chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore at injection site; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included surgery on 2016 (The pain is what was felt prior to having surgery in 2016). The patient's concomitant medications were not reported. The patient experienced sore at injection site (injection site pain) on an unspecified date. Caller, reported on the Pfizer vaccine and who was calling to report and ask some questions. It was explained that with her first vaccine that was on 20Jan2021 about 1pm and though this doesn't have anything to do with it, the nurse that gave it, her masking kept coming down. She gave the injection and the caller felt it was weird where she gave even though her friend said it can be given in different areas. It was administered up high and toward the mid line, more toward the middle of her body. That night 21Jan2021 22Jan2021 and half the day of 23Jan2021 she was very sore at the injection site and a few days later, in fact she was still having pain. She reports that it was a similar pain that she experienced prior to having surgery in 2016 between C5 and C6; she had a fusion. The pain was from her scapula down throughout the elbow to the forearm and to her fingers on that side. She was calling because she was concerned it from vaccine though she was told it probably wasn't by her friend that was a nurse. The patient underwent lab tests included magnetic resonance imaging (for a fusion surgery on C5 and C6, a pinched nerve from bending her neck) on 12Feb2021. The action taken in response to the event for bnt162b2 was not applicable. Outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Blood clots in lungs, legs, and other areas of the body; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (Blood clots in lungs, legs, and other areas of the body) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient got hospitalized that lasted for more than 1 week. Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by other health care professional, concerning an elderly male patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Thrombosis, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. As reported, patient had blood clots in lungs, legs and other areas of the body. He was hospitalized for more than 1 week. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
On 02/01/2022 I started to feel really tired. Another (Privacy) tested positive so I decided to take a rapid test on 02/02/2022 and it came back positive. I had a video conference with my Dr. and she told me to increase my Vitamin C and Zinc and make sure to take my regular vitamins. I retested after 7 days and it came back negative.
Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
covid 19; Sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) and ILLNESS (Sick) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included AFib.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid 19) and ILLNESS (Sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and ILLNESS (Sick) had resolved.            Patient was not sure whether this was his 3rd or 4th dose.  Patient stayed at home and was sick for about a week. No concomitant medication was reported.
I got shingles from the shot too/suspected vaccination failure; I got shingles from the shot too; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting. This case had been linked with case US2021AMR073595, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073595:same reporter, different patient
I started getting pain in the arm type 10 at night I already had body discomfort, fever, nausea, muscle pain, chills, strong pain in the head, by the second day the pains became stronger and I was very tired and discomfort. By the third day, Saturday, I had a convulsion attach where I could only stay home since I am in the country as a tourist. On the sixth day, I woke up with a headache and nausea, seventh day, Monday September 20, I still have a lot of head pain and nausea with certain numbness in the body as if I were going to start a convulsive attack but they go away and then they come back. Honestly it scares me a lot to be like this.
Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine.  On Tuesday, March 23, 2021 I had the second vaccine and had flu symptoms the next day with body aches and fatigue.  I felt better the day after that-Thursday.  This morning, Saturday, as soon as I got out of bed, my face burned and turned bright red.  I looked like I had a sunburn.  My arms, especially around my elbows turned an angry red. They didn't burn as badly as my face.  Around an hour later, the redness subsided, but my face still feels hot. I don't feel like myself and am taking it easy today.  I want to report this so you are aware of the reaction. I take no medications and am extremely healthy.  My last vaccine was in 1976.
Vomiting every few minutes, nausea, extreme headache, high BP, woozy, chest pressure.
Patient missed the schedule for her second dose of IMOVAX, with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who missed the schedule for her second dose of Rabies (Hdc) Vaccine [Imovax Rabies] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Aug-2023, the patient received a dose 1 (dosage text: once) of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (Strength: standard, Frequency: once, expiry date and lot number not reported) via unknown route in unknown administration site of immunization. Information on the batch number was requested.   On 08-AUG-2023 the patient missed the schedule for her second dose of imovax, with no reported adverse event (routine immunisation schedule incomplete) (latency: 7 days).  It was reported that" Patient missed the schedule for her second dose of IMOVAX which was supposedly on 08AUG2023. Pharmacist was asking if it is okay to administer the second dose today and how will it affect the schedule of the third dose. Patient was not yet administered with the second dose during the call. "  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
pt devel pruritis, red raised rash in conjunction w/flu like sx 72 hrs post inject w/Engerix-B inject #2; pt advised to see MD; 2NOV92 still had itching but @ 10% level as compared to prior 100% level; has not consulted MD;
Patient fainted for 10-15 seconds after administration.  On 10-12-2007, her father reports that since that incident she has experienced every few days a rash that is slightly erythemic, progressively pruritic and lsats 3-4 days, on the chest and upper thighs, and lower abdomen that fades away. Fatigue, fever and nausea associated.
