chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Covid arm for a few days after both 1st & 2nd doses. After 2nd dose, had headache and fever the next day for a few hours & felt somewhat weak & tired. Took a Tylenol the day after in the evening & the fever & headache  went away after 30 minutes. 10 days later, on Wed 3/24, began having rashes on both arms around the inside elbow area & also upper arm. Very itchy & got larger, although tried not to itch. First 1 arm, then the other, This woke me at 3:30 am. Then, bottom of left foot on the side got a 2" red area that started itching also. Then yesterday, a larger area on the right foot. These all subsided after maybe 2 hrs.. They keep coming back again, one after the other,very itchy. Looks like poison ivy almost & 2 on the arms had blisters.  I feel hot occasionally, but no fever
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Oct2021 10:45 (Lot number: EW0217) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "Sore upper arm of injection"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "swollen lymph nodes arm of injection "; NAUSEA (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "Nausea"; PAIN (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "full body aches "; IMMUNISATION (non-serious) with onset 13Oct2021 10:45, outcome "unknown", described as "third dose". Therapeutic measures were taken as a result of pain in extremity, lymphadenopathy, nausea, pain.Additional information: The patient also takes concomitant medications of Omega-3 methyl esters and multivitamins.  Follow-up attempts are completed. No further information is expected.
Stopped babbling for approx 5 weeks, extreme sleepiness, temporary loss of appetite, would not make eye contact as she had before. Vax's given: Rota, Hib, PCV, and IPV/OPV.
No Adverse Event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No Adverse Event) in a 22-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-May-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 06-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose,  for COVID-19 vaccination.  Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,.  On 08Jan2021 at  04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events  resulted in a Physician office visit.  Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and  rest.  The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
Hives on upper chest and face turned bright red and hot to the touch; and itchy all over
Double vision of left eye.  Totally exhausted, no energy.  SOB, anxious & crying.  Hoarseness, no appetite, hot flashes & nite sweats.    Bloodwork, ultrasound of thyroid, diagnosis: Hyperthyroidism, Graves Disease.  No family history of thyroid disease.  Presently under care of an endocrinologist.
12/18/2021 I felt fatigue and couldn't eat with chills. I went to a public health clinic to get a test. Took a Antigen COVID Test (positive). I woke with a really bad headache and I had migraines before but after taking Excedrin for 3 days without any improvement. My test returned on 12/28/2021 and was still hurting from my headaches. 03/10 I finally got to see my doctor I was given a blood test (normal) and was advised on HBP and was prescribed amlodipine besylate, ibuprofen for it and was told to come back if it does not improve. I will be going back on April 27th to follow up and get help with my headaches. No improvement since started.
feeling tired; headache; upset stomach; hard to take full breath in; dizziness; heart beating fast/HR 78; slight temp; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 19th June 2020, 1 days after receiving Shingrix, the patient experienced tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature were unknown.   It was unknown if the reporter considered the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced tired, headache, upset stomach, hard to take full breath in, dizziness, heart beating fast, slight temprature. The patient was able to talk without difficulty. It was reported requesting 2nd dose of Shingrix be cancelled. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135190:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR137983:same reporter
A lot of difficulty breathing, catching breath and getting oxygen; stabbing burning pain all over and joints ache; dizziness with eyes wanting to always close and seeing black spots; severe facial pain around bridge of nose and eyebrows; tremendous fatigue and weakness.
tested positive for COVID-19; feeling bad; pneumonia; A spontaneous report was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling bad (feeling abnormal), tested positive for COVID-19 (COVID-19), and pneumonia.  The patient's medical history, as provided by the reporter, included a heart operation and pulmonary problems and respiratory insufficiency since then.  Concomitant medications included salbutamol sulfate.  On 14 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The patient reported that after receiving the vaccine, he travelled outside the country.  He was feeling really bad and thought it could be due to the vaccination.    On 18 Jan 2021, he tested positive for COVID-19.  The patient consulted a healthcare professional while abroad, who detected pneumonia.  The patient was "feeling well" at the time of this report.  Treatment for the events included cortisone, an antihistamine, and isolation.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of feeling bad, tested positive for COVID-19 (COVID-19), and pneumonia were considered resolving.; Reporter's Comments: The patient's COVID-19 is unlikely to be due to Moderna's mRNA vaccine. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053411:
Pt recv vax 22JUN95 & c/o swelling of lateral arm along w/induration few minutes p/vax;
Patient reports that 2 days after her vaccines she experienced pains and swelling at the injection site. She reports that 5 days out the redness is larger and itchy.
