chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was sick; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date in 1968, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event of being sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient was sick as a dog for three days on the couch.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Impaired work ability, Malaise
Clinical narrative: or so sick/flu shot made me sicker than a dog; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient reports that he/she had to be off work a day or so sick, dont recall if he/she had flu or not went to dr got flu shot made him sicker than a dog never again. Had take another couple days off before got somewhat well.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient did not had the flu since stopped having it injected into the body each year.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: The sickest person reporter ever saw with the flu got it from a flu shot; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of unknown age and it was reported the sickest person reporter ever saw with the flu got it from a flu shot (influenza), while being received vaccine influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, it was reported the sickest person reporter ever saw with the flu got it from a flu shot (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product administered at inappropriate site
Clinical narrative: 2 month old male patient administered 0.5ml of the liquid component of the Pentacel vaccine, no AE; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a two month old male patient who received only liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], (product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 23-Nov-2020, the patient received a 0.5 ml only liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ332AA and expiry date: 04-Jun-2021) via an unknown route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (latency on same day).  Reporter relationship: HCP (health care professional), Product used: used, First time product used: no, Still using product: no  At the time of report no adverse event 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. 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: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of QUADRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from ann other health professional via regulatory authority (Reference number- 00377535) and transmitted to Sanofi on 01-Dec-2020.  This case involved a 6 year old patient of unknown gender who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which had the expiry date of 10-Sep-2020, via unknown route at an unknown administration route on 18-Nov-2020, as an prophylactic vaccination (expired product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a true medication error due to expired product administered (latency same day).  Reporter wanted to know if there was a window on expired products and if the patient needed to be re-vaccinated.   At the time of this report, no adverse event 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.  There will be no information regarding the batch number for the case.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: IPOL vaccine was given to a child one day after expiration with no adverse event; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a nurse via regulatory authority (Reference number- 00386646) via call center.  This case involves a 04-years-old male patient who was vaccinated with expired vaccine (expired vaccine used), IPV (VERO) [IPOL] on 08-Dec-2020 (lot number: P1F54 and expiry date: 07-Dec-2020) at 0.5 ml dose via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  This was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: patient moved leg and it is unknown how much of the vaccine was received believed some was administered but not all with no adverse event; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case from an other health care professional.  This case involves a 19-months-old female patient who moved leg and it was unknown how much of the vaccine was received believed some was administered but not all (incorrect dose administered), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] suspension For Injection (lot number: UJ341AAA and expiry date: 22-Jun-2021) at an unknown dose via intramuscular route in the unknown site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  This was an actual medication error case due to incomplete dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient administered expired Pentacel/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional. This case involves a 4-months-old female patient who e received 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, lot number: UJ057AAA and expiry date: 07-Nov-2020 via Intramuscular route in the left deltoid) (expired product administered) on 03-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event 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.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient was given only the liquid part of the Pentacel and ActHIB has to be given separately, No AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a six-month-old female patient who was administered with the Dtap-IPV liquid part of the PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and throwed the powder part, Thus Act-HIB have to be used separately as there is no diluent left to administer.  