chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse advents occured as follows:  1.  Around 1am, the patient felt like he was burning inside and that it was going form his chest to his stomach and then pain all over 2.  Then he felt dizzy like he was going to fall down and sat down instead, moaning 3.   He then felt like he was going to pass out 4.  He went to the toilet and threw up violently and went to sit on the bed and then went back to the toilet again to throw up but didn't and then was so dizzy he couldn't get off the toilet for about 10-15 minutes. 5.  Then he went back to the bed, still dizzy. His wife said his eyes were glazed over and then rolled in the back of his head. He then fell backwards on the bed and started shaking/convulsing and gurgling.  His wife had to pull him to the floor in a upright position just to get him breathing because he seemed like he was choking.  She said he was going in and out of consciousness.  She talked to him but he wasn't able to speak.  His wife then called 911. 6.  When the ambulance arrived he said he was temporarily blind and this lasted off and on for 2 days
6-8-12 - Reported not feeling well. Temp 102.2 at 110pm. T - Resolved to 98.8 at 1605. Spiked again at 1550 on 6-9-12. No temp. Indicated since 6-9-12 left arm with edema, warmth on 6-8, cont to increase on 6-9-12; edema resolving on 6-10 continue to decrease each day. MD started AUGMENTIN 850 mg 1 tab 1 12 hour x 5 days for cellulitis.
Same day: Pain in left arm injection site starting about an hour after injection Pain began moving though shoulders and neck and fatigue at about 3pm On and off headache began at about 4pm 1145pm severe chills began  Next Day: 345am Hot and Sweaty 630 am woke up body aches and fatigue 10 am chills and fatigue (took nap) 12pm woke up hot and sweaty but no chills and less fatigue 2pm Clamy feeling and body aches Fatigue and body aches continues throughout the evening  2 days after shot: 630 am woke with body aches and mild fatigue that last throughout day  3 days after shot: 630 am woke with headache and body aches and mild fatigue
Chills; Weakness; Headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), ASTHENIA (Weakness) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, CHILLS (Chills), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient received 1st dose of Moderna vaccine on 06-Apr-2021 and on 07-Apr-2021 started having chills, weakness, headache everyday. His father went to doctor twice and doctor gave him IV but no medication and told him these are side effects from vaccine and could not do anything. The patient's son did not have vaccination card so he did not provide information about lot number.The physician gave him intravenous fluid but no medication and told him these are side effects from Moderna vaccine and can not do anything.  The concomitant medications were not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dizzy Spells and Vertigo for about a week and a half any time I bent over or reached my arm in the sky; Dizzy Spells and Vertigo for about a week and a half any time I bent over or reached my arm in the sky; Exhaustion too but that seems to be expected.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Mar2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease and microvascular Disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified cardiac medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 the patient experienced dizzy spells and vertigo for about a week and a half at any time she bent over or reached her arm in the sky and exhaustion too but that seemed to be expected. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's dizzy spells and vertigo for about a week and a half at any time she bent over or reached her arm in the sky and exhaustion too but that seemed to be expected was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
p/vax pt started feeling bad, c/o dizziness, fever & weakness in legs & trouble walking;T103.5 took APAP;no problem next morning;
Sore throat developed on 4/11.  Tested positive for COVID-19 on 4/22
patient's left knee gave out; Patient has had a very weak left arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Patient has had a very weak left arm) and KNEE DEFORMITY (patient's left knee gave out) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Patient has had a very weak left arm). On 12-Dec-2021, the patient experienced KNEE DEFORMITY (patient's left knee gave out). At the time of the report, MUSCULAR WEAKNESS (Patient has had a very weak left arm) and KNEE DEFORMITY (patient's left knee gave out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-411705 (Patient Link).
