chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart Racing; out of breath; shaky; dizzy; exhausted always; just don't feel good; voice keeps going out; A spontaneous report was received from a type concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart racing(palpation), shaky(tremors), dizzy(dizziness), exhausted always(fatigue), out of breath (dyspnea), just don't feel good (malaise), voice keeps going out (aphonia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out.  Treatment details included Beta blocker.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue; Joint aches; Headaches; Fever that advanced in severity; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 (Lot Number: EL3248) (at the age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccine within four weeks of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 AM (Lot Number: EL0142) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. The patient did not have covid-19 prior vaccination. The patient fatigue, joint aches, headaches, fever that advanced in severity on 27Jan2021 09:00 AM. The patient did not receive any treatment for the events. The patient was tested for covid-19 post vaccination on 02Feb2021 by nasal swab and the result was negative. The outcome of the events was recovered in 2021.  No follow up attempts are possible. No further information is expected.
My heart was racing really fast, I felt dizzy and had a headache. For ten days I was feeling weak, tired, dizzy, pain in my legs. I still have the muscle pains and is currently getting therapy.
Patient states 3 days post injection the injection site became swollen and red. Patient states that she has taken BENADRYL which did help with her symptoms. Today is day 6 post injection and site is still red no swelling noted.
Swelling in face, legs, arms, belly, weakness, loss of urine. Symptoms came on slowly, swelling in eyelids week after vaccine. Steroid treatment.
My period was 10 days late. It has never been late before and I was not pregnant. I was given a pregnancy test by a doctor.
Rheumatoid arthritis flare up; Elevated liver enzymes; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4396536-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), since 10Feb2022 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (Dose 1, Daily dose: First dose (1 in 1 once), route of admin: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose 2, Daily dose: Second dose (1 in 1 once), route of admin: Intramuscular), for Covid-19 immunization. The following information was reported: HEPATIC ENZYME INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Elevated liver enzymes"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovering", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: Hepatic enzyme: (2022) Elevated. The action taken for adalimumab was temporarily withdrawn. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial. Reported that, Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's assessment of the causal relationship of "elevated liver enzymes" with the suspect product(s) 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 reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "elevated liver enzymes" with the suspect product adalimumab (HUMIRA) was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Arthritis pain in hands, knees and toes with fatigue. 2nd dose on 11/8/99 and 3rd dose on 9/28/00. Follow up: I am still feeling alot of pain in my joints.
Fever of 104 degrees started afternoon of 6/16/18, gave her ibuprofen and temperature stayed 102 degrees until 6/18/18. Her temperature was normal the night of 6/19/18. She couldn't walk on her right leg on 6/15/18. Used a cool cloth on her thigh. Started to walk on it 6/16/18. Started to vomit 6/16/18 - 6/18/18. Not exactly sure which DTaP was given.
This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and birth control implanted in arm, and other pre-existing medical conditions included the patient was not pregnant at the time of this reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included atenolol for hypertension. On 11-APR-2021, the subject experienced lightheaded. On 11-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced cold at nights. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, lightheaded, cold at nights, nausea, sore arm, and feeling hot. This report was non-serious.
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 61-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
patient recieved 1.3ml pfizer vaccine instead of the 0.3ml  thus far patient has not had any adverse reaction to the increased dose given
Sore arm; Morning stiffness; Lower back pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    The patient's past medical history included Early morning stiffness in 2020, Low back pain in 2020, Injection site bruising in 2020 and Bruising in 2020. Concurrent medical conditions included Ankylosing spondylitis.   On 22-Jul-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported included immunosuppressant and non steroidal anti-inflammatory drugs.
Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Felt sick couldn't eat lost weight slept most of day for 7 days. Went back to family doctor got a counter reaction vaccine to get it out of my system 9/7/11 still feel sick something not right. 9th day still sick. I borrowed 50.00 for gas went to ER and to family doc.
This spontaneous report was received from a Registered Nurse via company representative regarding a 15 year old female patient. The patient's pertinent medical history, historical drugs, drug allergies/reactions, concurrent conditions and concomitant medications were unknown. On an unknown date, during the same office visit in 2018 the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, lot # and expiry date were not provided) intramuscularly for prophylaxis and other suspect therapy included DEPO-PROVERA (dose, frequency, lot # and expiry date were not provided). On an unknown date the patient experienced total hair loss. It was reported that patient was in office when event occurred. No treatment was given for the adverse event. The outcome of the event alopecia was unknown. Causality assessment was not provided. There was no PQC involved in the case.
Hives & itching forearms and abdomen 1:00 PM transported to ER, treated with oral BENADRYL. Released to father 5:30 PM.
I had a sore arm for two days after I received my shot. And just recently on 04/12 I started to experience a pain under my skin in my underarm area, I assume a swollen lymph node.
