pain during and after injection at the injection site late spreading to whole arm within minutes followed by inability to lift and move the left arm for more than 5 weeks. Was prescribed tylenol Codeine for the pain but no relief. Unable to lie down on my left side, unable to lift wight to move my left arm.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye pruritus, Nausea, Ocular hyperaemia, Pruritus
Clinical narrative: Red itchy eyes and red "splotchy" on chest starting aroung 2pm on 11/6/19.  Felt Dizzy around 3pm 11/6/19.  The evening of 11/6/19 stated they felt nausas and develped a fever and Hives on neck.  The morning of 11/7/19 stated they felt better, hives were gone, but was feeling itchy.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Rash macular, Urticaria
Clinical narrative: Red itchy eyes and red "splotchy" on chest starting aroung 2pm on 11/6/19.  Felt Dizzy around 3pm 11/6/19.  The evening of 11/6/19 stated they felt nausas and develped a fever and Hives on neck.  The morning of 11/7/19 stated they felt better, hives were gone, but was feeling itchy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Heart rate increased, Ocular hyperaemia
Clinical narrative: High fever- 103.5, rapid heart beat, extreme shaking and body chills on every part of body.  feeling cold weak, and blood shot red sclera in both eyes
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: High fever- 103.5, rapid heart beat, extreme shaking and body chills on every part of body.  feeling cold weak, and blood shot red sclera in both eyes
Age: 27.0
Sex: F
Vaccine: ANTH, FLU4, RAB
Symptoms: Abdominal pain, Condition aggravated, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Patient stated that she had been feeling bad since the morning. She was told she needed to be vaccinated and went to the SRP site for her vaccinations around 1100. Patient stated that she told vaccinators her symptoms. The vaccinator informed patient that because she did not have a fever, she would receive the vaccines. Patient reports having chills and feeling cold during the day before vaccination. Since vaccination, she has vomited x3, fatigued, cough/sneeze, abd pain, sore throat.
Age: 27.0
Sex: F
Vaccine: ANTH, FLU4, RAB
Symptoms: Sneezing, Vomiting
Clinical narrative: Patient stated that she had been feeling bad since the morning. She was told she needed to be vaccinated and went to the SRP site for her vaccinations around 1100. Patient stated that she told vaccinators her symptoms. The vaccinator informed patient that because she did not have a fever, she would receive the vaccines. Patient reports having chills and feeling cold during the day before vaccination. Since vaccination, she has vomited x3, fatigued, cough/sneeze, abd pain, sore throat.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction. Patient was just given an extra dose of MMR. Provider was notified right after incident, patient was okay. Mom was also made aware this happened right after incident.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysstasia, Nausea
Clinical narrative: ABOUT 5:00PM ON 11/6 BECAME CHILLED AND WEAK,  ABOUT 4:00AM ON 11/7 ON TRIP TO THE BATHROOM HAD TROUBLE STANDING AND EXTREME NAUSEA,  8:00AM ON 11/7 JUST SLIGHTLY WEAK AND IMPROVING.  NO TREATMENT OCCURRED FOR THE REACTION.  REPORTED REACTION TO THE PHARMACY WHO WILL REPORT TO MY DOCTOR AND DISCUSS PLAN FOR THE 2ND SHOT.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Magnetic resonance imaging, Neck pain, Pain in extremity, Skin warm
Clinical narrative: Right arm became hot and aching, hurt all night. On the 28th of Sept, the pain went up my arm into my neck. The pain became very sensative. I figured it would subside in a few days.It did not. I've been in pain since the 27th of Sept. I'm scheduled to have a spinal injection of steroids in C6-7 on 11/11/2019 to knock out the enflamation.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Intrusive thoughts, Loss of personal independence in daily activities, Obsessive-compulsive disorder, Quality of life decreased
Clinical narrative: Within less than two weeks, I began to have intense symptoms of obsessive-compulsive disorder consisting of intrusive thoughts and sensations.  I continue to suffer from OCD.  I have recently been diagnosed with Chronic Inflammatory Response Syndrome  for which it is not unusual for individuals to have negative reactions to vaccination.    The result or outcome of the adverse events is this ongoing battle with OCD, decreased life satisfaction, and inability to function at prior levels .
