chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed itchy B-B size elongated bumps on arms & legs evening of 12-12-07.  Throat is scratchy but no difficulty breathing.  Bumps are not red.  Advised medical care.
12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness for 36 hours. Went to ER. COVID and flu tests done. Both negative.
cold with rigors; body ache; chills; tired; rigors; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors). At the time of the report, NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. Treatment included some tonic water with quinine.
Pallor, diaphoresis, nausea, vomiting, light-headedness, dizziness, chills, shivering, lower abdominal pain
weakness; Fever; Dehydrated; Dizzy; This is a spontaneous report from a non-contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 04May2021 (age at vaccination: 68-years-old) as dose number unknown, single for covid-19 immunization. Medical history included Hypothyroidism, Degenerative Disc Disease, High blood pressure and Overactive bladder. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); tizanidine hydrochloride (ZANAFLEX); baclofen (BACLOFEN); gabapentin (GABAPENTIN); lisinopril (LISINOPRIL); oxybutynin hydrochloride (DITROPAN); nortriptyline (NORTRIPTYLINE); tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, patient experienced weakness, fever, dehydrated, dizzy. The outcome of the events was reported as recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
injection side pain; felt sick; she was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 1, single (Lot number: FF2588) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "She got covid a year ago", start date: 05May2021 (unspecified if ongoing), notes: She got covid a year ago and almost died in the hospital. That was 05May2021. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection side pain"; MALAISE (non-serious), outcome "unknown", described as "felt sick"; ILLNESS (non-serious), outcome "recovered", described as "she was sick".  Additional information: The reporter reported that with her initial vaccines she had injection side pain and felt sick but no other symptoms. After her first vaccine in the series she was sick for a day and then she was fine. She got covid a year ago and almost died in the hospital. That was 05May2021, before her primary series. But she did not have swelling or other symptoms. Other conditions and investigations were not reported. Other products were not provided. Vaccination facility type reported as medicine mart. Vaccine administered at a facility were reported as no. None of the AE(s) required a visit to emergency room or physician office. No prior vaccinations reported within 4 weeks. List of other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) were reported as no.  Follow-up attempts are completed. No further information is expected.
Elevated and erratic blood pressure, accompanying headaches, first noted 3 days post vaccination but may have started sooner
large erythematous, hot to touch, swollen area encompassing entire deltoid; tx w/ATB & started to resolve w/in 24 hrs; 2MAY94 f/u addtl info on event included fever,  gen arthragias, myalgias w/swollen lymph nodes of neck & auxilla;  sore
Right Knee Pain; Sore Left Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Left Arm (Injection Site)) and ARTHRALGIA (Right Knee Pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (Injection Site)). On an unknown date, the patient experienced ARTHRALGIA (Right Knee Pain). At the time of the report, VACCINATION SITE PAIN (Sore Left Arm (Injection Site)) and ARTHRALGIA (Right Knee Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; 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.
Site soreness redness for 2-3 days and then it completely went away.  January 3, 2020 - COVID (Rapid) Positive  Woke up with those symptoms - on January 3rd. fever; cough; Fatigue; lost taste and smell (lost it Jan 6-7); sinus congestion; post nasal drip; body aches. I had those symptoms for 12 or 13th of January. Went to PCP Dr. and I got a ZPack and over the counter - Vit D, C and a baby aspirin. I didn't go back to work until 18th of January. Still have fatigue somewhat but otherwise symptoms resolved.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 168 hours with the lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)) and the other one of 96 hours with a lowest recorded temperature of -1 Fahrenheit (F) (-1 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient was given Anthrax vaccine absorb at left arm on 9 May 2007. He developed swelling, pain at site. He rated pain as 8/10. Signs and symptoms appeared the next morning (10 May 07).
Fever, Body ache and injection site soreness. Took paracetamol - felt better.
Approximately 5 min after administration are is tingling, then got light headed.  Next AM at 0700 was extremely tired.  When getting out of bed in AM blacked out and fell to the floor.  Was able to get up but head was cloudy all day long.  She felt very sore and head hurt all day.  The next am had headache.
