chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt a little "weird" right after vaccine, after an hour she felt like she was suffocating.  Went to ED for SOB, felt like throat was closing.  Given prednisone, benadryl.  Questionable if she was given epinephrine in ED.  Will follow up with allergist before second dose.  HX of allergy to cats and grass.  No hx of anaphylaxis.
Hives at various locations around my body, swollen hands, knees, lips - ongoing problem
eyes felt puffy; itchy and flushed again/felt itchy all over; heart rate quickened; felt sick to stomach; coughing; itchy and flushed again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20May2021 03:30 (Lot number: EW0177) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mastocytosis" (unspecified if ongoing); "meningioma" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; ALLEGRA; PEPCID [FAMOTIDINE]; SINGULAIR; ASPIRIN [ACETYLSALICYLIC ACID]; ETORICOXIB. Vaccination history included: Bnt162b2 (dose 1), administration date: 29Apr2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION, reaction(s): "felt itchy", "flushed". No other vaccine in four weeks. The following information was reported: PERIORBITAL SWELLING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "eyes felt puffy"; PRURITUS (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again/felt itchy all over"; HEART RATE INCREASED (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "heart rate quickened"; NAUSEA (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "felt sick to stomach"; COUGH (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "coughing"; FLUSHING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again". The events "eyes felt puffy", "itchy and flushed again/felt itchy all over", "heart rate quickened", "felt sick to stomach", "coughing" and "itchy and flushed again" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of periorbital swelling, pruritus, heart rate increased, nausea, cough, flushing included Epinephrine, pepcid.   Follow-up attempts are completed. No further information is expected.
blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness; feeling unwell; nausea; numb arm; heat flash; chills; This is a spontaneous report from a contactable consumer.   An 18-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:30 (Batch/Lot number was not reported) (at the age of 18 years-old) as a single dose, for  COVID-19 immunisation. There was no medical history. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  No other vaccinations given within last 4 weeks. On 30Apr2021 at 1445, the patient experienced Shallow breathing, rapid heart rate, difficulty breathing or talking, dizziness and blackout, weakness, feeling unwell, nausea, numb arm, heat flash and chills. The outcome of the events was recovering. The patient did not have COVID prior to vaccination and was not tested post vaccination.
Dizziness, injection site itchy and loss of appetite. Treated with Keflex 500mg and Prednisone 10mg.
Pt recvd vax & has not had menstrual period; A urine HCG on 6NOV92 was neg; No further details were provided;
Itching all over with small bumps on face and hands.  Hands became a little puffy. Continued until about midnight of same day.  Patient had no residual s/s the next day.
Initial case received from a literature article on 11 April 2014. This case is linked to the case nos.2014SA052439, 2014SA052440, 2014SA052441 (same reporter). Out of the 23 patients who received Influenza vaccine on an unspecified date, 10 patients were tested positive for influenza A (subtype pending). The patient's demographic details, medical history and concomitant medications were not reported. The batch number, route and site of administration of Influenza vaccine were not reported. Laboratory data and corrective treatment details were not reported. At the time of this report, the outcome was unknown. List of documents held by sender were none.
received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test; received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (ongoing), notes: he is a diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); CRESTOR, start date: 18Jun2022 (ongoing); ALTACE (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing); ZINC [ZINC SULFATE] (ongoing); PEPCID [FAMOTIDINE] (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received 4 doses of the Pfizer COVID-19 vaccine but unfortunately, he has tested positive for COVID via a PCR test. The caller states that he is a high risk COVID patient as he is a diabetic.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Information has been received from a health professional referring to unspecified patients. On unknown dates the patient were vaccinated with improperly stored GARDASIL (lot # K007828, expiration date, route and dose unspecified). No adverse event. This is one of several reports received from the same source. Additional information has been requested.
Fever and sore arm x24 hours. 4 days later she had redness around the injection site that was itchy.
On 4/16/21, I fainted and fell/hit my face on the fall requiring stitches.  I had received first dose of Pfizer on 4/1/21
ITCHINESS ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; HIVES ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bee sting allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced itchiness on lower extremities, upper extremities and ears. On 22-MAR-2021, the subject experienced hives on lower extremities, upper extremities and ears. Treatment medications (dates unspecified) included: famotidine, diphenhydramine hydrochloride, and cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness on lower extremities, upper extremities and ears, and hives on lower extremities, upper extremities and ears. This report was non-serious.
