chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 34 year old female.  Initial information was processed with the additional information received on 06-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number:1808986 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 around 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, right after the vaccination, the patient experienced sore arm which worsened after 3-7 days, and then it lingered and had gone away after 3 weeks. On 05-AUG-2021, the patient got an antibody tests done (antibody neutralizer SARS-COV-2), which had come back as less than 10% (confirmed immunological vaccine failure). The HCP told the patient that less than 10% result could be considered as negative. The patient had results in the hand and the PCP(primary care physician) was aware of the results. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 22-JUN-2021, and had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188681.; Sender's Comments: V0-20210810669-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient's mother noticed rash on the child's body starting on 9/9/23. Patient's mother reported that child had lesions in her mouth which seemed to cause a decrease in oral intake. Child was still having wet diapers. No fevers were reported.   Patient's mother took child to the ER on 9/11/23 at 2:00 AM  where the child was diagnosed with you vaccine-induced varicella.   Patient then followed up with her PCP (APRN) at 9:40 AM on 9/11/23. Patient was prescribed triamcinolone acetonide cream (0.1%), ibuprofen 100mg/5mL, and Benadryl Allergy 12.5mg/5mL.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015 12:52, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.3 (4hours 8mins) and 1.0 (4hours 8mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Nerve pain, tingling in arms, hands, legs and feet, and then extending to scalp, lips, and tongue. Tingling and numbing sensation in pelvis and hip areas, that then extended to perianal area and eventually severe bleeding hemorrhoids and pressure in anal area. Diarrhea over one week period. Lymph nodes also swollen on right side, in front of ear with redness and pain lasting one day. Lymph nodes swollen under left arm during recent mammogram. Nose bleed x 1. Fogginess and overall fatigue.  Pain in lower back near hips with a burning sensation.  Ringing in ears, both. Fever and body aches day after second dose of vaccine.
administration of Dtap-IPV component of PENTACEL separately from its Hib component with no reported adverse event; Initial information was received on 11-FEB-2022 regarding an unsolicited valid non-serious case received from a pharmacist  via call center.  This case involves a 2 months old male patient who experienced administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.     On 03-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  via Intramuscular route in thigh (with an unknown strength, batch/Lot number and expiry date) for immunization   On 03-FEB-2022 the patient developed a non-serious event "administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event" (product preparation issue) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of Dtap-IPV component of PENTACEL separately from its Hib component with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administration of dtap-ipv component of pentacel separately from its hib component with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had my vaccination on 10/10/2022. On 01/01/2023 started to experience symptoms to include a dry cough sore throat and runny nose. I tested COVID-19 positive 01/02/2023. I was prescribed PAXLOVID. I presently feel good on 01/10/2023. This is the second time I have had COVID-19. I was COVID-19 positive on 04/07/2022.
Patient expressed that she felt bullied by PCP to take covid vax. Took vax around noon, and cousin called patient to check on her around 8pm. Patient expressed feeling very fatigued and wasn't feeling good. Mentioned feeling confused upon doing normal activities. Cousin (reporter) felt like things sounded wrong and was exhibiting symptoms. Patient normally sharp, but was shocked by the confusion. Patient was found dead in her recliner by midnight - stating from police that she was dead for hours. No autopsy, body was "donated to science". Found that she died from stroke.  Last person left in her immediate family.
Right side of tongue swollen for 12 hours.  Treated with Benadryl, 3 doses. Resolved.
The patient was in the observation area with wife after being vaccinated. At 13:22 the patient fell out of his chair, he became unresponsive and started having a seizure which lasted 2 minutes. The paramedics arrives at 13:23 and took his vitals. At 1325 the patient had another seizure which lasted 1 minute and 42 seconds. After the seizures he became responsive, but very lethargic. He was transported to the hospital at via ambulance at 13:26.
Patient experienced a mild TIA which lasted approximately 15 minutes.  This began about 5.5 hours after the vaccination. I was unable to read from my phone, could not come up with common item names from memory, and my wife reports I used incorrect words in speech.   I had experienced a mild headache two hours after the vaccination, had taken a short nap, and experienced the TIA-like event after getting up. After 15 minutes, words were coming back, I was able to read and converse normally. The mild headache continued for 24 hours and the sore injection site continued for 48 hours.
