chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling bad; Out of it; Soreness of left arm; Drenched in sweat; Fatigue; Aches; Could not get out of bed; Could not eat; Could not stand up; A spontaneous report was received from a consumer of age 25-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up.  The patient's medical history included COVID-19. No concomitant medications were reported.  On 23 Dec 2020 at 17:19pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037R-20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up. Treatment for the event(s) included, Tylenol and the symptoms were ongoing but seemed better.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event(s) feeling bad, out of it, soreness of left arm, drenched in sweat, fatigue, aches, could not get out of bed, could not eat and could not stand up were considered as resolving.; Reporter's Comments: This case concerns a 74-year-old female with PMH of COVID-19 who had NS unexpected events of pain, pain in extremity, feeling abnormal, hyperhidrosis, feeding disorder, dysstasia, and bedridden and NS expected fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment included Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT IS PREGNANT.  HAD FLU SHOT THEN AN HOUR LATER COMPLAINED OF HEADACHE AND NAUSEA, ALSO SLIGHT RASH.  4 MONTHS PREGNANT.  NEVER HAD FLU SHOT BEFORE.
Patient was given 3 shots of pediarix, Heb, PCV13 & 1 oral Rotateq on 10/21/19. Developing high fever as 103F on the same evening. F.U/& seen by us on 10/22/2019. Temp trending down, patient doing well on the next day.
big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blood clots coming out of nose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 (Batch/Lot Number: EW0151) as single dose, for covid-19 immunization. Medical history included ongoing sjogren's syndrome and ongoing lupus. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  07Apr2021, she started having a nose bleed. She explains she wasn't doing anything in particular, just talking on the phone, and blood just started pouring out of her nose. Blood clots started coming out as well. She ended up calling 911 and they sent an ambulance. The EMS helped her stop the bleeding. She didn't go to the ER or anything. However, she is getting implants done for her upper teeth so she wanted to double check and make sure nothing was pressing against her nasal cavity because the nose bleeds were so off/random. The doctor said there was no pushing. The doctor completed a panoramic exam/x-ray and confirmed there was nothing pushing. The doctor did suggest she go to the ENT. She made an appointment with an ENT doctor for the following day, 08Apr2021, and the ENT put a camera down. She confirms she explained to them she just had the vaccine and she was googling information. She was told to not google anything and to let them check it out.  The caller states she explained to the ENT the reason she was there was because she was concerned, she is not a nose bleeder and nose bleeds never happened to her. Once blood clots started coming out that way, she was terrified. They didn't see anything alarming, but they wanted to make sure and do further research, so basically they planned to do a CT/CAT scan. She was scheduled for a CT/CAT scan on Monday, 12Apr2021, but she was allergic to the contrast and was sent home because they were not prepared for pre-medication. She is waiting for the doctor to schedule another appointment so she can go back. She felt she needed to report these nose bleeds because she has been seeing Johnson & Johnson had severe blood clots, but she took Pfizer's vaccine, and was also getting blood clots. Her nose bleeds just happened right after both vaccines. On an unspecified date, she had a little bump that went away. She had this big bump on her arm and a big rash developed. At first, the bump was the size of a quarter and then grew double in size. The bump finally went down, but the rash she can still see. The rash hasn't grown, it's just there- there is just a red blotch on her arm. She has not had another nose bleed since the one that occurred on 07Apr2021. She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. The outcome of events was unknown.