Area of injection warm. Welt on injection site per patient about 6 inch per call.
didn't feel well; lethargy; felt nauseous; headache; constantly tired, no energy; pain in the arm at the injection site; every joint in her body just hurt, she couldn't bend her fingers, her finger joints hurt; no energy; fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). This 57-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 26Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown , prediabetic from an unknown date and unknown if ongoing (Additional Information for Other Conditions: She says she has had this condition for 10 years. The patient's concomitant medications were not reported.  The patient experienced fever on Apr2021, felt nauseous on 01May2021, headache on 01May2021, constantly tired, no energy on Apr2021, pain in the arm at the injection site on Apr2021, every joint in her body just hurt, she couldn't bend her fingers, her finger joints hurt on Apr2021, didn't feel well on an unspecified date, lethargy on an unspecified date.  She says the not feeling well started 2 hours within the injection. She says the injection was between 3:00 and 4:00 pm and by 5:00 pm she was on the couch. She says every joint in her body just hurt, she couldn't bend her fingers, her finger joints hurt. She says she woke at 4:30 or 5:00 am Monday because of the nausea, the nausea just came over her. She says Friday she didn't do anything, she was just constantly tired, lethargic, no energy. She says on Sunday there was no lethargy, she was able to push through it, she felt good on Sunday. She says everything improved Sunday and came back Monday. She says she was nauseous early Saturday morning, she thought the headache was why she had the nausea. She says on Sunday she felt good; everything went away except she was a little bit tired but she was able to push through the tiredness Sunday. Then the fever, headache, and nausea came right back early Monday morning. The patient was not recovered from fever, felt nauseous, constantly tired, no energy, outcome of headache, every joint in her body just hurt, she couldn't bend her fingers, her finger joints hurt was recovering, recovered from pain in the arm at the injection site on 30Apr2021, outcome of didn't feel well, lethargy was unknown.  No follow-up attempts are needed. No further information is expected.
Pregnancy report received from a Health Care Professional on 24 JUNE 2012. A female patient (date of birth not reported) whose medical history and concomitant medications were not reported had received a dose of ADACEL (lot number, route and site of administration was not reported) on an unspecified date. The patient presented 9 cm swelling and itching at injection site over a week after receiving vaccines. The patient was pregnant at the time of vaccinate. Corrective treatment and laboratory investigations were not reported. The patient pregnancy history, LMP date and expected date of end of pregnancy was not reported. The outcome was not reported. Documents held by sender: none
One week after injection my arm around the injection site started to itch. Then it had a ring on my arm a few inches in diameter. The area felt hard and the site hurt. Still bothering me over a week later but getting better.
Breakthrough case admission after 4 vaccines  Pfizer 2/8/21 Lot# EL9265;  Pfizer 3/1/21 Lot# EN6202;  Pfizer 10/28/21 Lot# FF2593;  Moderna 8/25/22 Lot# 055A22A
Abdominal pain starting midafternoon day of vaccine.  Followed by nausea that become extreme in to the evening, overnight and the into the all of next day & evening.  Fatigue starting in evening of vaccination  and continued for 36 hrs.  Pulsating headache starting day following  vaccine and continued for 3 days following vaccine. 48 hrs after vaccine a silent migraine occurred influencing my vision lasted only 2 hrs.  Day 4 after vaccine all symptoms had disappeared.
Information has been received from a Registered Nurse (R.N.) concerning an 18 year old female who on 02-APR-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 0558X).  Concomitant therapy included MENACTRA.  On 02-APR-2009 the patient experienced dizzy and an elevated heart rate (Tachycardia) beginning several hours after her initial dose of vaccine.  The patient sought unspecified medical attention.  The symptoms persisted for several hours and resolved without treatment overnight.  The patient was recovered on 03-APR-2009.  Additional information has been requested.
All body skin rash. Presented between breasts and diagnosed as fungal/jock itch but spread over whole body.
