chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 13:30 (Lot number: FA7484) at the age of 61 years as dose 2, single and administered in arm left, administration date 07Jul2021 13:30 (Lot number: EW0185) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious), TINNITUS (non-serious) all with onset 09Jul2021, outcome "not recovered" and all described as "Severe ringing in the ears, tinnitus". Therapeutic measures were not taken as a result of tinnitus, tinnitus. Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Follow-up attempts completed. No further information expected.
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 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years 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 was not reported. Patient had no known allergies. Date of last menstrual period: 19Feb2022. The patient is expected to deliver a baby(s) on 26Nov2022. Concomitant medication in 2weeks included: PRENATAL VITAMINS [ASCORBICACID; BETACAROTENE; CALCIUMSULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC AC-ID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONO-NITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient is pregnant now and Gestational period: 22.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2/22/21 Fatigue has been started till now.  The week of 2/22-2/25/21 he fainted a few second then found himself sitting on the floor.  2/26/21 evening he fainted and fell from the chair.  He had lower back pain then couldn't walk well.  He was taken to ER  and disharged 3/4/21.  5/31/31 He had chest pain and lower back pain. He was taken to ER and disharged 6/2/21.  Onchologyst thought he has cancer. After that He went to Hospital. Based on his thyroid biopsy and bone biopsy, he has been diagnosed with a stage IV medullary thyroid cancer metastatic to bone, liver and lymph nodes.  Currently he is under home Hospice Care.
Tested positive for COVID 3/15/21. Completed COVID vaccine series 1/20/21. Symptom onset 3/8/21.
Patient reported feeling dizzy. About 5 mins later had syncopal episode w/syncopal seizure. BP 70s/40s, P 45-47. 911 called. Patient became more alert but was transported to ED based on hypotension and bradycardia.
felt like she had Covid; injection site was hot to touch; she couldn't raise her arm above her head; weakness; loss of appetite; diarrhea; fever; body aches; vomiting; her joints hurt for about a week; injection site was swollen; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt like she had Covid), VACCINATION SITE WARMTH (injection site was hot to touch), MOBILITY DECREASED (she couldn't raise her arm above her head), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure high.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SUSPECTED COVID-19 (felt like she had Covid), VACCINATION SITE WARMTH (injection site was hot to touch), MOBILITY DECREASED (she couldn't raise her arm above her head), ASTHENIA (weakness), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), PYREXIA (fever), MYALGIA (body aches), VOMITING (vomiting), ARTHRALGIA (her joints hurt for about a week), VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, SUSPECTED COVID-19 (felt like she had Covid), VACCINATION SITE WARMTH (injection site was hot to touch), MOBILITY DECREASED (she couldn't raise her arm above her head), ASTHENIA (weakness), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), PYREXIA (fever), MYALGIA (body aches), VOMITING (vomiting), ARTHRALGIA (her joints hurt for about a week), VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE ERYTHEMA (injection site was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10-MAY-2021 and events outcome was updated to resolved. On 22-Jul-2021: No New Information added.
Had DVT (left leg) and PE, never had that before and 18mos prior had ultrasound of leg veins showing no problems,
This spontaneous report as received from a consumer regarding his wife, refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with M-M-R II, GARDASIL and (Oka/Merck) VARIVAX route reported as injection. The reporter stated that on an unknown date the patient just found she was pregnant. The pregnancy outcome was outcome pending. the outcome of event reported is unknown. The patient had not sought medical attention. No product quality complaint was involved. Additional information has been requested.
Vague complaint of left arm feeing colder than right and slowly moving throughout the body over 15-30min, also lightheadedness which resolved with positioning patient supine with feet propped up. Sensation of cold arm continued however physical exam and vital signs were normal so patient was discharged.
Patient experienced memory loss after vaccination and more on her second dose of the vaccine. She also had a stroke  though they believe the stoke to be possibly unrelated to the vaccine
Information has been received from a physician concerning a 6 year old male who on 18-OCT-2001 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 638245/0779L). The patient had no illness at the time of vaccination. On 06-APR-2007, the patient developed a rash on her "belly and chest." On 07 APR 2007, the patient recovered from the "rash on belly and chest." No lab diagnostic tests were performed. Additional information is not expected.
Chronic spontaneous urticaria and dermatographia affecting torso, arms, hand, buttocks, and neck areas. Sudden onset lasting 2-3 hours and subsiding before propagating elsewhere. Worsened by itching. Erythema and   Presented 10 days after booster (3rd dose) of Moderna vaccine. First noticed on scalp area.
Nausea and vomiting began the evening of 06/25/14 and continued throughout the night into the following morning. The patient also experienced fever and chills. The patient took two Tylenol Extra Strength (500mg) tablets every four hours for 3 doses and reported a temperature of 99.5 degrees Fahrenheit after the third dose.
