chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bloating; Nausea; Mucus in stool; Abdominal issues since the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 29Mar2021 at 15:45 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included nephrotic syndrome (remission), allergy to tree nuts and liquid latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified birth control medication within two weeks of vaccination. On 26Apr2021, the patient experienced abdominal issues since the vaccine, bloating, nausea and mucus in stool. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. On 11Jul2021, the patient underwent SARS-CoV-2 test and the result was negative. The clinical outcome of the events abdominal issues since the vaccine, bloating, nausea and mucus in stool were not resolved at the time of this report.
I started experiencing flu-like symptoms at around 5 PM on 3/14/21.  I was feverish and had chills, muscle aches, and a headache.  I had very strong chills for a few hours and then I noticed that my resting heart rate was around 128 bpm at around 1:30 AM on 3/15/21.  I was running a 100.6 fever at that time.  My fever subsided in the morning and the headache persisted throughout the day, and I was very tired as I did not get much sleep the night before.  I did not work that day (Monday, 3/15).  At the time I was about 7 weeks pregnant.  I noticed some very light spotting later in the day on 3/15, and then I continued spotting on 3/16.  I consulted a midwife at the  facility at 4 PM on 3/16/21 and took a blood test to measure my hCG hormone levels.  The following day, 3/17, I received the results that I had a normal level of hCG hormone and normal hemoglobin levels.  As the day continued, the spotting turned into bleeding, and eventually the bleeding became heavy starting around 4 PM.  I received an ultrasound on 3/18/21 at 8 AM and later spoke with a midwife from facility at 11 AM that day, confirming that there was no viable pregnancy detected via ultrasound.  I had lost quite a bit of blood at that point.  I am, as of 8:35 PM on Friday,  March 19th, still bleeding and experiencing the impact of miscarriage.
Approx 4 hrs after vaccine administration c/o back hurting at work.  States it continued to bother her.  She took her prn meds for back pain around 2200 that night with no relief.  States it continues to hurt in lower back and down into legs
Information has been received from a registered nurse concerning an elementary school aged child who on 24-SEP-1997 was vaccinated with a dose of varicella virus vaccine live. On 01-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Patient is a 75 y.o. female of MD with history of COPD that presented to Hospital with shortness of breath for 1 week.  Patient was positive for COVID-19 and CXR concerning for multifocal pneumonia.  Patient required BiPAP since admission and was DNR DNI.  She gradually continued to decline and became unresponsive to physical stimulation and painful stimulation.  Additionally, patient's abdomen is distended due to air from BiPAP.  Discussed at length with family members we decided patient should be DNRCC and be taken off the BiPAP.  Comfort orders were placed, BiPAP was removed.  Patient expired at 1245 on 11/7/2022.   Acute hypoxic respiratory failure secondary to multifocal pneumonia from Covid-19 Virus Infection Acute COPD exacerbation secondary to pneumonia Concern for Viral Sepsis due to COVID pneumonia, POA Date of onset of symptoms: 1 week Symptoms present on admission: Shortness of breath Date of covid positive test: 11/1/2022 Vaccination status: vaccinated Imaging: Chest x-ray shows multifocal pneumonia Oxygen requirements on admission: BiPAP Current oxygen requirements: BiPAP with supplemental oxygen FiO2 40% Medical therapy: Completed course of remdesivir.  Was being given steroids.  Bacteremia Blood culture turned positive with staph species. This is likely contaminant. Discontinued vancomycin.  Thrombocytopenia Possibly related to viral infection   Nutrition Patient unable to take adequate nutrition being BiPAP dependent
severe GI pain, diagnoses of clots around colon/intestines, hospitalization requiring heparin /blood thinners
Client vaccinated between 0900 & 1130 on Fri., 10/30/2015. Swelling, bruising and puffiness was verbalized that late afternoon. On Mon., 11/2/15 bruising, soreness and no swelling reported.  Client has no other complaints.
vaccinated 3/15/2021 with 2nd dose of Pfizer. Tested (+) PCR 11/30 with admit to local Medical Center 11/30/2021. Patent was not interviewed thus no details about symptoms, course of illness or past medical history was obtained.
Noticed enlarged/swollen lymph node near left side collar bone, same side as injection.  Noticed approximately one week after injection.  Swelling is visible and can also be felt by touch. No other side effects - no pain, no fever, no headaches.
arm was stiff; This is a spontaneous report from a contactable consumer and other healthcare professional. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; ruxolitinib phosphate (JAKAFI), oral from 30Jan2020 (Batch/Lot Number: 1232358; Expiration Date: 28Feb2023) to an unspecified date, at 5 mg, 2x/day for chronic myeloproliferative disease. The patient medical history and concomitant medications were not reported. Ruxolitinib phosphate was used off-label for chronic myeloproliferative disease. Patient's arm was stiff on an unspecified date. Relevant test included on date unknown: routine EKG on tread mill (unknown results), Stress test by cardiologist visit with no problems (normal). The action taken in response to the events for ruxolitinib phosphate was unknown. The outcome of event was unknown.  Information about Lot /Batch number has been requested.