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Pruritus, Throat irritation, Urticaria
Clinical narrative: Generalized urticarial/hives over entire body except face/head, itching, scratchy throat. Started 3 hours after receiving flu vaccine and progressed slowly within the next 24 hours. Seen in Employee Health on 10/25 8:00am and advised to start taking Benadryl 25mg and referred to Fast Track/ED for further treatment (she was not experiencing any additional systemic symptoms at that time (no problems breathing, swallowing, no edema/stridor- vital signs stable). Employee declined going to ED and when hives persisted and increased in intensity the following day and she started to complain of a scratchy throat- she finally agreed to be seen in Urgent Care/ED for further treatment. Received the following in ED-  Famotidine 20mg IM x 1, Methylprednisolone 125mg x 1, and Diphenhydramine 25mg x1 Sent home with following meds: Famotidine 20mg BID x 7 days, Prednisone 20mg BID x 7 days and Benadryl 25mg Q6hrs/prn (all po) The employee took Benadryl 10/25 with no relief and then was seen in ED on 10/26 and treated as above. Symptoms then took about 5 days to finally resolve- completed treatment with no residual symptoms noted.  Advised of Flu vaccine allergy and not to receive flu vaccine going forward.
Age: 65.0
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue
Clinical narrative: Talked to patient on 11/4/19 only reports feeling tried
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient is 17 y/o and should have received a pediatric dose. Adult dose was administered in error.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Throat irritation, Urticaria
Clinical narrative: Patient reported within about an hour of receiving her flu vaccine she began to get hives behind her ears within about 15 minutes of hives developing she reported that her throat became scratchy, and began to experience a cough.  She indicated that she took Benadryl and began feeling "back to normal" within an hour or so.  This morning she indicates that she is completely fine with no hives, itching, or scratchy throat.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Feeding disorder, Headache, Mobility decreased
Clinical narrative: Within a few hours of injection,  my arm became very painful  and ached and painful to touch and pain was so great that I could not raise my arm  over my head.  Had to go straight to bed unable to eat or drink.  Terrible headache and nausea was constant.   Stayed in bed for twenty-two straight hours.  Only able to consume one small popsicle and few sips of sweet tea during that whole time.  Here it is two days later and I still have no appetite.  Was almost ready to go to ER for fluids.  I am still feeling nausea and weakness 2 days later.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Within a few hours of injection,  my arm became very painful  and ached and painful to touch and pain was so great that I could not raise my arm  over my head.  Had to go straight to bed unable to eat or drink.  Terrible headache and nausea was constant.   Stayed in bed for twenty-two straight hours.  Only able to consume one small popsicle and few sips of sweet tea during that whole time.  Here it is two days later and I still have no appetite.  Was almost ready to go to ER for fluids.  I am still feeling nausea and weakness 2 days later.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Eye movement disorder, Foaming at mouth, Headache, Hyperhidrosis
Clinical narrative: Within 60 seconds of vaccines given, patient became lightheaded, headache, sweating, eyes rolled back, mild frothing at mouth, brief loss of consciousness, no tonic activity of extremities. Episode lasted approximately 2 minutes, then patient regained consciousness and oxygen applied. EMS called for transfer to ER.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Within 60 seconds of vaccines given, patient became lightheaded, headache, sweating, eyes rolled back, mild frothing at mouth, brief loss of consciousness, no tonic activity of extremities. Episode lasted approximately 2 minutes, then patient regained consciousness and oxygen applied. EMS called for transfer to ER.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # s003868 with expiration date on 08-AUG-2020 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 6 (7.2) to 14 degrees Fahrenheit for 10 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient received a vaccine following a temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 25-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration and anatomical location were not provided) following a temperature excursion, for prophylaxis. The vaccine underwent excursion with the lowest temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (35F) in a time frame 430 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; inadvertently received first doses of VARIVAX and PROQUAD; inadvertently received first doses of VARIVAX and PROQUAD; This spontaneous report as received from a nurse refers to a 19-month-old patient of unknown gender. No information on patient's pertinent medical history and drug reactions or allergies was provided.  On 28-OCT-2019, the patient was inadvertently vaccinated concomitantly with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019463, expiration date 24-JUN-2021, dose, route of administration and anatomical location were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020, dose, route of administration and anatomical location were not provided), both for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed misuse was related to human error and not product confusion. No adverse effects reported.  This is one of 2 reports from the same reporting source.; Sender's Comments:  US-009507513-1911USA000786:
Sex: U