SEVERE headache Uncontrollable shaking and chills 103 temp Body aches Weak joints and body  Felt like the flu x?s 600
Fever >101.0 Redness, warmth, and induration at injection site.
Contracted Covid-19; Contracted Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had 2 primary doses of Pfizer BioNTech vaccines and 1 booster dose. Contracted COVID-19 and took Paxlovid then experienced viral rebound after Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201135572 same drug/ event, different patient;
Painful and swollen joints, especially knees, stomach problems (diarrhea, vomiting), big increase in breathing difficulties
Pt had varivax administered on 3/8/97 and developed disease on 1/16/03.
I was pregnant at the time I got Moderna. I got the first January 14, 2021 and the second on February 12, 2021.  All scans had been normal until then and I was about 5 and 6 months pregnant respectively.  A few weeks after I received the second shot I was sent for a fetal echo based on maternal age.  The scan came back that the baby had a small pericardial effusion.  I was told not to worry but that was impossible to do.  I was told I had to wait one month and re-do the scan which I did.  Fortunately, it was gone at the second scan.  Given the timing and the fact that I had a very strong reaction to the shots, I think it?s possible this was linked to my reaction although, of course, I don?t know whether it was.  The baby was born healthy.  I had a high fever (102), body aches and a headache for several days after the vaccine. The headache lasted one week.  Having lived through this and been very early in getting vaccinated while pregnant, I highly recommend all pregnant women get vaccinated, however, I personally believe Moderna was too strong for me and maybe also for other pregnant women.    Had I known Moderna was so much stronger, I would have tried to get one of the others instead.   Again, I can?t say for sure if what happened is even linked to the vaccine but it did show up in the scan only a few weeks after I had a strong immune response so it?s possible.
Symptoms = fever (100.8), headache, chills, body ache, pain at injection site, heat radiating from injection site, moodiness,
Her upper head, her teeth, and the inside of her mouth were feeling weird; Her upper head, her teeth, and the inside of her mouth were feeling weird; She couldn't swallow; Mouth pain; Tongue abnormal feeling of; Numbness in toes; Her upper head, her teeth, and the inside of her mouth were feeling weird; Fall; Tooth pain; Pain in her arms and sides; Glands swollen; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Her upper head, her teeth, and the inside of her mouth were feeling weird), DENTAL DISCOMFORT (Her upper head, her teeth, and the inside of her mouth were feeling weird), DYSPHAGIA (She couldn't swallow), ORAL PAIN (Mouth pain) and PARAESTHESIA ORAL (Tongue abnormal feeling of) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  The patient's past medical history included COVID-19 (Experienced in October/November.), Diarrhea (Experienced during COVID) and Loss of smell (Experienced during COVID). Concomitant products included METFORMIN, CLOPIDOGREL, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced FEELING ABNORMAL (Her upper head, her teeth, and the inside of her mouth were feeling weird), DENTAL DISCOMFORT (Her upper head, her teeth, and the inside of her mouth were feeling weird), DYSPHAGIA (She couldn't swallow), ORAL PAIN (Mouth pain), PARAESTHESIA ORAL (Tongue abnormal feeling of), HYPOAESTHESIA (Numbness in toes), ORAL DISCOMFORT (Her upper head, her teeth, and the inside of her mouth were feeling weird), FALL (Fall), TOOTHACHE (Tooth pain), MYALGIA (Pain in her arms and sides), LYMPHADENOPATHY (Glands swollen) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Her upper head, her teeth, and the inside of her mouth were feeling weird), DENTAL DISCOMFORT (Her upper head, her teeth, and the inside of her mouth were feeling weird), DYSPHAGIA (She couldn't swallow), ORAL PAIN (Mouth pain), PARAESTHESIA ORAL (Tongue abnormal feeling of), HYPOAESTHESIA (Numbness in toes), ORAL DISCOMFORT (Her upper head, her teeth, and the inside of her mouth were feeling weird), FALL (Fall), TOOTHACHE (Tooth pain), MYALGIA (Pain in her arms and sides) and LYMPHADENOPATHY (Glands swollen) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She went to the ER where they gave her antibiotics and painkillers.