Fever, malaise. Given advil. Fever improved. Malaise persists today.
approx 2wk p/vax pt neck & head swelled up;also had diff breathing & had joint pain;pt was hosp for 3 days;@ the date of this report pt cannot work & can barely walk;
Severe abdominal cramps; Diarrhea; Dizzy; Almost passed out; Slept most; Mild pain in elbow and wrist/right knee in lots if pain (not normal), and left elbow; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: Er2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 18Mar2021 11:30 (at the age of 67-year-old), at dose 1, single for covid-19 immunization from doctor's office/urgent care. Medical history included CAD (coronary artery disease), PVC's (ventricular extrasystoles), Sjogrens high cholesterol, allergies to Percoset (OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL), pork, history of vasovagal when sick from pork allergies. Concomitant medications included atorvastatin; acetylsalicylic acid (ASPIRIN LOW). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist on 19Mar2021 03:00, right knee in lots if pain (not normal), and left elbow on 21Mar2021. No treatment was reported for the events. The outcome of the event right knee in lots if pain (not normal), and left elbow was not recovered, and severe abdominal cramps, diarrhea, dizzy, almost passed out, slept most, mild pain in elbow and wrist were recovered on Mar2021.    No follow-up attempts are needed. No further information is expected.
Hypothyrodism - diagnosed 1999. Asthma - diagnosed 2000. Daily hoarseness - unknown cause - ENT unable to diagnose cause circa 2000. Atrophied Testicles and no Sperm count - 2000 - 2003.  The medical records received on 1/23/04 reviewed and states obstructive airway disease. Reviewed misc. medical records, generalized swelling (EDEMA), abdominal bloating (FLATUL), fatigue (ASTHENIA), and simple cyst of R kidney (CYST).
Tiredness after vaccine. In the evening around 9:30pm I suddenly started having an upset stomach and felt sick to my stomach, nausea. Followed by vomiting, diarrhea throughout the whole night including hours in the morning.
I had tenderness at the injection site. The day after receiving the vaccine, I had joint pain in my right arm and lasted a few weeks. I tested positive via home test for COVID-19 on 09/05/2022. I had a sore throat, low grade fever, congestion, headache and runny nose. I contacted my doctor via an email but have not heard back from her. I am taking ALEVE for my symptoms.
The next day after vaccine I got a fever, body aches, nausea, sore throat with swollen glands, headache, and flu like symptoms. After a week sick, I went to the doctor. She recommended Nyquil and Ibuprofen. These symptoms lasted about 5 days. Then, on 1/13/2022, I developed COVID symptoms and got a positive COVID test. I went to the ER and got a COVID test. I did a telehealth visit and I was told to treat the symptoms with OTC meds. I took a home test 1/21/2022 which was negative.
Dull Pain in Left Shoulder along with pain in left and right kneecaps, more intense pain in right knee. Pain in the knees also ran along the course of both legs. Pain lasted roughly 3 days.
This spontaneous report was received from a 60 year old male consumer regarding himself. On 28-JAN-2014 the patient was vaccinated with ZOSTAVAX. On 29-JAN-2014, the patient developed redness, swelling, soreness and warmth at the injection site. The outcome of injection site redness, warmth at the injection site, injection site soreness and injection site swelling was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient did not see any medical attention. Additional information has been requested.
PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 71 year old male with a PMH of MS currently on Ocrevus IV infusion (last treatment 12/30/2022), type II diabetes mellitus, COVID-19, hypertension, CAD, and hyperlipidemia who presented to the ER on 1/14/2023 with weakness. Patient is fully vaccinated for COVID-19 with moderna vaccine (3/16/21, 4/27/21, 1/4/22).   Patient stated that he 3 days prior to admission he developed generalized weakness, sore throat, fever, headache, and persistent cough. He took a home test while at home which was positive for COVID-19. Patient's son, whom he had been in contact with, was also positive for COVID-19. Patient's wife also came down with COVID. As the days progressed, patient became increasingly weak. He struggled to open a door at home, pulled the knob too hard and fell onto his back. Denied hitting head, losing consciousness, or being on a blood thinner. He reported that weakness worsened to the point that he was unable to get out of his chair at home. At baseline, patient is able to ambulate independently with a walker.   While in theER, vital signs were reassuring. Labs were significant for WBC 13.59, pro-cal 0.06, Na 134, chloride 97, K 4.5, CBG 127. Patient's xray was unremarkable. He tested negative for influenza A/B, and RSV. Patient was positive for COVID-19. Due to weakness and COVID-19, hospitalist asked to admit patient.   During his admission, patient was started on Decadron 6 mg IV. Patient did not qualify for Remsdesivir. Home medications were resumed as appropriate. It was noted during patient's physical assessment that he had developed oral thrush. He was treated with nystatin oral swish and spit during hospitalization. While admitted, he was evaluated by PT/OT. It was recommended that patient receive outpatient PT at discharge. During course of hospitalization, patient's weakness improved so that he required minimal assistance with ambulation with a walker. His labs also continued to improve. His sodium normalized to 135, chloride 106, K 4.1, and CBG 109. WBC decreased to 8.87. Thrush has significantly improved with nystatin treatment. Patient remained off of oxygen during course of hospitalization. Patient was hemodynamically stable during hospitalization. At this time, he is medically stable for discharge. He will be discharged with Decadron 6 mg PO x 7 days to complete full course, nystatin PO, and prescription for outpatient PT. Plan of care discussed with the patient who is agreeable to the plan at this time. Questions answered to his satisfaction. Recommend patient follow up with primary care provider within 1 week of discharge.
Information has been received from a physician concerning a 7 year old patient who on 10/04/1996 was vaccinated with a dose of varicella virus vaccine live.  On 03/26/2003 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 experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Patient received the vaccination in the afternoon of 6/15/18. She stated that by the evening her arm was swollen and tender. She said she did not think much about it but by Saturday morning she was not feeling well and had flu like symptoms. Her blood pressure was 190/85 and she reached a fever of 101.1. She stated that she felt dizzy and exhausted as well. She slept the entire day on Sunday and by Monday morning she felt much better. Her normal blood pressure runs between 140-150/80.
6 year old female received her 1st dose of Pfizer Covid-19 vaccine and was inadvertently administered 12+ dose of Pfizer instead of 5-11 year old dose.
My tongue became very red, you may say inflamed; You may say inflamed and it felt that way; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot GN5318, second dose) solution for injection intramuscular in the left arm on 05Feb2021 (at the age of 83-years-old) at single dose for COVID-19 vaccination. Medical history included depression. Concomitant medication included bupropion for depression. Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient stated, "my tongue became very red, you may say inflamed and it felt that way" on 06Feb2021. Treatment for the events tongue became very red and inflamed included diphenhydramine (BENADRYL). The outcome of the event tongue became very red was not recovered. The outcome of the event tongue inflamed was unknown.
adult patient received  a pediatric dose of VAQTA; pediatric dose of VAQTA was administered to an adult patient; This spontaneous report has been received from a physician refers to an adult patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported.    On 08-OCT-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S037574, expiration date 10-APR-2021) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Cluster of 3 cases out of an unspecified number of vaccinees who received DECAVAC lot# U1923HA. Initial report received on 23 March 2007 from a healthcare professional. A 43 year old male patient, received on 13 March 2007 a dose of DECAVAC (lot # U1923HA), intra-muscular into the left deltoid, (needle size - 25 gauge). No other vaccines were given at that time. On 15 March 2007, approximately 2 days post vaccination, the patient experienced fever and local reaction. On 19 March 2007, he was seen in the clinic with a 2x2 cm circumference area of erythema and swelling at injection site. Lump was palpitated. Resistant range of motion to left shoulder. He required a doctor visit. Treatment included ice and MOTRIN. The patient's outcome was unknown. Medical history included allergic to therapy. Had Td over 10 years ago with no adverse reactions. Denied illness, medical conditions, other vaccinations and other medications at vaccination time. Follow-up information received on 16 July 2007 from a health care professional. The case was reviewed by the reporter, and there was no additional information at this time. The reporter is the same as in case 2007-00900 and 2007-00901.
Red burning eyes, rash, joint and muscle pains, diarrhea, chest pain.
