chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information was received from a consumer (patient's mother) on 11 July 2008. A four year old female patient with no past medical history received a right deltoid injection of DAPTACEL (lot number C2953BA) and a right deltoid injection of IPOL (lot number A08362) on 03 July 2008 at 12:30 pm. The consumer reported that the patient received two other unknown vaccines on the same day in the left arm. On 05 July 2008, the patient experienced swelling and pain in the right arm. On 09 July 2008, the patient was sent to the ER by his physician. As a result, he was admitted overnight and was given antibiotics and MOTRIN. On 10 July 2008 the pain and swelling decreased and the patient was discharged. The patient recovered from the events. No other information was reported.
Feeling ill, headache, severe pain in hands, coughing, runny nose, tightness in chest, slight difficulty in breathing, at home temperature = 100.9. Lasted several days. Contacted the Covid 19 Hotline and was instructed to go to the Care Clinic for verification and further treatment if required. Told to isolate for 5 days. Received an infusion ,Covid 19 Monoclonal antibody treatment. Directed to wear mask when out, and monitor symptoms.
redness and itching around the injection site that is still there 9 days after injection.  Patient reports that a knot formed at site of injection the day of the shot and still remains after 9 days.  No temperature
can not raise his shoulder/his shoulder locks right up on him; can not tie his shoe; ache/couldn't sleep on his left side; couldn't raise his hand above his head; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (ache/couldn't sleep on his left side), LIMB DISCOMFORT (couldn't raise his hand above his head), JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GLIMEPIRIDE, TAMSULOSIN, LISINOPRIL, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN (ache/couldn't sleep on his left side) and LIMB DISCOMFORT (couldn't raise his hand above his head). On 22-Mar-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe). At the time of the report, PAIN (ache/couldn't sleep on his left side), LIMB DISCOMFORT (couldn't raise his hand above his head), JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Lab details were not provided.
Fatigue muscle pain joint pain chills headache.  pain tenderness and redness at the injection site
Flu like symptoms- aches, chills, sinus pressure; sore, swollen left arm, swelling in armpit (lymph node) under left arm, painful, tender to touch, swelling in neck.
This case was reported by a physician via sales rep and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, urinary frequency, nausea, vomiting, chills and general body pain. On an unknown date, the outcome of the fever, urinary frequency, nausea, vomiting, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, urinary frequency, nausea, vomiting, chills and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches. Limited information was provided by the sales representative from the physician.
Breakthrough COVID: Fully vaccinated. Patient is an 87 year-old female ,  She took 4 rapid antigen covid tests at home which were all positive. Due to worsening lethargy to the point where patient was unable to ambulate, she was brought to the ED. No shortness of breath, chest pain, fevers, nausea, vomiting, abdominal pain, or dysuria. In the ED, her vitals were stable and she was saturating 90-98% on room air. She was placed on 2 L nasal cannula for comfort. Labs were notable for mild metabolic acidosis and UTI. She had no leukocytosis. Chest x-ray did not show consolidation or infiltrates.  She was given 1 g Rocephin in the ED as well as decadron for dyspnea/wheezing. She was admitted for acute metabolic encephalopathy, UTI, and covid-19 upper respiratory infection.
Soreness, 2 inch circle, joint pain, fever, loss of appetite, nausea (on 7/6/18) recommended Ice for 20 minutes, TYLENOL and/or ibuprofen and BENADRYL as needed. Itching, and fever (on 7/8/18) continue with BENADRYL and ibuprofen.
Pruritic lesions appeared over body. Some interference with breathing. Family friend advised Benadryl which helped but lesions continue to appear 96 hours later.
Immunized 10/14/10 AM. On afternoon of 10/14/10 developed temp of 102. Which continued through 10/19/10. On 10/18/10 developed blurry vision - saw ophthalmologist who told pt. it was from fever and could be permanent.
dizzy and off balance  Then I felt like I would faint like a feeling of receiving anesthesia meds before surgery.  Stayed with me for 45 minutes.  Arms and legs felt heavy, too. Breathing was shallow. Symptoms only on that date.
12-05-08 9:30 AM received PNEUMOVAX vaccine 0.5 mL 25 mg. Friday afternoon felt burning pain. Friday night (L) arm and axillary pain. Ignored. Saturday evening found (L) arm (upper) with red streaks encircling upper arm and posterior axilla. Burning pain and swelling took 100mg Benadryl 800mg. IBU and iced the upper arm and axilla. Monday Morning red streaks disappeared. No pain. Trust slight puffiness of posterior (L) upper arm.
