chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, NauseaVomiting, Vertigo Narrative:  Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover
Rapid heart rate, slight nausea, slight numbness to front right cheek and lips.  Onset within 1 minute of injection.  No treatment given.  Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes.  Numb areas returned to normal within 45-60 minutes.  Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction.  I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.
Small bumps that itch on legs, back and arms; Small bumps that itch on legs, back and arms; This is a spontaneous report received from a contactable consumer, the patient. A 62 years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201 via an unspecified route of in left arm on 27Feb2021 at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to penicillin, tetracycline, sulfur and general anaesthesia. The patient medical history was reported as degenerated disc disease, neurogenic claudication and hypertension. Concomitant medication reported as gabapentin (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) from an unknown date and it is not reported if its ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 06Feb2021 at15:00, (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient did not have symptoms associated with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 03Mar2021 (4 days after dose 2 vaccination) at 04:00, the patient experienced small itchy bumps on legs, back and arms which broken out into rash. Patient was still fighting rash with Benadryl and bumps with a cream which was suggested by the dermatologist. The patient received Benadryl and cream as a therapeutic measure for the events. The events not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of event itchy rash and rash all over was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Lip swelling within 2 hours of injection. Nausea and vomiting the following morning. BENADRYL taken on day of infection. Unsure of outcome or if additional medications/treatments needed.
Report 2001018585-1 described red raised projections in a vaccinee of  unspecified age and gender who received hepatitis a vaccine inactivated (Havrix). Allergies, medical history, and concomitant medications were not specified. On  an unspecified date, the vaccinee received her first dose of Havrix. Subsequently, she experienced a 5 X 3 (units unspecified) area of red raised projections. As of 31 July 2001, the outcome of the event was unknown.
Extreme headache; vertigo; nausea; chills; fatigue; unable to sleep most nights; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 10:15 (Lot number: ER8731) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: ED6955, Administration time: 10:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 28Mar2021, when the patient was 57 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "Extreme headache"; VERTIGO (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "fatigue"; INSOMNIA (non-serious) with onset 21Apr2021 17:00, outcome "not recovered", described as "unable to sleep most nights". The events "extreme headache", "vertigo", "nausea", "chills", "fatigue" and "unable to sleep most nights" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vertigo, nausea, chills, fatigue, insomnia.  Additional information: Extreme headache, vertigo, nausea, chills, and fatigue starting about 36 hours after 2nd shot. Symptoms have continued on and off for 14 days. Symptoms are more severe during the night. Difficult to make it through work, have needed to take sick days, unable to sleep most nights. Some days patient was bed-ridden with severity of symptoms. Patient not received any other vaccine in four weeks. Patient not had covid prior vaccination. Patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
experiencing extreme shoulder blade pain that has been preventing her from moving her shoulder; This is a spontaneous report received from a contactable consumer. This 21-years female consumer (patient) reported for herself. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date (Monday) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. By the middle of the day on Tuesday, she has been experiencing extreme shoulder blade pain that has been preventing her from moving her shoulder. She has been taking tylenol but it has not been working. Outcome of the event was unknown Information on the lot/batch number has been requested.
