chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TERRIBLE PAIN; FEEL ROTTEN/SICK; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 01-AUG-2021, the subject experienced terrible pain. On 01-AUG-2021, the subject experienced feel rotten/sick. On 01-AUG-2021, the subject experienced nausea. On 01-AUG-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.4 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, terrible pain, fever, and feel rotten/sick. This report was non-serious.
Neurologic; muscle pains all over body; joint in left knee hurts a lot; inflammation; hard to walk without feeling fatigued and needing to rest; nightmare; stomach aches and cramping; menstral cramping constantly; emotional; generalized anxiety; foggy brain; inability to concentrate; vitiligo; nausea; extreme pressure on left side of the head; tingling in left eye ongoing; body tingling all over;  PTSD shock pains;
That night I got sick and coughed, and my voice changed. I took Nyquil, my cough subsided but I had a fever all night. The next day my arm was swollen (COVID arm). The 1/8 had a circle around the vaccine, red and hot. Two days later the arm was spreaded and grew around it. My fever (97.3) went away and my friend recommended Levothyroxine 5 mg, one every 24 hours for 5 days and my arm got better. A week later it changed color (from red to brown) and on January 15 it was still swollen. Two days later (1/17) the color turned into blisters with water. I popped them and the skin started to change and the swelling went down. I have a little swollen.
Developed urticarial rash and scratchy throat approx. 45 min after receiving flu vaccine. Has never received flu vaccine in the past.
PT GOT FLU SHOT INSEAD OF COVID - HAD ALREADY RECIEVED FLU SHOT EARLIER THIS FLU SEASON
Metallic taste in mouth, dizziness, weakness, altered mental status, difficulty raising arms, "heavy like a slug", HR 81, BP 112/78.  reaction immediately after vaccination.  Symptoms did not resolve after an hour.  Patient taken to ER for evaluation.
Patient reported swelling of arm several hours after vaccination that resolved the following day after taking diphenhydramine and applying hydrocortisone. The swelling returned after 3 days and has progressively become worse since the time of vaccination. She appears to have cellulitis, and this may be a result of the vaccinator using a 1 inch needle to administer the vaccine vs. a 1&1/2 inch needle. This patient's weight is greater than 200 lbs and if a 1 inch needle was used this vaccine would have been administered subcutaneously instead of intramuscularly.
Admitted to hospital 4/23/2021 with syncopal episode. Discharged to home 4/25/2021. Covid vaccination history: Pfizer 2/1/2021 and 2/23/2021. Covid PCR positive on 4/23/2021. Submitter does not have access to further vaccine or hospital medical records.
Information has been received from a RN concerning a 25 yr old male student who on 16Sep04 at 09:00 was vaccinated SC in the left arm with his first dose of varicella virus vaccine live (lot 641990/1313N). Concomitant vaccinations included the first dose of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix) (lot AHABA015BA) given IM in the left arm. The nurse reported the pt developed a mild fever and cold symptoms on 30Sep04 which lasted 2-3 days. On 03Oct04, the pt developed approx 8-10 red, raised itchy bumps on his face, left hand and head; no pustules were present. Unspecified medical attention was sought. The lesions resolved after about one week and the pt was noted to have fully recovered. The pt received a second dose of varicella virus vaccine live (lot 641990/1313N) SC in the left arm on 20Oct04 at 08:30. Additional information is not expected.
Started feeling dizzy 6 days after the vaccine. Could not stand up. Went to ER. Said it could be from vaccine. They referred me to a specialist. Got meds. Doctor also said it could be from vaccine.
Patient developed bilateral hand tingling.  Diaphoretic approximately 11 minutes after the dose.  Ice pack to the back of the neck, water/apple juice and saltines provided.  Vital signs taken: BP 116/79 HR 71 Patient stated that he had not eaten all day; only had a large coffee prior to the vaccine dose.  Patient also stated that he had not slept the night before.  Patient refused to lie on the stretcher.  He sat for an additional 10 minutes then stated he was feeling better, tingling resolved and he was ready to leave.
A spontaneous, non-serious report of diarrhea has been received from a nurse concerning a 33-year-old male patient which occurred one day after receiving FLUMIST. Medical history and concomitant medications were not reported. On 13-Oct-2010, the patient received FLUMIST. On 14-Oct-2010, the patient called the office and reported that he had developed diarrhea after receiving FLUMIST; the event had resolved prior to the call. The outcome for the event, diarrhea, was resolved. Additional information was received on 08-Nov-2010 and was incorporated into the narrative: diarrhea was resolved prior to the event being reported.
