chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-042832, MOD-2021-042866 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up has outcome information.
Ten minutes post immunization, the patient became pale and was complaining of dizziness, nausea, and feeling lightheaded. Nursing staff evaluating patient when witnessed, syncopal episode occurred. Episode lasted for less than 15 seconds with no injury to patient. Patient was in a seated position at time of event and was then placed supine with legs elevated. No incontinence and patient remembers everything up to and following the brief episode of syncope. (Patient has a previous history of syncope following HPV9 immunization.) Once supine, patient's pallor improved as well as other symptoms. At 10:20 am, repeat vital signs taken in the seated position: HR 80 (regular and strong), RR 20 (non-labored), BP 100/54 (left arm).  Patient denied any complaints at this time. Patient stated that she had a small amount of chocolate pudding for breakfast. Denied any issues with blood sugar. Patient was given and consumed peanut butter crackers, Munchkin donuts, and water without difficulty. She did not drink the protein shake, but chose to take it home with her. Dr. was notified of the event and followed up with patient and father. Patient was monitored for another 30 minutes. Vital signs at 10:35 am: HR 84 (strong and regular), RR 20 (non-labored), BP 110/62 (Right arm). Skin color back to normal. No complaints. No dizziness, lightheadedness, or feeling faint when standing. Gait normal. Patient instructed to always notify health care staff of history of syncope after injections and to always wait at least 30 minutes for delayed symptoms. Patient discharged to home with father. No complaints or concerns. Follow up call placed at 5:45 pm and patient out and about with mother, no complaints. Family notified to call back with any questions or concerns.
headaches; off from her work for 2 months; chills; little bit of a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing), notes: caller had Covid, which was two weeks before caller got the first shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization.The following information was reported: HEADACHE (hospitalization), outcome "recovered", described as "headaches"; IMPAIRED WORK ABILITY (non-serious), outcome "recovered", described as "off from her work for 2 months"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "little bit of a fever". The patient was hospitalized for headache (hospitalization duration: 6 day(s)).   Additional  information: The reporter mentioned that before caller got her very first primary shot of the Pfizer Covid 19 vaccine, caller had Covid, which was two weeks before caller got the first shot. Reporter also mentioned that she experienced headaches and felt like she had Covid again, transfer agent not able to specify if this occurred with the first, second, or third shot. Reporter also mentioned that she ended up in the hospital for 6 days and this caused her to be off work for 2 months. Also mentioned that her sister who also got the Pfizer COVID-19 shot did not experience the same side effects as caller's side effects. The caller believed that caller's sister did not experience any side effects, but transfer agent is not sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid Rapid Test Positive; Covid Rapid Test Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EK5730, Expiration Date: 31Mar2021) and as dose 2, single (Lot number: EL3249, Expiration Date: 31May2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Feb2022, outcome "unknown" and all described as "Covid Rapid Test Positive". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (24Jan2022) Low, notes: 0.24 (IU)ml; SARS-CoV-2 test: (08Feb2022) Positive, notes: Moderate symptoms.
Breakthrough case of COVID-19: I was not feeling well, I took a rapid test and my results were positive. I had a slight fever and a tingle in my throat.
Child started with severe diarrhea and loss of appetite, 24 hours, post vax. Called pediatrician and child admitted to hospital on 1/13/01. Telephone call to mom (does not speak English). Information obtained through interpreter; on 1/12/01, had 1 stool. This AM, appetite remains poor.
DTaP & Varicella 1/29/13, 1/30/13 fever onset 101-104 degrees comes decreased with MOTRIN to 102. Rt swollen, hard to walk on it. Advised to use MOTRIN, Epsom salt baths 2x daily, vitamin C 500 mg q 2 hours during phone call 1/31/13. Leg swelling resolved 2/4/13-came down with viral illness.