Narrative:  Patient was vaccinated with Moderna COVID Vaccine 1st dose: 3/11/21 2nd dose: 4/8/21 booster: 1/3/22. He reported no side effects to any of the 3 doses. The patient was found deceased by local PD on 1/20/22. Cause of death unknown, not suspicious, considered natural. relevant medical history: 1. Congestive heart failure with reduced systolic function, transthoracic echocardiogram 12/2/2021 at Medical Center shows evidence of prior anteroapical infarction, severely depressed left ventricular ejection fraction around 25%, pulmonary hypertension, moderate to severe mitral regurgitation, and moderate tricuspid anteroapical infarction based on thinned myocardium and  akinesis to severe hypokinesis Pt had contacted the triage line at the hospital on  1/14/22 to report the following: Pt calling in regards to ongoing issues. He states he has recently seen Cardiology and been referred to undergo cardiac cath procedure. He states he was told he suffered a minor "heart attack" in Sept. Pt states the consult was placed on 1/3 and he has been waiting 10 days to hear back. He is frustrated stating no one has called him to schedule. He states in the  meantime, since meds have been changed, he is experiencing increased fatigue. He states Cardiology started him on Furosemide and since then he feels "exhausted" all the time. He reports excessive day time fatigue, reporting that he often falls asleep in his car for 30-40 minutes when he arrives home after work. He states "when I go on break at work, I fall asleep". He states has ongoing SOB with exertion which is not new but slightly worsening as time goes on. He denies new swelling, chest pain, wheezing, fevers ect. He states he continues to have a cogh which has also been consistently 103/80's, p80's. He denies dizziness/lightheadedness.
Manf syringes have peel off labels to affix to the paper chart to document vaccine admin. Over 40 expired vaccines (Pediarix) were administered, nurses didn't take time to read the labels, they just stuck them to the chart documentation forms (could have easily been wrong vaccine, too).
tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: tired). The outcome of the tiredness was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     It was unknown if the company considered the tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient via interactive digital media.  The patient stated that there was a blood test, if you were immune to shingles or not, ask to the physician. The patient did the test and then got his or her vaccination and was tired just for 2 days and was then ok. The patient will have second vaccine between 2 to 6 months. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown demographics. On an unknown date in January 2018, the patients were vaccinated with improperly stored VARIVAX for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effects reported. The temperature reported was 6F to 14F. The time frame was reported as 30 minutes. There was no previous temperature excursion. No product compliant reported.
Hives (L) arm within 12 hours. Tx with BENADRYL, ice, CORTAID cream.
since the second dose the neuropathy is "three times worse"; since the second dose the neuropathy is "three times worse"; missed work because his feet and legs bother him; like standing on pins and needles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0186 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 01Aug2021 at 16:00 hours (Age at vaccination was 55 years) as dose 2, single for covid-19 immunization. Medical history included ongoing neuropathy peripheral. The patient did not have any other adverse event within 4 weeks of vaccination and also prior to vaccination. The patient did not take any additional vaccine. There were no concomitant medications. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EY0584 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm, on 8Jul2021 (Age at vaccination was 55 years) as dose 1, single for COVID-19 immunization. In Aug2021 patient reported that he had a previous diagnosis of peripheral neuropathy in his feet and legs, related to his work in a battery factory, and since the second dose the neuropathy is three times worse like standing on pins and needles. The patient was missed work because his feet and legs bother him, like standing on pins and needles that diabetics usually get, but he was not diabetic. The patient did not perform any relevant tests. Patient was treated with Gabapentin 800mg 3 times a day, which was almost the max dose. Patient states he went to the doctor a week and a half ago and discussed it with him and he said to stick with what he was doing and if it doesn't get better to come back. Patient states it doesn't seem to be letting up, but some days are worse than others. The outcome of all the events was not recovered.  No follow up attempts are needed. No further information is expected.
I felt fatigued for 24-36 hours beginning 4hrs after injection. I experienced chills overnight after the injection. The morning following the injection I had moderate - severe upper arm pain at and around the injection site leading to impaired mobility and limited ability to use my arm. I also felt nauseous, had a headache, dizziness, and general malaise. I took Tylenol and my symptoms began to improve. The arm pain is still present but is slowly improving.
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with "all three doses" of GARDASIL (Lot# unknown) at a different physician office. The physician reported that the patient received the GARDASIL series before becoming sexually active. The patient had an abnormal pap smear and on an unspecified date was referred to the reporting physician who "did a culture test" (results not provided). The physician also stated that the patient had four-quadrant dysplasia and the biopsy results were still pending. The patient did not seek medical attention. Additional information has been requested.
lyme vax clinical trial 3 years ago-@ 12 mo booster 3rd dose did not go into arm-has since taken booster-75min post vax severe chills, body aches, fever, fatigue, went to bed;
Rash erythema, swelling and itching to site of injection  Narrative:  employee presented with itching, erythema, and swelling to site of injection past 48 hours of injection.
