chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; DRY COUGH; CHILLS; SORE THROAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in the left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced dry cough. On 17-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, chills, body aches, and dry cough. This report was non-serious.
having headaches.Patient took one tablet of Advil, and still has ongoing headache, advised patient that he can take 2 tablets of Advil every six hours as needed. If headache gets worse recommended for him to see primary provider.
Developed pain at injection site and then pain moved down her Rt arm and into her upper back, around to rib cage area and up into her neck. Developed redness, swelling and fever.
Muscle ache spread from the arm where the shot was received throughout my body, I was very tired. Next morning dizziness and headache along with continued fatigue and body ache. Some shivering and chills while in the shower. It was all bad enough that I came home from work early and went to bed. By the following morning, I felt fine.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot to the touch), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash on her left arm just below the injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and PYREXIA (Fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M201A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot to the touch), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash on her left arm just below the injection site) and VACCINATION SITE ERYTHEMA (Injection site is red). On 31-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot to the touch), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash on her left arm just below the injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Numbness; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received (solution for injection, subcutaneous, batch number: Unknown) 45 mg, frequency was not reported, from 29-SEP-2018 for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the patient experienced numbness, and was hospitalized for 3 days in the early MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of numbness was not reported. The reporter provided no causality assessment, the company causality between ustekinumab and numbness was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V:20210749072-covid-19 vaccine ad26.cov2.s-numbness. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received 2nd HBV in left arm on 7/25/00. Per pt, developed swelling/redness, 2 days, post vax. Seen in ER on 8/4/00 and given Demerol and Ancef. Given RX for Keflex and Vicodin and Ativan. Denied misusing injection drugs.
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 20-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Employee has Nausea , vomiting  headache daily. Symptom were  exacerbated after  vaccine  was given leading to  Hospitalization and IV hydration.
Had a severe Allergic Reaction; Fever; Achiness; Had to stay in bed for a couple of days; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction, fever, pain, mobility decreased and fatigue. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the fever, pain, mobility decreased and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, fever, pain, mobility decreased and fatigue to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient's spouse.  The reporter stated that his wife had a severe Allergic Reaction when she took the first Shingrix vaccine in 2019. He states that she had Fever, Achiness, and had to stay in bed for a couple of days. She did not remember which arm she had the injection. The reporter consented to follow up. All information was not available.
Rash on left side of body; Extreme tiredness; Head aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 27Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021 at 10:00, the patient experienced rash on left side of body, extreme tiredness and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events rash on left side of body, extreme tiredness and headaches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
In January, I got COVID-19, I had fever like symptoms and was very fatigue and dizzy. I had an elevated heart rate and that queued me to go to the hospital. They monitor my heart rate and did a EKG. After an hour I was discharged and prescribed Paxlovid 150-100mg, after threes day I felt fine.
gastrointestinal (GI) distress; patient presented with fever of almost 102; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from non-health care professional (Pharmacy-other).  This case involves female patient of unknown age who experienced GI (gastrointestinal) distress (abdominal discomfort) and presented with fever of almost 102 (pyrexia), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 02-Sep-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA VACCINE (lot number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious GI (gastrointestinal) distress (abdominal discomfort) and presented with fever of almost 102 (pyrexia) on an unknown latency following the administration of INFLUENZA VACCINE. Patient had reported to hospital following receiving vaccination yesterday.  No other relevant laboratory test results reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  There will be no information available on the batch number.; Sender's Comments: This case involves female patient (unknown age) who experienced serious abdominal discomfort and pyrexia on an unknown exact latency (approximately one-two days) following vaccination with INFLUENZA QUADRIVAL A-B HIGH DOSE VACCINE. The time to onset was compatible. However, detailed additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data were not reported. Based upon the reported information, the role of the vaccine cannot be assessed. Missing data needed for further assessment of the case.
Soreness, itching, redness and swelling at injection site. Soreness under left arm and into breast
Pt was anxious to get shot, following immunization co achiness, feeling "impaired", trouble finding right words, feels "weird", like when talking on a cell phone with the echo that you hear yourself talking, was warm to touch but not sure if fever. This morning at 11:30am, was feeling a bit better but still felt a bit "foggy in the mind". No nodule in arm, but noted tightness in arm. Instructed to monitor over weekend, continue Ibuprofen, Benadryl and told pt to go to ER if problems get worse or become concerning.
Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg.  On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school.  She came home from school on the 6th screaming in pain.  Her ankles were so swollen, we had a lot of trouble getting her boots off.  She couldn't walk and had a rash all over her legs and ankles.  We saw a pediatrician who immediately sent us to hospital.  She had lots of tests and IV steroids and antibiotics.  They later diagnosed her with Lupus.  PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u.  Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx:  Lupus. F/U 2/19/09, 4/6/09 with Impression:  The presence of anti-histone AB suggests drug-induced Lupus 2' to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess:  Worsening Lupus now with nephritis.  Admitted 7/7-12/09 with D/C DX:  Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria.  7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis.  Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus  Other causes of encephalitis and encephalomyelitis: 323.814,
After the second dose the temperature of my body decreased from 36.7-8 to 35.1-5/her body temperature dropped from 98.1 dropped to a fluctuating range between 96.1 and 95.3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 10:00 (Lot number: EN6208) at the age of 63 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Hipertension Arterial" (unspecified if ongoing); "Enfermedad Renal Cronica Stage III" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; OMEGA3 JACK; ROSUVASTATIN. Vaccination history included: Bnt162b2 (1st dose, Batch/lot number: EN6198 , Date of start of drug: 27Feb2021, Anatomical Location: Arm Right), administration date: 27Feb2021, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "COVID-19 immunization". The following information was reported: BODY TEMPERATURE DECREASED (non-serious) with onset 21Mar2021 10:00, outcome "not recovered", described as "After the second dose the temperature of my body decreased from 36.7-8 to 35.1-5/her body temperature dropped from 98.1 dropped to a fluctuating range between 96.1 and 95.3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased.  Additional information:Additional information- event has remained this way since receiving the 2nd dose of the vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. Patient wanted to know that if it is a side effect or you have other people reported this.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: Fs9943) at the age of 65 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 01Apr2021 as dose 2, single (Lot number: Ep7533), in left arm and on 20Oct2021 at 11:00 as dose 3 (booster), single (Lot number: Ff2590), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lanolin, reaction(s): "Known allergies: Lanolin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
patient arrived to ED for stroke like symptoms on 11/4/2021. Admitted for 2 days (11/4-11/6/2021) and discharged home with diagnosis of acute ischemic stroke.
Her heart was racing just a very little bit; She had dizziness for three to four days; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Her heart was racing just a very little bit) and DIZZINESS (She had dizziness for three to four days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PALPITATIONS (Her heart was racing just a very little bit) and DIZZINESS (She had dizziness for three to four days). On 03-Apr-2021, PALPITATIONS (Her heart was racing just a very little bit) had resolved. At the time of the report, DIZZINESS (She had dizziness for three to four days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106537, US-MODERNATX, INC.-MOD-2021-106610 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106537:Brother case US-MODERNATX, INC.-MOD-2021-106610:Reporter's case
WITHIN 5 MINUTES OF RECEIVNG FIRST DOSE OF COVID19 PFIZER VACCINE, PATIENT RETURNED TO PHARMACY STATING HE WAS FEELING DIZZY, AND COLLAPSED INTO COUNTER. MANAGER WAS ABLE TO HELP HIM TO A CHAIR SO HE DID NOT FALL, PATIENT CAUGHT HIMSELF WITH THE SHIELD/COUNTER. CALLED 911 AND EMS ARRIVED WITHIN A FEW MINUTES. ASKED PATIENT TO DESCRIBE SYMPTOMS, PATIENT RELAYED FEELING DIZZY, TROUBLE SEEING, VERY WARM, SWEATY. PATIENTS VITALS WERE CHECKED BY EMS, PARENTS AND PATIENT CHOSE NOT TO TRANSPORT AFTER ABOUT 30  MINUTES PATIENT WAS CLEAR OF ALL SYMPTOMS.
Case number PHEH2012US024155 is an initial spontaneous report received from a nurse on 03 Dec 2012. This report refers to an 18-years-old female patient. Her medical history was not reported and concomitant vaccinations included influenza vaccine (other manufacturer, batch number: not reported) and chicken pox vaccine (other manufacturer, batch number: not reported) on right arm 17 Oct 2012. She was vaccinated with MENVEO (batch number: A11042) and a tuberculosis skin test (other manufacturer, batch number: not reported) on left arm on 17 Oct 2012. Two weeks after vaccination, she experienced induration in the left arm. It was reported that she experienced an indention in her arm with a pocket of swelling right below it. It was reported that the patient did not notice the reaction and someone else has noticed it on her. The outcome of the event was not reported. No further information was provided.
