chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dec 6:  Ear and jaw pain onset Dec 7:  Amplified Noise Dec 8:  Vision Blurry and excessive tearing Dec 9:  Facial paralyzes Dec 9th called the clinic with my concerns and condition.  Spoke to a nurse who consulted with the Dr.  Was told it did not sound like a reaction to the vaccine, that it sounded like Bells Palsy and was coincidental in the timing.   I was not able to get an appt at the clinic until Dec 12th  and was advised to  go to the clinic in the next town.  From there I was advised to go to the ER at their facility.
23MAR95 1230PM tc from mom to PHN; mom stated pt was @ sitters & had been crying (unconsolable) since 930AM; advised to take pt temp & call MD-1PM mom brought pt to clinic; pt cried 3 1/2 hrs but stopped when held;fretful, congested & cough
Serious muscle aches, severe joint pain (shoulders and hips), and headache; nausea and vomiting (probably just because I took a large pill for pain/fever that caught in my throat and seemed to trigger the nausea); insomnia; feverish and chills but didn't take my temperature to confirm a fever. Symptoms started about 7.5 hrs after injection, mild at first but quickly became severe. When I felt well enough the next morning to try to take another pain/fever reducer, I did with no vomiting and was able to eat a small breakfast, and now it is about 27 hrs after injection and I feel almost 100% again. :)
This medically confirmed spontaneous report (initial receipt: 16-Oct-2012) concerns a 72-year-old male patient. On 04-Oct-2012 the patient received AFLURIA (batch number was not provided) injection at a single dose of 0.5 mL intramuscularly. The patient noticed tingling and numbing on the side of the body where the injection occurred. The event outcome was not reported.
pt recv vax & devel an inj site rxn characterized by a 10-cm area of redness, swelling & pain;pt was seen by MD who prescribed warm compresses & APAP;
I immediately became lightheaded and dizzy upon receiving the Pfizer bivalent 4th booster.  I received the booster at approximately 11:45 am. By 8pm I started experiencing moderate to severe body aches, joint and muscle pain, fatigue, nausea, abdominal pain around my liver, Severe headache with intense light sensitivity, and since the booster there has been a noticeable increase in my blood pressure. My blood pressure since booster has been on average about 157/103 and it is not going down. I am very concerned about the blood pressure and the severe headaches as the headaches are not subsiding and are interfering with my daily life and the blood pressure is very concerning. I am also having moderate cramping in left leg that is quite uncomfortable. I have taken blood pressure medication and it had been unable to bring down my bp since the booster.
Temperature has been normal, it is a red, heated rash located on right thigh. The injection was given on Friday 3/6/09 the rash appeared on 3/8/09. Treatment given was BENADRYL and hydrocortisone cream. (Rash covered from underwear line to the knee).
Headache, Fever & NauseaVomiting Narrative:  Employee got the 2nd dose vaccine 2/3/21, at 11am she claimed that later in the day she stred having fever, headache, nausea and vomiting employee missed work 02/04/21.
This is a literature report for the following literature source(s): "A Possible Case of COVID-19 Booster Vaccine-Associated Rhabdomyolysis and Acute Kidney Injury", Journal of Pharmacy Technology. A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "mood disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "pedal edema" (unspecified if ongoing); "asthma" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: remote history in remission. The patient's family history included: "polymyositis rheumatica" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rosuvastatin for hyperlipidemia; Furosemide; Losartan; Metformin. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHABDOMYOLYSIS (medically significant) with onset 13Oct2021, outcome "recovering". The event "rhabdomyolysis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (8-22): (13Oct2021) 211 IU/l; Aldolase (normal high range 8.1): (unspecified date) 18.2 IU/l; Antibody test: (unspecified date) negative; Aspartate aminotransferase (8-45): (13Oct2021) 235 IU/l; Blood creatine phosphokinase (25-190): (13Oct2021) 8394 IU/l; (19Oct2021) 855 IU/l; (20Oct2021) 467 IU/l; Blood creatinine (normal high range 0.8): (11Oct2021) 1.77 mg/dl; (13Oct2021) 2.51 mg/dl; (13Oct2021) 2.73 mg/dl; (19Oct2021) 2.04 mg/dl; (20Oct2021) 2.02 mg/dl; (16Dec2021) 1.16 mg/dl; Glucose-6-phosphate dehydrogenase: (unspecified date) unremarkable; SARS-CoV-2 test: (13Oct2021) negative. Therapeutic measures were taken as a result of rhabdomyolysis. Sender's Comments: As there is limited information in the case provided, the causal association between the event Rhabdomyolysis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Approximately 4 hours following the vaccine the employee was taken to the E.R. for an anaphylactic reaction. She developed hives and the sensation of her throat closing, 102.0 degree temperature, vomiting and body aches. Employee improved with treatment and returned to work within 2 days. A latex rast was performed and was negative.  No other information was provided.
No adverse effect; patient was administered an improperly stored VARIVAX; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On 24-JUN-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132 and expiration date 02-JAN-2021 for prophylaxis (dose, strength, route of administration, and frequency were unknown).  The patient experienced no adverse effects. The temperature excursion was of 6°F to 14°F (8.2 F) for 1 hour and 25 minutes; 15°F to 46°F (16 F) for 5 minutes. No digital data logger was involved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, she was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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. This is an amended report, a lawyer was added as the primary reporter.