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE (HEPATITIS B VACCIN) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 10-Dec-2020 , the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [lot number: UJ341AA and expiration date: 21-Jun-2021] via intramuscular route in left thigh for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: The vaccine got leaked on the patient arm during administration/ leakage was between the needle attachment to the syringe, no Ae; The patient did not receive the full dose of the vaccine, no AE; The vaccine got leaked on the patient arm during administration, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 36 years old female patient who had received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] [0.5 ml, lot number: UJ509AA and expiry date: 10-MAR-2021] on 7-DEC-2020 via intramuscular route in the left arm for prophylactic vaccination that got leaked on the patient arm during administration and did not receive the full dose of the vaccine as the syringe- needle wasn't screwed on correctly or tight enough (Syringe issue) (underdose) (exposure via skin contact).   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  This was an actual medication error due to vaccine underdose and exposure via skin contact [latency was same day].  This was also a case of syringe leak.  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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: M
Vaccine: FLU4
Symptoms: Vaccination site pain
Clinical narrative: shoulder pain in area where shot was given; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional via consumer.  This case involves a 67 year old male patient who experienced shoulder pain in area where shot was given (vaccination site pain), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 03-Sep-2020, the patient developed a non-serious shoulder pain in area where shot was given (vaccination site pain), six days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Nausea, Vomiting
Clinical narrative: nausea/vomiting, elevated heart rate and cough
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Full blood count normal, Heart rate increased, Metabolic function test normal
Clinical narrative: Patient received COVID 19 vaccination and developed elevated heart rate.  It is less likely that this was a reaction to the vaccine given no complaints of nausea, vomiting, itchiness, shortness of breath, abdominal or epigastric pain, wheezing which are typical signs of a reaction.  Most likely this was an anxiety event.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test negative, Urine abnormality, Urine analysis normal
Clinical narrative: Patient received COVID 19 vaccination and developed elevated heart rate.  It is less likely that this was a reaction to the vaccine given no complaints of nausea, vomiting, itchiness, shortness of breath, abdominal or epigastric pain, wheezing which are typical signs of a reaction.  Most likely this was an anxiety event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: Severe nausea/abd pain lasting 24 hours
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Developed headaches the week of vaccine, especially Saturday, 12/26/2020.  Experienced body aches on 12/26/2020, intermittent in nature and fatigue.  Called Nurse to report symptoms and confirm clearance to return to work on 12/28/2020 and was instructed to complete potential vaccine reaction.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Woke with nausea/vomiting, chills, and dizziness
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Pruritus, Throat irritation, Urticaria
Clinical narrative: pt with history of anaphylaxis to latex and fruit, presents to ED with urticarial skin reaction with itching, throat itching, cough, lightheadedness soon after receiving Covid vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Day 1 injection site pain, Day 2 extreme fatigue and temperature of 100.4, injection site red, warm with a 5 cm hardened lump, Day 3 injection site red, warm with a 3 cm hardened lump, day 4 injection site remain red and warm, no longer swollen
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Day 1 injection site pain, Day 2 extreme fatigue and temperature of 100.4, injection site red, warm with a 5 cm hardened lump, Day 3 injection site red, warm with a 3 cm hardened lump, day 4 injection site remain red and warm, no longer swollen
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Pain, Pruritus
Clinical narrative: Patient developed a soreness and then itching developed.  She then noticed a knot to the left of the injection site.  She has now developed approximately 2 inch long area of redness across her deltoid.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Musculoskeletal stiffness, Swelling
Clinical narrative: within minutes of being vaccinated, developed feelings of swollen lymph nodes, fullness and stiffness in her neck. She has redness across her upper chest. She has experienced side effects similar to this from other vaccines she's received in the past.  She was observed in the ED but no medications were administered. Her symptoms improved and she was discharged with a prescription for an EpiPen and an appointment to follow up with an allergist.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: 12/27 woke up with pain in left armpit. Swelling increased throughout the day. Pain was manageable without medication, did hurt when swelling was palpated or I squeezed my left arm down to my side. Woke on 12/28 with same pain, does not appear to be further swelling, but hurts in my armpit to hold my arm above my head.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Approximately 20 hours later, I began getting chills. When I put on a jacket, I began sweating profusely., yet freezing cold. My head was pounding. Came home from work a couple hours later and took a nap for a few hours yet woke up multiple time covered in sweat, yet again freezing cold