He completed his first series of six injections in Jan 2000. Other than slight soreness, he denied problems with previous immunizations. It was at 6-10 months following AVA #6 that he began to notice problems with his short term memory to include difficulty with recall, learning new information, where he placed things and birthdays, states family has commented on his memory. He reports that he continues to notice difficulty with memory and has not had it formally evaluated. He stated he did mention it to his PCM when he first noticed it approx 9yrs ago. He denies any other symptoms.
Swollen lymph node in collar bone, arm, headache, general muscle soreness in side that was vaccinated.
Facial edema, cheeks were very swollen and painful, tongue and tonsils inflamed as well
patient complained of dizziness/SOB/CP and light-headedness about 30 minutes or so after receiving the vaccine - called 911, emt's came and said patient's vitals looked normal except her BP was slightly elevated (152/90). Patient did not want to get in ambulance. Since patient still wasn't feeling well-she decided she would drive to ER
Dizziness that occured while seated, relieved when laying down; dizziness still occurs upon standing but goes away shortly after. Also developed a rash on the rt hand on 12/09/2009, that is slowly going away. Also developed diarrhea on 12/09/2009 with abdominal pain.
Patient presented with swelling of knee left and rash around immunization site.  Itching and warmth present.  Symptoms started 06/12/2003 per mother.
I didn't notice anything physically at first. In early June, I went to the medical center to donate blood and my blood pressure was high and they wouldn't take my blood. A week later I went and saw my doctor about it. I got tested and it was still elevated, and she put me on blood pressure medication. It's not as elevated as before, but it's still significantly higher than where it originally was. I've been asking my doctor if it has anything to do with the vaccine and she doesn't know. Unusual event for me. Game plan was about 3 months with dietary changes and medication to see if that would improve the situation. I went back in after 3 months and had that rechecked and it was still about the same level. I had my annual physical last Friday 11/19/2021, they did a full blood panel and to check for kidney function and thyroid function. Still waiting for results. Wanted to see a urine sample for kidney function - no results yet. Blood pressure medication makes me feel a little fuzzy
The pt called PAC 12/20 and spoke to LPN. She related after 10" of leaving the office she had shooting pain up her legs with heaviness in her chest. About a hr later she had a 101 temp on 12/17/10. 12/18 site felt warm & hard.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number not reported) on or about 15-MAY-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a nurse practitioner for a painful vesicular rash that was diagnosed as shingles. The patient was prescribed avalacyclovir (VALTREX) and lidocaine 4%  to manage her excruciating symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the shingles is unknown. Additional information has been requested.
A dose was drawn from a vial that was punctured after 12 hours, which dose was expired around 9 hours. Patient was contacted immediately upon discovery and was advised to come to pharmacy for another dose according to CDC recommendations. No harm was done in this accident.
Hives; skin writing, where if you scratch your skin it resulted in hives; It was strong itching; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives), PRURITUS (It was strong itching), CHILLS (chills) and MYALGIA (body aches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 048B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). On 13-Dec-2021, the patient experienced URTICARIA (Hives), SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives) and PRURITUS (It was strong itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives) was resolving and SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives), PRURITUS (It was strong itching), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient sometimes  take treatment medications Zyretic and Benadryl at night, depending on whether the hives start back up that evening. No concomitant medications were reported.   This case was linked to MOD-2022-443685 (Patient Link).
Vaccination given on left arm 1" above smallpox vaccination scar. 1/2 hr after injection, area around smallpox scar raised, red, & warm to touch. 2 days later, area still (1-1/2 diameter) red, warm & tender to touch. Is the smallpox vaccination scar related to this?
Systemic: Dizziness / Lightheadness-Severe, Systemic: Cold clammy hands-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium