chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; My left hand was going numb, my legs were going numb on and off; Vomiting every half an hour for 12 hs, then it went to 1 hour, and 24 hs passed in total; Chills; Fever below 104 F; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN (Body aches), HYPOAESTHESIA (My left hand was going numb, my legs were going numb on and off), VOMITING (Vomiting every half an hour for 12 hs, then it went to 1 hour, and 24 hs passed in total), CHILLS (Chills) and PYREXIA (Fever below 104 F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was given by the reporter.  Concomitant products included METOPROLOL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced PAIN (Body aches), HYPOAESTHESIA (My left hand was going numb, my legs were going numb on and off), VOMITING (Vomiting every half an hour for 12 hs, then it went to 1 hour, and 24 hs passed in total), CHILLS (Chills) and PYREXIA (Fever below 104 F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, VOMITING (Vomiting every half an hour for 12 hs, then it went to 1 hour, and 24 hs passed in total) had resolved. On 04-Feb-2021, PYREXIA (Fever below 104 F) had resolved. On 05-Feb-2021, PAIN (Body aches) had resolved. On 06-Feb-2021, HYPOAESTHESIA (My left hand was going numb, my legs were going numb on and off) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 104 f (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-056957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The follow up received on 26-APR-2021. No New Information is added(NNI).
I had no side effects following the injection until  February 23, 7 days after receiving the shot in my right arm,  the vaccination site became itchy and a little sore. I noticed later there was more swelling, the area was hot to the touch and a red rash developed over the area that was most swollen.
Cough, shortness of breath, nausea, light headed, itchy throat. I had to see my allergist and was put on steroids and oxygen.
Received Pfizer vaccines on 2/19/21, 3/16/21. Tested positive for COVID-19 on 7/10/21.  Symptoms began on 7/6/21 w/ cough, dysgeusia, fatigue. Hospitalized on 7/13/21; transferred to ICU on 7/22/21.  Patient expired on 7/25/21 due to pneumonia d/t COVID-19. Patient was intubated; given dexamethasone 6 mg x9 d, 5 day course of remdesivir, one dose of tocilizumab for COVID pneumonia.  PMH significant for  past medical history significant for pulmonary sarcoidosis, on prednisone 5 mg daily; immune thrombocytopenic purpura, on rituximab.
129/80-82-28 94% 97.7 - Pt had vaccine, waited 15 mins, the left, itching all over about 20 minutes after leaving, returned to vaccine site. Benadryl 25mg PO given, waited x 30 mins. Itching improved
Fever (99.2-100.3) for at least 6-8hrs overnight along with body aches which lasted even after the fever subsided.  No medicine was taken and symptoms resolved themselves without needing to see a doctor.
ADMINISTERED THE COVID-19 VACCINE TO A 17 YEAR OLD PATIENT; This spontaneous report received from a pharmacist concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced administered the covid-19 vaccine to a 17 year old subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the covid-19 vaccine to a 17 year old patient was not reported. This report was non-serious.
After the standard and expected aches and pains within the first 24 hours, I woke up on 6/13/2021 with pain in my right leg above my knee. It was not muscular, it was in the varicose veins I have in that area. I took aspirin with the hopes of preventing a clot or stroke scenario. The pain has not gone away and the site is now hard and warm on 6/15/2021.
Information has been received concerning a 13 year old male who on 16-JUL-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot#654282/0776U). On 17-JUL-2007, the patient developed redness and swelling. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963, was received by the partner on 01-SEP-2022 and forwarded to Agency on 02-SEP-2022, from a health professional.  Due to the nature of the event, the causality between the event "Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 6 hours 40 minutes", and Vaxelis was not applicable.  Further information is expected.  For reference purposes cases is linked to: MCM-003974 and MCM-003975.
Patient has pain in arm of injection site. Pain is ongoing and pt has limited movement. Pt has seen two different MD's.
Chronic Urticaria; he cannot sleep because it itched too much/Difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic Urticaria) and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 032B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced URTICARIA CHRONIC (Chronic Urticaria) and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping). The patient was treated with CETIRIZINE at a dose of 1 dosage form once a day. At the time of the report, URTICARIA CHRONIC (Chronic Urticaria) had not resolved and INSOMNIA (he cannot sleep because it itched too much/Difficulty sleeping) outcome was unknown.            Patient had rashes all over his body and had itched too much. Patient then consulted an allergologist who advised the patient had chronic urticaria. Treatment medications included antihistamines to be taken for months.
vaccinated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 01-Aug-2022 Reporter's comment: The registered pharmacist reported that the patient was vaccinated with an expired dose of Havrix. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 14-MAR-2016, the patient was vaccinated with an improperly stored dose of GARADSIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Swelling of the upper arm and spreads up to the chest and down to the wrist on the left arm where DTaP was given. Also blisters along the upper left arm.
Large itchy raised red welt on upper left arm (5 inches long, 4 inches wide)
Information has been received from a NP concerning a 13 month old female pt with no past medical history who on 02/09/04 was vaccinated SC with a 0.5mL dose varicella virus vaccine live (Lot # 642997/0459M).  Concomitant therapy included Zyrtec. On 02/16/04, the pt began breaking out in lesions. On 02/18/04, the pt presented to the medical office with about 100 lesions scattered all over her body. Lab tests were not performed. Prescription drug treatment was not required. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information has been requested.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-FEB-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Visual hallucinations that would  be noticeable when eyes were closed that lasted about one month before spontaneous resolution.
5-6 hours after vaccination, started having cramps at injection site. Vaccine given around 7:45am. Overnight, so 16-24 hours later spiking fevers to 103, severe body aches, headaches, nausea, and vomiting. Currently 26 hours out from vaccine and still having all symptoms.