Teacher saw child lying on floor on her back, jerking her head and one shoulder for about 10 sec- Nurse observed child lying on floor; was pale, diaphoretic with pupils equally dilated; responsive. Incident happened about 5 min after child received H1N1-Im injection pain only at injection site.  Vitals @13:40 T-98, P-72, R-16, BP 90/60.
pt stood up to leave after waiting about 15 minutes after vaccine given once she stood up see complained of dizzyness, the patient fainted immideatly, was noted very pale within sec pt was alert but tired and nausea, very pale it took a total of 1 hour before pt was ok to leave when pt left still felt a little dizzy.
12/07/01 shots, 12/14/01 rash fever, 12/15/01 diarrhea, rash in mouth & allo over body. Fever 101-fine pinpoint rash Mom got gastrointestinal flu 12/15/01
TINGLING. BODY ACHES AT BEDTIME. FREEZING THEN COLD. WOKE UP AT 2:30AM WITH A HEART RATE OF 96 AND TEMP OF 99.6. NEXT MORNING TEMP WAS 99.9. TOOK TYLENOL.
About 1,2 weeks post 2nd vaccination I developed arthritic like symptoms in the fingers in my Left hand. I have arthritis in my pointer. I thought I was or had developed in my other fingers( 3, 4, and 5) About a week later I had a thought that maybe this is a side effect from the vaccine. I have been learning that this is a possible side effect and so I am filling this form out. I would rather be annoyed by random pain in my fingers than have Covid!  The discomfort and stiffness continues randomly. I am able to continue my ADL. I bought a squeeze ball and have not sought out medical help.
Pt arrived at ED 01/10/2022 with generalized weakness, fatigue.  Admitted to hospital due to sxs secondary to UTI, possible COVID Infection and acute or chronic renal failure.  Pt was vaccinated and had received booster, and was living with daughter who recently tested + for COVID. Pt tested + 01/10/22. Pt died 01/14/2022 from Cardiac Arrest and Respiratory Arrest.
This spontaneous report as received from a licensed practical nurse refers to a 84 year old female patient. On 30-APR-2013 the patient was vaccinated with a single dose of PNEUMOVAX23 lot # H017759 Exp 04-JUL-2014, 0.5 ml, intramuscular. On 30-APR-2013, the patient experienced extreme fatigue and not feeling good several hours after administration of PNEUMOVAX23. The patient called the office for medical attention but no treatment was prescribed. No lab test was performed. The nurse stated she contacted the patient "today", 01-MAY-2013, and the symptoms were improving. The relationship between the events and PNEUMOVAX23 was unknown. Additional information has been requested.
1st vaccine 2/10/21; developed chest pain 2/21/21; seen at ED and admitted to Hospital 2/22/21 for chest pain.
really bad headache; left arm where I received the vaccine is sore; fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "really bad headache"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "left arm where I received the vaccine is sore"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigued".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
presented w/ c/o of red-raised 3" diameter area on lt deltoid from Td-MD advised pt not to recvd any more tetanus inject; apply warm compress to site TID & take plain APAP;
Swelling and redness at site of injection. Advised to continue monitoring area, take Benadryl and use cold compress.
Patient received her second vaccine in the Moderna series 7 days before its time. According to database; her first dose was on 12/09/2021 and she received her 2nd dose on 01/09/2022 which makes the period between the two doses 21 days instead of 28 days according to the CDC guideline. In database her 2nd dose shows as invalid because because it was administered too early.
Not as warm but more itching; tiredness; headache; my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad; my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Not as warm but more itching), VACCINATION SITE SWELLING (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad), VACCINATION SITE ERYTHEMA (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad), FATIGUE (tiredness) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date. Concomitant products included LOSARTAN and HCTZ for Blood pressure abnormal, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]) for Bone disorder (NOS), POTASSIUM for Low potassium therapeutic diet, PRAVASTATIN SODIUM, CARVEDILOL, IRON and AMLODIPINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced VACCINATION SITE SWELLING (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad) and VACCINATION SITE ERYTHEMA (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Not as warm but more itching). an unknown date, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). The patient was treated with mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Not as warm but more itching), VACCINATION SITE SWELLING (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad), VACCINATION SITE ERYTHEMA (my pink swollen area around the injection site was back and Again about the size of a 4 x 4 pad), FATIGUE (tiredness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication included centrum silver qd by mouth for age.
Information has been received from a registered nurse referring to an unspecified number of patients. At an unspecified time in the past the patients were vaccinated with unspecified doses of PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018; L042835, expiration date 19-AUG-2018) which were improperly stored at 8.2 degree centigrade. There was no prior excursion. No adverse effects were reported. Additional information has been requested.