Client developed vertigo on 1/18, after receiving dose 1 of series on 1/13.  Vertigo resolved 1/20. Sought care and consulted with allergist, who instructed her to drink fluids.
Itching head to toe Chills fever  Metal taste Vomiting  Down two weeks after first shot and two weeks after second shot
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Influenza vaccine Quadrivalent. Additional information reported as follows: The patient was 65 years old at the time of reporting. The age at vaccination was not reported. The patient reported that she had a flu shot in the past (unknown date, unknown manufacturer) and also experienced redness (red spot) on her arm at the injection site. This case has been linked with US2018125484 reported for the same patient.
This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. This case might have been reported by the sales representative previously however, no duplicate case was found. This case was linked to case US2017GSK135088, reported by the same reporter.
hives /  little red itchy spots; hives /  little red itchy spots; hives /  little red itchy spots; This case was reported by a consumer and described the occurrence of hives in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included heart disorder.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 5 months after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced hives, pruritus and red rash. Shingrix was discontinued. On an unknown date, the outcome of the hives, pruritus and red rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, pruritus and red rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient did not have lot number.  The patient received shingles shot in September or October of 2020, along with a flu shot.  The patient had hives. They break out with little red itchy spots it was ok during the day but at night he must get up and put gel on the spots to stop the itching. The patient got a shot for itching but they were still itching.  The patient spots moved to his legs and arms, the patient did not plan on getting the second shot. The reporter did not consent to follow-up. This case was linked with US2021025209 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025209:same reporter
Patient received dose 1 on 2/12/2021 and dose 2 on 3/15/2021 from community pharmacy.  Tested positive on 4/7/2021.  Hospitalized for COVID on 4/19/2021.  Discharged on 4/29/2021 to hospice.  Passed away on 5/1/2021.
about 45 min after vaccine, I had a weird feeling in my teeth. About 15 min later, I had a rash and a hive on my chest and tightness in lungs. I took 2 Benadryl and went to ER area in case things got worse, but didn't go in.  Symptoms got better after a few hours, but still feeling a little tightness in upper respiratory area, so took 2 Benadryl about 8 hours later.
NIGHT TERRORS/NIGHTMARES, SORE ARM TO INJECTION SITE Narrative:
3 hours after vaccination, I presented with excruciating pain in the right shoulder radiating down to Rt. elbow and into Rt. ring finger. I couldn't lift my arm at all, pain was so bad I was shaking, my teeth were chattering. I have never had pain at this level before, even broken bones didn't hurt this bad. I took BAYER aspirin every four hours starting around 1800 every four hours did not exceed 4 doses as per directions. Got little sleep, arm in horrible pain, this morning I now have terrible ringing in the ears. Today at 2:00 PM I am still in a good pain but able to move my arm more.
bilateral eye swelling / he had slight puffiness around eyes; This spontaneous report was received from a physician concerning to a 11 year old male patient. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.     On 01-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose and route of administration were not reported; lot # R004689 and expiration date 29-NOV-2019) , diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid ( DPT ) (strength, dose, route of administration, lot number and expiration date were not reported), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (strength, dose, route of administration, lot number and expiration date were not reported). All the vaccines were administered because he was 11 years old.  On 01-JUL-2019, the patient experienced bilateral eye swelling 7 hours after administration of vaccines. The physician reported the patient's father "gave the patient diphenhydramine hydrochloride (BENADRYL) (strength, dose, route of administration route, lot number and expiration date were not reported). The physician reported that the patient came back to the office on 02-JUL-2019 for medical attention, and he had slight puffiness around eyes (eye swelling), normal breathing, normal exam.   The outcome and causality assessment between eye swelling and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Pt called and reported she was experiencing a hard, red, swollen left arm at injection site. She also stated she was experiencing pain and knot on her left clavicle that's about 2 fingers in length. She states the knot was fluid like and moves around when she touches it. She went to the MD and they told her it may just be fluid reaction from the vaccine or potentially a cyst. It is on the soft tissue not the bone. She is due for a virtual follow up visit to assess if its gotten better or worse in 2 weeks. She us no longer experiencing pain on her clavicle
Headache (12+ hours), fever/chills (12+ hours), body/muscle/joint pain (12+ hours), injection site pain (12+ hours), earache (8 hours), lethargy (12+ hours)
Moderna 7/3/2022 right deltoid, abdominal pain, sleep at 7 pm, 3 AM 103F and pounding headache, couldn't breathe due to shortness of breath unknown if anxiety. Back pain, sore. Past history. Fever until 2 PM. Local Pharmacy. Note will be placed in MyChart.  Moderna Covid-19 , mRNA, LNP-S, PF Vaccine lot number 014B22A.
I previously tested positive for Influenza A and subsequently contracted the COVID-19 virus. 06JAN2023 Negative test I came off all the cold meds and was still having vertigo, sinuses, and a headache. 10JAN2023 doctors office visit I was diagnosed with a viral sinus infection now bacterial and Eustachian tube disfunction. Ten days of antibiotics ending 20JAN2023 09FEB2023 I was still having symptoms before and after this visit I had a long list of symptoms as previously mentioned, headache, stomach upset body aches, extreme fatigue, tender abdomen, bad gag reflex, mental fog,  dizziness, loosing clumps of hair all above normal or strong symptoms. It was March 2023 before I was feeling anywhere close normal again.