Breast fed right after receiving vaccine. Baby immediately broke out with facial rash and signs of lethargy 0 labored breathing noted. Cleared by EMS.
Loss of appetite for 5 days. Disorientation for 2 weeks, general malaise, sever constipation. Constant fatigue and lightheaded for 7 days, weak urination, heart fibrillations for 3 days, whole body weakness for 5 days, poor sleep for 7 days. Constant body sweats for 5 days. High temperature, profuse perspiration after a short walk. First week intense lightheaded almost led to passing out.
Hyperpyrexia (102.4) 12-18 hrs post admin 2 mo vaccines including Rotavirus.
This spontaneous report was received from a registered nurse refers to an unknown number of kids. On an unknown date patients were vaccinated with a doses of MMR II (doses, route and lot numbers were not reported). It was reported that the kids have screamed and cried after receiving MMR II (onset date and outcome were not reported). This is one of several reports received from the same source. Additional information has been requested.
c/o generalized malaise, h/a, hives, nausea, tired, & eyes swollen;
Temp between 101.5-102.5  for three days, muscle aches and exhaustion for a week
After taking first dose of covid vaccine, I felt a little light headed; my face and head started itching; This is a spontaneous report received from a contactable female consumer. A 43-years-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:00 (at the age of 43 years) as dose 1, single for covid-19 immunisation. Medical history included hypertension. Patient had allergies to medications, food, or other products. Concomitant medication(s) within 2 weeks of vaccination included Losartan, Zyrtec, Probiotics. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After taking first dose of Covid vaccine, she felt a little light headed and about an hour after taking the shot, her face and head started itching. Around 6:00 or 6:30, she was itching all over her body. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was told to take Zyrtec. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.         The patient experienced after taking first dose of covid vaccine, i felt a little light headed (dizziness) (non-serious) on 15Apr2021 16:00 with outcome of recovering , my face and head started itching (pruritus) (non-serious) on 15Apr2021 16:00 with outcome of recovering.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of after taking first dose of covid vaccine, i felt a little light headed (dizziness), my face and head started itching (pruritus).
She got her vaccine, she felt dizzy, felt like she was going to pass out.  She has had diarrhea, vomiting.  She has a knot on her arm with a red area, and pain in the arm.  She has been taking Benadryl, and has put ice on the area.  This has helped some, but still has diarrhea.  She has not called her doctor regarding her symptoms.
Info has been received from a registered nurse concerning an 84-year-old male who on 03/11/2003 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). The reporter indicated that the pt developed swelling around the upper arm, and the area became red and hard. It was noted that this has not yet resolved, and the pt has not yet been seen. Unspecified medical attention was sought. The reporter indicates that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01441 and 0303USA)1442). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
This spontaneous report was received from a pharmacist refers to a 23 year old female patient. On 18-AUG-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 669285/0691AA, expiry: 17-AUG-2013) dose 3. No adverse effect reported. Additional information has been requested.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: Lymph Node Swelling-Mild
Patient had COVID vaccine on 12/28.  Mild symptoms day after with site tenderness all of which resolved.  Then woke up on 1/5 with baseball size reddened area with hardened center at injection site.   Patient seen at urgent care and was put on doxy for ? cellulitis.  Patient to report to V-safe.
No symptomatic AE. No additional AE.; Nurse reporting an AE for PNEUMOVAX 23 that was administered to a 6 month old patient.; This spontaneous report was received from a Registered Nurse regarding a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U027357, expiration date: 25-MAR-2023, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No symptomatic adverse event was reported.
SHAKES; FEVER BROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced shakes, and fever broke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever broke and shakes was not reported. This report was non-serious.
within a hour of my first vaccination i felt ill and my face began to swell on my left side (side of injection) The swelling in my face lasted nearly three days. I got flu like symptoms later in the day and all through the next but also lost the grip on my left hand and could not hold my phone. This lasted for a day and a half. The injection site itself hurt very little. For several weeks I had what I can only describe as  pain that felt like it was in my heart. I have had incontinence issues since my vaccination and have never had an issue ever. Looked up this as a side effect  but did not see it but I know my body and it began as a result of the vaccination so I wish to report it. All other symptoms have cleared but this had not and it gives me great concern
Started with abdominal pain on 11/16/2021 admitted to hospital 11/17/2021 with bowel obstruction had to have colon resection on 11/23/2021
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358679-00 (RA). A 66-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years and in Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), since 17Jul2019 (ongoing) at 40 mg (citrate free (40 mg, 1 in 14 day)), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2021, outcome "recovered", described as "Crohn's disease flare"; INFLAMMATION (non-serious) with onset Jan2022, outcome "recovered" (2022); MOBILITY DECREASED (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Loss of mobility of hand"; PERIPHERAL SWELLING (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Swelling in right hand". The action taken for adalimumab was dosage not changed. The reporter considered "crohn's disease flare" related to BNT162b2. The reporter's assessment of the causal relationship of "loss of mobility of hand", "inflammation" and "swelling in right hand" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira (Adalimumab): The reporter's causality for the event(s) Mobility Decreased, Inflammation, Hand Swelling was no reasonable possibility. The reporter's causality for the event(s) of Crohn's disease flare with Humira (Adalimumab) was a reasonable possibility. Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran), unknown: The reporter's causality for the event(s) Mobility Decreased, Inflammation, and Swelling was nor reported. The reporter's causality for the event(s) of Crohn's disease flare with Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran), unknown was Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, the events of crohn's disease, inflammation, mobility decreased, and peripheral swelling are assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.