chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Onset of severe dizziness on 1/10. Dizziness and spells of vertigo off and on until present (1/28)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO, start date: 01Sep2022; LEVOTHYROXINE, start date: 01Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 19Nov2022 to 24Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Myalgia (generalized), fatigue, malaise for about 24 hours.  Chills for about 12 hours.
On 11/5/21 at approximately 11:16 AM, 38 year old, male client ( DOB 07/12/1983) arrived to County operated vaccine site and requests to receive Janssen COVID-19 vaccine.  Client reports receiving one dose of Moderna vaccine at 11:00 AM  on 2/11/21.  Client reports that at 1:00 AM on 2/11/21, and for 3 days thereafter, he began to experience swelling of lips, hives, and denies experiencing SOB.  Client reports HR of 145 while experiencing these symptoms.  He reports going to Urgent Care at 9:00 am on 2/11/21, which informed client to hydrate.  Client denies receiving treatment or any medications from Urgent Care, and denies taking Benadryl or any medications for these symptoms.  Client reports following up with PCP who recommended that client receive a non-mRNA COVID-19 vaccine in the future.   Elevated concern to Clinical Supervisor, who completed medical consult, with approval by Doctor to  administer Janssen COVID-19 vaccine to client at this time, and Doctor recommends observation time of 30 minutes.  Janssen (Lot# 1855194) administered to client by this nurse at 11:16 AM on 11/5/21.  No adverse reactions of side effects reported by client or noted by EMT during post-observation period.   Explained risks, benefits, and emergency precautions to client who verbalized understanding. - RN.
Feeling really tired and like he does not have any kind of energy; Feeling really tired and like he does not have any kind of energy; This is a spontaneous report from a contactable consumer (patient's daughter).    A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling really tired and like he does not have any kind of energy with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (had been put on hypertension medication). Concomitant products included LOSARTAN for Hypertension.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not provided.  This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-066369 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Began within a few hours with pain in arm that gradually increased until I could not even move the arm due to pain. 12 hours later the arm swelled for about 6 inches below the injection site. The site was also red with inflammation, warm to the touch, and painful with touch.
Woke up projectile vomiting, extreme diarrhea, blood in stool, with 104 fever
This spontaneous report as received from a physician via poison and drug center refers to a 20 month old male patient. The patient had no medical history and his past drug history was unknown. It was reported that patient was healthy. On 25-AUG-2014, the patient was to receive the second pediatric dose of VAQTA, instead he was accidentally given the adult dose of VAQTA lot # H010269 (dose, route of administration and expiration date were not provided). The patient did not take any concomitant medication. The physician reported that the patient was fine. It was unknown if there was any relevant laboratory data. As of 25-AUG-2014, it was unknown if the patient would receive VAQTA again and he was fine after receiving the adult dose. Additional information has been requested.
Patient developed T10 left dermatome shingles (typical presentation of shingles) within 48 hours of COVID vaccination.   Patient had varicella as a child. Had not received shingles vaccine or any other vaccination within 4 months of the COVID vaccine. No other illnesses were present at the time of vaccination.
A few days after receiving flu shot had red blistery area at site of injection. Rash followed. As blisters resolved - red, some blistery, some not. Rash has spread over past few months to hands, trunk, legs, hips, buttocks - everywhere. Seeing PCP & dermatologist.
patient has been experiencing pain since she received her 2nd dose. The pain is a daily and on a scale of 1 to 10 she stated it was a 7.
Initial misuse report received from a healthcare professional on 29 July 2013.  02-year-old patient received an extra dose of ACTHIB making a total of 5 doses. No adverse event was reported. List of documents held by sender: none
Pt. had initially spoke to her PCP regarding adverse reaction to oral Typhoid after second dose.  She had complained of high fevers (did not take her temperature) and lethargy. Her PCP advised her to stop medication and to call the clinic. The clinic was called to discuss her adverse effects. Patient was advised due to "high" temp and lethargy to go to the emergency room for further evaluation, pt refused.
Moments after getting shot, arm felt weak. Left clinic 15 minutes later and immediately noticed an odd (but growing in intensity) chemical or metallic taste in my mouth. This lasted several days and was quite intense. The bad taste finally seems to be mostly gone (1 week later). Arm soreness went away after 3 days, but at exactly the 1 week mark, my soreness returned, and my injection site was itchy.