High heart rate, high blood pressure, asthma recurrence, headaches, dizziness, lightheadedness, nausea, vomiting - since COVID vaccine 08/24/2021 *POTS - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Tachypnea - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Distal Postganglionic Sympathetic Sudomotor Impairment - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Limited Autonomic Neuropathy - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Orthostatic Intolerance - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Neuropathic Postural Tachycardia - symptoms since COVID vaccine, officially diagnosed 11/04/2022 *Supraventricular Premature Complex - symptoms since COVID vaccine, officially diagnosed 11/04/2022
Information has been received from a nurse practitioner and from a healthcare worker concerning a 39 year old white female physician employee, with allergies to penicillin and sulfa and no other pertinent medical history, who on 08/12/2004 at 10:15AM was vaccinated subcutaneously in the left upper arm with a second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  It was noted that the patient was not ill at the time of vaccination.  On 08/12/2004, the patient complained of pain and injection site tenderness and fatigue.  The patient was afebrile and there was no redness, swelling, tenderness or lymphadenopathy.  There was no treatment required.  On 09/21/2004, the patient reported that she felt the pain had increased and she felt more tired.  It was noted that the events occurred from 08/12/2004 through 09/23/2004.  The patient was reported to have recovered in September or October 2004.  On 11/15/2004 the nurse practitioner reported that the patient had informed her that the fatigue and injection site tenderness had resolved 1-2 months ago.  It was also mentioned that the patient tested negative for rubeola immunity, and positive for rubella immunity on 07/13/2004.  No product quality complaint involved.  No additional information is expected.
1450 COVID19 vaccine given.  1503 Patient verbalized a racing heartbeat.  1504 Vital signs obtained, BP & HR were elevated.  1507 Physician paged.  1509 Patient reports feeling much better.  1511 Physician arrived to evaluate.  1516 Patient no longer had symptoms.  Vital signs improving.  Verbalized understanding to seek medical attention if symptoms reoccur or new symptoms begin.  Patient left.
Red Rash 2 inches by 1 inch around injection site. Slightly itchy, hard to touch and warm.
involuntary muscle movement; positive strep culture; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An 8-year-old patient received BNT162b2 (BNT162B2), as dose 2, 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "involuntary muscle movement"; STREPTOBACILLUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive strep culture". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia.  Additional information: These muscular issues required physical therapy. Clinician shared that child had a positive strep culture around the same time that muscle movements occurred.  The information on the batch/lot number for BNT162b2 was requested and will be submitted if and when received.
From individual  "10/12/23, I administered 2 vaccines to patient. She called the pharmacy approximately 4 hours after receiving Shingrix and Flulaval and is reporting arm pain, swelling, and decreased range of motion with the left arm that she received the vaccines in. I administered both vaccines in the left arm after palpating the acromion process and placed both vaccines 2 finger widths below this landmark. The 1st vaccine was given 2 finger widths below the acromion process in the deltoid and the second shot was separated by the first by 1 inch. I informed the patient that I would be reporting this adverse event and that should would be contacted by management/a supervisor per her request."
Pt got red rash that started at injection site and spread over next 12 hours to shoulder and down arm to elbow.  Pt said rash began to resolve the next day, Sunday.  Rash was almost gone by Monday when pt came in to pharmacy to report incident.  Pt said she was fine.
got her third booster a week go friday 24Sep2021 but tested positive for covid after.; got her third booster a week go Friday 24Sep2021 but tested positive for covid after.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her third booster a week ago, on Friday 24Sep2021, but she tested positive for covid after. She took Regeneron on Tuesday 28Sep2021. She asked if she should be getting another booster shot. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
pt recv vax 15AUG95 & 15SEP95 pt exp rash;rash appeared one month p/pt recv vax & 2wk p/sibling recv vax;
Rash on left side of forehead into edge of hairline and around both eyes. Not raised, splotchy and red.
Information has been received from a physician concerning a 6 month old patient who on 18-SEP-2009 was vaccinated with a dose of VAQTA (Lot # was unknown). It was reported that the nurse who gave the VAQTA meant to grab Hepatitis B vaccine and grabbed the VAQTA by accident. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Pt recvd vax 2OCT92 & exp sever pain, was unable to move lt shoulder; seen by MD dx as having bursitis & was suggested that pt discontinue the vax series;
Information has been received from a physician concerning a 30 month old patient who on 12/1/99 was vaccinated with a dose of varicella virus vaccine live. On 5/29/01, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446 and 0409USA01855 through 0409USA01870 and 0409USA01872 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
soreness and muscle aching in vaccine arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness and muscle aching in vaccine arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (soreness and muscle aching in vaccine arm). The patient was treated with IBUPROFEN for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness and muscle aching in vaccine arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
I had typical flu like symptoms beginning 12 hours after my second dose of Moderna- fever, chills, body aches, and headache.   Two days later I had a flair of hives covering my legs, torso, and arms that is still ongoing.
Around July not sure of the day or time but I started having feet swelling on both feet but mainly the right foot and it had a dent on the side of the ankle. Along with burning and tightness. My doctor said to keep my feet elevated and didn't seem to concern I don't want to go too much into detail but just want this not be noted.
Hard lump at injection site; feels a warm at the injection site; itchiness at the injection site; Headache; Rash at injection site; Low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Rash at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Patient plans to use cortisone cream for itching. No Concomitant  information was  provided.   This case was linked to MOD-2021-163443 (Patient Link).
patient received expired Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-Aug-2022 Reporter's comment: The Pharmacist reported patient received Bexsero that expired 5 days prior to the administration date. The administration date was not available. The healthcare professional could not provide any adverse event details. The healthcare professional consented to follow up by safety team. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
This spontaneous report as received from a nurse refers to a 5 year old patient with unknown gender. No information regarding the patient's medical history was provided. On 26-MAR-2014 the patient was vaccinated with PROQUAD, lot # H015631, which had been expired on 23-FEB-2014. No concurrent medication was reported. No adverse effect was reported. No outcome was reported. The case was linked to case # 1404USA006599 (same reporter, different patient). Additional information has been requested.
partial loss of vision R eye, progressed to L eye, found to have optic neuritis.
Pain in left deltoid immediately after injection and continuing today 8/10/09. 8/25/09 Follow-up: Subject reports that he has recovered from left deltoid pain. Treated with Bayer Back and Body for pain (Aspirin 500mg w/ caffeine 3.25mg-oral). He estimates the date of recovery was 8/15/09. Denies hx of migraine headaches and reports no prior history of adverse events after vaccines.
ache; feel crummy afterwards; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA305872, 2020SA305873, 2020SA305880, 2020SA305875, 2020SA305876, 2020SA305879, 2020SA305870, 2020SA305874, 2020SA305871, 2020SA305871.  This case involves a patient of an unknown age who experienced ache (pain) and feel crummy afterwards (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient experienced ache (pain) and feel crummy afterwards (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Pt had severe headache, severe myalgia, nausea diarrhea or 3 days
sudden onset of shortness of breath diffuse anxiety  total body shaking - within 15 min of vaccination since then has been nauseated, weak, fatigued, short of breath intermittently. never back to normal
Itchiness and slight hives for a few hours at injection site Onset of the following symptoms about 12 hours after injection: Tachycardia (HR up t0 148bpm at rest) Heart palpitations Severe headache Fever (100-101) Chills Soreness in arm for one week Treated with tylenol Felt okay after 36 hours
no appetite; No energy; Back ache; Pain on left flank; Sick; nausea; Vomiting; Extreme flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), NAUSEA (nausea), VOMITING (Vomiting), INFLUENZA (Extreme flu symptoms) and DECREASED APPETITE (no appetite) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (Sick), NAUSEA (nausea), VOMITING (Vomiting) and INFLUENZA (Extreme flu symptoms). On 11-Feb-2021, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (No energy), BACK PAIN (Back ache) and FLANK PAIN (Pain on left flank). At the time of the report, ILLNESS (Sick), VOMITING (Vomiting) and INFLUENZA (Extreme flu symptoms) outcome was unknown and NAUSEA (nausea), DECREASED APPETITE (no appetite), ASTHENIA (No energy), BACK PAIN (Back ache) and FLANK PAIN (Pain on left flank) had not resolved.            Concomitant medication includes high blood pressure medication. Treatment information was not provided.