chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (physician) concerned a 74 year old male.  Initial information was processed along with the additional information received from a regulatory authority on 18-FEB-2021. The patient's weight was 230 pounds, and height was 71 inches. The patient's concurrent conditions included: borderline diabetes controlled with diet, environmental allergy, alcohol user of one glass of wine or whisky once every two weeks, and non smoker. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, 1 total, administered in right arm on 07-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s.  The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number:1855835 expiry: unknown) dose was not reported, 1 total administered in right arm on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient (health care professional reported that he had Covid-19 after he received two doses of the Janssen Covid-19 vaccine (First dose on 07-APR-2021 and Booster dose on 03-DEC-2021). On 15-FEB-2022, He tested positive (fast test /rapid antigen test). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient had suspected clinical vaccination failure. The test was performed by a medical technician at his own clinic. He awaited PCR (Polymerase chain reaction) results. On 13-FEB-2022, the patient had suspected covid-19 infection as symptoms started on same day. On an unspecified date, the patient had sore arm. He felt better and energetic on the day of reported. His oxygen level was over 90 and pulse was over 70. He decided to not take oral antivirals. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and was recovering from suspected covid-19 infection, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000218079.; Sender's Comments: V0:20220242740-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Metallic taste in the mouth. Came off topical prescription with no success. Lasted 3 months and still get maybe once a week.  Had blood work done to make sure everts else was okay. All was fine. Went to the Dentist, saw no alarm. They called me back a2 weeks later to say they have since heard 2 others with the same effect.
Narrative:  Pt stated to Primary Care nurse in the past he had a Severe allergic reaction (e.g. anaphylaxis) to a vaccine component Comment: "deathly sick" patient states from Influenza vaccine. Nurse flagged chart as historical allergy including other symptoms - nausea, vomitting, diarrhea, rash & abdominal pain. Since this is a historical report from pt, no information is available on place and lot/exp/ brand or exact date of vaccine.
Pt was feeling faint and lost color for a minute. We gave him juice, water and he ate a snickers bar. After 15 minutes he was feeling better and left with his mom.
Fist clenched uncontrollable in injection arm. Too several minutes to unclench.
About 12:30 AM I decided to go to bed. I started shaking like I was convulsing. It could have been my anxiety. I settled down after I woke up in the chair about 4 AM. I went to bed and woke up that morning feeling awful. I had a major headache, my hips hurt and I felt clogged in my head. My ears were hurting like a earache. I just stayed in bed all day. That evening I decided to eat that evening at 6PM. I did not take any medicine. I contacted my PCP and was told to take ibuprofen. I feel much better today. My arm is still a little tender at the site.
Death on March 8 due to a large blood clot at the base of his brain. This was 16 days after innoculation.
05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
10/19/15 pt called to report shoulder/joint pain. 10/2/15 Hep B vaccine IM right deltoid, 10/3/15 Stated had sore throat for 1 day. 10/5/15 Bilateral shoulder pain hard to raise arm over head. (R) shoulder arm felt weaker. Tired. Sharp pain at Hep B site Sun/Mon. Oct 4th/5th. Has lifted wts.
Pt received influenza vaccine and Td on 10/5/04. Returned to office on 10/11/04 with complaint of Knot on back of neck. First noticed knot on 10/8/04. Examination showed SC tender lymph node lt posterior lower neck, not hot, one cm, no enlarge nodes on remainder of neck, axilla, or groin.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On 12-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J006957) in the left arm. Concomitant medications were not reported. The patient was administered vaccines stored at inappropriate temperature (out of range temp logs and the vaccines that have been administered to patients). The outcome was unknown. Additional information has been requested.
Tonsillitis symptoms: swollen tonsils, fever, sore throat, difficult swallowing when drinking/eating, congestion (7 days)
Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 4th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2023 The pharmacist called to inform that a patient received the 1st dose of Havrix back on 04th October 2022 had not received the 2nd dose yet. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
Immediately after receiving vaccinations, client fainted. He lost consciousness for approximately 45 seconds then regained consciousness. Client remained upright in the chair and no injury occurred. He drank water and ate crackers. Client and his mother reported he did not eat breakfast that morning and needles "made him nervous". After 15 minutes of close observation client was feeling "back to normal" and his mother drove him home. They were advised to have him eat more and watch for any other abnormal symptoms.
Swelling of fingers on the left hand, on the arm of the vaccination site. Pain and swelling have increased daily from the time of vaccination.
Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted and hit my head, was unconscious a couple of minutes.
mild COVID-19 infection; mild COVID-19 infection; asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP); IgA Nephropathy; This is a literature report for the following literature source(s): A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "mild COVID-19 infection", "IgA Nephropathy Following mRNA COVID-19 Vaccine", "mild COVID-19 infection". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mild COVID-19 infection"; CONDITION AGGRAVATED (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP)"; IGA NEPHROPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: normal; Oxford MEST-C score: M1E0S1T0C0; Microscopy: continued to have persistent, notes: microscopic hematuria; Protein urine: continued to have subnephrotic proteinuria; Red blood cells urine: dysmorphic; Renal function test: normal; Rheumatological examination: Negative; Urinary casts: rare; Urine analysis: revealed proteinuria, dysmorphic red blood cells,, notes: and rare granular casts; Urine protein/creatinine ratio: 14, notes: Unit: g/g; 976, notes: Unit: mg/24h; 2063, notes: Unit: mg/24h.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-PV202200130613 Same article/event/drug/patient (Dose 1);
had immunizations on 7/15. One week later had redness , dryness, itchy, burning on face, cheeks, forehead. Now is peeling. No signs of infection. Afebrile.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4506591-00.  A 22-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164825) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), Suspected COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Suspected Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Suspected covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Patient's arm became red and swollen with a knot the size of an egg within 2-4 hours. Within 6 hours the knot was the size of a softball and entire upper arm was red and swollen.