Severe pain in left arm - elbow, wrist and forearm.  Had same reaction to flu shot in December but didn't correlate it to the shot until this second event
Fever, cough, itching, rash around vaccination site and around face, runny nose, chest pain associated with cough, sore throat, headache, chills
Flushing; Itching; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (Flushing) and PRURITUS (Itching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concurrent medical conditions included Hyperlipidemia, Penicillin allergy and Drug allergy (Sulfa allergy). Concomitant products included EPINEPHRINE and DEXAMETHASONE for an unknown indication.   On 29-Jan-2021 at 4:55 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 5:00 PM, the patient experienced FLUSHING (Flushing) and PRURITUS (Itching). At the time of the report, FLUSHING (Flushing) and PRURITUS (Itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was reported to receive epinephrine and dexamethasone in the clinic prior to arrival. Patient was reported to be treated with intravenous fluids, dose of corticosteroids and H1 and H2 blockers in the emergency department. On discharge, he patient was asked to continue Benadryl (diphenhydramine hydrochloride) if needed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
it has gotten worse; He had a severe headache, so much that he can't talk; severe headache/Or it is just extremely painful that makes the headache ramp up even more; He has been unable to work since that time; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. This female consumer reported for brother that a 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single, on 07Apr2021 (Batch/Lot number was not reported) as dose 2, single (both at the age of  62-year-old) for COVID-19 immunisation.  Medical history included blood pressure high.  There were no concomitant medications.   There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  The patient started experiencing a severe headache after the first dose of the Pfizer COVID vaccine on 18Mar2021.  He had a severe headache, so much that he could not talk on 18Mar2021. Or it was just extremely painful that made the headache ramp up even more. He had been unable to work on 18Mar2021 since that time. The consumer thought it would go away in 2 months, but it has gotten worse.  The consumer clarified the patient works, but he only went in a few hours a week and he could not handle it anymore and then went home. He was still trying to work, it's just not happening.  He had not gone to the ER. The patient had been in severe pain and has been to his regular doctor. He was now seeing a headache specialist. He only had video appointments with the specialist because he didn't want to drive to the office.  Relevant Tests: None; He had the MRI coming up on 03Sep2021.  Outcome of the events was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I experienced dizziness, grogginess, lightheaded, and sluggish. The next day, I had a sharp pain that began in my legs and moved into my groin area which has not resolved. I was fatigued for 2 days, and had 3 bumps that appeared as bruises which have appeared at random on my legs and arms accompanied with pain since.  The whelps and blisters keep comin up on my legs and arms, I'm also experiencing discoloration (white pigment) on my right wrist and right ankle. My adverse symptoms have not resolved.
Employee reports at 5 pm on day of Tdap vaccine she felt localized soreness. Next day 8/22/07 she felt flu like symptoms lethargy, achy with redness traveling in 1" streak down to elbow
severe fatigue; migraines; double pneumonia; seizures; disorientation; severe swelling over her whole body; her quality of life has diminished; This spontaneous report was received from an approximately 25-year-old female patient concerning herself. The patient was allergic to latex. No concomitant therapy was reported. The patient reported not having any health issues and was not on any medication before the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.        The patient experienced severe reactions to the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, one hour after the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), she experienced disorientation and then quickly experienced severe swelling over her whole body. On unknown dates, the patient experienced severe fatigue, seizures, migraines and double pneumonia. She had to be hospitalized on different occasions due to her suffering from symptoms on unknown dates. Her quality of life had diminished since the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention. Due to the symptoms, she received seizure medications, treatments for migraines, and antibiotic therapy from when she was suffering from the double pneumonia. Multiple labs and diagnostics were completed when she was hospitalized, but she was unable to provide information at this time. The patient was not recovered from all events. The reporter considered all events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, pneumonia and seizure were determined to be medically significant.
Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue.  Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on patient's pertinent medical history or drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were administered improperly stored doses of GARDASIL 9 (lot # L043213, expiry date 28-AUG-2017, lot# M007764, expiry date 30-JAN-2015, lot # M004116, expiry date 12-OCT-2017 (doses and routes were unspecified) that underwent temperature excursions in 49 Fahrenheit degree for 227 hours. Data logger was involved. There were no previous excursions and temperature was back in range. No adverse effects were reported. This is the one of the several reports from the same reporter. Additional information has been requested.