Rash at injection site at left arm; raised, erythema, papules; apparently occured with 1st injection as well; rash after 2nd injection more pronounced.
Exactly 36 hrs after the injection I got chills,  shivering, muscle aches, nausea and very painful deltoid muscle which continues 48hr. Got a COVID-19 test which was negative and the symptoms resolved. I had no fever, cough or SOB.
Following administration of the first dose of the COVID19 vaccine (Pfizer) patient reported right sided lip tingling (no swelling or drooping), and a "weird" feeling in chest (no additional details provided).  Patient appeared anxious, but declined feeling anxiety. Patient declined medical treatment/follow-up and her symptoms resolved.  Note: Patient received second dose of COVID19 vaccine (same lot# EH9899) on 1/8/2021 with close monitoring and no adverse reactions occurred.
This spontaneous report as received from a healthcare worker refers to a 12 month old patient. On 15-AUG-2014 the patient ws vaccinated with (Oka/Merck) VARIVAX (0.5ml, subcutaneous, lot # not provided) which was improperly stored dose exposed to a maximum of 9-C for total 2.5 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. thi sis one of the several reports received from the same reporter. Additional information has been requested.
Immunizations at 2:30 PM. Five minutes after administration, client reports itching at site, dizziness, difficulty breathing, tight throat. 0.3ml epinephrine SC below immunization site. EMT alerted. No audible wheezing or stridor. EMT arrived to transport at 2:50. Administered O2 by mask, IV fluids. Assessed and evaluated, observed at hospital. Given 50mg Benadryl; symptoms elevated. Anaphylaxis undetermined by physician and referred to own physician. Released to home at 7:30 PM. Information from medical records fails to confirm anaphylaxis, does state panic attack. msv
A female patient (age unspecified), experienced chills after her third dose of RabAvert following exposure to a rabid cat. The patient was exposed to a rabid cat(date unspecified). Eight hours after her third injection of RabAvert she developed chills. She wrapped up in blankets and went to bed. Within 7-8 hours, the chills completely resolved. No other symptoms were associated with the chills. The reporter assessed the event as possibly associated with the RabAvert. Follow up information Received on 09/27/2004: The patient reported another episode of chills following RabAvert dose number 4 received on 09/04/2004 (lot number335011 exp. Jan 2007) On 09/24/2004, approximately twelve hours after receiving the RabAvert injection, the patient developed chills which lasted four to six hours. Follow up information Received 10/11/2004: The subject received the first two RabAvert injections(lot# unspecified) and the following two RabAvert injections from lot# 335011 with an expiration of January 2007. The fifth rabies vaccine was Imovax HDCV and she did not experience a reaction to that vaccine. Follow up information Received: 10/19/2004, The subject received the first two doses of an unspecified rabies vaccine(lot number unknown) the third and fourth doses of the vaccine series with RabAvert and the fifth dose was Imovax(Aventis Pasteur). p
This spontaneous report as received from a medical assistant refers to a 3 year old female patient. On 10-FEB-2010 the patient ws vaccinated with a third dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, in an unspecified site). Previous dates of vaccinations were not reported. The reporter stated that his error occurred when they were converting their paper charts to electronic records. No adverse effect experienced. This is one of several reports from the same reporter. Additional information is not expected because the reporter does not want to be contacted.
Patient received dose 2 of Pfizer covid vaccine too early, received first dose on 3/4/2021 and second dose on 3/17/2021., shorter than the recommended 3 week interval. has not reported signs and symptoms currently
Pt presented for first COVID vaccine dose on 1/21/22. Person accompanying pt requested pt be given Moderna vaccine. Pharmacist administered 0.5 mL Moderna COVID 19 vaccine. After administration, provider made 3 outreaches via phone on 1/24, 1/25 and 1/26 to review event with patient/parent/guardian.  Provider left voicemails with clinic phone number for return call. Calls have not been returned as of date of submission.
during admin partial dose given with no issue, remainder of dose expelled from syringe needle hub.  CDC was contacted for instruction, recommended repeat dose in 8 weeks. patient had no adverse or ill outcome
Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awake, dizziness subsiding Sat 10am Dizziness Subsiding, general malaise, Nausea Sun Dizziness gone, Runny Nose, Stuffiness, full/congested feeling Mon 99.5, Nausea, Drainage