chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately (a minute or two) after receiving the vaccine: lightheadedness, nausea, nearly fainted, vision started going blurry/black, sweating for about  5-10 minutes. Stayed seated until it mostly passed, then went outside for fresh air and to cool down. Put a cold rag on forehead/back of neck for half hour following symptoms. Drank water at soon as possible. For the next 36 hours after receiving the vaccine: sensitive skin, muscle weakness, tiredness, headache, body aches (including the sight of injection), chills, hot flashes. Took Advil every few hours to reduce pain, kept lights off, laid in bed to rest.
Weakness, excessive tiredness.  Later high blood pressure, preeclampsia.  Diagnosed with cardiomyopathy (heart failure) and ejection fraction of 18 following pregnancy. No health issues prior to the flu shot; however, experienced extreme fatigue following. Issues with pregnancy well documented. Eventual diagnosis of non-ischemic cardiomyopathy (no known cause).
12/29/21 presents to EC ED for "worsening cough and weaknesss". PMHx of "CKD, PE on Eliquis, PAD, seizure, HTN"
Moderna COVID-19 Vaccine administered in right arm.  Side effects include fatigue, pain at injection site and pain from injection site to elbow, and swelling in right hand.
Large local reaction, localized pain increasing in severity over the day, and developed a warm red rash.  Pt. will continue Ibuprofen and given ORAPRED 30 mg X 3 days.
Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who was vaccinated with two doses of FLUBLOK QIV on 21-Sep-2018 (lot QFAA1816, expiration date: 30-Jun-2019) via unknown route in unknown administration site) and on 29-Oct-2018 (lot QFAA1834, expiration date: 30-Jun-2019) via unknown route in the right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is an actual medication error case due to extra dose administered. It was reported that the patient received two doses of FLUBLOK QUADRIVALENT 38 days apart and stated that the patient had not complained about anything. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
FEVER,REDNESS AND SWELLING OF 1/3 OF DISTAL THIGH NEAR INJECTION SITES OF MMR,DTAP,AND HEP A.
Client complained of palpitations 20mins after receiving vaccine. First vitals at 1637: pulse 147, blood pressure 124/78, oxygen 99%. Alert and oriented x4. Client denied chest pain, shortness of breath, headache, or blurry vision. Per Father client had asthma that resolved years ago, no current medications or allergies. Pulse at 1638: 127. Vitals at 1640: blood pressure 118/70, pulse 124, oxygen 100%. Per client palpitations improving. Alert and oriented. 1644: client hands shaking, client stated only had breakfast. RN brought client juice and snack. Client began to eat. Father denied client having diabetes. 1648 vitals: blood pressure 122/80, pulse fluctuating from 110-low 120s, oxygen 97%. Symptoms the same with new onset o blurry vision, per client could not focus image. PHN  offered Father to call paramedics for further assessment and he declined. PHN advised for client to follow up with provider. Per Father client's sugar lowers when he skips meals. PHN asked Father is he has followed up with provider or checks client's sugar at home, Father denied. Per Father he knows his son and "he needs to eat or sugar goes low". At 1656 client stated he wanted to vomit, emesis bag given. 1658 client pale, PHN asked client how to was feeling. Per client feeling like he "was going to pass out". At 1700 client stated he could not feel legs, RN assessed for sensory and motor. Per client felt like legs "were asleep". PHN  assessed for level of consciousness, client unable to answer, client lethargic. 1701 client lost consciousness. PHN and RN lowered client to floor from chair. EMT called 911 at 1703. RN did sternal rub, client unresponsive, breathing normal, pupils reactive. 1704 client woke up with urge to vomit. PHN and RN turned client on side. EMT able to place emesis bag near. Client had 1 small vomit episode. Client's eyes open, blank stare, not answering questions. At 1707 client went unresponsive again. Paramedics arrived at 1709 and assumed care. Client transported to hospital at 1717
Cough; heaviness to the chest; Stomach pain; Coughing so much his ribs get sore; Experiencing shortness of breath together with the cough; asthma; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 12May2021 13:00 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. There was no additional vaccine administered on same date of the BNT162B2. The patient did not receive any other vaccine within four weeks prior to the first administration date of the BNT162B2. Medical history included he had thyroid removed one time and it grew back and acid reflux. Family medical history was none. Concomitant medications included medications for an acid reflux. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 16Apr2021 around 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. The patient stated he got the COVID shot and started having problems. He stated he hadn't figured out what was the cause, clarifying he had all kinds of medical tests done, but everything came back normal. He couldn't figure out why he had the cough. He didn't have a cough until he took the last COVID shot in May2021. The patient stated if this was a side effects from the vaccine. They were thinking it might be asthma, he had never had asthma. The patient had tests on his heart. Trying to figure out if that's it or what. The patient clarified his problem as cough and heaviness to the chest in May2021 which began week after the second dose on 12May2021. The patient was coughing so much his ribs get sore in May2021. He started off as a mild, little cough. Had gotten worse. The patient was also experiencing shortness of breath together with the cough in May2021. The events required visit to emergency room and physician office. The doctor ran a chest x-ray. The patient was also having stomach pain too which began around the same time as the cough. The patient thought it was just gas and an acid reflux situation. Was on medicine for acid reflux. Then it was changed to a different medication and the stomach pain stopped. A CT of abdomen and pelvis was performed. Ultrasound of thyroid was performed. All tests performed had come back normal. He then contacted his heart doctor, who started running tests on his heart. The patient then went through the ER and was admitted to the hospital for tests. Hospital did a lung function test, which showed back normal. The patient was admitted to hospital on 29Jul2021 and was kept for 4 days. The outcome of the events Cough and heaviness to the chest was not recovered, of the event stomach pain was recovered in 2021, of the other events was unknown.