C/O hands and forearm started to itch and burn 1 hr after vaccine, no redness, no temp, no hives, C/O hand swelling.
The 2nd Shingrix shot gave me Guillan-Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: The 2nd Shingrix shot gave me Guillan-Barre Syndrome) (serious criteria GSK medically significant).The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix.   The company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The Shingrix shot gave him/her Guillan barre syndrome. No he/she could not take any kind of vaccines, not even the flu nor pneumonia vaccine. The reporter stated that think hard about what was the best for you before you commit.
Less than 24 hr after first injection, awoke the next morning unable to walk with severe pain in all joints (knees, elbows, ankles, wrists, hips).  Severe pain in thighs and calves. Severe headaches, dizziness, disequilibrium. Evaluated by primary care ~ 2 weeks after injection. Had blood work and CT head scan. Symptoms lasted  until a few days before second shot.  Taking acetaminophen 650mg QID.  The morning following the second injection, he experienced a repeat of all the above symptoms with even greater intensity. Unable to walk again and with excruciating bilateral leg pain. Was re-evaluated by primary care again ~ 2 weeks after second injection. Referred to radiology for bilateral lower extremity US and found to have extensive DVTs in both legs  ("3 in each leg" with greater thrombus burden in R leg).  Started on apixaban 5 mg BID.  Clots have since resolved on repeat venous doppler US 3 months later. Has residual bilateral LE pain and difficulty walking, as well as severe headaches up to 3 x/week.
lightheadedness; drowsiness; This is a spontaneous report from a non-contactable healthcare professional (patient). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9231, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced lightheadedness and drowsiness on Jan2021 15:00. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Right after the injection, patient's face became pale, started to have nausea, dizziness, tried to vomit about 10 minutes, did not threw out anything. Then patient urged to have bowel movement, almost incontinent, hurried to went to bathroom with her mother and nurse's assistance. Patient had a big bowl movement, regular stool, no diarrhea. Then patient back to the clinic room, stated felt better, and observed 5 more minutes, patient face pale not sever, patient was back. The total time was about 25 minutes.
A couple days after the vaccine I developed a tingling and paralysis in my left hand. In my thumb to the wrist area. I have pain and pins and needles sensation also in the forearm as well. The arm at the injection site still pains off and on from time to time and I have begun to develop numbness and tingling in my tongue and lip. It has also caused a Herpes flare up as well. To date my hand feels like it's trying to a cramp in my thumb area. I have an appointment to see a Neurologist tomorrow for further testing.
Information has been received from a nurse practitioner concerning a female between 16-20 years of age, who on an unspecified date was vaccinated with GARDASIL vaccine. The nurse practitioner reported that within the last 4-6 months the patient had experienced fainting and dizziness after receiving GARDASIL vaccine. It is unclear if the fainting occurred after all three doses or not. At the time of the report the patient had recovered; she was fine before leaving the office after receiving the vaccine. The patient did not seek medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
Had the shot, had the worst case of Shingles/Suspected vaccination failure; Had the worst case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, unfortunately the patient still got worst case of shingles. The patient stated that, not everyone was immune. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
MMR, Hib, Flu vaccine received 9/26/14. Admitted on 10/4/14 after having 2 febrile seizures. Had a 3rd brief seizure after admission. Discharged home on 10/6/14.
Patient had dementia, and presented for a Moderna COVID vaccine on 2/8/21 and 2/16/21, so she received her two doses only 8 days apart. Patient had no unusual outcome, but was told not to get another dose in February/March.
Sore arm, full body aches and extreme fatigue for 24 hours starting 2/6.
mom doesn't remember specifics but reports pt was crying & irritable for remaineder of day w/fever as high as 105 plus vomiting & diarrhea;pt given APAP;did not consult MD;was fine next day
This is a spontaneous report received from a contactable reporter(s) (Physician). An adult patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety disorder" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; SPRINTEC. Past drug history included: Codeine, reaction(s): "Drug Allergy", notes: known Allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient codeine known allergies and other medical history: included anxiety disorder, depression. Other medication in 2weeks product was Lexapro & sprintec. Patient had COVID 19 Treatment with brand Paxlovid. Treatment start date was 23Jul2022  & stop date was 27Jul2022 via oral indication treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states day of vaccination she had severe swelling (like a knot) form at the site of injection shortly after receiving the flublok in her left arm.  Over the course of the next few days she had severe swelling (the size of a lemon) on her arm with severe redness and it was very hot to the touch. She denied running a fever, but did state she was very tired overall.
After my second shot I have had swollen muscles and joints. Day two after my shot I had a lump start on my left arm above my wrist on right side and was unable to move or work on my job that I was designated to do that day. My left middle finger has been swelling up and making my job more difficult to do.  Also I was feeling confusion  for a week or two on and off.
pt recv vax; had sz; to ER & had fever of 106; dx of febrile sz;