19MAR2023 That evening I felt tired people on my video call told I did not look good. I hung and went to bed at three AM  I woke up with  a bad fever so bad I had trouble standing my thermometer said one hundred an five degrees I waited until nine am and called the on call doctor at ten am they called back and agreed to give me Paxlovid. I started to take it immediately and the fever broke very early the next morning.  I improved the next evening I was off work and for about two weeks afterwards I had extreme fatigue and have only begun to exercise today and I am taking all precautions so that I never catch this again
HIS ARM WAS SWOLLEN TO THE SIZE OF A GOLF BALL. THERE WAS SEVERE REDNESS, RASHY BUMPS, AND THE ARM LOOKED AS IF IT WAS PRESSURE LIKE THE SWELLING WAS TIGHTENING THE ARM. HE HAD TO BE PRESCRIBED ANTIBIOTICS AND RECOMMENDED TO AN ALLERGY SPECIALIST. HE HAS ALSO HAD TO TAKE BLOOD TEST TWO TIMES BECAUSE OF THIS.
Sore; Chills; Slight fever; Tiredness; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EWO153), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 DOSE 1, SINGLE for covid-19 immunisation. Date of 4May2021 was given for the next dose. The patient medical history and the patient's concomitant medications were not reported. Patient height was 6'1" or 6'2". No HCP information was provided at this time. Caller was unsure if the third letter was a U or O, stated it could be a zero, provided lot number as EWO153. Patient stated he had covid before, but never had these symptoms. Patient did not receive other vaccine in four weeks of vaccination. On 14Apr2021 the patient experienced chills, slight fever, tiredness, headache and sore. The outcome for the event tiredness was recovering and sore was unknown and rest of the events was recovered. No follow-up attempts are needed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, it was unknown if patient was taking any other medications/products within 2 weeks of starting covid-19 treatment. The patient previously received a COVID-19 Vaccine. No known allergies. The patient received Paxlovid (route: oral) for the treatment of COVID-19 from 01Oct2022 to 06Oct2022. 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 known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Pt reports fever 99.8, extreme muscle soreness, arm swelling, rash/hives.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Patient received vaccine without issue.  Stood up, moved to observation area.  Within 20-30 seconds, patient collapsed and hit her head on the consultation room doorjam and door.  When attending to the patient, the patient's eyes were open and she appeared to be having a seizure.  Her limbs were stiff-to the point that I was unable to raise her legs to increase blood flow to the head.  Her eyes remained open until she regained conscienceness. She then vomitted.  Squad took her to hospital.
swelling and redness on injection arm; swelling and redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm). At the time of the report, VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Additional information
PT received vaccines at 4:45pm - on 9/16/11. Mom noticed swelling, redness, warm to touch at 1000 on 9/27/11. Per MD advice --> taken to ER. Reaction - left arm only.
Patient received first dose of Pfizer COVID vaccine and was standing waiting for her mom to receive her dose when she fainted. She fell backwards and hit the ground harshly. I responded by lifting her feet and she seemed to regain consciousness quickly. We let her sit on the floor to regain some stability and then moved her into a chair. She was given an icepack for the back of her neck/head, as we assumed that she probably hit her head. We could not feel any lump, and she did not complain of her head hurting but did feel a little dizzy. We also gave her a water and then a sports drink as she could not remember eating breakfast, only coffee, and was on her way to eat lunch. She asked what happened, was laughing, and said it felt like an out of body experience. At that point, her coloring began to look off (pale) according to her mom so we returned her to the floor and elevated her feet. Her coloring seemed to return quickly, she was laughing again, and she said she was feeling better. We took time to let her sit up on the floor and then moved to standing position but then she said she felt "a little weak," so I had her sit in a chair. At this point I asked her birthday (correct  response), the president (correct response), and what day it was (she did not know but said she wouldn't normally.) Her mom followed up with asking what time soccer practice was and she thought for a long time but then said "is it 8 am?" which was incorrect and already past for the day. At this point, I became more concerned about time orientation and concussion concerns. I checked her pupils which seemed equal and reactive. We asked if she remembered what happened and she could not but she did know that she had came in to get her shot. A few minutes later it became apparent that she still didn't remember what happened after she asked what happened again. She asked or didn't know what happened 4 times what happened in about a 20 minute time period. Mom asked if she thought I should take her to the hospital and I said that I probably would since she doesn't seem to be getting better as far as remembering what happened. Her mom, and I walked her outside and her mom went to get her vehicle. At this point, we believed she was going to the ER to be assessed and would follow up in a couple hours. However, her physician's office called about 20-30 minutes after they left to get details about the incident and ask why we didn't refer to the ER. Mother had told office that she was instructed to call the office. I told her that we thought she was going to the ER and relayed the details of this report. Office reported that they are going to see her and told mother to take to the ER if her condition worsens. I will call the mother in a couple hours to check on her.