pt recv vax 13OCT97 & that same day pt exp itching, myalgia & nausea;
Had 1st Moderna shot on 4/22/21 and the 2nd shot on 5/20/21 (I recorded for #4) and he ends up in hospital with a blood clot, went to ER on 6/6/21 and was diagnosed with a blood clot that is why I reported since it was so close to date of Vaccine on 5/20/21.  He got sick on 6/3/21 chilling, getting hot, temperature, coughing-went to Urgent care did x-ray-said had pneumonia-6/6/21 had hurting in side, chest, breathing problems-took ER found a blood clot in his chest, no pneumonia. (not sure of time of vaccine)
Varicella Information has been received from a registered nurse (RN) concerning a 6 1/2 year old male student with asthma and a history of pneumonia and ear infections and no allergies who on 14-APR-2004 (also reported as 14-APR-2004) was vaccinated subcutaneously in the left thigh with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck) (lot# 630683/0439J). No illness at the time of vaccination. Concomitant therapy included  montelukast sodium (MSD) daily and albuterol inhaler PRN. On 23-OCT-2005 the patient developed a rash. he was seen in the physician's office on 25-OCT-2005 with patchy crusted rash on the left side of his neck, cheeks, upper arms, trunk and was thought to have impetigo. The physician ordered acyclovir and cetirizine hydrochloride (Zyrtec) for treatment. The patient continued to have itching and the rash was spreading to the other side of his body and was seen by the physician again on 27-OCT-2005. He was diagnosed with questionable zoster and prescribed acyclovir ointment. He was seen again on 29-OCT-2005 and had lesions in multiple stages consistent with chickenpox. Symptomatic relief and isolation were ordered as treatment. At the time of this report the patient was still having itching and was still on acyclovir, reported to be no laboratory or diagnostic tests were performed. No product quality complaint was involved. Follow-up information received from a RN on 17-NOV-2005 indicated that the patient was seen in the physician's office a fourth time on 02-NOV-2005 with persistent evolving varicella versus zoster rash. The RN reported that she spoke to the patient's mother via telephone on 10-NOV-2005 and the rash had dried and no new lesions had formed. The patient was reported as recovered as of 10-NOV-2005. The physician considered the patient's adverse event to be an other important medical event. Other business partner numbers included: E2005-05114 Additional information is not expected.
2 vaccines left arm patient reported "Hives" around injection site, swollen, hard, hot to touch left deltoid 1/9/10 (AVAC. given 1/7/10) 1/9/10 patient tx'd at hospital ER. Give antibiotic and anti inflammatory med. (Patient states ER MD -said didn't appear to be infection).
sz beginning 48 hrs p/vax; hospitalized-nl LP, EEG, head CT, resolved completely;
dizziness; headache; body aches; This case was reported by a physician via sales rep and described the occurrence of dizziness in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Bexsero. On 23rd May 2019, 2 hrs after receiving Bexsero, the patient experienced dizziness, headache and general body pain. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ketorolac trometamol, ketorolac trometamol (Toradol). On 24th May 2019, the outcome of the dizziness, headache and general body pain were recovered/resolved.   The reporter considered the dizziness, headache and general body pain to be related to Bexsero.  Additional information received were as follows: The patient experienced extreme dizziness and body aches. The patient experienced headache followed the center of her head line a mohawk pattern would be. The patient went to the local emergency room where she was given IV fluids and Tordal. The symptoms resolved the next morning. The physician does believe the issues were related to the vaccine. The reporter consented to follow up.
Symptoms very like a bad flu began that early evening and lasted approximately 36 hours. My normal body temperature is about 96.5. During the early morning hours of Saturday, April 3, my temp was 100.7. Headache, chills, body aches, painfully sensitive skin; upset stomach, painful vision and hearing. Bad pain in the entire right arm, into which the injection was made. Even today, 4 days after the injection, I'm chilly (though it is 75 outside), tissues in my mouth/gums are painful, I had stomach cramps, diarrhea and a bloody stool. I'm much better, but not quite back to normal.  I think it may be significant that I am 5 foot 2 inches tall and weigh 110 pounds. I wonder if the doses should be matched to body weight, and if that would cut down on side effects. This was pretty brutal.
My regular period began 3 days earlier than expected (on July 10th rather than the 13th) and was supposed to end on July 19th. The bleeding has been on going for 30+ days now. This is my first period since my first vaccine dose. July 10th-August 7th and possibly longer. I am on birth control (the Implant, Nexplanon), however my periods prior to the first vaccine were steadily at 7 days in length.
pt recv vax & devel an inj site rxn which persisted for more than 1wk & was characterized by tenderness, redness & swelling;
Painful to the touch, redness at injection site. Has been painful since shot was administered. RN note: large area of visible redness to injection site with clearly defined circular dark -> light redness moving outward from site. Palpable borders, heat, raised area of redness.
Nausea and vomiting, fever 99 degrees F- 100 degrees F, chills for 3 days.
she had the systemic reaction at site of injection and then ended up developing shingles on her lower back, she covered the rash and put betadine on it, then went to urgent care and got a Valtrex 1gram prescription
Fever of 102.1, severe body chills, tachycardia, anxiety attack.
palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization.  Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.
elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon.  5 baby ASA taken po and drove to hospital ED at 4:30am.  First EKG negative for changes.  First tryponin lab 0 and negative.  Approximately noon, 2nd tryponin elevated at 0.54.  Right radial access heart catheterization at approximately 1pm shows small branch of LAD with SCAD.  Medical management with IV heparin, Plavix, and daily baby ASA 81mg.  Discharged to home 4/4/21.