chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent fatigability; Myalgia; This is a spontaneous report from a contactable physician, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Sep2021 at 16:30, the patient experienced persistent fatigability and myalgia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fatigability and myalgia was resolved with sequelae on an unknown date in Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid; 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid; This is a spontaneous report received from a contactable pharmacist. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot Number: el8982) as 2nd dose, single dose, via an unspecified route of administration on an unspecified date (Batch/Lot Number: en5318) as 1st dose, single dose for covid-19 immunisation. The patient medical history was notand concomitant medications were not reported. On an unspecified date, a fully vaccinated patient with the pfizer covid 19 vaccine had contracted covid. Reporter had 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and had contracted covid. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the people. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted covid. The seriousness was reported as non serious by the reporter. The outcome were unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021669273 same reporter/drug/event, different patient;US-PFIZER INC-2021669261 same reporter/drug/event, different patient
fever chills ache   dizzy  a dizzy spell caused her to fall and break her back.    still recovering after 7 weeks
Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypertension-Severe, Systemic: Weakness-Severe, Additional Details: wife came in and complained that patient was unable to get out of bed and that blood pressure has been elevated
50 year old woman received TD and developed chills, sore arm and limited range of motion, 2 days later. She used Tylenol for pain. 2 days later, she sought medical evaluation and a 13cm X 9cm area of erythema, tenderness and swelling was noted although she was feeling better overall.
Patient stated that on 5-5-18 she experienced swelling and a bruise. On 5-6-18 she experienced redness, itching, diarrhea, and an earache. On 5-7-18 symptoms seemed to intensify and in the evening she experienced numbness/tingling/tightness in arm to elbow so she went to the ER.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a male patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was administered in the fatty tissue in the back of the arm instead of into the deltoid muscle, which led to inappropriate site of vaccination. When he got home his arm was red and swollen. This case has been linked with the case US2018134620, reported by the same reporter.
Pt c/o small painful fluid filled blister on both hands for one week. pt was seen by provider 13 Aug 2010.  Pt was told to monitor and f/u.
High fever, wheezing, hoarseness, dizziness, headache, behavior changes ('thought I was going crazy'), left work early
The patient was given first dose on 30Jul2021 and second dose on 02Aug 2021, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (Reference number- 00714095) and transmitted to Sanofi on 06-Aug-2021.  This case involves a 9-month-old male patient who had 2 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] 3 days apart instead of recommended 7 days apart (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccination.  On 30-Jul-2021, the patient received a first dose of the suspect RABIES (HDC) VACCINE (lot T1C662M) via unknown route in the left thigh for Pre-exposure immunisation.   On 02-Aug-2021, the patient received a second dose of the suspect RABIES (HDC) VACCINE (lot T1C662M) via unknown route in the left deltoid for Pre-exposure immunisation.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency: same day of 2nd dose)  It was reported that "Pharmacist reports that a 9 month old baby was advised to get pre-exposed vaccine for rabies for travelling purposes. Patient received it 3 days apart instead of recommended 7 days apart and caller needs information to proceed. Pharmacist from a travel clinic states the child was given first dose on 30Jul2021 and second dose on 02Aug 2021. States they had the child coming back in today for the next dose and were going to count this as 7 days from the dose on 30Jul2021 because everything they have read says not to count an early dose. Caller wants to know if this is correct and to get the child back on the 7 day apart schedule and give them a 4th dose or will they give 3 doses total. IF they give 3 doses total for the pre-exposure when would be the next dose? They travel out of the country on 25Aug2021"  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 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.
Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jul2021 at 15:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had known allergies (unspecified). It was not reported if the patient received any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Jun2021 at 13:15 (at the age of 13-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 four weeks prior to the vaccination. On 21Jul2021 at 20:00, the patient experienced really bad headache high fever and really bad stomache pain. And fast heart rate. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of really bad headache high fever and really bad stomache pain; and fast heart rate and included treatment with intravenous (Iv) fluids blood work and migraine medicine. The clinical outcome of the events really bad headache high fever and really bad stomache pain; and fast heart rate was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) positive, notes: strongly positive; (Mar2023) positive, notes: very faint positive; (Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound after resolution of symptoms and very faint positive line on rapid test on day 6 (day 0 = positive test and symptoms, day 1 = first day of Paxlovid), nasal congestion and cough returned and began worsening, and rapid tests were strongly positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm swelled with fluid and pain. Had to go to family doctor and was put on antibiotic for 10 days. Had cellulitis. It was pneumonia shot.  Follow up on 01/03/2002: "This was given at church.  do not have any other information."
Dizziness. Seems to be BPPV or very similar. Noticed this when getting out of bed the second morning after the shot. That was 3 days ago and am still experiencing same symptoms. Most noticeable when rolling over in bed but also when bending over with certain head movements.
Patient received vaccine on 2/13/17. 2/15/17 patient reports having a firm, golf ball sized round area that is warm/hot/sore. This started at approximately 7:00 pm on 2/15/17. Patient also stated on 2/13/17 in the evening she developed a cough that became productive with green phlegm the following day. Taking ibuprofen. Intends to apply cool compresses and will contact physician following cold compresses - swelling went down. Called physician and physician told not unusual. 2/20/17 - All resolved except small bump. Pt and Dr felt cough due to sinus not vaccine per patient 2/20/17.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 12-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster or shingles. On or about 11-MAY-2016, the patient was treated by a physician for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested. .