patient mention arm pain that radiates from wrist upwards to shoulders that has lasted for over 7 weeks from injection date, he is unable to sleep on that side of his body. He did have a recent change in statin medication but that was weeks after the flu vaccination
Covid Arm. Sudden itching at the site of the shot . After scratching, a raised welt formed like a mosquito bite. Took an antihistamine and went to bed. This morning, area is red and still some what raised and slightly itchy. Also have a weird sensation around that part of my arm.
Resident was vaccinated as above on 12/17/2020 and 1/5/2021 with the Pfizer Covid-19 vaccine.  On 4/5/21 she tested positive for Covid-19 using an anterior nasal swab and tested.
herpes zoster on shoulder & over the rt arm dermatome in which recv inj;the vesicles spread proximally & distally but were largely gathered over the rt deltoid muscle;
Three days after I received my second dose of the shingles vax, I had dry heaves, upset stomach, and gagging. Just nausea, along with hurting in the stomach. My arthritis seemed to be aggravated by it. Paramedics were called to my home, and they gave me some antibiotics and prednisone. I have whitish/green phlegm, I have a lot of phlegm. Yesterday I was given a blood test, and the way they did it was awful. They left a huge bruise on my arm. I only talk to the doctor over the phone. Never went in to see him. ***I will call back with f/u of dates of vaccination and dates of ae***
Initial reaction was severe headaches which persisted for about two months.  I was also diagnosed with Guillain-Barre in Nov.  I was treated with high dose steroids and IVFG for.
pt recv vax & w/in 15min post vax pt was nauseous while lying down;pt did not vomit & there were no c/o pain or dizziness;pt was observed for 3hr & sent home;no tx given;to the reporter's knowledge pt is OK;
pt recvd vax & 3hrs post vax exp general aching,achy joints,weakness,leg pains,swollen lips,& could not stand;seen in ER & also by MD:tx DPH;missed 2 days of work;
It felt exactly like the flu. Severe body aches, weakness, throwing up, fever, could not eat. It only lasted for one day.
I had to go to the ER on 8/24/2021 because I started having shortness breath, heart beating really fast and chest pain. Am then about a week after that I started having them again along with severe back pain. I am now seeing my PCP for all the complications. She also started me on 81 mg Aspirin and Albuterol.
Myalgia, Fever, Diarrhea, NauseaVomiting, Fatigue, flushed face, chest, neck, was covid positive previously Narrative:
Sore arm since vaccine was administered. Woke up on 3/2/06 with pain in the shoulder and arm muscle. In arm vaccinated with the pneumococcal vaccine.
4 month patient administrated with Kinrix; Kinrix was administrated instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Infanrix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The four month old patient received Kinrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143285 and US2022143282 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143282:Same reporter US-GSK-US2022143285:Same reporter
fainted after receiving trumenba; This is a spontaneous report from a contactable other hcp via a sales representative. This other health care professional reported similar events for two patients. This is the second of two reports.  An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's medical history was not reported. Concomitant medications included hpv vaccine vlp rl1 4v (yeast) (GARDASIL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, it was reported that the patient fainted. The patient is no longer using TRUMENBA due to this. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event faint based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202101076767 same reporter, drug, and event, different patient.
No additional adverse events; Medical Assistant reports the administration of improperly stored ROTATEQ.; This spontaneous report has been received from other health professional (medical assistant) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 22-DEC-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1741817 has been verified to be a valid lot number, expiration date was reported and established as 30-JUL-2022; vaccination scheme, and anatomical site of vaccination were not reported), orally, 2 milliliters for prophylaxis. The administration of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) was reported.  The vaccine was exposed to a temperature of 50.5 F, for a time frame of 57 minutes. There were no previous temperature excursions. No additional adverse event were reported.
Patient reported experiencing slurred speech on July 17, 2021 (5 days after initial dose). Patient felt extremely dizzy and called 911. While on call, patient had slurred speech and emergency was dispatched. Patient was admitted same day to Hospital in city.
Feeling like I was drugged. Whoozy, not able to think right,  body feeling like was going to collapse. Slowed speech