6/8/04: fever 103 lasting 2-2.5 (103-100 degrees) mom gave Motrin/ Tylenol. 6/11/04 child would "stiffen body as if in pain, unable to calm child. Mom took child to ER: was diagnosed with Viral infection. 6/12/04: rash appeared on face- red/fluid filled (several pox) shortly after body covered with red rash, no pruritus. 6/14: no fever, feeling better. Still has red rash covering body. 2 weeks ago. 6/1/04 (approximately) was exposed to a child with a red rash on face. the rash was not diagnosed.  Follow up on 09/08/04 states: "06/15/04, child has fine pink rash from head to toe, no fever, rash subsiding."
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-SEP-2015, the patient was treated by the emergency department at a hospital (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
On 4/29/2021 admission to medical progressive care unit for hypoxia (from inpatient rehab - treated for acute back pain due to metastatic prostate CA); on 05/08/21 pt. discharged home with hospice.
Note from NP at clinic 6/11/21: "She (pt.) received the shot and about 5 minutes later started to feel flushed, tachycardic, and said her throat felt "numb." She was laid down on a cot, her vitals were taken (BP 148/90 and pulse 112 apical), she was given 25mg of liquid Benadryl and symptoms resolved after about an hour. She was given instructions to contact her PCP Dr. after leaving the clinic and should symptoms return to go to the ER for further evaluation."  Follow-up note from Health Department Medical Director 6/14/21: "She (pt.) told me that within 5 minutes of having the Pfizer she developed numbness of her lips and tongue and a sensation of throat numbness.  She was evaluated and her BP was high and she was tachycardic and she was told to lay down.  She felt some trouble breathing more with laying down and she had some nausea in addition to some itchiness of her face and neck.  She was given Benadryl.  She also remembers having almost an instant headache and hot feeling with her symptoms. Once the Benadryl started to take effect, she felt her breathing and tingling and itchiness was better.  She did go to see her primary care that same day and her symptoms did return.  She was given steroids orally and told to take Benadryl every 4 hours.  She noticed that her symptoms of throat tingling and lip tingling and face and neck itchiness and splotchiness would return when she was due for Benadryl.  The last time she noticed this was Saturday morning.  She is still taking Benadryl every 4 hours and is no longer having any symptoms as of today."
Cellulitis of (L) upper arm; heat. Follow-up was done at Urgent Care 6/6/17.
Patient felt lightheaded, dizzy, with sweating around 20 minutes after the dose. Pulse was 76, R-20. Systolic BP was 117 couldn't hear diastolic (maybe around 70). Oxygen was 98-99%. No epinephrine given. Transported to Hospital via EMT.
The pt experienced hyperpyrexia, no signs of infections 24 hours post vax.
COVID 19 Treatment; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown, Vaccine lot unknown reason: Unable to locate or read the details) at the age of 35 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 had no relevant medical history. Known allergies: no. There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Anti viral details:  Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14May2022, Treatment stop date: 19May2022. Adverse event: Symptoms resolved and I tested negative last week. I am now testing positive and am experiencing different symptoms. Adverse event start date: 24May2022. If patient recovered: Not recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (May2022) negative, notes: Symptoms resolved and I tested negative last week; (May2022) Positive, notes: I am now testing positive and am experiencing different symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
he had a low grade fever and headache after receiving both injections; he had a low grade fever and headache after receiving both injections; This is a spontaneous report from a non-contactable consumer (patient) reported that a 70-year-old male patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included having low grade fever and headache "all the time". Concomitant medications were not reported. Patient previously took acetylsalicylic acid/caffeine/salicylamide (BC Powder) for low grade fever and headache routinely. Patient stated that he had a low-grade fever and headache after receiving both injections and wanted to take some BC Powder, but heard that he should not do so with the vaccine.  Patient stated that he has low grade fever and headache "all the time" and routinely uses BC Powder to treat. He would like to know if it's okay for him to take it after receiving his Pfizer covid vaccine the other day. Patient also wondered how long it takes after receiving the second vaccine to be fully vaccinated and whether there is any information on protection against the new variant strains. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I think that the vague discomfort in my left hand started  about 1-2 weeks after the shot. It has now progressed to joint pain in my left hand and starting to spread to my right hand and left elbow.  My knees are also getting sensitive with joint pain/discomfort.  Left jaw pain started yesterday.. I've been tested for Lyme which was negative.  I've had blood work done  to check for arthritis, lupus type issues, but they've all come back normal. I'm not sure if it's the vaccine, but the timing seems very coincidental.