2 weeks or so after the vaccine my arm started hurting. I thought I had slept on it funny and ignored the pain for some time. By September 18 the pain was worse.  On September 24 I went to the emergency room and was diagnosed with deep vein thrombosis of the left arm.
I started getting symptoms of chest pains in the right side that went away during the night. The next morning I had a headache and tiredness. I had to take Tylenol. By that afternoon, I still felt very tired with a headache. ON 5/5/2022, I felt worse so I took a COVID-19 home test that was positive. I took a second one which was positive as well. I called a pharmacy to get another test done, which was also positive. Today, I feel congested. I have spoke with my PCP and lung specialist which told me that I could possibly get Paxlovid but I have not needed it yet.
COVID positive on 11/7/2021.  69-year-old female presents to the ED complaining of generalized weakness, slight shortness of breath, cough with white sputum production, fatigue, myalgias, dysuria and frequency. Vital signs show patient is febrile with fever of 101.6 and tachycardic but no hypotension noted. Patient meets SIRS criteria, initiated sepsis bundle with 30 cc/kg and Rocephin for antibiotic coverage. Patient also given Tylenol for fever control. Patient while in the ED has not been hypoxic with O2 sat dropping below 88%, after fluid, Tylenol and antibiotic administration states feels much better. Patient was discharged with Keflex for antibiotic coverage for UTI, given pulse oximeter prescription with strict return precautions to the ED if become hypoxic or if fever continues to get worse and is not controlled with Tylenol.
Stomach cramps and vomiting. Vomited once then felt fine. Resolved in one day.
Swelling and pain in hand. Went to ER and was treated with steroids. Swelling and pain subsided after treatment.
Patient developed swelling from the left breast to the anterior aspect of the neck with anterior lymphadenopathy.  Patient received 8 mg of Decadron IM on 2/2/21.
Pain in jaw and chest around 1:00am after receiving the vaccine at 4:30pm the previous day.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On 14-SEP-2015, the patient was vaccinated with the first dose of an improperly stored dose of MMR II (lot # K003806, expiration date 13-MAR-2016) 0.5 ml, subcutaneous (anatomical location of administration was not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported after improperly stored vaccine was administered. Additional information has been requested.
Headache will not go away , shortness of and trouble with breathing , weak after a short time of physical anything , chest pains , veins in legs are showing. These all came on a few days ago and the headache last night was almost unbrarible and i never have headaches
All joints in body extremely sore, all muscle groups from neck to feets seizing and cramping, alternating fever/chills.
Arm with injection throbbing, lymph node soreness in underarm of the arm with the injection, fever of 101.5 approximately 12 hours after the injection, which persisted for the next 24 hours. Headache and malaise persisted for about 36 hours after the injection
Information has been received from a registered nurse concerning a male who was vaccinated with RECOMBIVAX HB (Lot # 655148/0005U), instead of hepatitis A virus vaccine inactivated, who reported this was a "staff error only". The nurse stated "the child has received more than three doses of hepatitis B containing vaccine, but has not experienced any adverse effects".  Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
No adverse reaction noted. See continuation page for explanation.On August 28, 2023, RN was preparing to administer a Menveo-meningococcal vaccine to a patient. She noted that there were 2 component/powder-Vial 1 and one Vial 2 component left in Menveo box. In inventory, it showed that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode #1389665, 4 doses had been previously administered. Those 4 doses had been administered by 2 other RNs.
10 cm x 6.5 cm mild erythematous non tender slightly raised patch with central injection site puncture to ant (R) thigh 3.5 cm diameter mild erythematous - non tender slightly indurated raised patch with central injection site puncture wound to ant left thigh. Warm compress to thighs twice a day - BENADRYL PRN f/u with PCP in week. Send to ER increase redness fever -puss.
Itching at the site, large welt, raised, hot, red. Called the doctor to report incident. Doctor gave shot at 45 degree angle. Questioning SQ administration vs. IM.
I thought that I had allergies due to extreme sinus headache, sinus pressure and my right ear felt like it would burst. I was also tired. This went on for 3 days and I called my doctor on the 4th day to check my ear. Her assistant came out to the car and gave me a PCR COVID-19 Test which I tested positive for. They had me go home and isolate. I took Tylenol Cold and Sinus and isolated at home for the next 5 days and wore a mask for 5 days. The symptoms went away temporarily but I then developed Vertigo with Migraines. The most recent occurrence was this morning. I was prescribed medication for Vertigo but once the spinning is over I develop a migraine headache with extreme sensitivity to light. The doctor is having me chart how often it happens to determine whether I need to be on an additional medication to treat the migraines. I was driving when the Vertigo hit in the middle of a thunder storm. I had to drive 27 miles. I went to the hospital and had a CT Scan, Chest X-Ray, and a blood panel. I was given medications for the vertigo and nausea and headache. This has happened at least 3 times in the last 7 days.