Pain started 12-20-05. Red 2-3 mm in size. Pain down left arm
Arm  swelling; Fever; Nausea; extended warm, raised rash; extended warm, raised rash; warm, large red raised rash extended to elbow; swollen, tight arm with pain; Red, large raised rash, tight and swollen arm with pain; Soreness, Tenderness, redness at injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (extended warm, raised rash), VACCINATION SITE WARMTH (extended warm, raised rash), RASH ERYTHEMATOUS (Red, large raised rash, tight and swollen arm with pain), INJECTION SITE WARMTH (warm, large red raised rash extended to elbow; swollen, tight arm with pain) and PERIPHERAL SWELLING (Arm  swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo on 06-Feb-2010, Oscillopsia on 06-Feb-2010 and Migraine on 08-Dec-2008. Concomitant products included MECLIZINE HCL from 06-Feb-2010 to an unknown date for Dizziness, SUMATRIPTAN from 10-Feb-2014 to an unknown date for Migraine, PROMETHAZINE from 10-Feb-2014 to an unknown date for Nausea.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 28-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness, Tenderness, redness at injection site shoulder). On 29-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red, large raised rash, tight and swollen arm with pain). On 31-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm, large red raised rash extended to elbow; swollen, tight arm with pain). On 24-Apr-2021, the patient experienced RASH PAPULAR (extended warm, raised rash), VACCINATION SITE WARMTH (extended warm, raised rash), PERIPHERAL SWELLING (Arm  swelling), PYREXIA (Fever) and NAUSEA (Nausea). On 15-Apr-2021, RASH ERYTHEMATOUS (Red, large raised rash, tight and swollen arm with pain) and INJECTION SITE WARMTH (warm, large red raised rash extended to elbow; swollen, tight arm with pain) had resolved. On 20-Apr-2021, INJECTION SITE PAIN (Soreness, Tenderness, redness at injection site shoulder) had resolved. At the time of the report, RASH PAPULAR (extended warm, raised rash), VACCINATION SITE WARMTH (extended warm, raised rash), PERIPHERAL SWELLING (Arm  swelling), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.            Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-071108 (Patient Link).  Treatment information was not provided. Patient race is reported as Black.
Posterior auricular lymphadenopathy; Moderate to severe pain lasting; Severe lethargy; Left axillary swelling without pain; Chills; Joint pain; This is a spontaneous report from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 41-year-old), as dose 2, single, in left arm for COVID-19 immunization at Urgent care center. The patient's medical history included hypertension, anxiety and attention deficit hyperactivity disorder (ADHD). Patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on 12Jan2021 at 12:45 as single dose in left arm for COVID-19 immunization. On 01Feb2021 at 19:00, 6 hours 15 minutes after the second dose of vaccine, the patient experienced left axillary swelling without pain, and 8 hours after the second dose, the patient experienced chills and joint pain for 1-2 hours. 20 hours post injection, the patient had severe lethargy for 36 hours. On 06Feb2021 at 19:00, the patient experienced posterior auricular lymphadenopathy with moderate to severe pain lasting more than 24 hours and was ongoing. At this time adverse events was not medically attended, however, if ice and Motrin 800mg are ineffective, she would be seeking medical care on 08Feb2021. The patient had not received any treatment medications for the other resulted events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist via company representative refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX (route of administration, dose, lot number, expiration date and indication were not reported). On an unknown dates, the pharmacist saw a lot of people who experienced injection site reactions to ZOSTAVAX. Some people experienced more severe reactions than others. The pharmacist requested information about "a correlation between the severity of injection site reactions and the efficacy or immune response to ZOSTAVAX." The outcomes of injection site reaction were unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
sore arm; slight headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 16Mar2021 12:00 (Lot number: EP7534) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional Information: The patient had no known allergies to medications, food or other products. The patient received antihistamines (unspecified) within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unknown date (2021), the patient experienced sore arm and slight headache after the 1st shot. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404776 Same patient and drug, different dose and events