chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urinary infection; burning sensation when urinating; The cough is still there; headach; Joint pain; muscle aches; Fatigue; Chills; Flu-like symptoms that lasted seven days; something came out between the axilla and chest; feel like powder in my throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, TOPIRAMATE (TOPAMAX) and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days), AXILLARY MASS (something came out between the axilla and chest), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), COUGH (The cough is still there), HEADACHE (headach), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). On 03-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection) (seriousness criterion hospitalization) and DYSURIA (burning sensation when urinating). On 09-Apr-2021, HEADACHE (headach) had resolved. On 14-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted seven days) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary infection), OROPHARYNGEAL DISCOMFORT (feel like powder in my throat), DYSURIA (burning sensation when urinating), COUGH (The cough is still there), MYALGIA (muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown, AXILLARY MASS (something came out between the axilla and chest) had not resolved and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treated with Tylenol every 6 hours and Ibuprofen 200mg 2 tablets PO every 6 hours.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-114993 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114993:Original Case : MOD-2021-114900
On 9/27/00, had fever and seizure. Had 3-4 seizures in 24 hours with fever 100F-101.5F. Seizures occurred when child was afebrile, but fever came off and on during 2 days of seizures.
March 27 woke with severe headache lasted 24 hours. Monday tops of my legs hurt so much it was hard to lower myself to sit. Lasted till Thursday. April 11 woken by severe headache, couldn't see clearly.  Very dizzy blurred vision threw up went to er was admitted. Had. Ultrasound, CT scan, EKG, MRI. Left hospital Monday evening, still dizzy till Thursday. Head still doesn't feel right.
Excessive vomiting for days after ROTATEQ given. Happened during first dose as well, yet parents did not recognize a pattern until the second ROTATEQ was given and the same symptoms happened. Patient is unable to keep anything down 24 hours following the ROTATEQ vaccine and vomits several times for a few days following. Refuses to eat. Also gets very irritable, fussy, and takes a few weeks to start acting like himself again.
Client had a fever starting at 4pm on 1/5 approximately 48 hours after vaccination. Fever was controlled with Tylenol, was highest at 104 degrees on 1/6. Fever on 1/9 at 99.7 degrees.
INCREASED  REDNESS HARD   ITCHY  HOT TO TOUGH AT INJECTION SITE
Large local reaction on right anterior thigh area or erythema, induration and warmth, measuring 8.5 centimeters by 9 centimeters.  Ibuprofen recommended.  Reaction evaluated 3 days after immunization.
Within a couple minutes of getting the shot, I could feel that my body was reacting. I started itching around my shoulder and chest area on the same side the shot was administered. Then my scalp and face stated itching. I decided to take two children's benadryl chewables (25 mg total) that I had in my purse. I notified the person watching us and he sent a supervisor to talk to me. I stayed about 45 minutes. They kept checking on me. I was itching all over and we all agreed that I needed more Benadryl but also that I shouldn't drive home after taking the full adult dose. I decided to go home and then take some more Benadryl once I got home. My throat was starting to get tight, but it wasn't awful. I took another 25 mg of Benadryl when I got home, for a total of 50 mg. After about 15 minutes, the itching went away. I had to lie down about 30 minutes later when the Benadryl made me sleepy. I didn't have any more serious issues after that.
Swollen, red rash on both legs that is itchy. Started a few hours after the vaccine and continued to get worse and more swollen.
temperature is now 99.1 / down this morning but back up presently; shivering; head discomfort; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and allergy. Concomitant products included Herpes zoster (Shingrix).   On 26th January 2021, the patient received the 2nd dose of Shingrix 50 mcg/mg. In January 2021, 12 hrs after receiving Shingrix, the patient experienced fever, shivering and head discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering and head discomfort were unknown.   It was unknown if the reporter considered the fever, shivering and head discomfort to be related to Shingrix.  Additional details were reported as follows: The patient had head discomfort, shivering and fever 99.1 degree F 12 hours after vaccination. The patient also developed headache. The patient was asked whether, to take acetaminophen to reduce temperature or develop a headache. The Fever was down on reporting morning but back up at time of reporting. For tolerance with 2nd dose refer case US2021AMR019585. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019585:Same reporter.
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 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 23 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 and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Negative, notes: no symptoms; (21Dec2022) Positive, notes: symptoms started. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible. No further information is expected.
Thrombocytopenia treated with IVIG 10/6/08-records received for DOS 10/1-10/2/08-DC DX: Idiopathic thrombocytopenic purpura. Few days prior to admission developed fever and diagnosed with viral syndrome. Clear rhinorrhea. Night prior to admission developed rash with small red dots and bruising noted. PE: positive petechial rash on face, trunk and extremities with ecchymosis.
Patient received vaccine around 12:30 pm and was fine, however a couple hours later in the afternoon she began to feel tired. By 6:00 PM the tiredness progressed to immense fatigue, to the point the patient had to pause after every step on stairs (patient normally is able to ascend stairs without much trouble). Patient felt so fatigued she did not eat and simply moved clothes from one room to another before giving up and retiring to bed earlier than usual. The next day, symptoms had passed.
one eyelid got swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CORTISONE. The following information was reported: SWELLING OF EYELID (non-serious) with onset 01Jan2022, outcome "not recovered", described as "one eyelid got swollen". The event "one eyelid got swollen" was evaluated at the physician office visit. Additional information The patient had cortisone injection to  knee every 3 months (ZILRETTA) cortisone injection,  the patient received the first dose of the Pfizer COVID-19 vaccine on 22Dec2021 and 10 days later, she had one eyelid swell up. She clarified it was only one eyelid. The eyelid was still a little swollen. Her doctor prescribed her 20mg of Prednisone for 3 days. she had not taken the Prednisone yet.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Labwork completed on 7/16/21 showed TSH level had dropped to .21 after being normal in previous years.  She repeated the labwork on 8/13/21 and her TSH had dropped even further to .01.  When she tried to take her concerta she became very nauseous and had to stop taking it.  She is off all medications but feels fid fidgety and more anxious than normal.
Information has been received from a physician concerning a 13 yr old pt who on 13Jul98 was vaccinated with a dose of varicella virus vaccine live. On 08Mar06, the pt came into the physician's office with five to 10 lesions which started on 05Mar06. The pt had 24 hrs of pain from the shingles. Additional information has been requested.
received the FLUZONE HD QIV post transit duration excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA303907.  This case involves a 87 years old male patient, received the FLUZONE HD QIV post transit duration excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.7 ml dose of suspect Influenza quadrival A-B high dose HV vaccine lot U8138DA via intramuscular route in the deltoid nos for prophylactic vaccination (strength: unknown), received the FLUZONE HD QIV post transit duration excursion with no reported adverse event(poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered   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 and Regulatory Authority 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.
Sores on his tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLOSSODYNIA (Sores on his tongue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GLOSSODYNIA (Sores on his tongue). At the time of the report, GLOSSODYNIA (Sores on his tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information provided, mouth wash to treat the events
Enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes, vaso vagal episode, chest pains.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Hives, rash, temp within 24 hours of immunization administration, Tylenol Prednisone.
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days.  3rd day post injection nausea continued and started experiencing back/flank pain.  4 and 5th day post injection still have nausea/back pain and chest pain, headache.  Overall tiredness and weakness. I was also tested for Covid and it was negative.
From initial information received on 28/Mar/2005 from a registered nurse regarding an adverse event, it was reported that a 32-year-old male patient, who is a physician, received a dose of TD ADS ADULT, lot number U1341AA, administered intra-muscularly in the right deltoid on 25/Mar/2005.  That same day, the patient developed swelling and tenderness of the supraclavicular and axillary lymph nodes on the right side.  He also experienced chills, but did not have a fever.  He self-medicated with ibuprofen.  The patient received the vaccine for wound management following a needlestick.  At the time of this report, he had not recovered from these events.  Follow-up information was received on 26/AUG/2005 from a physician.  He reported that all of the lab work performed was within normal limits.  The symptoms were treated with ibuprofen and the patient recovered from these events.  No further information is expected.
Initial solicited report received from a consumer (online market research respondent) in a study on 04 December 2015. The subject (gender and age were not reported) did not like its side effects after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). During a prompted discussion, the subject reported to have taken the high dose vaccine a couple years ago and did not like its side effects. The subject was offered high dose this year but refused it. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Low grade fever (100) and severe leg pain (leg the shots were given). By 1 AM the fever was 103.5. The high fever lasted about 24 hours.
pt was anxious prior to vax; recvd OPV/MMR/DTP immed p/fell back in mom's arms; eyes rolled back & began jerking; was lowered to floor became incont & seizure ended; pt began to vomit;
pt recvd vax & 1 1/2 hrs p/vax exp hives lt deltoid; pt took DPH; sx resolved p/24 hrs;
Breakthrough case admission after 3 vaccines  Moderna 3/9/21 lot# 010A21A;  Moderna 4/6/21 lot# 025B21A;  Moderna 2/20/22 lot# 046L21A
This is spontaneous case, initially received on 12-Dec-2017, by other non-health care professional, concerning a 43-year-old, adult pregnant patient. The patient had history of previous pregnancy and had no miscarriage. The patient's last menstrual period was 20-Mar-2017. The patient's current condition included diabetes. The patient had no history of major congenital anomalies and birth defects in previous pregnancies. The patient had no relevant maternal medical history relevant to pregnancy. The patient had no relevant paternal medical history. The concomitant medication included NOVOLOG for diabetes. On 26-Oct-2017, the patient was administered with INN (anatomical location, batch number, expiry date) (first vaccination). On 11-Dec-2017, the patient was administered with FLUCELVAX QIV (anatomical location: left arm, route of administration, batch number, expiry date: not reported) at weeks of pregnancy (second vaccination). The EDD (estimated delivery date) on 17-Dec-2017. The reported considered this case as non-serious.
COVID-19 Pfizer LOT #FT9142 kept in fridge BUD. Received 7/26/22 and administered 11/30/22.
Patient came into Public Health Clinic and asked for the Bivalent Booster.  One was prepared and given to him.  He received his second dose of the Moderna Bivalent booster in error.   (first dose given 9/8/22). Spoke with Patient today (12/7/22) to evaluate why he thought he should get two vaccines and he stated, " I heard I was supposed to get another."  Asked where he heard that information and he said he thought he heard it in the news.  Patient is showing no side effect from the double bivalent vaccination.
ST x 2D assoc with stomachache 1 wk after H1N1, IM vaccine.
About  2 days after exposure to covid, symptoms started with sore throat and continued with mild to moderate cold-like symptoms.
Extra dose of PCV 20 given on 10/02/23. Pt had already recieved a dose in May 2023. And is up to date with PCV vacicne. No complications or symptoms reported.
I would have sudden loss of breath, randomly throughout the day. It went away after about a week.
PANIC ATTACK; KNEE PAIN; PAIN AROUND THE BRA STRAP IN THE BACK; SLEPT ALL DAY; ARM HURTING FROM THE INJECTION; FLU LIKE SYMPTOMS; DIZZINESS/FELT DIZZY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotic allergy, and metal allergy, and other pre-existing medical conditions included patient is allergic to pain medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced dizziness/felt dizzy. On 29-JUL-2021, the subject experienced flu like symptoms. Laboratory data included: Blood pressure (NR: not provided) normal, 98/58 mmHg, and Body temperature (NR: not provided) 99 F. On 30-JUL-2021, the subject experienced slept all day. On 30-JUL-2021, the subject experienced arm hurting from the injection. Treatment medications included: ibuprofen. On 03-AUG-2021, treatment medications included: ondansetron. On 05-AUG-2021, the subject experienced pain around the bra strap in the back. On 05-AUG-2021, the subject experienced knee pain. On an unspecified date, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, panic attack, knee pain, and pain around the bra strap in the back, and the outcome of dizziness/felt dizzy, arm hurting from the injection and slept all day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810461.
Fever, chills, muscle pain, unable to swallow solid food and headache for 48 hours. Large rectangle red rash that is warm to touch surrounding injection site appearing at 48 hours and is still present 5 days after injection.
Approximately 12 hours after getting vaccine employee developed severe body weakness. She reported being unable to lift arms, legs or sit up. Sent to ED for evaluation.
Red, hot, swollen arm within 12 hours. Subsided within approximately 48 hours. Reemerged hot, red, and itchy at day 7 post vaccine. Day after extreme fatigue and headache. Subsided within 24 hours.
Adverse Event Reported: "a host of serious health issues including: daily seizures, convulsions, and vision loss."; Adverse Event Reported: "a host of serious health issues including: daily seizures, convulsions, and vision loss."; Initial report obtained from a social media (SM) site, received from a consumer, regarding a case in litigation concerning a 22-year-old (adult (inconsistent information as it was also reported as a teenager)) female patient. On an unknown date (reported as a teenager), the patient was vaccinated with vaccine was quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as the company human papilloma virus (HPV) vaccine) as prophylaxis (exact dose, vaccination schedule, route of administration, lot number and expiration date were not provided). The reporter states that the patient had a host of serious health issues including daily seizures, convulsions, and vision loss (also reported as developed side effects) from the HPV vaccine. The outcome of the events was not provided. The claimed events were considered related to the HPV vaccine.  This case was considered non-valid due to lack of patient's identifiers.
Notes 17-year-old otherwise healthy male presents to ED for evaluation of dizziness for the past 6 days. About 6 days ago patient states that he developed dizziness. Patient states that that he feels as though the room is spinning. Patient has had some associated nausea but no vomiting. Patient was evaluated for this at an outside hospital where he was given a migraine cocktail in some fluids. The seem to help symptoms somewhat, however the following day patient experienced dizziness again. Patient was seen at a different outside hospital where they gave him IV fluids. Additionally they got an EKG, blood work, and tested patient's urine. Labs are within normal limits. Patient was also given a dose of meclizine which helped to resolve symptoms. Patient symptoms returned the following morning and if not improved which prompted his visit to the ED today. Patient family has been trying to get in touch with ENT specialist, however they have not been able to make an appointment for any time soon. Patient denies headaches. However he states that his whole body feels heavy. No numbness or tingling or weakness of his extremities. Patient denies chest pains or palpitations. No medications prior to arrival. No recent fevers or illness. No recent head injuries. No other complaints at present.. Review of Systems