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a infant patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   The reporter considered the vomiting and diarrhea to be possibly related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional information received were as follows: The age at vaccination was not reported. 2 years before the reporting date, the patient received flu vaccine. The patient did not know the name of the flu vaccine. The patient had vomiting and diarrhea following the vaccination. They cause was believed to be a reaction to formaldehyde. Did not consent to follow-up. The patient hung up before additional information could be obtained. This case has been linked to US2019189804, reported by the same reporter.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Redness /red welt at the injection site; Redness /red welt at the injection site / red beat; Swelling; Hard /hardness; Crying; This case was reported by a nurse via call center representative and described the occurrence of injection site wheal in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (1st dose received on October 2018, refer case US2019AMR194606) and Pediarix (2nd dose received on February 2019, refer case US2019187934).   On 24th April 2019, the patient received the 3rd dose of Pediarix. In April 2019, less than a week after receiving Pediarix, the patient experienced injection site wheal, injection site erythema, injection site swelling and crying. On an unknown date, the patient experienced injection site induration. On an unknown date, the outcome of the injection site wheal, injection site erythema, injection site swelling, injection site induration and crying were recovered/resolved.   It was unknown if the reporter considered the injection site wheal, injection site erythema, injection site swelling, injection site induration and crying to be related to Pediarix.  Additional case details were reported as follows: The reporter was the patient's mother. The patient received vaccine at 6:30 pm on 24th April 2019 and 24 hours later the patient had persistent crying for 2.5 hours. The 24 to 36 hours after it was administered, a red welt measuring 3.5 by 3.5 inches appeared at the injection site. It was swollen and beat red. The hardness took 3 months to fully resolve. The reporter did not consent to follow up. This is 1 of the 3 linked cases reported by the same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Malaise, Mass, Tendon pain
Clinical narrative: feeling ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of malaise (received on 10th October 2019 and experienced low energy, swollen lump,redness and soreness on achilles heel tendon,for tolerance of flu vaccine refer case US2019195528).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 72 or 73 years. The patient experienced feeling ill for one day after receiving Shingrix. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Paraesthesia, Post herpetic neuralgia
Clinical narrative: Tingling; Get more nerve sensitive afterwards / Tingling than normal since I had the shingles; Nerve sensitive; This case was reported by a consumer and described the occurrence of tingling in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced at end of February on on the left side of head and face) and post herpetic neuralgia (shortly after that shingles). Previously administered products included Shingrix (1st dose received 2.5 to 3 months before the 2nd dose).   On 25th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced tingling, condition aggravated and post herpetic neuralgia. On an unknown date, the outcome of the tingling and condition aggravated were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the tingling, condition aggravated and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient asked could get more nerve sensitive after the vaccination. The patient did not experienced pain just more tingling than normal since he had the shingles. The patient was told that after he got shingles it could take up to a year for the nerves to settle down. The reporter did not have the lo tnumber and expiry date since he was driving. The reporter asked asked him for MD contact information and he did not want to provide it at this time without first speaking to his MD. The patient's symptoms of postherpetic neuralgia had not resolved. The reporter referred him to his MD and referred offered that his MD could call medical information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that things were going well with arm and next day had pain and more pain. The patient quickly took two Ibuprofen, iced my arm, and decided not to go back for the second shot. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac failure congestive, Condition aggravated, Pneumonia, Pulmonary embolism, Systemic lupus erythematosus
Clinical narrative: Congestive heart failure; Pneumonia; Pulmonary embolism; Lupus has been awakened; This case was reported by a consumer via interactive digital media and described the occurrence of congestive heart failure in a 59-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, 1 day after receiving Tdap Vaccine, the patient experienced congestive heart failure (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria GSK medically significant and life threatening), pulmonary embolism (serious criteria GSK medically significant and life threatening) and systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the congestive heart failure, pneumonia, pulmonary embolism and systemic lupus erythematosus syndrome aggravated were unknown.   It was unknown if the reporter considered the congestive heart failure, pneumonia, pulmonary embolism and systemic lupus erythematosus syndrome aggravated to be related to Tdap Vaccine.  Additional details were provided as follows: It was reported that, Tdap vaccine almost killed the patient 2 weeks before the date of reporting.  The patient was a healthy rambunctious expecting 2 new grand babies within a month. The patient received whooping cough vaccine just to be safe.  The patient had lupus and discussed it with the pharmacist and was told there would be no reportable side effects at all. It was reported that,  24 hours after receiving Tdap, the patient was in the emergency room (ER) with congestive heart failure, pneumonia and a pulmonary embolism.  The patient felt lucky to have survived but the life expectancy was cut much shorter that the lupus had been awakened by the vaccine.