chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) had resolved and PYREXIA (Low grade fever) outcome was unknown. Not Provided          Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Stiff while getting out of chair, feet feel like cement blocks, hands with no grip or strength, purpura spots, swollen wrists and joints in feet sore. (Missed diagnostic for month); is trying to recover. NOTE: RN is not 100% sure of name of mfr; sounds like she didn't document it.
headache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Jun2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on Jun2021. Patient mentioned that not a huge reaction; just looking for something to take the edge off. The outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
Vaccine administered (L) deltoid IM 9/7. Pt called 9/10 complaining of low grade fever, extreme tenderness at injection site, facial pruritus, with chest pressure and fatigue and 2" circumscribed area (L) deltoid-red and hard to palpitation. Blotchy hives on face and arm. T:98.9 full range of motion in arm vs stable. as of 9/11-Doing better with ice and Tylenol
Pregnant patient received Fluarix; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV  (Fluarix Quadrivalent 2022-2023 season) (batch number 53y2g, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: The nurse reported that it was unknown what trimester the patient was in, the estimated delivery date, date of last period and any concomitant medications. The reporter did not know date of birth of the patient. No other information was reported to governance, risk and compliance agent by the reporter. The reporter consented to follow-up. Additional supportive information: A pregnant patient received a dose of Fluarix in left arm on the day of reporting, which led to vaccine exposure during pregnancy.
Onset yesterday after receiving influenza vaccination. Related symptoms: Complaining of muscle pain, left shoulder pain and mild swelling. Complaints of difficulty lifting/moving the arm without pain. Patient is able to move the arm but is painful. Exam revealed muscle spasm to the left arm left deltoid. No acute deformities, erythema, swelling or discharge. The affected area is not warm to touch. Patient is able to move for range of motion but expresses pain with certain movements. Will treat conservatively. Recommend over-the-counter Tylenol take as directed, consider using Tizanidine for muscle spasm that as previously prescribed, alternate with ice and heat.
Chills, fever, headache, body ache.  Three Advil. Symptoms went away after  about 9 hours
pneumonia of both lungs due to infectious organism; bronchospasm; sepsis; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 11-NOV-2016, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient experienced suffered severe shortness of breath, cough and fever; additionally, the patient was ultimately hospitalized and diagnosed with bronchospasm, pneumonia of both lungs due to infectious organism and sepsis. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of bronchospasm, pneumonia of both lungs due to infectious organism and sepsis were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events pneumonia and sepsis were considered as medically significant.
mom c/o of knot in lower rt thigh;advised mom to keep cool compresses on leg 3-4times a day;HIB vax given in lower rt thigh;
Pt taken to ER on 01/08/10 with weakness in legs and tremors. Seen in ER and returned home. Seen in ER again on 01/10/10 with similar symptoms. Admitted to hospital on Thursday Jan 14, 2010. Pt. remains hospitalized. R/O viral myalgia. R/O GBS.
Acute, sporadic; comes and goes. Itchiness, red bumps accompanied by small pustules. Calamine may help but have only monitored. Will report to pharmacist.
Excessive night perspiration since first dose, evening low grade temperatures 99.6-99.8 average, loss of appetite  Some weight loss
Pt was exposed to her sister who was vaccinated with one dose of varicella virus vaccine live. The pt developed chicken pox, three days later. The vaccinee did not develop a rash. The pt sought unspecified medical treatment. Additional information has been requested.
the patient was given an expired dose of Quadracel , no adverse event; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves an unknown demographic patient who was vaccinated with a 0.5 ml one dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AB and expiration date 09-Oct-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 14-Oct-2020.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to expired vaccine used (latency was same day).  It was reported that someone at the facility had put a mark on the product at the location of the expiration date on the box. The facility's mark made someone think the expiration was 19-Oct-2020 instead of the actual 09-Oct-2020.  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.
Within 10 minutes of getting the flu shot, I was driving my co-workers back to the office when I felt dizzy, like I was going to faint.  I had to pull over the car and lay down for a few minutes until I felt better.  I went back to the clinic and got some juice and had my blood pressure taken.  I felt good enough by that time to go back to work.
7th grade PE at 1100, health, given ADACEL and MENACTRA. At about 2000 - generalized T.C. seizure (2 min). No fever.