Rash all over her body a few days after  First Monovalent Booster; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash all over her body a few days after  First Monovalent Booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over her body a few days after  First Monovalent Booster). At the time of the report, RASH (Rash all over her body a few days after  First Monovalent Booster) outcome was unknown.    No concomitant medication was reported.  No treatment medication was reported. The patient had the reaction after receiving Moderna COVID-19 vaccine.  Few days after the vaccination, the patient had rash all over the body. The patient stopped and did not receive any more COVID-19 vaccines.   This case was linked to MOD-2022-670267 (Patient Link).   Reporter did not allow further contact
Tested 1/14/2021 positive, fever & malaise 1/19-21/21, admitted with severe CoVID pneumonia 1/22/2021  1/25/2021, required supplemental O2 1/22-24.
I had a classic "COVID arm" -- woke up with a perfectly round, darkened, raised area around the injection site, maybe 3 inches in diameter and 1/2 inch raised. It was firm to the touch and felt as if it were filled with liquid. It went down in about 24 hours, and there was lingering soreness. I had absolutely no reaction after the 2nd shot given on 03/19/2021, not even any appreciable soreness.
Developed severe headache and bilateral shoulder and neck achiness and heaviness not relieved with Ibuprofen.
Patient got PREVNAR injection on 6/23/15. She came back on 6/30/15 her injection site red and warm. Told the patient to follow up with MD and I called MD to let them know about it.
I lost my speech one morning and much of the control of my right side. This was due to an Ischemic Stroke in the left brain from a blood clot.  I had previously reported full body numbness from my first vaccination but now I realize that was a T.I.A. or Mini-Stroke.  Which I unknowingly had a few of after receiving the first and second doses. I went to the emergency room and after some tests they admitted me.  They then transferred me to see if the clot could be removed.  It was too late and I then had to recover from the Stroke.  I went to a speech therapist, occupational therapist, Neurologist, Hematologist, and Cardiologist.  They all have no answer to why the stroke occurred and won't admit that it was from the vaccines.
Swelling & redness from injection site to shoulder, almost to elbow, almost around arm; advised to give BENADRYL & MOTRIN.
A day after vaccine, lymphnodes in armpits swelled to size of baseball, waited four weeks after second vaccine to see doctor. Went in for mammagram, mass was detected. Went back in for ultrasound, found the mass was a lymph node from vacccine. Want to return in six months.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient's grandmother), for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient experienced chills, pain/body ache and sore, malaise/felt sick and felt cold, onset Jun 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient's Left upper arm became inflamed. Hard to touch & sore. First 48 hours patient had a hard time moving upper Left arm. Symptom's gradually subsided after 48 hours.
8/10/21 evening, patient began to c/o pain to left arm.  On the morning of 8/11/21, patient c/o severe left arm pain and there was redness and swelling to injection site.  Later on 8/11/21 caretaker noticed tactile warmth at injection site.  Mom was advised to apply cold compress in 10 minute increments and monitor for fever.  By 8/12/21, the redness and tactile warmth had worsened and patient was seen in our office.  Caretaker also noticed on 8/12/21 that the right arm had some tactile warmth but no swelling or redness.
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sever back ache and muscle spasms in back. Stiff neck, swelling and pain in shoulder, pressure headaches in back of head. Sometimes have problems speaking heard herself making error in speech content. Sugar levels have been unstable lately she never had those problems before. Some relief when lying down. On 7/26 while on a trip, had to go to the ER and was treated with Tylenol with codeine which helped relief some pain.
Blood Clot - Right calve -cramp in lower calve since injection discoloration at site of blood clot Treatment - Xarelto - 20mg  Tightness in Fingers/joints  Treatment - pending Pain in chest  Treatment - TBD
Felt dizzy and nauseous immediately after shot, during the next day I had a severe headache and experienced dizziness so severely that I thought I might pass out and went home early from work.
Seen in ER with complaint of dizziness, lightheadedness, tingling sensation of her skin, blurred vision, and headache approximately eight hours after receiving immunization. Seen again in ER 8/14/16 with same symptoms and weakness, swollen lymph nodes.
Hives and/or large welts (approx. 2" x 2") on my shoulder and arm pit area - 7 of them. The first appeared about 6 hours after the shot then they appeared approx. every 8 - 12 hours for the next 3 days. Very sore! I have been given 3 pneumonia shots in the past 2 1/2 years and feel this might be the reason for the reaction.
