chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting on September 14, 2009, soreness of muscles in legs, fatigue and weakness in same area. Numbness followed throughout the week. This continued until Sept. 23, 2009. On the morning of the 24th of September, I began losing my balance and falling down onto the ground until the next day I was paralyzed from the waist down. On 26th of September I was taken by an ambulance to the hospital. On September 25th, 2009, I did see my doctor at 10:30 AM. I was unable to walk. They took blood tests and I had an MRI done. They also found I had been low on Potassium. So they gave me potassium pills to take, by the morning of September 26th, 2009, I was worse and unable to get out of bed. At about 10:30 AM I was transported by ambulance to the hospital. They also transported me to another hospital and admitted me in to ICU where I stayed for five days. I was diagnosed with Guillain-Barre syndrome.   11/23/09 Hospital Records and DC summary received for DOS 9/26/09-10/01/09. Assessment: Unusual Guillain-Barre Syndrome axonal varient. Migraine headaches. Pt. presented with bilateral pain and weakness in thighs x 1-2 days; reported falling secondary to knees buckling, difficulty sitting up, and bilateral upper extremity weakness, pain in both feet and thighs, and difficulty voiding. IVIG. Headache.
Less than 8 hrs. after receiving vaccine, skin itchy. By 12-16 hrs. had hives that responded to Benadryl. No other symptoms.
small size lump in axillary area primary doctor who told her he didnt believe in the vaccine recommendations to use warm compresses 10mins on/off caller verbalized understanding and that she is going to she her cancer doctor friday since her PCP offered her no advise. 4/28-contacted the patient , lump hasnt gotten any better or worse , will get biopsy on friday
Within seconds my right arm began to hurt.  Over the course of a week my body became stiff as a board and I could not move, I had a cough, fever, chills, and both arms hurt as it felt like I had been given a shot in both arms.  I had Covid-19 in December 2020 and recovered fully and had never felt better in my life up until the vaccination was issued on October 4th as a condition of employment with my employer.  19 days later I am still sick with cold like symptoms, including a cough, headache, soreness over my body, congestion in my sinus.  During this time period I have had brain fog conditions with memory issues as well.
This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st January 2019, the patient received the 1st dose of SHINGRIX. On 1st January 2019, less than an hour after receiving SHINGRIX, the patient experienced knee pain, leg pain and movement disorder. On an unknown date, the outcome of the knee pain, leg pain and movement disorder were recovering/resolving. It was unknown if the reporter considered the knee pain, leg pain and movement disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 70 years or 71 years. The patient received SHINGRIX on the right arm. Within an hour after receiving SHINGRIX, the patient developed severe pain in her left knee from the back of the knee and down her leg. It was difficult to raise her foot so for the last two days from the date of reporting, she had slid her foot along the floor. The pain did not subside when she sat or laid down. The patient could not take inflammatory medicines but used ice which provided temporary relief. When the patient woke up in the morning on the day of reporting, her leg and knee were much better and she could raise her knee to her waist level with only a twinge. The patient wanted to provide only her name.
Abdominal cramping and diarrhea everyday beginning 2 days post second dose. No other changes in diet or lifestyle to note.
Localized redness at site. Slightly swollen. Warm to touch. Suspect reaction to vaccine.
feeling like he had the flu; arm hurting; Body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Patient had no allergy or history of Covid-19.  Family history included Palpitation (his father and sister). Concurrent medical conditions included Diabetes, Blood pressure high, Cholesterol blood excessive and Palpitation.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medicines for diabetes, high blood pressure and cholesterol. Patient received dose 1 on19-Mar-2021 (batch no: 044A21A), dose 2 on 16-Apr-2021 (batch no: 025B21A), dose 3 on 04-Nov-2021 (batch no: 939906-B) and dose 4 on 22-Apr-2022 (batch no: 022J21-B).  Patient had usual symptoms like body ache, arm hurting, and feeling like he had the flu. He still went to work with all the vaccinations and did his normal activities. Treatment medication was not reported.   This case was linked to MOD-2023-744827, MOD-2023-746194 (Patient Link).