Has had an allergic skin reaction on her face; This is a spontaneous report from a contactable nurse, the patient. This 62-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) on 15Mar2021 (at the age of 62-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECT COVID-19 mRNA VACCINE, Lot number: unknown) on 05Apr2021 (at the age of 62-years-old); both via unspecified route as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported she had Pfizer vaccine 15Mar and 05Apr. Since then patient has had an allergic skin reaction on face (2021). She had been treated with prednisone and antibiotics. Every time that she was done with the medicine the reaction flared up again. Patient clarified that this started after first dose and it got better. She decided to get the second dose and then it got really bad. The outcome of the event was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided a contributory role of BNT162B2 to the event allergic skin reaction cannot be excluded.  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.
I have a prior diagnosis of Nonspecific autoimmune syndrome, mild degenerative discs neck and LS and osteoarthritis. Prior to vaccine I had episodic mild arthralgias in 1st MCP's (OA) and cervical and lumber mild discomfort, occasionally radicular, and occasional costochondritis. I was working full time in a busy internal medicine practice. The only medication I needed was Feldene or Ibuprofen. After the vaccine I developed progressive arthralgias in joints never before involved (2nd & 3rd MCP's on right, shoulders, hips, knees) proximal myalgias, chest pain, anterior and posterior (probable serositis) and progressive debilitating fatigue.I have had to close my internal medicine practice. Before the vaccine I never needed any pain Rx (except rarely for a migraine. Since 12/00 I've needed Vicoprofen daily and Plaquenil for the last year. Before the vaccine my ANA was 1:160-1:320. Since the vaccine it runs 1:320-1:640. My complement (C4) was never low until after the vaccine, now is consistently mildly low (15.7-17), lower limit of normal is 18. My immunoelectrophoresis now shows a diffuse gamma band, previously it was normal. My clinical worsening and changes in lab tests are all temporally related to the LymeRix. I did not previously report these symptoms since I am not 100% certain that the vaccine is causal. But now that clinical evidence in the literature shows molecular similarity between Opson A and HLA stuctures in humans, I am concerned that this vaccine is responsible for the severe progression of my symptoms.  Follow up: coronary artery disease diagnosed 03/29/2000.
Vaccine administered 02/23/04.  Same day Temperature 102-104, lethargic.  02/25/04: petichial rash on groin/axillae.  Pt was sent for CBCD, blood culture, started on Cefdinir 125mg per mouth every day for 12 days.Follow Up: Pt admitted to hospital secondary petichial rash, was eventually diagnosed with voseola.
2 days following immunization patient developed a large local reaction which lasted for 5 days. no treatment - reassurance to patient
Patient was given vaccine @ 10:47am, sat in observation area for about 20 minutes then reported sore throat (of sudden onset) EMS was on site and attend patient. Patient reports history of anaphylaxis x 3.
Headache for 36 hours; chills, shivering, body aches, for 15 hours, fatigue for 60 hours. No medical attention needed.
Patient got localized rash (looking like hives).   Very swollen thigh around area of injection.  Entire leg above knee is red.  Still ongoing 3 days later.