1st dose on 19Jul2021, will be getting 2nd dose today; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-Jan-2023 Reporter's Comment: The reporter stated that the patient had not yet gotten the second dose.  The reporter stated that the patient would be getting the second dose today.  The reporter did not had access to the original dose's lot number and expiration date. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt recvd vax; exp high fever w/ screaming episodes;apap given immed p/ vax; T 103;
TRIGGER FINGER  PAIN; NECK PAIN; LOWER 5 VERTEBRAE PAIN; DULL TOOTHACHE TYPE PAIN; BOTH HAND PAIN; BOTH ANKLE PAIN, LEFT KNEE PAIN, HIP PAIN AND RIGHT SHOULDER PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent condition included pain. The patient had all complaint areas were previous medical trauma issues from 1972 forward. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced trigger finger pain. On 02-APR-2021, the patient experienced neck pain. On 02-APR-2021, the patient experienced lower 5 vertebrae pain. On 02-APR-2021, the patient experienced dull toothache type pain. On 02-APR-2021, the patient experienced both hand pain. On 02-APR-2021, the patient  experienced both ankle pain, left knee pain, hip pain and right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, lower 5 vertebrae pain, both ankle pain, left knee pain, hip pain and right shoulder pain. on 02-APR-2021, was recovering from both hand pain, and trigger finger pain, and the outcome of dull toothache type pain was not reported. This report was non-serious.
CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
FAINTING EMS WAS CALLED. PARAMEDICS INTERVIEWED THE PATIENT. PATIENT WAS RELEASED WITH NO ADVERSE REACTION.
Patient received Monovalent vaccine as a booster shot when Bivalent vaccine was on the market. Clinic was not up to date on most recent Bivalent vaccine recommendations, so Monovalent was being given as booster.
sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sharp pain in the rib area; soreness in the shoulder area; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included rib pain (prior to the vaccination).   On 09-SEP-2023, the patient received Arexvy (left arm) and Flu vaccine (right arm). On 12-SEP-2023, 3 days after receiving Arexvy and Flu vaccine, the patient experienced rib pain (Verbatim: sharp pain in the rib area). In SEP-2023, the patient experienced shoulder soreness (Verbatim: soreness in the shoulder area).The outcome of the shoulder soreness and rib pain were unknown.   It was unknown if the reporter considered the shoulder soreness and rib pain to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the shoulder soreness and rib pain to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter was the patient.  The patient received Arexvy and a Flu vaccine (unknown manufacturer).  The patient believed that the Arexvy was given in left arm and the Flu vaccine in the right. The patient experienced soreness in the shoulder area (right and left) after receiving the vaccines.  The patient also experienced a sharp pain in the rib area on Tuesday. The patient had experienced pain in the rib area in the past (prior to the vaccinations). Currently, the patient had a Chiropractor working near the area of the rib cage. The reporter/patient gave consent to follow up with healthcare professional (pharmacy). The reporter consented to follow up.
First 2-3 days felt normal discomfort at injection sit. It got progressively worse and began to feel like a torn rotator cuff.  A lot of pain (7-8) unable to sleep on that side and unable to lift more than two pounds or drive or reach above my shoulder without pain of about a 10 on scale of 1-10.  Saw orthapedic physician assistant  on 03/26   who gave me a steroid shot in that shoulder with 75%  relief by the next day. Still some minor residual discomfort at this writing.  Also ran a fever with nausea and headache exactly two weeks after first shot.
I received the Moderna vaccine March 8, 2021.  Nine days later, on March 17, I awakened with my arm itching, and a swollen, hard, warm, bright red/blotchy area at the injection site approximately 2" x 3".  It's the same reaction I've had in the past to spider bites.  The itching is relieved with Caladryl lotion.  Four days later (as of this date March 20), the area is still itchy and mildly swollen and red, but improved.
Pt vaccinated with DTP developed fever to 103F, irritable, crying x 36 hrs.
The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 01Aug2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A report was received via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot R45100), intramuscular in left deltoid on 31May2017 at 0.5 ml, single for immunisation. The patient medical history was not reported. Concomitant medication included MENACTRA (Lot U5514AB) received on 31May2017 intramuscular in right deltoid at 0.5 ml for immunisation. On 31May2017 the patient experienced severe headache, upset stomach, pain in lf arm x3 days. The outcome of the events was recovered.