This spontaneous report as received from a registered nurse refers to a 12 month old female patient. The patient had no pertinent medical history and drug reactions or allergies. Concomitant therapies included amoxicillin for ear infection, ordered on 26-OCT-2017. On 26-OCT-2017, the patient was vaccinated with M-M-R II lot # M042846, expiration date 21-OCT-2018. Other suspect therapies included administered on the same day VARIVAX lot# N012486, expiration date 24-APR-2019 (reported as 20-APR-2019), PREVNAR 13 lot # R37130, expiration date 30-MAR-2018 and FLULAVAL lot # ZJ5XA, expiration date 31-MAY-2018. Dose and route of administration was not provided for any of the vaccines. On 02-NOV-2017, the patient experienced erythema multiforme and hives. Unspecified treatment was given for the events. The patient was seen in physician's office. On 03-NOV-2017, complete blood count was normal and showed right shift which might indicate an early viral illness. The outcome of erythema multiforme and urticaria was reported as recovering. The causality assessment was not provided. Upon internal review, the event of erythema multiforme was considered to be medically significant.
Burning feeling in the hands and feet; itchy but no rash; full body itch; Pins and needles; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles), PRURITUS (itchy but no rash; full body itch), BURNING SENSATION (Burning feeling in the hands and feet), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anaphylactic reaction to venom (Patient has anaphylactic reaction to venom or anything that stings.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 30-Jan-2021, the patient experienced PARAESTHESIA (Pins and needles). On 02-Feb-2021, the patient experienced PRURITUS (itchy but no rash; full body itch). On 05-Feb-2021, the patient experienced BURNING SENSATION (Burning feeling in the hands and feet). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (Pins and needles), PRURITUS (itchy but no rash; full body itch), BURNING SENSATION (Burning feeling in the hands and feet), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) 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.   No relevant concomitant medications reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Arthralgia and myalgia are consistent with the product safety profile.
couldn't move again after the 2nd dose; was in a lot of pain; she was very sick at the time; diamond shaped blister at the injection site that lasted for months; She also experienced red, diamond shaped blister at the injection site that lasted for months; she had a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time) and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (highly allergic to a lot of things).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BURNING SENSATION (she had a burning sensation). On an unknown date, the patient experienced DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time), VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months). At the time of the report, BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain) and ILLNESS (she was very sick at the time) outcome was unknown and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient says that after the 2nd dose, she was out for 2 weeks. Her healthcare provider thinks that she may be allergic to the propyl glycol in the vaccine and that could have caused the reaction both times.   This case was linked to MOD-2021-403016 (Patient Link).
starting about 4pm the day of vaccination the patient reports extreme abdominal distress, nausea and vomiting, and dry heaves which lasted about 12 hours and subsided around 4am 2/9/2021.  Patient tells me she "didn't care if I lived or died" during that period.  As of 2/11/2021, she called the Pharmacy wishing to report her experience.  She told me she feels better now, just some residual "crampiness" from the dry heaves
As of this past Monday I started to experience severe fatigue and body ache. Symptoms have only increased. Today muscle twitch and electrical sensation began, mostly in my upper arms.
Severe headache, vomiting, high blood pressure, dehydration, body aches. Was seen in Er at  on Friday night.
Large local reaction - 7-8 cm in diameter approximately 8 hors after injection.
Macular papular rash with halos surrounding starting on anterior thighs, spreading to B arms, anterior chest and neck
Covid 19 vaccination given to 16 yr old male. No ID provided at time of vaccination, father signed consent form.
numbness tingling in my lower left leg; numbness tingling in my lower left leg; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 11:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to peanut. Concomitant medications were not reported. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other vaccine within 4 weeks prior to the vaccination. The clinical course was reported as follows: on 13Apr2021 at 14:00, the patient experienced numbness and tingling in the lower left leg. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness and tingling in the lower left leg was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
muscle pain, weak, tired, headache, stomach ache, diarrhea and nausea
This spontaneous report as received from a pharmacist refers to an 83 year old female patient. There were no drug allergies/reactions. On 24-JUL-2013 the patient was vaccinated with ZOSTAVAX, (lot # J000433. expiration date 10-APR-2014), 0.65 ml, subcutaneous, (anatomical location unspecified). Concomitant medications were not reported. On 25-JUL-2013, the patient experienced redness at injection site. The patient sought medical attention and no treatment was given for the event. Lab diagnostics studies were not performed. The outcome of redness at injection site was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Initial unsolicited case received from a nurse on 31 Oct 2017. This case ID linked with 2017SA214850, 2017SA214851, 2017SA214852, 2017SA214853 (same reporter). This case involves a female patient (age reported as from 30 years to 90 years who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe arm pain and arm pain was so severe that it was difficult to the patient to move her arm. Relevant lab tests were not reported. As a corrective treatment the patient received TYLENOL which did not help reduce the pain and was also given oxycodone. As of 31 Oct 2017, the outcome of the events was reported as recovering. List of documents held by sender: none.