I had rhabdomyolysis 4 months after vaccine and was asked to document this after reporting it on a regulatory website.  Immediately following the rhabdo I had a kidney infection, then a severe cold, then an outbreak of cold sores.    I was hospitalized for the rhabdomyolysis and was seen in the ER for the kidney infection.  I was assessed for the cold to r/o covid at the urgent care at the hospital.    While in the hospital, I received fluids and bicarb for the rhabdomyolysis, and then rest and more fluids.   My legs swelled prior to diagnosis and were incredibly painful to the point of not being able to walk.   2 weeks later I had leg weakness, twitching in my legs, and lost approximately 1/2" of muscle mass all over my body, but most especially my legs and butt.   My CK levels came back to normal approx 3-4 weeks after diagnosis.    I no longer have weakness but still have the twitching.  I had a EMG to r/o muscle disease and was told I have severe peripheral neuropathy in my legs but they couldn't explain the continual twitching of my right calf muscle.  I am now gradually getting my strength back.    I received antibiotics for the kidney infection and rested.   Approximately a week and a half later I was tested for Covid/RSV/flu x 2 while sick with a cold.  It was all negative.  I had a cough, sorethroat, and body aches.  I was placed on steroids, which cleared it up a week later and it also stopped the pain in my legs related to the rhabdo and back problems.  I am now on a maintenance dose of valcyclovir to try and control the cold sores and sores in my mouth.    I have been cleared to exercise again.
This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. On an unknown date in 1992, the patient received vaccination with M-M-R II, subcutaneous injection. No other concomitant therapies reported. On an unknown date in 1992 the patient suffered from limited vision (disability) and was discharged due to limited vision. The action taken of the event with the suspect product was assessed as not applicable. The patient sought medical attention by contacting the physician. It was unspecified whether the event was life-threatening, and also unspecified whether hospitalization occurred. Intervention to prevent the seriousness criteria was unspecified. There was no overdose, no cancer and no PQC involved. The outcome of limited vision was unknown. The causality of the event was unspecified. Additional information is not expected.
Became dizzy about 21 hrs after flu shot. Periods in which it was not wise to drive or work.  My Dr prescribed meclizine and a decongestant.  4 days later added Medrol dose pack and 5 days later Augmentin x 10 days after reporting a temp of 100.5.
sudden right ear hearing loss, vertigo, tinnitus. Hearing loss in right ear is 100% and permanent
Client received vaccine on 5/2/22 and developed a varicella type rash on 5/19/22 "all over body".  Rash was itchy and relieved somewhat by Benadryl.
Rash all over the body - chest, abdomen, breast, upper legs and arms, shoulders; Itching; Chills; Fever; Nausea; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 20Feb2021 16:00 (Batch/Lot number was not reported) (at the age of 73-years-old) as SINGLE for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 23Jan2021 on an unspecified time (Batch/Lot number: E79231) (at the age of 72-years-old) as SINGLE for covid-19 immunization. Patient Medical history included pituitary problems, she had a tumor twice and had radiation and surgery from an unknown date and unknown if ongoing. The patient mentioned a previous reaction to a tetanus vaccine, it had to have been a DPT, when she was a baby. The patient's doctor told her mother to never get her another one. The patient does not have the lot number or expiration for it. Patient denied for any concomitant medications. It was reported that patient had the second dose of the Pfizer Covid vaccine and on the 20th, on the Tuesday after that she started getting a rash over quite a bit of her body and is still there. The patient mentioned the paperwork said that a bad rash all over the body could mean a severe allergic reaction but she has had no difficulty breathing, no swelling of the face, tongue and throat, and no fast heartbeat. On 20Feb2021 4:00, The patient received the shot and by 4:00 in the morning of 21Feb2021 she started getting chills, fever, and nausea. All of those symptoms may have lasted 24 hours, but the patient is not having those symptoms anymore, it is just the rash that is bothering her. The patient knows that the rash was there on Tuesday but it could have been Monday when she had some itching, but she did not look at that time. The patient wanted to knew if she should worry about this and how long would the rash last. The outcome of events for chills, fever, and nausea was recovered on an unspecified date in Feb2021 whereas for Itching it was unknown and for rash all over the body chest, abdomen, breast, upper legs and arms, shoulders outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
arm soreness starting day of and persisting for two days after the vaccination, erythematous rash on deltoid just now starting 7 days after injection