Vasovagal syncope. States hadn't had anything to eat or drink, snack and water provided. Vitals taken/stable, rested on cot for an hour before leaving.
An uncomfortable feeling in the back of throat; "Within a few hours my arm is terribly sore arm"; "by the end of the night I felt slight nausea"; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included renal failure, high blood pressure , PTSD, depression, asthma, anxiety, GERDS, kidney cancer (left kidney removed) and COVID-19. The patient had known allergies to penicillin and cephalosporins. Concomitant medications included buspirone hydrochloride (BUSPIRONE), amlodipine (MANUFACTURER UNKNOWN), norethisterone (NORLYDA), apixaban (ELIQUIS), lurasidone hydrochloride (LATUDA) and other unspecified drug; all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 11:00, after the patient first got the shot, the patient experienced an uncomfortable feeling in the back of the throat, within a few hours her arm was terribly sore and by the end of the night she felt slight nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events an uncomfortable feeling in the back of the throat, within a few hours her arm was terribly sore and by the end of the night felt slight nausea was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
a rash on her right facial cheek and chest; Her right ear was also red; itchy tongue; extreme pain and soreness; patient's speech was slurred; This is a spontaneous report from a contactable pharmacist. A non-pregnant 26-year-old female patient received bnt162b2 (brand Pfizer), dose 2 intramuscular, administered in arm left on 13May2021 17:45 (Batch/Lot Number: EW0168) as dose 2, single for covid-19 immunisation. Dose 1 was received on an unknown date for covid-19 immunisation. Medical history included known allergies: Penicillin. Facility type vaccine is hospital. No other vaccine in four weeks. Other medications in two weeks included inpatient medications. It was unknown if covid prior vaccination and if covid tested post vaccination. Patient reported extreme pain and soreness on 14May2021 12:00, the day following the vaccine. Two days after her second vaccine shot (15May2021), she presented with a rash on her right facial cheek and chest. Her right ear was also red and the patient complained of having an "itchy tongue." A few hours later, the patient reported that the pain was getting worse. RN did full assessment and found that the patient's rash had become worse on her ear and that the patient's speech was slurred. Vital signs were obtained and WNL (May2021). Patient not experiencing any respiratory distress. Patient send to ED to evaluate for adverse reaction. Patient returned later that evening. Adverse event resulted in emergency room/department or urgent care. The treatment included acetaminophen and diphenhydramine. The patient was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted event namely "Pain" cannot be excluded based on a compatible temporal relation. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 38 year old female with asthma and no history of drug reactions/allergies who on 25-JUL-2007 was vaccinated with PNEUMOVAX injection for prophylaxis against pneumonia.  On 25-JUL-2007, after being vaccinated, the patient experienced hot flashes as well as her throat began to swell.  Medical attention was sought.  She was given oxygen and all symptoms were gone within 7 minutes.  The patient was prescribed an epi pen and was told to take BENADRYL if swelling reoccurred.  On 25-JUL-2007, the patient recovered.  Additional information was received from the physician who reported that the reaction was anaphylaxis.  No other information was provided.  No further information is expected.
Patient reported redness, soreness and warmth at the site of injection the evening after receiving FLUZONE HD. It lasted for 3 days and resolved on the evening of the third day.
Beginning day of injection, had left arm soreness and local erythema where got Shingrex. Beginning 1 day after administration, started to have severe unilateral facial pain.  Then spread to both sides. Prevented her from moving her face normally. Extreme tenderness to palpation of soft tissue over zygomatic arches. No skin changes. No difficulty chewing or swallowing.  No breathing difficulties.
Starting on December 24 and lasting until March 1, I experienced the worst insomnia I had ever experienced, as well as depression, anxiety, and paranoia.  Previously, I was doing well. My parents and I saw a night and day difference. I was also throwing up regularly.  I also became much more angry and moody.  I often felt sick to my stomach.
chills and body aches Narrative: employee states: she felt fine after receiving the vaccine however around 22:k00 that evening she developed chills with no fever and body aches. Her chills disappeared by 6am, after taking Motrin PM but she still had body aches and headache for another 24 hours. she missed work x 2 days and felt "normal" by the 3rd day
fever to 104, thrombocytopenia. Started 2/28/21. had leukocytosis, near syncope and high recurrent fever with all cultures negative. Is improving as of 3/2/21.
Approximately 2 inches below the site of injection patient experiences swelling, redness extending down to the elbow.  Red area is about 1/3 of arm area.  Onset was within 6 hours of administration.  Over the past 48 hours the swelling and redness have reduced but not returned to normal baseline.  No pain except for typical soreness at injection site.  There was an area that was palpable and hard to the touch.  That has softened somewhat but not yet disappeared.
temp 106 axillary-still 102-103 on 13APR98;febrile sz lasting 2-3min;severe papular erythematous measles rash entire body;rash worsened 13ARP98;
rash all over chest to neck and lower face, started resolving on own, but took allergy med before bed.  Mostly gone in am
pt recvd vax;baby found sleepy face down in crib by mom; not breathing; to er by amb;SIDS at 8:56pm;