Pt given MMR and PPD on 6/11/03, had PPD read 6/13/03. Came in on Monday 6/16/03 stating she just found out she is pregnant. Has not been to MD for care yet. Told to do so and we would follow up.  Telephone call to pt 6/19/03 and 6/20/03.
TINNITIS - Loud Roaring in head that is continuing today and every day. Visited 3 ENTs, 2 Internal Medicine Doctors, 2 Neurologists 2 eye Doctors, and visited the Emergency Room twice. Symptoms : dizziness, vomiting, nausea and glands in mouth watering.  fLoud roaring buzzing that continues today.    TESTS:  Hearing - recommended hearing aides,  I have them but it doesn't help.  Two cat scans 5/16 and 6/01.  Did not determine what could be causing the loud roaring noice.
2 days after 1st oral cap Typhoid: lower GI gurgling liquid diarrhea x 2 wks-> took one day off work. Occurs late morning and early afternoon 1130-1600, occasional nausea, after the initial 2 week diarrhea progressed to soft stool with continuous abdominal gurgles.
dizziness; heavy head; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (heavy head) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HEADACHE (heavy head). At the time of the report, DIZZINESS (dizziness) and HEADACHE (heavy head) 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.   No concomitant medications were provided. No treatment medications were provided.
Pt called on 6/17/21 hospital call center. Pt received first Pfizer vaccine on 6/4/21. Pt states having pain, burning and bruising at the the injection site (right arm) for 2 weeks and is not getting better. Pt advised to go to closest urgent care for further evaluation.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route and lot # not reported) exposed to 32 F for 30 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
12/23/20 Covid Moderna 1/20/21 Covid Moderna 8/14/21 ill 8/16/21 + Covid PCR 8/25 RTW
Patient became very fussy and lethargic about a few hours after five different vaccines were administered. The next morning, she began vomiting, which continued for more than 24 hours. Then she experienced fever and diarrhea the following 24 hours. She remained fussy and leghargic the entire time. We called the doctor's office numberous times. In the meantime, she's on other medications administered orally, which she was unable to keep down.
Pt started with fever of 103 and chills the same night as vaccine. Next day, he had left leg discomfort, unable to bear weight and by afternoon was refusing to walk. On exam, noted to have warmth over site of injection, + swelling but no erythema. Extremity was also noted to be cooler distally. Dorsalis pedis and posterior tibial pulses of left leg WNL, 2+. Sent to ED for further examination.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: MOTHER WHO IS A NURSE REPORTED SIMILAR SYNCOPY LIKE REACTIONS TO YEARLY FLU SHOT - BUT NOT AS SEVERE
No adverse reactions noted. A nurse gave Havrix Adult dose  of Hepatitis A to a 15yr old instead of giving a child's dose. There were no adverse reactions reported to the clinic. Clinic Manager brought the incident to me as the Immunization Coordinator and ask that I report the incorrect dosage given to the patient. I called and spoke with the mom of the patient on 12/08/2021 to ask how patient was feeling and she stated that patient had no fevers, chills or any other adverse reactions to any immunizations given on 12/02/2021
Headache, sore throat, pressure neck, shoulders, runny nose, congestion, fatigue starting on 9/15/21. Daughter tested positive for COVID on 9/12/21, unclear if daughter vaccinated
Temp of 103.4 body aches and lasted 24 hours then felt just fine.
02/14/2000 pt was admitted to the ER, then hospitalized for ten days after a dx of meningitis. The pt was treated with an unspecified antibiotic. It was noted that on 02/16/2000 the pt was transferred to another facility for worsening neurological symptoms. The pt recovered in February. Additional information has been requested.
sx shakes & pains, cold;signs: visible shaking, low grade fever 99.6;
Hyporesponsive rxn; Very pale, cynosis around mouth 10-12 hrs p/inject; No tx;
Information has been received from a physician concerning a 1 year old female who 3 to 4 weeks ago, in approximately January 2006, was vaccinated subcutaneously with a dose of MMR and varicella vaccine live.  There was no concomitant medication.  7 days post vaccination in approximately February 2006, the patient experienced a measles like rash.  The patient was taken to the emergency room to be seen.  She was treated with Benadryl and subsequently recovered.  There was no product quality complaint involved.  Additional information has been requested.