Papular rash partially circling arm near site where immunization given. Rash progressed to chest, abdomen, inner thighs, anterior neck, and face. Started approximately 7 hours after receiving immunization. Took Benadryl with no relief, Claritin with some relief. Notified HD 3 days after event began.
Headache, Myalgia, NauseaVomiting, fatigue Narrative: N/A
Narrative: 86yo male pt with: Problem list:-Chronic obstructive lung disease- Primary malignant neoplasm of prostate - Hypertension -BMH - Mild Neurocognitive Disorder - Alcohol Use Disorder (In sustained remission)- Anorexia - weight loss died on 11/20/2021 at long term care nursing facility . Pt had received covid vaccines on 6/7/21 & 7/8/21. This death is likely not related to the vaccinations due to patient's cormorbidities, advanced age, and length of time from vaccine administration.
I?ve had a persistent  migraine since the day following receiving my 2nd Shingles vaccine even after taking prescription medication for the migraines.  I have informed my PCP & have an appointment on 5/19/21; Shingrix 50 Mcg/0.5ml, Zoster Vac Recombinant Adjuv. MFG: Glaxo Smit
Patient came back over an hour post vaccine saying his arm was sore all around the deltoid area and even had a little bit of tingling in his fingers for a little while, but that had subsided.
Initial and follow-up information has been received from a physician concerning a 16 month old female with a history of allergic atopic dermatitis who in June 2008, also reported as three months ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). Subsequently, approximately 5 days after the administration of the vaccine, the patient developed generalized urticaria which lasted 3-4 weeks. On approximately 20-AUG-2008, also reported as two weeks ago, the patient was inadvertently vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and  route not reported) instead of MMR due to human error. One week ago, also reported as within 48 hours of vaccination, the patient developed more severe urticaria than after the first dose. It was reported that the urticaria was with generalized presentation of skin lesion which were pruritic and increased agitation of child. The patient was also irritable with a little fever and vomiting after the second dose (also reported not associated with fever, joint pain or vomiting). The patient was on steroids for 5 days and was on antihistamines at time of reporting. The patient was recovering from the events. No further information is expected.
a sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore left injection site arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 024M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (a sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (a sore left injection site arm) outcome was unknown.            No concomitant medications were reported.  Patient received the booster dose (third dose) in his left arm shoulder deltoid muscle. No treatment information was provided.   This case was linked to MOD-2022-546519, MOD-2022-546521, MOD-2022-546515 (Patient Link).
She fainted and was out between 5-10 minutes. This has never happened before, she?s healthy, nothing unusual except getting vaccine yesterday.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: other medical history: thyroid; "diabetes" (unspecified if ongoing), notes: other medical history: diabetes; "7 stent" (unspecified if ongoing), notes: other medical history: 7 stent; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ASPIRIN 81; CENTRUM FOR WOMEN; FUROSEMIDE; IRON; JARDIANCE; LEVOTHYROXINE; LOSARTAN POTASSIUM; METFORMIN HCL; METOPROLOL TARTRATE; VITAMIN C 1000 PLUS ZINC & BIOFLAVONOIDS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Saturday 7/13/19 woke up at 5am with an intense amount of pain and took ibuprofen which helped Swelling in deltoid at that point Sunday 7/14/19 noticed more swollen on tricep and red and splotchy  Was told to ice and take benadryl  Less splotchy today, but more all over red and now hot   Provider treating for cellulitis after examination
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
A nurse reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 2/25/03, the subject received his fifth injection of Infanrix (lot DTPA567A2). On the same date, he also received injections of inactivated poliomyelitis virus vaccine and MMR vaccine. Later that day, he developed an injection site reaction at the site of Infanrix administration. On 2/26/03, the subject presented to the physician, who observed a 10cm by 11cm area of redness, mild tenderness, and warmth. In addition, he had a fever. The physician prescribed an unspecified antibiotic. The reporting nurse considered the events to be related to Infanrix administration. The events resolved on 3/5/03.
6 hrs post-vax: muscle aches/headache/weak 9 -20 hrs post-vax: muscle aches/fever/extreme headache/weak/sleepless 9-44 hrs post vax: fever/weak
fluttered or rushed heart beats; having a bad headache; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), ATRIAL FLUTTER (fluttered or rushed heart beats) and HEADACHE (having a bad headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing). On 21-Mar-2021, the patient experienced ATRIAL FLUTTER (fluttered or rushed heart beats) and HEADACHE (having a bad headache). On 19-Mar-2021, DYSPNOEA (difficulty breathing) had resolved. At the time of the report, ATRIAL FLUTTER (fluttered or rushed heart beats) had not resolved and HEADACHE (having a bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  Treatment details included pain medication and sinus pills.
Information has been received from a Registered Pharmacist concerning a 78 year old female patient who on 10-DEC-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). On 30-MAR-2011 the patient was seen by an unspecified physician and was diagnosed with a mild case of shingles. On the same day, the patient was treated with tramadol hydrochloride (manufacturer unspecified) and VALTREX which was ordered by the physician for the event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I had high fever of 102. Then, I had sore throat, body ache, and coughing. Then, my PO2 dropped. I went to the ER.  They did chest x-ray, bilateral intrathecal. They gave me prescription medicine. These lasted for 3 or 4 weeks. On Feb 12th, I tested positive for Covid-19.
Janssen COVID-19 Vaccine EUA: uncontrolled muscle contractions causing full body shivers as if cold including teeth chattering; body shivers lasting over 30 minutes causing muscle ache and joint ache
Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension Cardiac" (unspecified if ongoing), notes: Hypertension Cardiac. The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Dose lot unknown reason stated as not available/provided to reporter at the time of report completion. Reporter was reporting for his/her mother. After first vaccine she started having hives. For 2 years she had dealt with this issue. Treated and seen by multiple doctors. Phototherapy was used as well as medications (multiple). Case was reported as non-serious. Known allergies included none. No COVID prior vaccination and COVID not tested post vaccination.  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-202300124661 same patient/event and different drug dose;
rash in the injection site several days after receiving SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site rash after vaccination. The patient would like no know how to proceed with 2nd dose.
Individual received Moderna vaccine on 03/29/2021.  On 04/30/2021, individual received the Pfizer vaccine, when Moderna should have been the the 2nd dose.  This writer attempted to call writer on this date and left message for him to return my call.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.
Patient received covid vaccine #1 on 3/20/21, the following day developed rectal bleeding that persisted for several days. Office visit 3/25/21. CBC normal, rectal exam without hemorrhoids or mass.
Immediate raised redness at injection site and red patches under L arm, on L upper chest, and lower back, itching.
PATIENT STATED THAT SHE DEVELOPED HIVES ON HER ARMS ABOUT 6 HOURS AFTER VACCINE ADMINISTRATION AND UPON AWAKENING THIS AM, HAD DEVELOPED HIVES ON HER ABDOMEN AND LEGS-.. PATIENT STARTED BENDRYL THIS MORNING AND DENIES SHORTNESS OF BREATH OR OTHER SYMPTOMS.  ADVISED TO SEEK IMMEDIATE EMERGENCY ASSISTANCE FOR ANY WORSENING OF SYMPTOMS, SHORTNESS OF BREATH  OR TIGHTNESS OF THE THROAT OR CHEST.
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature.   Clinic has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 31 days. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule and patient will not need to be re-vaccinated.
A Movovalent Covid-19 vaccine was given instead of a Bivalent dose to patient. Both vials have gray top's and the employee pulled the wrong gray top vaccine.  Notification: Via phone on 11/14/22
Chills; Nausea; Tiredness; Little fever; Injection site pain; Mild headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204), via an unspecified route of administration in the left arm on 15Mar2021 at 15:00 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took potassium and experienced hypersensitivity. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6198), via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization and experienced vaccination site pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient stated that, 12 hours after 2nd dose (16Mar2021, 03:00), the chills woke her up. She had nausea, tiredness, little fever, injection site pain, and mild headache. After taking a Tylenol, she felt better a little. Therapeutic measures were taken as a result of events. The clinical outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Moderna Covid-19 Vaccine EUA( fact sheet handed out at the site says to put this in first line of box #18. After the shot, my arm was sore for 3 days. No other reaction until today, 1 week after the shot. My arm itches and there is a slightly raised, painful spot on the arm where I got the shot. It isn't too sore, annoyingly itchy, not serious enough for me to seek medical attention, although I did email my primary care doctor to get her advice.
Patient passed out twice within two minutes- looked like seizure activity. He could not walk and was helped to the car. Was taken to the Emergency room at the local hospital.
Headache 2-3 days post vaccine till current, joint pain, fatigue, rash on face at hairline. Bilateral red streaks on arm, inner leg and foot, rash and swollen fingers both hands, swollen eyes "hive" bump over right eye. Doctor gave steroids.