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Flushing, Headache, Paraesthesia, Paraesthesia oral
Clinical narrative: Within 10 minutes of receiving the Pfizer COVID vaccine, she complained of chest tightness, feeling flushed, mild headache, and paresthesias in her hands and mouth.  Symptoms lasted approximately 10 minutes and resolved spontaneously.  No treatment was administered. The patient was observed and discharged to home with no additional treatment.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Nasal congestion, Tachycardia
Clinical narrative: TACHYCARDIA, NASAL CONGESTION, MODERATE HEADACHE, FATIGUE
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema at injection site measuring 4 inches by 2.5 inches lasting 3 days. Day 2 had an excruciating headache unrelieved by Tylenol or Aleve.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient received the Pfizer Vaccine. Mild rash was noted on the forearms by the patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Palpitations
Clinical narrative: 10 minutes after receiving vaccine patient complained of head heaviness, palpitations and feeling hot in the ears.  BP = 166/97, HR = 129, O2 SAT = 100%, Temp. = 98
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Myalgia, Nasal congestion
Clinical narrative: Pfizer-BioNTech COVID-19 vaccine EUA on 12/15/2020--12/19/2020 @ 0300 I woke up with joint pain in all joints including hands, feet, fingers & toes, also muscle aches. I had an occasional cough, nasal congestion, nausea and headache. The joint and muscle pain lasted approximately 48 hours and was relieved with Tylenol and ibuprofen  every 4-6 hours. The HA lasted until 12/22/20. As of today 12/23/20 I still have some nasal congestion but no other symptoms. I never ran a fever.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Pfizer-BioNTech COVID-19 vaccine EUA on 12/15/2020--12/19/2020 @ 0300 I woke up with joint pain in all joints including hands, feet, fingers & toes, also muscle aches. I had an occasional cough, nasal congestion, nausea and headache. The joint and muscle pain lasted approximately 48 hours and was relieved with Tylenol and ibuprofen  every 4-6 hours. The HA lasted until 12/22/20. As of today 12/23/20 I still have some nasal congestion but no other symptoms. I never ran a fever.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Swollen tongue, Tongue eruption
Clinical narrative: Tongue swelling a bit. Postules formed. Bumps all over tongue. No fever or other symptoms
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: FEVER 100.1, HA, body aches
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Eye irritation, Fatigue
Clinical narrative: These are expected side effects, I was told I still need to fill out this form by my boss. Temp 100.2, extreme fatigue, chill, extreme muscle pain, cough, left eye irritaion
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: These are expected side effects, I was told I still need to fill out this form by my boss. Temp 100.2, extreme fatigue, chill, extreme muscle pain, cough, left eye irritaion
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Myalgia, Nasal congestion
Clinical narrative: Serum sickness syndrome, fever not greater than 101, severe muscle and body aches/pains, nasal congestion, extreme fatigue, cough, nausea, loss of appetite First vaccination in 55 years
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Serum sickness
Clinical narrative: Serum sickness syndrome, fever not greater than 101, severe muscle and body aches/pains, nasal congestion, extreme fatigue, cough, nausea, loss of appetite First vaccination in 55 years
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: 12/23/2020 0200 Severe Tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: 12/23/2020 0200 Severe Tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Nausea, Pain, Presyncope
Clinical narrative: 12/23/2020 0200 Severe Tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: 12/23/2020 0200 Severe Tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site bruising
Clinical narrative: Bruising at site of injection and multiple areas covering body (limbs, back, abdomen) that was noticed beginning 12/24/20 and has continued over several days
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: 12/20/2020  12:00 PM DEVELOPED LAPID ATRIAL FIB.  WENT TO ER WHEN IT PERSISTED, MEDICAL CENTER. ADMITTED TO INPATIENT; 12/21/2020 - ELECTRICAL CARDIOVERSION. MONITORED OVERNIGHT.  12/22/2020 - DISCHARGED *ON CHRONIC BLOOD THINNER
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Pain
Clinical narrative: 12-23-2020 severe chills, nausea, and severe body aches did not check temp. 12-24-2020 she still feels off, but not as bad. Temp is normal
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness, swelling, left upper arm at injection site.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on abdomen approximately 2x4 inches with slight itching that lasted about 3 hours without requiring any treatment.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Almost immediately after vaccination the recipient felt faint. She was helped to lay on the ground, vitals were checked and monitored, and remained stable. She quickly felt better and stayed in observation a total of 25 minutes. She reported that she has experienced this in the past when getting a blood draw or vaccine. She returned to her work unit with a colleague. We checked in with her a few hours later and she was completely fine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Syncope
Clinical narrative: Patient reports developing a mild headache post vaccination within 15minutes that progressed in severity with nausea, dizziness and fainting. Occupational Health is following up with patient and recommending comprehensive provider evaluation
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Patient reports developing a mild headache post vaccination within 15minutes that progressed in severity with nausea, dizziness and fainting. Occupational Health is following up with patient and recommending comprehensive provider evaluation
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Hypotonia, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccine recipient stated that he felt faint. Eyes rolled back and he became limp. Two nurses laid him on floor. He came to within seconds but was diaphoretic. Vitals were checked and monitored (BP 130/70, 118/74, 120/72; pulse 57, 72, 68; pulse ox 98%, 99%, 99%). He quickly felt better (within a few minutes), was given water, chocolate and a granola bar. He stayed in observation a total of 35 minutes. He reports that he had been very nervous about getting a vaccination. He returned to his unit with a colleague. We checked in with him a few hours later and he reported that he felt well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aches, fatigue. Treatment rest. Resolved by 12/27/2020
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue on 12.26, fever 101f on the night of 12.26, fevers 101 to 102 from 12.27 to today 12.28. headache beginning 12.28
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Moderna COVID-19 Vaccine EUA Headache for 2 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine recipient received the vaccine on 12/18/2020. On 12/19/2020 reported that the injection site had prominent redness and swelling. On 12/22/2020, the site was warm to the touch and the pain was mild, but bothersome. Over these 5 days the injection site became swollen with increased redness and pain. On 12/23/2020, the vaccine recipient reported that they were feeling better and has followed-up with occupational health with no further issues.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: low grade fever 99.8 F, slight nausea, over feeling not well, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at vaccine site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood test normal, Computerised tomogram normal, Eyelid function disorder, Facial paralysis
Clinical narrative: 12/25/2020 08:00AM patient awoke with left eye twitching, mouth drawn to left side. Neck severely aching from right earlobe to the back of neck, severe headache. Unable to close left eye.   ER visit  12/26/2020 in the morning - discharge diagnosis, Bell's palsy. Prescription Valacyclovir hcl 1 gram tablet,  Butalbital, Acetaminophen, Caffeine Oral tablet 50-325-40mg , solution eye drops , Azithromycin cream
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: 12/25/2020 08:00AM patient awoke with left eye twitching, mouth drawn to left side. Neck severely aching from right earlobe to the back of neck, severe headache. Unable to close left eye.   ER visit  12/26/2020 in the morning - discharge diagnosis, Bell's palsy. Prescription Valacyclovir hcl 1 gram tablet,  Butalbital, Acetaminophen, Caffeine Oral tablet 50-325-40mg , solution eye drops , Azithromycin cream
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Flu symptoms including headache, nausea, chills, joint pain and low grade fever of 99.3 Symptoms began in the middle of the morning about 10:30 - 11:00 am  while I was at work; worsened through the afternoon and night; all better by morning; symptoms completed gone
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu symptoms including headache, nausea, chills, joint pain and low grade fever of 99.3 Symptoms began in the middle of the morning about 10:30 - 11:00 am  while I was at work; worsened through the afternoon and night; all better by morning; symptoms completed gone
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swollen tongue
Clinical narrative: 12/22- swelling of right side of tongue.  took 12.5mg Benedryl; resolved in about 4 hours 12/23 - swelling of right hand, no treatment, resolved by around 11am 12/24
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Patient complained of tachycardia about 15 to 20 Minutes after receiving the vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Erythema, Injection site induration, Injection site pain