Swollen and sore arm (day 1), red, inflamed and hot to touch expanded beyond injection site by 24 hrs. Continued to spread across arm and developed rash. Fever started day 2 and stayed around 101.7 .  Fever, chills until day Day 4. Continued rash, hot to touch covering most of arm above elbow. Diarrhea started day 2 and continued through Monday (Day 5). Severe headache started day 2 and continued for 3 days.
mom states pt w/low grade fever during evening; slept well; 530AM 9JUN94 woke & heard pt snoring which is unusual per mom; noticed alot of jerking, felt very hot & seemed out of it; call hosp ER; no further sz activity;
felt part of the dose run down her arm or at least had that sensation.; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient claimed that on the first dose, she felt part of the dose run down her arm or at least had that sensation. The inoculator thinks the complete dose was injected. The patient was upset and wants a recommendation on if she should need a repeat of her first dose. The patient asked if there was any data on repeating the first dose vs. no action and proceed with the second dose in 21 days. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
x 3 days of spreading erythema, mild edema and pain at injection site, warm to the touch.   Keflex 500mg four times a day x 7 days prescribed, continue celebrex, may use benadryl spray or cream on the site.
Develop chills, then fever (99-100) in the early evening following vaccination the morning of May 4.  Fever lasted the night.  Took tylenol on May 5. in the AM.  This eliminated the fever but I continued to feel sluggish (hadn't slept well which didn't help).   Chills returned in the early evening.  Took another dose of tylenol.  Slept well.  This morning, May 6 I feel normal and was able to exercise (4.5 mile walk including some hills).
Meniere flare-up for 24 hours; Blurry vision; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 09Mar2021 at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy to Brazil nuts, buckwheat and shrimp. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3) and iron, all received from an unspecified date (within 2 weeks), at an unknown dose, for an unspecified indication. On 10Mar2021, the patient experienced blurry vision and Meniere flare-up for 24 hours. No treatment was received. The patient recovered from the events on 11Mar2021. Post the vaccination, the patient has not been tested for COVID-19.  The information on the Lot number has been requested.
Information has been received from a physician concerning a 62 year old female patient who on 14-JUL-2011 was vaccinated with a subcutaneous dose of ZOSTAVAX (Merck) (lot # and dose not reported). The physician reported that a few days after vaccination, on 16-JUL-2011, the patient developed a non itchy rash around the eye, the mouth and the middle of the chest. The physician thought it resembled the herpes zoster rash. The patient was referred to an ophthalmologist who treated the eye for conjunctivitis. At the time of the report the patient was working with her healthcare provider to address the symptoms and was recovering. Conjunctivitis was considered to be an other important medical event by the physician. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Moderna 10/30/2021, started experiencing symptoms of body aches, headache, and chills (no fever reported). Symptoms lasting 36hrs then subsiding. No noted Primary visit/communications.
Injection site tightness in the arm during the day similar to what I had from the 1st shot. No other issues after the 1st shot. The 2nd shot had the tightness, but it also had 103.2 fever started in the late evening 10:00 PM the day of the shot.  The fever broke about 5hours later without any medication. No other issues the next days or the days to follow.
Elevated blood pressure and pulse. Sweaty and clammy. Pale. Almost passed out. Hot and cold at the same time.  EMS checked patient out and cleared her to go home.
Severe swelling, erythema pain at at injection x for first 4 days  Headache,  first day. Day two fever, body aches started. Third day  joint aches, cough, congestion, sore throat started and continue  today.
later on died 9 hours after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 98-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death), 9 hrs after the suspect product(s) administration, outcome "fatal", described as "later on died 9 hours after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.; Reported Cause(s) of Death: later on died 9 hours after getting the vaccine
Fatigue December 2021  February 2022 shortness of breathe  March - current (5/22/22) Low factor 8/blood platelets/blood volume.  Atypical  hemolytic-uremic syndrome
Narrative: The patient is a 64-year-old male with PMH of alcohol use, tobacco use, HLD, depression, back pain, hepatitis, and COPD was seen at hospital for a deep vein thrombosis. This was attributed to his COVID-19 vaccine Moderna 100 mcg/0.5ml dose. The patient had received all three doses and the last administration was on 11/16/2021. The patient was started on rivaroxaban 15 mg twice a day for twenty-one days then started on 20mg by mouth once a day.
Abdominal pain 4 days and continuing; chest heaviness/pains 3 days; diarrhea 3 days; vaginal cramping and bleeding outside of menstrual cycle 1 day and continuing; increased palpitations and skipped heart beats 4 days and continuing; fatigue 4 days and continuing; arm tenderness at injection site 4 days; redness at injection site 3 days; itching at injection site 3 days; lymph node tenderness in right arm 3 days; chills 4 days and continuing; night sweats 4 days and continuing; vomiting 1 day; body aches 4 days and continuing; leg pain/ cramping 2 days and continuing; joint pain 2 days; anxiety 3 days; insomnia 2 days
went deaf for a while; Trouble breathing; Swollen genitals; Injection site arm in severe pain; fever; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine, and who developed trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately one hour prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, approximately one hour after receiving the injection, he developed trouble breathing, swollen genitals and severe pain at the injection site.  He had a fever, and he went deaf for a while.    On 14 Jan 2021, the pain became so overwhelming that he went to the emergency department.  No diagnostic information was provided.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while, was not provided.  The event, went deaf for a while, was considered recovered/resolved on an undisclosed date.  The outcome of the events, trouble breathing, swollen genitals, injection site arm in severe pain and fever, was not reported.; Reporter's Comments: This spontaneous report refers to a male patient who experienced unexpected events of trouble breathing, swollen genitals, severe pain at the injection site, fever and went deaf for a while one hour after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown.  Based on temporal information provided and in the absence of any other etiological factors, a causal association cannot be excluded. Pain and fever are consistent with the known safety profile of the vaccine.
Fever to 102, myalgia, nausea, headache, chills and mild abd. pain overnight after vaccine was given. Decreased appetite -> IV fluids.