Severe Gastritis, weakness, wt. loss.Nausea, vomitting ,diarreha, anal spasms, vagal reflex responses, & paleness.  9/17/09 GI Consult records DOS 10/4/07 to 6/12/09 Assessment: Reflux Esophagitis. Eosinophilia. Patient presents with abdominal pain followed by diarrhea. Loose, watery bowel movements. Cramping, weight loss, burping, anxiety, sore throat, fatigue, reflux esophagitis.  10/12/09 ICD9 codes received for date of service 6/25/09: 789.09, 535.10, 787.91
Patient was given MMR vaccine around 10AM 7/25. Mom reports that on the night of 7/29 she became ill with sore throat, malaise, nasal congestion. On 8/3 symptoms continue with a cough, sore throat & fatigue. On 8/4 extreme fatigue so that she had to be carried to her bed. Temp 102.2 orally. Eyes sensitive to light, pallor. No appetite. On 8/5 she began to improve & has recovered for the most.
Ischemic Stroke 11/15/2021, received Alteplase within 90min of stroke symptoms (Left side paralysis, speech and vision changes, made full recovery
administered first dose of janssen covid19 vaccine to patient in left arm at 11:25am on 12/28/21. advised patient to sit for 15 minutes. when he stood up and walked a couple steps and looked down at his phone at approx 11:40 am he fell to the ground. went to check on patient. he reported he got dizzy and lightheaded. he did not feel short of breath and there were no injuries. he did not want us to call 911. gave patient water and advised patient to sit and wait until he felt better. after about 10-15 minutes pt said he felt better after sitting and was ok to leave.
Sore arm; Legs weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included TRAZODONE, ROSUVASTATIN CALCIUM (CRESTOR) and GABAPENTIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-034278 (Patient Link).
Fever 102.4, severe right upper arm pain (location of vaccine injection), right axillary lymph node swelling, right arm swelling. Came to urgent care.
She got her vaccine, and woke up with fever of 99.4, headache and soreness on her left arm.  She has not taken anything for these symptoms other than her regular medications.  Husband did call her doctor and waiting to hear back from them.
Headache ,Fever ,Chills, Body aches , no apelet, swelling under my arm and Vomiting
Began with headache about 4hrs after receiving. About 8hrs after shot, arm soreness. 15hrs after shot woke with fever, chills, elevated heart rate.
First covid vaccine administered was Moderna on 07/30/2021. Second Covid vaccine administered was Pfizer on 08/27/2021.  No reported adverse reactions
Patient stated she had swelling of her lips and roof of mouth for four days. Benadryl helped and she is feeling better on day 5.
Same day post vax, the pt developed an injection site reaction characterized by swelling, redness, and pain. Within the next two weeks, her entire arm began to swell. The pt recovered.
Presented with acute onset chest pain, found to have right lower extremity DVT and bilateral PEs. Required short stay in ICU for close monitoring given clot burden in her lungs. Required heparin infusion and then transitioned to lovenox for home-going therapy.
Pt received first vax on 05/24/1999. Approximately 2.5 weeks later, he experienced flu-like symptoms. No treatment was given. The most recent information received on 06/24/1999 reports the symptoms resolved in 36 hours.
Patient reports a sore spot at flu shot injection site.  She said 3 weeks later she can barely move her arm.  I advised patient to follow up with her primary care provider for more information.
dizziness; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. This female consumer reports receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine about a month ago. About 3 days ago, she started experiencing dizziness. The dizziness is continuing (not recovered).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Achy muscles, general malaise, fever for several days did not exceed 100.5; sore throat, cough, heavy congestion, headache, sneezing, loss of appetite, tender and swollen neck glands.  Gradual improvement of cough and achy muscles. Day 7 sore throat, hacking cough and congestion continue.
This spontaneous report as received from a physician refers to a 15 year old female patient. The patient's medical history included supraventricular tachycardia and hives reaction to AUGMENTIN. On 31-MAR-2015, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (Lot # K010215 expiration date was not reported). There was not concomitant therapy reported. On an unknown date in approximately in March 2015, reported as "shortly after received GARDASIL" the patient experienced rash and burning sensation in both legs, and urticaria reported as "hives in her stomach". The patient sought medical attention by calling to the physician's office. The physician stated that the patient's mother queried if the patient mother or not her daughter should receive the complete GARDASIL doses. The outcome of rash, urticaria and burning sensation was unknown. This is a linked report from the same reporter. Additional information has been requested.
Patient has not received her second dose/Second vaccine not scheduled for more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.