Clinical narrative: Quarter size swelling at injection site, entire deltoid became quite sore, firm, warm and extremely tender with significant decrease in ability to perform abduction and extension over the next hour. Pain and stiffness progressed to right shoulder blade and right trapezius. At this time these areas remain somewhat tender and sore, however ROM has improved. Of note, also developed some SOB and redness to neck and chest within 30 minutes of injection, Fexofenadine was taken and the SOB and redness to chest resolved by 4pm day of injection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Joint range of motion decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Quarter size swelling at injection site, entire deltoid became quite sore, firm, warm and extremely tender with significant decrease in ability to perform abduction and extension over the next hour. Pain and stiffness progressed to right shoulder blade and right trapezius. At this time these areas remain somewhat tender and sore, however ROM has improved. Of note, also developed some SOB and redness to neck and chest within 30 minutes of injection, Fexofenadine was taken and the SOB and redness to chest resolved by 4pm day of injection.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Alanine aminotransferase normal, Back pain, Blood alkaline phosphatase increased, C-reactive protein normal, Computerised tomogram abnormal
Clinical narrative: The patient developed back pain in March, 2019 (two months after the vaccine) and was diagnosed with constipation.  His symptoms persisted and he was ultimately diagnosed with Crohn's Disease in June, 2019
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Constipation, Crohn's disease, Haemoglobin, Platelet count, Urinary system X-ray
Clinical narrative: The patient developed back pain in March, 2019 (two months after the vaccine) and was diagnosed with constipation.  His symptoms persisted and he was ultimately diagnosed with Crohn's Disease in June, 2019
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: White blood cell count
Clinical narrative: The patient developed back pain in March, 2019 (two months after the vaccine) and was diagnosed with constipation.  His symptoms persisted and he was ultimately diagnosed with Crohn's Disease in June, 2019
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Within 12 hours of receiving the vaccine I developed sever flu-like symptoms - low grade fever, chills, body aches, extreme fatigue, runny nose
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Within 12 hours of receiving the vaccine I developed sever flu-like symptoms - low grade fever, chills, body aches, extreme fatigue, runny nose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, SARS-CoV-2 test negative
Clinical narrative: I had a headache, extreme fatigue, achy joints and muscles. I had a scratchy throat also.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: I had a headache, extreme fatigue, achy joints and muscles. I had a scratchy throat also.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus, Rash
Clinical narrative: who presents with complaint of rash , itching minutes after COVID vaccine. Also notes nausea and fatigue. Pt notes no throat swelling , pain , voice change , shortness of breath , abdominal pain , vd or other concerns. Pt has known allergy to flu vaccine and other medications as noted
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Cold sweat, Dizziness
Clinical narrative: Fever 100.1 to 101.5. 24 hours. I was very weak. I could barely walk to the bathroom. At 5 AM when the symptoms started I felt like it was going to faint or just collapse. I felt like I was going to faint on multiple trips to the bathroom. I  had no energy .I felt like I had Covid symptoms all over again. I had cold sweats for almost 24 hours had to take my clothes off to get comfortable.  I was so warm. exhaustion .slept for almost 24 hours. I just felt miserable my stomach was nauseated and felt very sore in my abdomen. aches and pains in my hips and legs.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Hypersomnia, Mobility decreased
Clinical narrative: Fever 100.1 to 101.5. 24 hours. I was very weak. I could barely walk to the bathroom. At 5 AM when the symptoms started I felt like it was going to faint or just collapse. I felt like I was going to faint on multiple trips to the bathroom. I  had no energy .I felt like I had Covid symptoms all over again. I had cold sweats for almost 24 hours had to take my clothes off to get comfortable.  I was so warm. exhaustion .slept for almost 24 hours. I just felt miserable my stomach was nauseated and felt very sore in my abdomen. aches and pains in my hips and legs.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.1 to 101.5. 24 hours. I was very weak. I could barely walk to the bathroom. At 5 AM when the symptoms started I felt like it was going to faint or just collapse. I felt like I was going to faint on multiple trips to the bathroom. I  had no energy .I felt like I had Covid symptoms all over again. I had cold sweats for almost 24 hours had to take my clothes off to get comfortable.  I was so warm. exhaustion .slept for almost 24 hours. I just felt miserable my stomach was nauseated and felt very sore in my abdomen. aches and pains in my hips and legs.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vein discolouration
Clinical narrative: After receiving the covid vax, I had shoulder soreness the first couple of days. That night, the vein , was a different color than the rest of my veins in my bicep. The discoloration of the vein was at the top of my bicep.  Now, the vein is visually fine now.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Coxsackie virus test positive, Eating disorder, Glossodynia, Herpangina