MILD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 118 pounds, and height was not reported. The patient's concurrent conditions included hashimoto's hypothyroidism autoimmune disease, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 98.4 to 99.9 Fahrenheit, 97.6 Fahrenheit, 100.0 Ferhenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 94.5 Fahrenheit.  On 28-APR-2021, the subject experienced mild headache. On 28-APR-2021, the subject experienced fever. On 29-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit. On 12-MAY-2021, treatment medications included: amoxicillin trihydrate/clavulanate potassium.  On 17-MAY-2021, treatment medications included: doxycycline, and methylprednisolone. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from mild headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Severe difficulty breathing, seemed unable to absorb oxygen plus cough, chills, & fever. Albuterol inhaler helped breathing + acetaminophen & diphenhydramine for other symptoms. Very scary & would have gone to ER (1 hour away) if inhaler had failed. Fully resolved the next AM.
Generalized vaccinia. Multiple vesicular (single) eruption on face, trunk, extremities, inside of mouth, symptomatic treatment.
Narrative:  Patient tested positive for Covid-19 and was hospitalized despite full vaccination. Received Pfizer 1 and 2, and booster received 11/16/2021, hospitalized 11/26/2021
Breakthrough case admission after 4 vaccines Moderna 3/10/21 Lot# 044A21A;  Moderna 4/7/21 Lot#025B21A;  12/21/21 Moderna Lot# 012H21B;  Moderna 8/19/22 Lot# 082B22A
Caller states the first shot reactivated her hot flashes, after being gone the hot flashes came back with a vengeance; vomiting; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hot flashes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Caller states the first shot reactivated her hot flashes, after being gone the hot flashes came back with a vengeance"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Follow-up attempts made. Follow-up attempts completed. No further information is expected.
Significant arm swelling noted 14 hours after Dtap administration--erythematous, mildly pruritic, warm, no fever or pain. No history of previous reaction. IM epi, benadryl and ancef did not help.
blood in stool; diarrhea/ flair ups diarrhea; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881-00 (AbbVie).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for non-infectious intermediate posterior and panuveitis, moderate to severe chronic plaque psoriasis, moderate to severe ulcerative colitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 ), administration date: 01Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Ulcerative colitis aggravated", "Blood in stool", "Flare ups increased to once a week", "got sick", "nauseous", "diarrhea", "sore arm on covid vaccine shot", "upset stomach", "headache", "Fever", "Flair ups diarrhea"; Bnt162b2 (dose 2 ), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Nausea ", "Headache", "Diarrhea". The following information was reported: HAEMATOCHEZIA (medically significant), outcome "not recovered", described as "blood in stool"; DIARRHOEA (medically significant) with onset 2021, outcome "recovered" (2021), described as "diarrhea/ flair ups diarrhea"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache". Booster and second vaccinations caused nausea, headache and diarrhea resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of flare ups increased to once a week, sore arm on covid vaccine shot, got sick with diarrhea and nauseous onset in 2021, flair ups diarrhea and blood in stool unknown onset, got sick with diarrhea and nauseous onset in 2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in March 2021, booster and second vaccinations caused nausea, headache and diarrhea onset in 2021, and flair ups diarrhea and blood in stool unknown onset was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels hot; Joints and body ache; felt like she was hit by a truck, and every bone in her body hurt; Dose: 3rd, Date: 07Oct2021; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was FF8841, Expiration Date: Unknown) via intramuscular, administered in Arm Left on 07Oct2021 (age at vaccination 65 years) for COVID-19 immunisation. Medical history included headache, body aches, joint pain. Concomitant medication(s) included paracetamol (TYLENOL A); ibuprofen (IBUPROFEN) taken for headache, pain, arthralgia, levothyroxine sodium (LEVOTHYROXINE SODIUM), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at 50 mg for thyroid disorder. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was EN6208, Expiration Date: Jun2021) intramuscular, administered in Arm Left on 03Mar2021 as dose 1, single for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was ER8737, Expiration Date: Jul2021) via intramuscular, administered in Arm Left on 03Apr2021 as dose 2, single for COVID-19 immunisation. No prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date the patient feels like crap, specifically has aches everywhere, does not feel good, feels like the flu, feels hot, joints and body ache everywhere. Patient stated that she felt like she was hit by a truck, and every bone in her body hurt then she was hot and had a glass of water and took some Ibuprofen which seemed to be helping also added she read the information that if you are immunocompromised, you might have issues and patient had always thought that thyroid deficiency was an immune disorder and maybe that was "part of feeling like crap. Patient stated that she is on Thyroid medication, Levothyroxine 50mg because she is immunocompromised and wanted to know if there is an interaction between Levothyroxine and the Pfizer COVID-19 vaccine. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected
Pt vaccinated with DTP developed redness & swelling of arm 1-2 days after immunization.