chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm 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. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "allergy" (unspecified if ongoing), notes: Known allergies: Yes. Other medical history was none (as reported). There were no concomitant medications (Other medications in two weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". After Paxlovid, patient got Covid again. Rebound. Patient was great after the medication and negative and then patient tested positive and got very sick on the 4th day following the last Paxlovid dose. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (unspecified date) Negative; (May2022) Positive, notes: was great after the medication and negative and then I tested positive and got very sick on the 4th day following the last Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 16May2022 to 21May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed a fever 12 hrs after shot with chills. next day vomit  x 14 times. Episodes of chills and fever of over 103.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL (lot #M014929, expiry date: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Migraine started at approximately 3:30 pm  Took Excedrin migraine and used an ice pack. No relief took Advil continued with an ice pack, no relief,  fatigue, slept for a couple of hours.  Took relpax at bedtime woke up with a continuing migraine. Migraine has continued since 4/10/21 with NO relief.
Information has been received from a registered nurse concerning a child who recently, in approximately April 2006 was vaccinated with a dose of MMR II.  In approximately April 2006, the child experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information is not expected.
hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was already vaccinated, although it hurts, but it was better to be safe than sorry. Additional supportive information: The follow-up could not be possible as no contact details were available.
Swollen, badly bruised arm. Fatigue, diarrhea, dehydration.
Bell's Palsy Face drooping, eye not blinking, numb face left side  Treated with Steroids for 10 days and antiviral medications  Started improving at 2.5 weeks and 4 weeks with minimal symptoms left. Slight weakness still on that side of face.
She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.; She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.; This is a spontaneous report received from a contactable reporter. The reporter is the parent.  A male patient received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She is calling on behalf of her son (declined to provide his age) who tested positive for covid19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for covid19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
THROMBOSIS IN MY RECTAL AREA; ARM VERY SENSITIVE TO THE TOUCH; SEVERE HEADACHE; CHILLS; SORE ARM; This spontaneous self-report was received from a patient of unspecified sex, age, race and ethnicity. 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 administration, dose, vaccination site, and batch number were not reported, ) administered on 16-MAR-2021 at 13:00 for prophylactic vaccination. The batch number will be requested in follow up. No concomitant medications were reported.  On 16-Apr-2021 in the evening post vaccination, the patient had severe headache and chills. The headache continued the whole next day, but was not as bad as the first evening. Her arm was very sore, and it hurt to move it the first day, and then very sensitive to the touch the next day, and continued for a whole week. On 29-Apr-2021 (13 days post vaccination), " thrombosis (according to my doctor) appeared in my rectal area that still hasn't gone away". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm very sensitive to the touch, severe headache, and sore arm, had not recovered from thrombosis in my rectal area, and the outcome of chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This patient of unspecified age, gender, and ethnicity reported to have "thrombosis (according to my doctor) appeared in my rectal area that still hasn't gone away" 13 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient also reported severe headache and chills on the day of vaccination that persisted until the following day, as well as arm soreness that persisted for a whole week.  No other details was reported.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
suspected vaccination failure; Had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient received several shots of shingles long time ago and experienced Shingles. The consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Began running a fever  until 5 a.m. on 3/5/2021.  The fever stayed at 100+ even with Tylenol.  Temperatures were:  101, 102, 103, 106.  I literally ran the same symptoms as I had when I was ill with covid a year ago.  I would have sought out help if it didn't break by the next day.  I kept cold compresses on my head and back of my neck.
Received Moderna vaccine on 03/18/21 and 04/15/21. COVID positive on 1/12/22. Presented to ER on 1/12/22. presenting from home with family noting hypoxia.  Patient's family member states that the whole family has COVID-19.  They have been continuing to monitor other mother's oxygen saturation.  They noted tonight that her oxygen saturation was low an undetectable therefore they called EMS for further evaluation.  Patient is pleasantly demented at baseline unable to provide any medical history.  She states that she feels very tired.  Unable to provide any additional history. received dexamethasone and 1 dose of remdesivir. Was discharged 19 hours later.
Induration 8 x 14 mm and erythema 9x12 mm left upper arm onset 8 hours post vax
Information has been received from a health professional concerning an 11 year old female who on 26-JUN-2007 was vaccinated SC on the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657618/0602U). On 28-JUN-2007, the patient developed injection site red, swelling and itching. No medical attention was sought. Additional information has been requested.
devel onset of partial complex sz w/bitemporal spikes on EEG on 28JUL93; w/u neg x/EEG;
Welts on arm, temples, and below eye. Severe pain in right eye. Started afternoon of the 24th and continued for six days.
(L) arm 2 x 2 cm erythema, induration & vesicular rash at site of injection 11 days post vaccine.