Clinical narrative: Two hours after the injection my tongue started swelling and pain increased throughout the day to the point where I could not eat.  The next morning (Dec. 23rd) I had painful white lesions under and on the sides of my tongue. This worsened over the next day and I was seen at an urgent care clinic who took culture swaps for lab test.  (eventually negative for oral herpes).  Pain and lesions continued to worse and I was admitted to the ER on December 26th.  Breathing, heart rate, and blood work all normal.  Diagnosed with Herpangina/Coxsackie Virus.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex test negative, Oral disorder, Swollen tongue, Viral test
Clinical narrative: Two hours after the injection my tongue started swelling and pain increased throughout the day to the point where I could not eat.  The next morning (Dec. 23rd) I had painful white lesions under and on the sides of my tongue. This worsened over the next day and I was seen at an urgent care clinic who took culture swaps for lab test.  (eventually negative for oral herpes).  Pain and lesions continued to worse and I was admitted to the ER on December 26th.  Breathing, heart rate, and blood work all normal.  Diagnosed with Herpangina/Coxsackie Virus.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Injection site pain x 2 days, nausea x 5 days, fatigue x 3 days, chills x 2 days, muscle + joint pain x 2 days, headache x 1 day, weird dreams x 2 nights
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: Injection site pain x 2 days, nausea x 5 days, fatigue x 3 days, chills x 2 days, muscle + joint pain x 2 days, headache x 1 day, weird dreams x 2 nights
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hive reaction began on day 7 post vaccine, isolated to left arm, back, trunk.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Bilirubin conjugated decreased, Biopsy liver abnormal
Clinical narrative: Patient developed autoimmune hepatitis diagnosed in early December 2020 approximately 6 weeks after vaccination
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin increased, Lipase normal, Liver function test increased
Clinical narrative: Patient developed autoimmune hepatitis diagnosed in early December 2020 approximately 6 weeks after vaccination
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein total decreased
Clinical narrative: Patient developed autoimmune hepatitis diagnosed in early December 2020 approximately 6 weeks after vaccination
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; a dose of ROTATEQ was given during a temperature excursion; This spontaneous report as received from a certified medical assistant refers to a 3-month-old patient of unknown gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 20-NOV-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter administered orally, lot # 1660954 has been verified to be a valid lot number, expiry date 07-MAR-2021, for prophylaxis. The administered dose underwent a temperature excursion between 48.8 degrees Fahrenheit and 32.7 degrees Fahrenheit for 47 hours and 15 minutes. There were no previous temperature excursions. Digital data logger was not involved. No additional adverse effect was reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lip blister, Neck pain, Pain in extremity, Vomiting
Clinical narrative: first start with sore arm and neck-then started hurting in chest- now have blisters on lip and throwing up
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Laboratory test, Peripheral coldness, Skin warm
Clinical narrative: Cold extremities, warm face & diarrhea - Monitored for 47 minutes, no abnormal finding except for elevated BP.  Client did not have any rash, hives, angioedema, difficulty breathing, wheezing or altered level of consciousness.  She reported all symptoms resolved and discharged home.  Additionally, she reported diarrhea  overnight which had resolved by the next day.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Nausea, Pain, Pain in extremity
Clinical narrative: severe cold chills started at 3am no fever used heating pad to get warm then had to work the next day severe aches and chills again with some nausea  took ibuprofen at 9am and chills and aches went away for about 5.5 hours then returned but not as severe.  right arm pain x 2 days
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Muscle aches, subjective fever, headache, sore arm
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain for 2 days and a very bad headache for 2 days and extreme fatigue.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Pain in extremity, Tearfulness
Clinical narrative: Hello I received my Covid Vaccination on 12/23/20 7:56 am at Healthcare Clinic.  I waited 15 minutes after the vaccination and then went and stayed home.  Six hours later my arm started to become very painful (no surprise) I then felt an overwhelming fatigue and sadness.  I had tears just streaming down my face for about 3 minutes.  I laid down and awoke later that night still feeling very fatigued.  I showered and crawled back to bed I awoke the next day at mid-morning, still tired but 60 % better.  I stayed awake for a few hours, showered, changed the bed sheets and went back to bed for several hours more.  I awoke tired ate a lite dinner and went back to bed.  I awoke at 8:00 on Christmas day feeling fine, just like my old self.  If you need any more information just call.  Oh my vaccine information is: PFIZER EJ1685 12/23/20 1st dose.  Thank you,   Medical Interpreter Center for Advanced Pediatrics Endocrine Department.