The next day (April 10), in addition to the pain, there was itching, irritation, hot and reddish like urticaria. As the days passed, the area spread throughout the middle of the arm, lasting 7 days.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4167592-00. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 2021 at citrate free for crohn's disease, rheumatoid arthritis. Relevant medical history included: "Moderate to severe Adult Crohn's Disease" (unspecified if ongoing); "Moderate to severe Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Nov2021, outcome " recovering", COVID-19 (medically significant) with onset 13Nov2021, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn on 2021. On 13Nov2021, the patient experienced COVID-19. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Jan2021, she received dose of COVID-19 Vaccine manufactured by Pfizer BioNTech.   Humira (Solution for injection in pre-filled pen) (Adalimumab): Causality:  Covid-19, Causality as per reporter (Drug/Vaccine): Not Related (also reported as not provided). Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): Causality: Covid-19, Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of the event drug ineffective with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
RASH; HEADACHE; BACK ACHE; GOOSE BUMPS; INSOMNIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced insomnia. On 10-MAR-2021, the subject experienced goose bumps. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced backache. On 12-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from headache, backache, and insomnia on 11-MAR-2021, and goose bumps on 10-MAR-2021, and had not recovered from rash. This report was non-serious.
I experienced a rash eruption in the right nostril and tip of the nose. I received Famciclovir 500 mg three times a day for ten days as treatment.
About 24 hrs after the vaccine was administered, I felt dizziness which lasted for about 2-3 hours. I went to bed and slept for 3 hrs. The symptoms disappeared and did not reoccur.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no known drug reactions/allergies who in January 2007, was vaccinated with a dose of 0.5 mL, IM, of  Gardasil. Thee was no concomitant medication. In January 2007, the day after receiving her first vaccine, the patient experienced nausea and vomiting. In March 2007, the patient received her second vaccination with a dose, 0.5 mL IM, of Gardasil. Subsequently, the day after the vaccination, the patient experienced nausea and vomiting. The physician noted the vomiting lasted for less than 1w hours both times. Subsequently, the patient recovered from the nausea and vomiting. Additional information has been requested.
flu systems; cold systems; coughing; sneezing; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who experienced flu systems (influenza like illness) and cold systems, coughing and sneezing (nasopharyngitis, cough, sneezing), after patient received INFLUENZA VACCINE.  It was reported that, every time patient had received influenza vaccine in past and had influenza like illness, nasopharyngitis, cough and sneezing.   Past medical treatment, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu systems (influenza like illness) and cold systems (nasopharyngitis) with symptoms of coughing (cough) and sneezing, (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported by the reporter that, that was patient's last one of that year.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for all reported events.   There will be no information available on the batch number for this case.
Fever 103, chills, fever continued to the next day. On 07/10/2015 started feeling pain in joint all over whole body, especially legs and hands, lower back pain. On 07/13/2015 went to emergency room, blood count for white blood cells --370. Pain in joints and muscles, swollen lymph nodes. Pain in joints and muscles continued during next weeks. Blood test from 07/22/2015 SED rate 80.  Inflammation due to a infection.  Referal to X ray. Pain in joints. Blood test shows rheumatoid  factor.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Moderately high blood pressure; "Cholesterol" (unspecified if ongoing), notes: cholesterol being treated. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 02Jan2018; ATORVASTATIN, start date: 03Jan2022, stop date: 12Apr2022; FLAXSEED OIL NATURE MADE, start date: 03Mar2022; MATURE MULTIVITAMINS, start date: 07Jul2015; GLUCOSAMINE & CHONDORITIN, start date: 07Jul2015; COQ10 [UBIDECARENONE], start date: 07Jul2015; B12, start date: 07Jul2015; TURMERIC [CURCUMA LONGA ROOT], start date: 07Jul2015; ASPIRIN 81, start date: 07Jul2015; PROSTATE HEALTH [SERENOA REPENS], start date: 07Jul2015; D3, start date: 07Jul2015. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 Immunization; Covid-19 vaccine (dose 2), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022 at 15:00, outcome "recovered" (01May2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative; (27Apr2022) Positive; (01May2022) Negative; (28Apr2022) positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Comment: Patient's husband took Paxlovid for five days until 16Apr2022. His symptoms gradually disappeared and then on 20Apr2022 he tested negative on the antigen test. He felt fine until 27Apr when symptoms returned. He tested positive that evening on 27Apr antigen test. He was given a PCR test at (name withheld) on 28Apr and the results came out positive. His symptoms this time have been very mild. Today, 01May, he tests negative on the antigen test and feels completely better. We will go into a (name withheld) tomorrow to get another PCR test. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Painful left shoulder following influenza vaccine increasing in intensity over time affect her ability to move arm. Followed up with her provider. Receiving physical therapy.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (contracted COVID-19 after receiving the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (contracted COVID-19 after receiving the first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted COVID-19 after receiving the first dose) 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.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.