Awoke in the middle of the night about 16 hours after injection with hard shaking chills. Got up and took acetaminophen 100mg by mouth. Went back to bed, rested until the shaking eased and fell back to sleep. I did not take my temperature because it was too difficult while shaking so hard. I was completely fine four hours later when I woke up.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Forehead would get very warmed when out in sun) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB for Psoriasis. Concurrent medical conditions included Psoriasis. In August 2022, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced FEELING HOT (Forehead would got very warmed when out in sun) and HEADACHE (Headache). At the time of the report, FEELING HOT (Forehead would got very warmed when out in sun) was resolving and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
I received shingles shot at 9:30 am on August 6 ,2020. At 9:00 pm I experienced blurryness and dizzyness and the chills. I went to bed at 9:30 pm. I had a headache and a neckache. about 12:30 am I got thirsty and needed to go to the bathroom. When I got up I was dizzy and had to hold on to things to get to the bathroom and the kitchen for a drink. As I laid back down on the bed, it felt like the bed was on fire. My fingers got stiff and I could hardly move for a while. I didn't sleep much and was concidering calling 911 or my family , as I live alone. I got awake at 3 am to go to the bathroom again. I was still somewhat dizzy and still had headache and neckache. I fell asleep and was awake at 6:30. to go to the bathroom again. I went back to bed and was up at 7:30. It was a horrible night.
after vaccination the patient began to bleed. a bandaid was applied. Within seconds the area where the injection was given had bubbled up and the blood had soaked through the bandaid. The patient reported that it did not hurt but was given an ice pack to apply to the area.
approx 13mos p/vax pt devel over 50 lesions that were described as small vascular lesions. f/u fr MD dx w/mild clinical varicella
Information has been received from a physician concerning a now 18 month male patient with no pertinent medical history who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). During vaccination, the vaccine was splashed because the needle was not firmly attached. The patient received only partial doses of VARIVAX (Merck). Subsequently, about 3-4 weeks later the patient experienced mild cold, fever, cough and 15-20 non-vesicular "dots" scattered over his body. The lesions had crusted over by the time the patient was seen in the office. At this time of reporting, the patient was recovering. Additional information has been requested.
fever (T max 105), vomiting, h/a, coughing, spasms;date of vax 6NOV96;onset of sx 8NOV96;seen in ER 9NOV96 dx tracheal bronchitis;
My armpit is getting quite swollen; skin feels jello like; (my armpit is getting) a touch painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My armpit is getting quite swollen), SKIN DISORDER (skin feels jello like) and AXILLARY PAIN ((my armpit is getting) a touch painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PERIPHERAL SWELLING (My armpit is getting quite swollen), SKIN DISORDER (skin feels jello like) and AXILLARY PAIN ((my armpit is getting) a touch painful). At the time of the report, PERIPHERAL SWELLING (My armpit is getting quite swollen), SKIN DISORDER (skin feels jello like) and AXILLARY PAIN ((my armpit is getting) a touch painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Took 3 typhoid oral pills as directed, on empty stomach. After 3rd pill noted white rash patches on skin, itchy woke up with increasing amt of rash limbs, trunk, not face. Some fist size felling dehydrated, hot. Went to walk-in clinic. Stopped typhoid pills, prednisone given. No prob with breathing. Legs did swell, hurt to bend.
Major pain and pinched nerve in the neck from the swelling of the trapezius muscle, affecting the C3, C4, and C5.  Treated with myotherapy, sonogram, and chiropractic adjustment, along with ice and a cervical collar.  The following day, had another myotherapy session and chiropractic adjustment, with continued wearing of the cervical collar and some ice.
Right arm red, hot, swollen. Treatment included compresses/ Benadryl/ Keflex for 10 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0153), in right arm and on 04May2021 as dose 2, single (Lot number: EW0173) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 051F21A), in right arm and on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis, vitamin D deficiency; "Vitamin D deficiency" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis, vitamin D deficiency. The patient's concomitant medications were not reported. Past drug history included: Sudafed, reaction(s): "Known allergies: Sudafed", notes: Known allergies: Sudafed and Neosporin; Neosporin, reaction(s): "Known allergies: Neosporin", notes: Known allergies: Sudafed and Neosporin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: I tested positive on rapid 01Sep; (09Sep2022) Negative, notes: This morning, 09Sep, I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, patient was tested positive on rapid 01Sep, started paxlovid on 04Sep and took the 3 pills morning and evening for 5 days. On 08Sep patient was started to feel lousy in the evening but continued with the last dose. That evening and through the night my symptoms returned, night sweats, aches, cough, running nose, fatigue, diarrhea and tickle at the back of my throat. This morning, 09Sep, patient tested negative despite the clear symptoms and overall sick feeling. Device timestamp: 09Sep2022.  No follow-up attempts are possible. No further information is expected.
Pt had #1 vaccine Hep B did not report adverse Rxn. Came for vaccine #2 Hep B denied previous issue and #2 given. She returned for #3 and states she had symptoms after #2 vaccine and #1 vaccine (both Hep B). She states she thought that sx after #1 was related to a virus at which sx were same after #2 she correlated it to vaccine. Sx: Fever, diarrhea, myalgia, joint pain.