Patient had passed out after receiving her first dose of Moderna vaccine. Patient finally woke up after giving her an ammonia inhalant. When she finally woke up, she felt dizzy, lightheaded, pale, and nauseated. Her blood was low (BP= 79/32, HR= 57, 0xygen sats- 98% on room air).  Her vital signs were retaken and it was (BP= 105/65, HR= 70, Oxygen sats- 97% on room air). Stat RN called and 911 called. Patient was sent to nurse treatment for observation. Paramedics were at the nurse treatment.
developed menstruation; stomach bloating; breast tenderness; This is a spontaneous report from contactable consumers (one is the patient). A 59-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular, administered in right arm on 15Mar2021 (Batch/Lot Number: EN6206) as dose 1, single for covid-19 immunisation. Medical history included tonsillectomy from 1969, c-section from 1990 and 1993, removal of benign Ovarian polyp from 2011, seasonal allergies and 18 months post menopause. Family history included mother: breast cancer three times, at 55 years menopause, alive-well receptor negative, lumpectomy radiation whole breast, Stage 1, lymph nodes negative; at 71 years old, mastectomy (Same breast as above), lymph node negative, Stage 1, Arimidex /15 years and at 83 years old, invasive ductal carcinoma, lumpectomy pinpoint radiation, accelerated partial, breast irradiation (APBI), receptor post-2016-open heart Surgery (BRCA negative) and father: died of medullary thyroid cancer (not carrier). Concomitant medications included ongoing fexofenadine hydrochloride (ALLEGRA) taken for seasonal allergies, ongoing fluticasone propionate (FLONASE ALLERGY RELIEF) taken for seasonal allergies, and ongoing calcium carbonate, colecalciferol (CALCIUM & VITAMIN D3). On 22Mar2021, one week after receiving first dose, the patient developed menstruation. Symptoms included stomach bloating and breast tenderness. The patient was 18 months post menopause. The patient underwent lab tests and procedures which included routine blood test: excellent negative in Aug2020 (yearly well checkup) and yearly mammogram: negative in Aug2020. The patient received 2nd dose of bnt162b2 on 06Apr2021 and got her period that lasted for 4 days and was very light. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. 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).
05/07/2021 7:00pm - tired, sore injection site 11:30 pm - headache and a bit of nausea   05/08/2021 2:30am: severe chills, shivering 4:00am: shivering stopped, chills persisted, body aches, extremely sore arm pit area on same side as injection site  6:30am: chills, body aches, soreness persist, severe headache, 101° fever 10:00pm: chills have stopped. Headache, injection site and surrounding area soreness and fever persist  05/09/2021 9:00am: slight headache, minor soreness at injection site and surrounding area. No other symptoms persist
Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0150) in the left arm, on 24Apr2021, at 12:15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  Relevant medical history and concomitant medications were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 02May2021, at 06:00 AM, the patient experienced fever, headache, sore arm and he was very tired. No treatment was received. Post the vaccination, the patient has not been tested for COVID-19. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Then, on 15May2021, at 09:45 AM, the patient received the second dose of BNT162B2 (COMIRNATY, Lot. EW0179) in the left arm, at single dose, for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
WITHIN 2-3 MINUTES OF ADMINISTRATION PATIENT BEGAN TO FEEL WEAK, LIGHTHEADED AND WAS SWEATING. PATIENT WAS EXAMINED AND ALL VITAL SIGNS WERE STABLE. WE SUPPLIED WET CLOTH AND COOL AIR. PATIENT THEN SAID HE THROAT FELT HEAVY AND LIKE SHE COULDNT SWALLOW. PT WAS ADMINISTERED EPI 0.3ML IM INTO R DELTOID. MONITORED PATIENT FOR ANOTHER 15 MINUTES AND TOLD TO GO TO ER FOR FUTHER WORKUP. PATIENT WAS STABLE AT THE TIME OF DICHARGE.
Severe chest pains; Shortness of breath (SOB); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Oct2021 (Lot number: FF8839) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "allergies". The following information was reported: CHEST PAIN (medically significant) with onset 20Oct2021, outcome "not recovered", described as "Severe chest pains"; DYSPNOEA (medically significant) with onset 20Oct2021, outcome "not recovered", described as "Shortness of breath (SOB)". The events "severe chest pains" and "shortness of breath (sob)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: negative; fibrin d dimer: normal; sars-cov-2 test: negative. The patient received Steroids for events. Clinical course: There was no other vaccine in four weeks. There was no covid prior vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.