Hospitalization for COVID19 pneumonia/pancytopenia/acute hypoxemic respiratory failure on dates 5/1/2023-5/9/2023.  Treated with dexamethasone, Remdesivir, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Nausea; diarrhea; vomiting/Throwing up; Hot and sweaty from head to toe; Hot and sweaty from head to toe; Fainted in the bathroom; Chills and could not stay warm; could not stay warm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 12Jan2021 (reported as yesterday) around 11 AM as a single dose for COVID-19 immunization, lot number: EL0140 3-4. Medical history and concomitant medications were reported as none. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on unknown date via an unspecified route of administration for COVID-19 immunization lot number: EL0140. Patient stated that she experienced side effects such as vomiting, diarrhea, fainting while going to the bathroom 14 hours after receiving her second shot of the Covid vaccine. She wanted to know if these were normal side effects and if she should seek medical attention. Patient reported the side effects that she had from the second dose of the Pfizer COVID Vaccine. She has gotten no answers regarding the side effects and she wanted to speak with someone about it. She got the second dose on 12Jan2021 (reported as yesterday) around 11 AM. She felt pretty normal. By 5 PM she got chills and could not stay warm. She thought it was normal. Then over night she got really nauseous, had diarrhea and was throwing up. She was hot and sweaty from head to toe. She tried to get up afterwards and fainted in the bathroom. She was reading what the pharmacy gave her for mild to moderate side effects, and none of what she experienced are listed on there. She also stated that nausea started around 1 AM this morning. It has persisted and is intermittent. Diarrhea occurred a little after 1 AM she got up to pee. Then went back to bed. Then about 10 minutes later had to go to the bathroom, and it started then. It is still occurring this morning. It last happened around 9 AM. She has not eaten anything new. Throwing up Lasted for about 15 minutes and fainted occurred one time. Patient recovered from chills and could not stay warm on 12Jan2021, she recovered from throwing up, hot and sweaty from head to toe and fainted in the bathroom on 13Jan2021, she had not recovered from nausea, diarrhea.
FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concerned a 60 year old Not Hispanic or Latino African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, menopause and other pre-existing medical conditions included the patient had drug allergies. past unremarkable history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced hot flashes and On 07-APR-2021 experienced cardiac flutter and fast beating of heart. She stated hot flashes symptoms come and go and sometimes had this feeling after eating peppermint candy, unknown if she had peppermint candy before receiving the Janssen COVID-19 vaccine. Her medical doctor was not yet notified and she had not treated her symptoms with any over the counter medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes and cardiac flutter. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210523500-Covid-19 vaccine ad26.cov2.s -Fluttering feeling around heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Day one after first dose, started with a slight headache which later developed into a 3 day migraine type with zero relief despite medication and hydration attempts. Then resolved. Second dose then gave me a constant headache with no relief from medication and hydration attempts. At times i feel a pulse in my head when bending over. some days i cannot get out of bed due to the pounding feeling and how heavy my head feels. Went to PCP, they ordered MRI/MRA and referral to neurology.
left upper arm muscle pain, left shoulder pain, some discomfort in left forearm and left elbow, decreased ROM left arm and left shoulder
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On an unknown date, the unspecified number of patients received an improperly stored dose of MMR II (dose, lot #, expiration date, therapy date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Narrative: 66yo male patient in hospice care at home died at home on 1/9/2022. Pt w/ hx of pancreatic CA s/p palliative rad and getting chemo - recent ERCP w/ stent replacement, COPD, CAD, DVT's and PE's, EtOH and PSA. Pt had received covid vaccines on 2/14/21 & 3/13/21. Pt was found to be covid positive on 12/13/2021 (day of ERCP) Pt seen in ER on 12/20/21 for lightheadedness post ERCP procedure. Pt decided to transfer to hospice after discharged from Er on 12/20/21. Since pt decided to go to hospice, he did not get monoclonal immunotherapy for covid + infection in the ER. Not clear if pt died of untreated covid infection or from cancer (or both). Pt had 2 doses of covid vaccine early in 2021 revealing failure to provide immunity from infection, as expected by now. Problem list: Seen by palliative care medicine service Primary malignant neoplasm of head of pancreas (SCT 372119009) Chronic obstructive lung disease (SCT 13Long-term current use of insulin (SCT 710815001) Chronic neck pain (SCT1121000119107) Coronary atherosclerosis (SCT 443502000) Neoplasm of uncertain behavior of left uChronic pain syndrome (SCT 373621006) History of bilateral total knee replacemDeep venous thrombosis (SCT 12805330) Anticoagulant effect (SCT 10191004) Benign prostatic hyperplasia (SCT 266569009) Contusion of hip (SCT 44801007) Restless legs syndrome (SCT 32914008) Pancreatitis (ICD-9-CM 577.0) Impotence, Organic Origin (ICD-9-CM 607.84) Osteoarthritis (SCT 396275006) L/T (CURRENT) USE0ANTICOAG (IICD-9-CM V58.61) Tobacco use (SCT 110483000) Depression (SCT 35489007) Caffeine-Induced Anxiety Disorder (ICD-9Alcohol Abuse (ICD-9-CM 305.00) Cannabis abuse, episodic use (ICD-9-CM 3Generalized anxiety disorder (SCT 21897009) Adj Reac W/Mixed Emotion (ICD-9-CM 309.2Cocaine Depend, Episodic (ICD-9-CM 304.22) Degeneration of lumbar intervertebral diOsteroarthrosis involving the knee (ICD-9-CM 715.98) Varicose Veins (ICD-9-CM 454.90 Hip Pain (ICD-9-CM 719.45) Benign essential hypertension (SCT 1010Diabetes mellitus SCT 73211009) Hyperlipidemia (SCT 55822004) Personal History of Venous Thrombosis and Embolism (ICD-9-CM V12.51) Other Pulmonary Embolism and Infarction Gastroesophageal reflux disease (SCT 235595009) Chronic Low Back Pain (ICD-9-CM 724.2) Osteoarthritis of knee (SCT 239873007) Colon Polyp (ICD-9-CM 211.3) Mood Disorder (ICD-9-CM 296.90)
Fever to 103F x 48-72 hours Severe myalgia Joint pains-knees, cervical spine Fatigue x 72 hour Nausea x 48 hrs Diarrhea x 24 hours
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unspecified date in July-2015, the patient was vaccinated with COMVAX, intramuscularly (lot # C4761AA (reported as not valid), expiry date: 03-JUL-2017). On the same day, the patient was also vaccinated with ROTATEQ orally, PREVNAR 13, IPOL and two doses of DAPTACEL. On the same day, approximately fours hours following the administration of the multiple vaccinations, the patient became limp and was taken to emergency room on the same day (July-2015). The primary reporter stated that an examination of the patient was performed by unknown physician and it was determined that the patient's vital signs were within normal limits and the patient was developmentally normal. The primary reporter confirmed that the patient was discharged from the unknown emergency room on the same day in July 2015, and was not hospitalized. The outcome of the event was unknown. The causality of the event was not reported. Additional information has been requested.
Gemeralized weakness; Lightheadedness; Dehydration (hospital diagnosis at time of emergency treatment)  Sudden complete loss of bowel contol (day after vaccination (02/26/2021)  Dizziness, loss of balance (02/27/2021)  Confusion, low energy, constipation, diarhea, limited ability to use computer (02/28-03/14/2021)
pt recv vax in upper rt arm;approx 1hr later extremity became itchy, reddened, edematous hard & hot to touch;no systemic reactions, no SOB or chest discomfort;
Swollen lymph nodes left armpit; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0191) via an unspecified route of administration in the left arm on 24May2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0176) in the left arm on 03May2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021 at 10:00 the patient experienced swollen lymph nodes left armpit, fatigue and body aches. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19The clinical outcome of the event swollen lymph nodes left armpit, fatigue and body aches was unknown.   No follow-up attempts are needed. No further information is expected.
Patient was fully vaccinated with Pfizer COVID19 vaccine first dose on 1/5/21 2nd dose on 1/26/21. Patient noticed COVID symptoms of sore throat, congestion, runny nose starting 8/8/21. Patient reported  a COVID positive PCR test result after testing on 8/16/21.
Red bumpy rash on neck, chest, arm/elbow crease, legs/behind knees.  very itchy.  using Benadryl cream to ease itchiness  Rash is still present
This spontaneous report as received from a other health professional refers to a 3 month old male patient with prophylaxis. On 06-AUG-2018 the patient was vaccinated with improperly stored LIQUID PEDVAXHIB lot # R001085 dose 1 in the right thigh for prophylaxis (product storage error). Other suspect therapies included PEDIARIX, PREVNAR and ROTATEQ. No adverse events reported. Patient did not have any reverse reactions to the vaccines.
Describes shooting pain that occurs when raising arm up that persists 7 days and after vaccination. Pain has not gone away affecting pt range of motion.
A 2 3/4 year old female was exposed to a rabid bat and was treated with RabAvert and rabies immune globulin for post-exposure prophylaxis. Twenty minutes, post vax, the pt developed urticaria and facial swelling which was successfully treated with Benadryl. The pt has had no previously known drug allergies. Follow-up information is pending.
Headache, chills, low grade fever, muscle and joint pain, sore throat, malaise, tiredness, itching & burning eyes, swelling, redness, pain, itching <5" diameter spread over several days at injection site, hard 'knot' 2" diameter at injection site, swollen lymph node in R armpit of injection arm. Benadryl topical, ice, heat, lymph drainage, ibuprofen to no effect. Symptoms currently lasting 9 days without signs of waning at time of report.
pt recvd vax & exp nausea, dizziness, SOB immed following vax; pt hands became rigid;