feels like someone beat her up; is hurting; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) at an unspecified dose and frequency. At the time of the report, PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Flu like body aches; Flu like body aches; low fever; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:45 (Lot Number: EN6207), at vaccination age of 58 years, as single dose for covid-19 immunisation.  The patient did not receive other vaccine in four weeks. Medical history included High BP treatment and Known allergies: Penicillin and Sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); sertraline hydrochloride (ZOLOFT); lamotrigine; ezetimibe, simvastatin (VYTORIN); amlodipine besilate, olmesartan medoxomil (AZOR), all taken for an unspecified indication, start and stop date were not reported.  On 19Mar2021 04:00 the patient experienced flu like body aches and low fever. The patient did not receive treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were non-serious with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Mar2021 (Nasal Swab). No covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Arm sore after 1st dose; Could feel a knot after 1st dose; Redness moving down arm after 1st dose; Arm felt thick after 1st dose; Big red spot on arm after 1st dose; Arm itching after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose) and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose), VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm sore after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose) outcome was unknown, VACCINATION SITE MASS (Could feel a knot after 1st dose) and VACCINATION SITE INDURATION (Arm felt thick after 1st dose) had resolved and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Menstrual spotting (which never done before). Spotting was 3/27-4/10. Menstrual spotting has lasted almost two weeks, which took her to  28 day mark of the cycle; Had also started going longer than 4 weeks between periods, but never shorter.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 at 14:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included mitral valve regurgitation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 17Feb2021, within four weeks prior to the COVID vaccine. Concomitant medications included nadolol (MANUFACTURER UNKNOWN), cannabidiol (CBD OIL), magnesium oxide (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and phosphoric acid sodium, sodium phosphate dibasic (PHOSPHATE); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 04Mar2021 at 14:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021 at 07:00, day after second vaccination, the patient experienced menstrual spotting (which never occurred before). Spotting was from 3/27 to 4/10. Menstrual spotting had lasted almost two weeks, which took the patient to the 28-day mark of the cycle, then moved into a normal period which she had for almost a week now (usually only 4-5 days). Period started 4/11-current as of 4/17. The patient had also started going longer than 4 weeks between periods, but never shorter. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual spotting (which never done before) and had started going longer than 4 weeks between periods, but never shorter were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
4-month-old receiving PENTACEL described as the liquid portion was not administered, with no reported adverse event; 4-month-old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl, with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination.  On 18-Sep-2023, the patient received 0.5 ml total (1x) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ853AB, Expiry date: 13-Apr-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for Immunization.  On 18-Sep-2023, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, with no reported adverse event (single component of a two-component product administered) (product preparation error) (latency: same day).  It was reported, A Clinic wanting to know how to proceed after a Medication error with a 4-month -old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl.  Action taken: not applicable.  Outcome: Unknown   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 the 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.
hot flashes; stomach upset; horrible headache; joint pain; injection site pain; fatigue; muscle pain/hurt/achy all over; chills; felt like they had COVID-19 all over again; swollen joints; they could hardly walk; got hot; bouts of diarrhea; dizziness; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints) and GAIT DISTURBANCE (they could hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided by reporter.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) for DOCTOR RECOMMANDED, VITAMIN D3 for LOW VITAMIN D3 LEVEL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for SEASONAL ALLERGIES, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for VITAMINS TO HELP EYE HEALTH.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 23-Mar-2021, the patient experienced COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEADACHE (horrible headache), HOT FLUSH (hot flushes), ABDOMINAL DISCOMFORT (stomach upset), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (injection site pain). At the time of the report, COVID-19 (felt like they had COVID-19 all over again), FATIGUE (fatigue), MYALGIA (muscle pain), JOINT SWELLING (swollen joints), GAIT DISTURBANCE (they could hardly walk), INJECTION SITE WARMTH (got hot), CHILLS (chills), DIARRHOEA (bouts of diarrhea), DIZZINESS (dizziness), PAIN (hurt/achy all over) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       comeds added in initial additional document .   This case was linked to MOD-2021-130422 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form-events updated
Baby had diarrhea with blood and mucous in the stool for several weeks.  She had been on supplemental formula since birth so Dr. didn't think there was any way it could be a milk allergy being that it came on after she was 6 months old, when we hadn't changed anything.  After running several lab and stool tests, no bacteria or causes were found.  Switched baby to a formula for babies with milk sensitivities, and the symptoms cleared up in a week or two.  Assume this to be a milk allergy caused by the rotovirus vaccine.  Baby also is now intolerant to gluten, while she previously had no issues prior to the vaccine.  Hoping she will grow out of it in time after her body heals but the risks of this vaccine far outweigh the risk of the disease, so we will NOT be giving it to any of our children in the future.  Please take this off the market!
Initially site given SQ below deltoid muscle .not given IM ( I am a retired nurse) and felt Like fluid moved down and around injection when given. Initial soreness and after few days skin stated to get red and tender to touch. Site got worse and now 3X5 inches dry,raised slightly pink area that still tender to touch. Area not subsiding. Not itchy and skin nml temp without any red streaks. No fever or other changes. I have never had reaction from a vaccine. No meds taken for vaccine site taken.
INSOMNIA W SLEEP APNEA 5/2/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) OBSTRUCTIVE SLEEP APNEA 5/2/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
pt recv vax 15MAY97 & 23MAY97 pt devel a gen rash w/about 30 to more than 50 lesions;
pt administering vax to staff member when the needle became disconnected from the syringe & the vax went into the eyes of the hlth care professional & the staff member;12NOV97 the hlth care professional exp burning of the eyes;s