Tinnitus is MUCH worse, starting Sunday April 4th, in the evening.  Much worse the following morning,  all day, subsided a small amount on Tuesday, then came back next day. Tinnitus has continued to be very much worse since that day
pt states about an hour after getting his 1st booster shot he started having bad chest pains.  He had heaviness in his chest like  angina.  His blood pressure was normal.  He thinks he may have myocarditis from getting this vaccine. The next day the pains were getting worse so he contacted his doctor.  His doctor ordered an echocardiogram but has not received his results from this test.  He will see his doctor today.  He still has chest pains at this time but seems to be some better.
Headache, Nausea, Vomiting, Chills, Fatigue, Joint pain, Fever.
Not really sure if it was an adverse effect but just had a metallic taste in my mouth (like the metallic taste of the needle) after administration. It didn't really bother me. It went away after 30 mins.
Vaccine given without diluent (full 6-dose vial given). Mild nausea and anxiety, no anaphylaxis. Admitted to hospital for observation via emergency room.
Redness, swelling and warmth to touch right deltoid x 2 days has been given Ibuprofen Q 6 hrs as comfort measures. Seen MD 4/28/06 prescription given for Keflex BID x 10 days. Cold compresses pm to right arm.
Arm Red, Warm and Swollen from arm pit to elbow. Significant pain with any movement.
a staff member administered an expired dose of Menactra to a patient/No AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and Expiry date 08-Jul-2020) via unknown route and administration site on an unknown date for prophylactic vaccination.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting no adverse event reported.  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.
Pt had mild Gi illness diarrhea and vomiting for 2 days, then was not producing urine. Found to be in kidney failure. Had to start hemodialysis
I95.9 HYPOTENSION 9/12/2022 DYSPNEA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/12/2022 DYSPNEA R57.0 CARDIOGENIC SHOCK 8/30/2022 DYSPNEA T78.40XA ALLERGIC REACTION, INIT 9/6/2022 DYSPNEA I95.9 HYPOTENSION 9/12/2022 CHF EXACERBATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/12/2022 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 8/30/2022 CHF EXACERBATION, UNSPECIFIED T78.40XA ALLERGIC REACTION, INIT 9/6/2022 CHF EXACERBATION, UNSPECIFIED I95.9 HYPOTENSION 9/12/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/12/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.0 CARDIOGENIC SHOCK 8/30/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA T78.40XA ALLERGIC REACTION, INIT 9/6/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 9/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R57.0 CARDIOGENIC SHOCK 8/30/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC T78.40XA ALLERGIC REACTION, INIT 9/6/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Anaphylaxis - rash, SOB, lip swelling. Body aches. Symptoms started within 1 hr of getting vaccine.
Bounding pulse and heart palpitations started 2-4 hours following vaccination. Insomnia began shortly thereafter and worsened greatly throughout January. Palpitations have worsened and affect my body?s ability to relax and sleep. Extreme tension, stress, and muscle fatigue/soreness are now common and worsen in the evenings and night while at rest. Experienced minor chest pain and tightness in late April. No symptoms have improved even five months later, and are in fact, continuing to worsen.
pt recvd vax in 1993 pt was dx w/lupus following c/o of fatigue, joint sx, lethargy & markedly pos ANA; No further details were provided;
noticed shingles 48 hrs p/inject; also hx of exposure to chickenpox;
Persistent headache; This is a spontaneous report from a non-contactable consumer (patient).  A 43-year-old (also the age at time of vaccination) non-pregnant at the time of vaccination female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for COVID-19 immunization. The patient had COVID-19 on unknown date prior to vaccination. There were no concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jun2021 (Lot number: EW0186) at 09:45 AM at the age of 43-years-old as COVID-19 immunization. Then, the 2nd dose on 10Jul2021 16:00. On 11Jul2021 08:00 (also reported as two weeks after second injects), the patient experienced persistent headache. The event resulted to emergency room/department or urgent care and was treated with unspecified intravenous (IV) medication. The patient had nasal swab in 2021 with unknown results. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
patient reports fever greater than 101F, severe headache, flu-like symptoms for 24 hours. Aspirin provided some relief.
Headache, Myalgia, Arthralgia & Fever Narrative:  Fever, myalgia, arthralgia, headache; took ibuprofen, s/s improving.
About 4:00 pm, pain in my back and then it kept getting worse and worse and I was feeling nausea and was in a lot of pain. Husband came home and took me to urgent care. They gave me a shot there, and it was a pain reliever, which relieved it and I think the kidney stone passed at that time; Toradol injection. After that I had to strain my urine and got some of the stones and took them in the lab to test it.