chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed extreme pain in left sacral area radiating down left leg to the arch of foot. I was diagnosed with Piriformis Syndrome by doctor. The diagnosis is an inflammatory process, it's an inflammation of the Piriformis muscle. The pain and symptoms are ongoing. I am going to therapy and taking Tylenol for pain. I also had basic bloodwork done but the results came back fine.
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
At 11:20am the nurse, was called into vaccination room for near syncope. Patient was lying down with the assitance of two vaccinators. She was alert and oriented x3. She reported feeling lightheaded and was moved to a chair, then a wheelchair. She was transferred to the observation room on the second floor of the clinic. VS were obtained and the care was handed over to another nurse. Patient was given gatorade, applesauce and resting comfortably for observation. At 11:30am denies injury or loss of consiousness. Stated she had nothing to eat or drink prior to vaccine appointment. She denies history of syncope.
Woke with vertigo- unable to stand, unable to drive.  Symptoms have somewhat improved, but not entirely gone.
Too tired to sign up for v-safe first & second days after vaccination.  I am concerned that v-safe will under report side effects like the chills, aches & fatigue that occurred to me the first couple days because of recipients feeling too sick to report
Stroke like symptoms; Confusion; Fog; Blurred speech; Respiratory rate fell; Blood pressure elevated dangerously; Turned red for 15 minutes; Fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke like symptoms) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke like symptoms) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously), ERYTHEMA (Turned red for 15 minutes), FATIGUE (Fatigue) and HEADACHE (headache). On 24-Feb-2021, SPEECH DISORDER (Blurred speech), RESPIRATORY RATE DECREASED (Respiratory rate fell), BLOOD PRESSURE INCREASED (Blood pressure elevated dangerously) and ERYTHEMA (Turned red for 15 minutes) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke like symptoms) outcome was unknown and CONFUSIONAL STATE (Confusion), FEELING ABNORMAL (Fog), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Treatment: ibuprofen (Advil) 15 minutes after the first shot she got asthma attack. Soon after second shot she turned red for 15 minutes, blood pressure elevated dangerously, had blurred speech, confusion and respiratory rate fell which created stroke like symptoms. All the symptoms resolved in a day. She was transported to the emergency room. Patient was still having fatigue, fog, head ache and confusion 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. Further information has been requested   This case was linked to MODERNATX, INC.-MOD-2021-081243 (E2B Linked Report).; Sender'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. Further information has been requested MODERNATX, INC.-MOD-2021-081243:
I am typing with an update of a possible issue with my Janssen Covid vaccine. I received it on March 31, 2021. I did not have any immediate ill effects noted other than a out of severe fatigue April 3/4, which may or may not have been vaccine related. I had a temperature 2 degrees above my normal for less than 24 hours on April 8 (99.7F temporal). I am currently having hotflashes which are not my baseline. I am aware that I am the age when I could be showing signs of menopause. I am also aware that the Mirena does not stop the symptoms of menopause. That said, I am aware that there have been questions related to female fertility and hormonal changes with the vaccines. I feel my new symptom of hotflashes should be reported for that reason. The hotflashes started on April 14, and having been growing in times per day I experience them (I had six yesterday, April 21). I do not believe I am having any life threatening ill effects, and do not seek an appointment at this time, but wanted to file a report. Thank you.
Increase pain/erythema/swelling at injection site (right deltoid) starting next day and continuing to spread 3 days later: approximate 8cm x 8cm, warm. Site outline. Pt to return in 3 days for follow up. No anaphylactic symptoms. Pt did have new sore throat 10-4-19 along with rhinitis but sx started prior to vaccine. Appears to be local site reaction.
SORE ARM; CHILLS; This spontaneous report received from a consumer concerned a 30 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, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and was recovering from sore arm. This report was non-serious.
No additional AE details; administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 30-DEC-2020 the patient was vaccinated with a temperature excursion of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, lot # T02003 was an invalid lot number, expiration date 08-MAY-2022; route was not reported) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature below 2 degree Celsius (°C) (1.3C) for 0 hours 24 minutes and time frame below 2°C (1.3C) for 0 hours 24 minutes. There had previous temperature excursion (below 2°C (1.6C) for 24 minutes). The digital data logger was involved. No additional AE details were reported.