Small-bowel/Small-bowel intussusception discovered on 5/10/13. Several days of vomiting, abdominal pain, and dehydration.
the symptoms are only obvious i think first 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Cholesterol and Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours). At the time of the report, IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours) outcome was unknown.            Grandma also got the Moderna.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bone on the left side of body.; Severe headache; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN 6203) via an intramuscular route of administration in the left arm on 08Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 05:00, the patient experienced severe headache, fever, mild body aches occurred the day after second vaccination and experienced a large swollen gland located near collar bone on the left side of her body and numbness in lower extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of severe headache, fever, mild body aches, large swollen gland and numbness in lower extremities were not recovered.   No follow-up attempts are needed. No further information is expected.
I did not have an adverse reaction to the vaccine. In 02/2023, I was diagnosed with AFIB. I went to my doctor and was referred to a cardiologist. I'm currently taking medication to help with my symptoms. When I went back to my doctor, the AFIB is better. I'm still taking the medicine until I see my cardiologist on 07/13/2023.
Patient has a red welt around injection site that has been growing in size. The welt is warm to the touch and painful to even have a shirt covering it.  She is experiencing pain going down toward her elbow. She also just overall doesn't feel well.
Patient is a 72 yo woman with PMH of TB, hyperparathyroidism, mitral regurg, HTN, diverticulosis s/p partial colectomy, and multiple food allergies (seafood and nuts) as well as penicillin and contrast dye allergy who presents for COVID Moderna vaccine dose 2.   Patient states that within 24 hours of her first dose, she developed body aches, fever to 102, as well as skin rash - had a raised rash on her arms and thighs on both sides of her body, but most prominent on her left thigh.   She states the fever and body aches improved with tylenol but the rash persisted and she noted that on her chest and her legs and arms she had small areas that came and went over the next week. She took no medications for the rash, no anti-histamines and no creams, and found the rash resolved over time.   She sees physician for allergy and immunology for her newly developed peanut allergy and she is in the process of establishing care with a new PCP.   1. I educated patient re: need to defer dose 2 of Moderna until she discusses her reaction with allergy and immunology provider 2. I educated that we can defer this dose safely until the location and management of her second dose is determined and that she will not need to restart her dosing schedule. 3. As she is established with allergy and immunology provider, will send message to her allergist, her PCP, and the healthcare facility front desk pool. 4. Allergy to COVID Moderna has been entered and can be edited as needed by allergy and immunology provider 3. Patient is very understanding of plan         COVID-19 Vaccine Adverse Reaction Flowsheet    Most Recent Value Did this reaction occur immediately following COVID-19 immunization while at the vaccine clinic?  No Did the symptoms start prior to the vaccine dose?   No What brand vaccine was administered?  Moderna Which COVID-19 vaccine dose is being documented on?  COVID-19 Vaccination Dose 1 Time of symptom onset:  24 What potential COVID-19 vaccine local injection site side effects are present?   Injection site redness Duration of local side effects:  > or equal to 7 days Which systemic symptoms that potentially could be a severe allergic reaction to COVID-19 vaccine are present?   Body rash, Hives, Itchiness What side effects could potentially be due to the COVID-19 vaccine or due to COVID-19 illness are present?   Body Aches (Muscle Pain/Joint Pain), Fever (> 100.0F) Temperature:  102 °F (38.9 °C) What possible symptoms of COVID-19 infection are present but not likely due to a COVID-19 vaccine are present?   None present Additional symptoms suggestive of Vasovagal reaction:  None present Are there any other symptoms of possible side effects not listed above?  No COVID-19 Vaccine related side effect?  Possible
allergic reaction- skin rash , throat itching. patient visited the ER and was given episode and steroids but returned because symptoms were not improving. She was hospitalized on 1/11 for this reason
The following report was received from another manufacturer. This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a 65 year old female subject who was vaccinated with influenza virus vaccine live for prophylaxis. Medical conditions included allergy to strawberries, drug reaction/allergy to Demerol, depression and hypertension. On an unspecified date, a number of years ago, the subject received an unspecified dose of Flu vaccine. An unspecified time after vaccine with the Flu vaccine, the subject developed an anaphylactic reaction. The subject sought medical attention. This case was assessed as medically serious (OMIC). At the time of reporting, the event was resolved.
Slight burning sensation in throat,  itching over body mostly concentrated to face, scalp, neck, arms and abdomen
inconsolable crying started about 1 1/2 hrs p/vax; lasted approx 16 hrs; wouldn't eat, feverish & perspiring; mom gave APAP;
6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fatigue. 24 hours later - itchy throat/roof of mouth (took benadryl). 36-48 hours itchy throat/roof of mouth continued but became itchy on arms and legs. 2-4 days post vaccine it progressed to itchy spots on my entire body. No hives - but a rash and redness. Feels like pin and needles.