Near fainting (syncope). NO redness, NO itching. Pale, clammy skin. Hypotension: BP 90/71 mmHg and pulse 54. Pt had ringing in ears, tingling in arm and felt hot. BP taken at 5:40PM. Given ice pack, Gatorade to drink. Note: patient was very thin and disclosed that he had not eaten anything all day. Both parents were with him. Vaccine administrator theorized stress due to shot added to lack of food and water that day lead to syncope, Arm at site of injection did not appear affected. Pt became more alert and was able to walk out with assistance. Advised to go to urgent care if he faints again or if redness appears at injection site.
#2 Varicella vaccine given SQ RA. 7/27/10 client presented to HD with 3" x 4" circular swelling with approx. 2" erythema/blistering in center. Discomfort only with palpation - Advised local reaction - use cool compress/TYLENOL/MOTRIN/BENADRYL. To return if not better 48 hours.
no adverse event at time of administration, developed headache midday 1/11, fever to 105 evening of 1/11 and then L lateral chest wall pain to palpation and swelling AM of 1/12, no pain/swelling in axilla or L deltoid at site of injection
She got a rash all over her body; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (hospitalization), outcome "recovered", described as "She got a rash all over her body". Therapeutic measures were taken as a result of rash.  Clinical information: On 13Jan2023, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 vaccine for an unspecified indication. The patient reported, their wife had one dose of the Pfizer vaccine and had a reaction. She got a rash all over her body and went to the hospital, they gave her steroids and she recovered, but she never got the second dose. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 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 received the shot on 3/10.  Had tenderness in my arm for the first three days, also had a localized lump,  but it didn't seem out of the ordinary for a vaccine.  On 3/19, I noticed the arm was itchy, swollen and red, localized in the injection arm.   The area is also warm.  It is now day 3 of this.  I read on line about a reaction people are getting about ten days after the injection.  Seems like that is what I have.  It appears to be an allergic reaction, similar to what I get with mosquito  and spider bites.  The people say that it should go away after 4 or 5 days.  I will call my doctor on Monday, just to report.  I am having no fever or breathing issues.  Still hopeful that it will resolve itself.
Seen by PCP, Peds MD on 8/4/06. Was well at visit and received HepB and DTaP. Later that night, developed nausea and vomiting and fatigue. Lethargy and altered mental status persisted and she developed ataxia and dizziness along with incoherent and inappropriate speech. Went to ER and admitted with encephalopathy on 8/6 and discharged home 8/10/06. Signs and symptoms persisted until 8/9.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6206), on 10Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: Paxlovid Treatment start date: 09Jul2022,  Treatment stop date: 13Jul2022, Indication: Treatment of covid-19
Headache lasted two weeks took Tylenol  Very bad lower back pain lasted a week saw my chiropractor and applied heat/ice Lower back pain lasted another week Applied heat  Sciatic Nerve pain lasted 4 days saw my Chiropractor  Phlebitis in both legs went to ER Took a prescription medication for a week. Pain and inflammation lasted a month  Elevated Blood Pressure has not lowered will see heart doctor on August 19th for evaluation  Left eye twitching has not stopped.  Left arm goes numb when elevated like when driving or when sleeping on left side. Still ongoing.
Fever up to 102.0, extreme body aches, fatigue, nausea, vomiting---12hrs post injection that persisted for 36 hours.
pt recv vax 10MAY95 & exp a red, splotchy rash on forehead, chest, & thighs; No further details were provided;
Information has been received from a physician concerning a patient who on 30-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 30-MAY-2007 the patient developed an injection site rash with redness, pain and inflammation at the injection site. The physician treated the patient with an antibiotic (unspecified). At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was sought. Additional information has been requested.
5-8 pts recvd vax & exp burning upon inject; The lot#'s involved included ENG1049A4 & ENG944A4;
ON 4/2/21 SHE ACCIDENTLY RECEIVED PFIZER AS HER 2ND DOSE, INSTEAD OF MODERNA. SHE UNDERSTANDS THE SERIERS IS COMPLETE
rash spread all the way down to elbow and close to shoulder; redness at insertion site; Warm area on arm; uncertain if allergic reaction; Rash and redness at insertion site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 30Jun2022, outcome "unknown", described as "Rash and redness at insertion site"; VACCINATION SITE WARMTH (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Warm area on arm; uncertain if allergic reaction"; RASH (non-serious) with onset 30Jun2022, outcome "unknown", described as "rash spread all the way down to elbow and close to shoulder"; VACCINATION SITE ERYTHEMA (non-serious) with onset 30Jun2022, outcome "unknown", described as "redness at insertion site".  Follow-up attempts are completed. No further information is expected.