Broke out with a rash starting at her shoulder down to her elbow; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Feb2021, after the vaccination, the patient broke out with a rash starting at her shoulder down to her elbow. The patient wanted to know if its normal or not. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  County Coroner called to say that patient passed on 3/20/21 from suspected stroke at home while asleep. Telephone if there are any questions. Due to patient receiving COVID-19 Vaccine dose #1 on 2/12/2021 and dose #2 on 3/20/2021 reporting as possible vaccine reaction.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (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: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 available information in the case, the causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
extreme stomach cramps; diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (extreme stomach cramps), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (extreme stomach cramps), DIARRHOEA (diarrhea) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (extreme stomach cramps), DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications also included blood pressure pills and cholesterol pills. Treatment information included water and Gatorade.
2nd day p/vax exp sore throat, cough, fatigue, malaise, fever, episodes of diaphoresis during noc, nasal congestion, green phlegm;fatigue & malaise still persisted for several weeks;
developed  fairly diffuse rash with subsequent onset of headaches.  No fevers.  neg MRI head  Saw ID specialist who felt likely mild post vaccine menningitis 2/18/09-records received-8/1/07 rash resolved after reaction to vaccine. Pusble, erythematous rash.  8/27/07-C/O dizziness nausea times 10 days. Nausea with head rotation, eyelids seem droopy, mild eyeball pressure symptoms severe after work. Works in a lab with macaque monkeys including primate herpes B virus. Assessment vertigo suspected secondary to varicella vaccine.  9/18/07-neurology consult for C/O headaches. Two weeks after receiving vaccine developed rash and some pustules, vaccine-associated chicken pox. C/O head feels swollen. Enlarged lymph node left retroauricular aread, cerumen impaction. Impression vaccine associated varicella. 10/3/07-follow-up neurology visit, recurrent headaches. Potential exposure at work from spash in left eye when dealing with monkeys started on valacyclovir. Red bumps on knees and shoulders.
Later she started getting hot flashes, fever and body aches and headaches. Still having symptoms.
Like a truck hit me a day later BP up to 86/85; Like a truck hit me a day later BP up to 86/85; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El 3248), via an unspecified route of administration at the right arm on 13Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered in a hospital. The patient's medical history included breast cancer, thyroid low, and known allergies to bee sting, shellfish, codeine and sulfur. The patient's concomitant medication included thyroid (as reported) that the patient received in two weeks. The patient had no other vaccine in four weeks. The patient had no COVID prior to the vaccination and has not tested for COVID post vaccination. The patient is not pregnant. The patient experienced "like a truck hit me a day later bp up to 86/85" on 15Jan2021 at 09:15 AM. Treatment received for the events was reported as "Emergency" (pending clarification). The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Pt developed rash on (R) hand and arm and back of neck day prior to admission. Day of admission fell from monkey bars, developed large bruises on thigh, gait ok. Later had problems with walking-painful. Came to E.D with severe pain in (L) thigh. Had vaccines (MMRV, IVP, DTaP) 2 weeks prior to this.  06/18/2007 MR received for o/n admission 5/7/207 for c/o large bruises and thigh pain after a playground fall.  The day prior, parent had noticed petechial rash on the right arm and hand as well as back of neck. PE (+) for petechial rash of the hand, arm, and neck as well as 8 x 10 cm bruise on the right thigh-red center with blue periphery.  Painful to touch. Txd with IV IG. Assessment:  Idiopathic Thrombocytopenic Purpura.
injection site reaction after receiving an unspecified flu shot; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; she experienced an inject site reaction within four hours of receiving PNEUMOVAX23; This spontaneous report was received from an 83-year-old female patient reporting on herself. Her concurrent condition included allergy to mango oil. Concomitant therapies included levothyroxine sodium, metoprolol 50 mg, aspirin, unspecified hair skin and nails medications and lorazepam 0.5 mg. No information regarding the patient's medical history was provided. On 31-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one vaccination, intramuscularly (exact dose, lot # and expiration date were not reported) for prevention of pneumonia. Other suspect therapies included unspecified influenza virus vaccine inactivated (reported as flu shot) received on an unknown date.  On 31-DEC-2019, within 4 hours of receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced injection site reaction. The patient mentioned the reaction appeared to be a rash that appeared to be 4 inch long, redness radiated into her soft tissue, felt inflamed and itched. As a treatment, the patient used ice pack, prednisone and diphenhydramine hydrochloride (BENADRYL). No lab diagnostics or studies were performed. The patient did not seek for medical attention. On an unknown date, she experienced an injection site reaction after receiving an unspecified flu shot. The outcome of injection site reaction after receiving an unspecified flu shot was unknown. The outcome of the rest of the events was reported as recovered on 04-JAN-2020.  No causality assessment was provided by the reporter.
arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm; arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and SIMVASTATIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
Reports rectal bleeding  around the middle of June Had Cologuard test and then colonoscopy in July/August with subsequent diagnosis of Crohn's disease Reports developed shingles 9/19/21
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose 4 (booster), single (Lot number: GJ6796) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8729), as dose 2, single (Lot number: EW0172) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history included: "cold induced asthma" (unspecified if ongoing); "upper respiratory it moves to her chest/upper respiratory thing", start date: Jun2019 (unspecified if ongoing). Concomitant medication(s) included: DULERA taken for asthma, respiratory disorder; LEVALBUTEROL [LEVOSALBUTAMOL] taken for respiratory disorder, start date: Jun2019; PRILOSEC [OMEPRAZOLE] (ongoing); PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Lab test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300072419 same patient, different vaccine dose/events.;
left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 05Feb2021 13:30 (at 70 years old) at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included bulging discs and known allergies to Penicillin, Dilaudid, and Sulphur.  Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (D), biotin, calcium, magnesium, and curcuma longa (TURMERIC); all from an unknown date for unspecified indications. The patient received these medications within 2 weeks of vaccination. At 70 years old, the patient received the first dose of BNT162B2 (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 15Jan2021 11:30 at a single dose for COVID-19 immunisation and experienced pain in left knee and down to ankle and knee arthritic. The patient was not pregnant at the time of vaccination; was not diagnosed with COVID prior to vaccination; did not receive any other vaccines within 4 weeks prior to BNT162B2; and has not been tested for COVID post vaccination. It was reported that after the administration of the second dose, the patient experienced left arm pain on an unspecified date. Patient realized that the pain was akin to what she felt in knee (after the first dose) but not as bad. No treatment was received in response to the event. Outcome of the event was recovered with sequelae. The event was reported as disabling.  Information on batch number has been requested.
I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)
systemic pruritus; rash on neck, arms, thighs; This is a spontaneous report from a non-contactable pharmacist. A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via intramuscularly on 30Mar2021 (age at vaccination: 51years-old) as dose 1, single for COVID-19 immunization. Medical history included asthma, hypertension, pre-diabetes, peptic ulcer disease from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient had known allergies with Aspirin, latex, strawberry. Patient was not pregnant at the time of vaccination. It was unknown if patient received any other vaccines within 4 weeks prior to covid-19 vaccine. It was unknown if the patient was tested positive for covid 19 prior to vaccination and tested post vaccination. On 30Mar2021, the patient experienced systemic pruritus and rash on neck, arms, thighs. Therapeutic measures were taken as a result of events. Diphenhydramine was not effective in reducing symptoms. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported swollen (from top of the shoulder to the wrist), red, and hot on the left arm. Patient reported that it was painful, and he couln't sleep on it. Treatment consisted of medrol pack and a z-pack and the time course was for six days.
Patients' wife states that at 2:00 am on 3/5/2021 Patient woke up not able to move his upper/lower extremities and couldn't talk.  So he started to shake/rock back and forth until he could move around and talk, which took him about 2-3 hours.  He then called his wife at 6 am. She told him to push his Alert to get help, but patient declined and proceeded to his car and he drove himself to the ED.  His wife felt they arrived about the same time because they were in separate cars around 7:00 am.  He was seen at ED, where he was evaluated/treated for stoke symptoms.  Patient's CT of head was normal, and all other testing was normal as reported by patient?s wife.  Patient was feeling normal and like his normal self once he arrived at the ED and after his d/c.  He was advised to F/U with his PCP at Medical Group.  He was seen either the 3/8 or 3/9 by Dr., who felt that he possibly had a reaction to the COVID Moderna vaccine as to the reason wife called to report the reaction.
Pt was dizzy and nauseous on 9-19 after receiving shot on 9-19. On 9-20 Pt woke with a swollen face and body with a rash on her arms and legs. Pt was given an IV with steroids, BENADRYL and PEPCID to  counteract the reaction. PREDNISONE was prescribed for home use.