High pitched ringing in the right ear. Intermittent dizziness and vision changes. Ringing began within 12 hours of vaccination and has persisted for 3 weeks.
patient was given Covid Bivalent past its use by date. Patient had no symptoms and was advised to repeat dose.
HEART PAINS; SHINGLES; LICHEN PLANUS BECAME MORE SEVERE; This spontaneous report received from a consumer via a company representative via media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced lichen planus/blisters with every meal (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced heart pains, shingles, and lichen planus became more severe (dose number in series 2). It was reported that, "Her booster brought heart pains and shingles a day later. And the lichen plantus became more severe. Get a few more shots. That'll show me. Idiot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lichen planus became more severe, and the outcome of heart pains and shingles was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220614567.; Sender's Comments: V0: 20221226022- heart pains. The event 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. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
The day following the shot I slept excessively and despite taking extra strength Tylenol my headache never went away. My joints and muscles were very sore. No energy and difficulty concentrating. The second day was the same - sleeping most of the day with continuing headache and sore joints and muscles. The third day I did not go to work. Slight headache and body aches. New muscle pain across my chest when using my right arm (the arm of injection site).
Chronic spontaneous urticaria diagnosed by dermatologist. Symptoms began about a week after booster was received. 8 weeks later I am still experiencing symptoms. I take a daily regimen of Allegra to manage but as soon as I come off the medicine the hives return. They break out all over my body from head to toe. I have no history of prior allergies other than small swelling reactions to ant bites.
3 to 4 days post vax pt devel erythematous patches on lower legs; On approx 22SEP91 pt recvd flu vax; pt sx progressed to erythema nodosum & was hospitalized 7OCT91; pt tx meds; @ time of report pt had weeping lesions;
Pt exp arthralgia p/vax. Arthralgia persisted as of Dec 17. No further info Pt did not grant permission for follow-up info
Received shot on morning of April 15th. Evening following shot felt unwell.  Major stiffness and soreness in left arm. Fever through the night. Next day ran fever, chills, body ache all over, nauseated with fatigue. Continued thru that night and next morning. Felt woozy and brain fog in morning, but gradually over the day of the 17th felt better.  Much improved by the night of 17th.  Morning of 18th felt normal.  Treated symptoms by alternating Tylenol and Advil every 4-6 hours with rest. This was my first vaccine.  I had Covid-19 in November of 2020 prior to receiving this vaccine.
Feel cold; I experienced severe chills, fatigue, aches; I experienced severe chills, fatigue, aches; I experienced severe chills, fatigue, aches; This is a spontaneous report from a contactable consumer (patient reported himself) . A 69-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 04Mar2021 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. On 04Mar2021, after the second dose of vaccination, the patient experienced minor chills. On 05Mar2021, the patient chills became sever and she also experienced fatigue, aches and feel cold most of the time. The patient reported that these events occur every day and sporadically throughout the day. It was reported that the side effects continue. He stated that the side effects were not uncommon after the second dose. He had experienced these side effects after other vaccines and did not think it was out of the ordinary. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May; daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. The reporter is the parent.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0151), on 05May2021 as dose 2, single (Lot number: EW0171) and on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "recovering" and all described as "daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: daughter with COVID; (06May2022) Positive, notes: Other; (07May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course included that unknown if other vaccine is administered within 4 weeks. daughter with COVID 02May then sx mild started 02May and then PCR test positive 07May and Ag positive 06May feeling better now.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Localized edema, pain, and redness at injection site. Fever (103 F) and vomiting about 12:00 PM same day. Removed from daycare.
red still continous; injection site(left arm) turned very red; rash; itchy but not too severely; warm at injection site; little discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included GABAPENTIN (GABAPENTIN "PCD") and LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (little discomfort). On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site). On 20-Jan-2021, the patient experienced ERYTHEMA (red still continous). At the time of the report, DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely), VACCINATION SITE WARMTH (warm at injection site) and ERYTHEMA (red still continous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.