PASSED AWAY; COVID-19; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. Initial information was processed with the additional information received from central complaint vigilance on 15-JUN-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, batch number: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got COVID-19 and passed away. The patient died from unknown cause of death. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of COVID-19 was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000182715. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210635272.; Sender's Comments: V0; 20210629346-covid-19 vaccine ad26.cov2.s Passed away. This event is considered unassessable. The event 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
devel a raised, skin colored rash approx 2 inches around inj site on 2nd day p/vax; rash lasted 2-3 days;no fever, no treatment;
neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
Pt developed a welt at site of injection within 24 hrs. Welt progressed so pt sought care from physician who diagnosed cellulitis & prescribed a course of antibiotics for patient.
Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice  Sore calf Sore quad Sore arm (injection site)  Sore neck left side. Fatigue
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 09-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
On 2/5/2021 Patient had an upper body rash on his back with itching.  There was some improvement.  About a week after he got the second does of Moderna on 2/21/2021 his rash was much worse,.  very very red, some blotching redness, some more like pimples with intense itching.  The itching continues 24/7.  At this point the rash is getting worse, under arm pit, about nipples, over chest and one arms and legs.  He itches everywhere not just where the rash is.
Saturday morning, the arm felt sore - I did notice a little red spot. I felt fatigue and a slight headache. Saturday night  to Sunday morning , the spot got bigger (on the injection site). I drew a circle around it. It got a little bigger on Sunday. They other symptoms subsided at the end of Sunday.  The redness didn't seem to be going away on the injection site. On Monday, I just had the red arm and it hurt pretty bad to touch. It was tender and warm to the touch. I was at work and I felt shortness of breath just walking down the hall. I took my pulse while I was standing still and it was about 120. Near the afternoon, I was instructed to go to URGENT CARE to get it checked out. Closer to the afternoon, I started noticing that the heartrate  (on my watch) it got to 164. I went to URGENT CARE and they stated it was a normal reaction to vaccine but because of my tachycardia they wanted to send me to Hospital ER. At ER they weren't worried about injection site (still pretty painful) they were worried about how fast my heartrate was going. The wanted me. The injection site and the tachycardia was back to normal.
NEGATIVE ANTIBODIES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 24-MAR-2021, the subject experienced negative antibodies. On 28-APR-2021, Laboratory data included: IgG (NR: not provided) Negative, and IgM (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibodies was not reported. This report was non-serious.
Left arm red, hot and swollen                 Pt. to take Advil and benadryl
inadvertently administered a high dose flu shot to a 63 year old patient / no AE; inadvertently administered a high dose flu shot to a 63 year old patient / no AE; Initial information and additional information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old patient who received  0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284aa (Expiry date 25-May-2020) via intramuscular route in the left deltoid on 22-Oct-2019 inadvertently.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
This case was reported by a nurse and described a female pt in her mid-20s who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt received three injections of Engerix B on unspecified dates. The reporter stated that the pt had "received at least two, maybe three, pediatric doses of Engerix B." In August 2003, one to two months after the third dose of vaccine, unspecified titers were "negative."
Patient complained of numbness and tingling sensations aroung mouth and lips and cheeks 3 hours after vaccination. Patient also felt dizziness. She took diphenhydramine and symptoms resolves in 30 minutes
Pt vaccinated with Recombivax HB c/o symptoms of a cold. Developed petechiae on his upper & lower extremities. PE revealed buccal ecchymoses. Lab revealed thrombocytopenia & positive monospot. Dx immune thrombocytopenia.
C/o felt light headed, after telling her mom this pt took off in a run. Pt found in floor a few feet away from checkout desk, this occurred within 10 min of receiving vaccine for HPV GARDASIL. Pt assisted to w/c and rested in treatment room. BP originally 94/34 after resting a few minutes 100/70. Checked by office PNP and released home with mom.
ED to Hosp-Admission Discharged  3/30/2021 - 4/17/2021 (18 days)    Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Discharge Summary    Inpatient Discharge Summary   BRIEF OVERVIEW      Admission Date: 3/30/2021    Discharge Date: 04/17/21   Primary Discharge Diagnosis Principal Problem:   Acute respiratory failure with hypoxia (CMS/HCC) Active Problems:   AKI (acute kidney injury) (CMS/HCC)   Type 2 diabetes mellitus with diabetic polyneuropathy, with long-term current use of insulin (CMS/HCC)   Mixed hyperlipidemia   GERD without esophagitis   OSA on CPAP   Pure hypercholesterolemia   COVID-19     Secondary Discharge Diagnosis  Patient Active Problem List   Diagnosis Date Noted ? AKI (acute kidney injury) (CMS/HCC) 03/30/2021     Priority: Medium ? Acute respiratory failure with hypoxia (CMS/HCC) 05/31/2019     Priority: Medium ? COVID-19 03/30/2021     Presenting Problem/History of Present Illness/Reason for Admission From admission H&P "  a 71 y.o. female with Past medical history metabolic syndrome morbid obesity, HL, DM2 on long term insulin, CKD3 due to DM2, OSA on CPAP presenting with fatigue, poor appetite, nausea, loose stools, cough past 1 week. Significant fatigue so got COVID test today and positive sent to ED as 74% on room air patient placed on high flow o2.   Currently reports feeling better on high flow, no chest pain, palpitations, LE swelling or calf tenderness. Confirms DNR/DNI status prior to admit
Sudden unexpected start of menstrual cycle. Last period was 2.5 years ago. Heavy and painful. Rash red spots on upper left thigh.
I received my flu shot around 6:20 PM yesterday evening.  The injection site (upper left arm) was sore fairly quickly after receiving the shot, but the pain was completely manageable and quite frankly, as expected.  Before going to bed. At approximately 12:30 AM on 9/27/12 I woke up with severe pain in both arms, both shoulders, my neck and my upper back. My arms also felt weak, tingly and slightly numb...the best way I can describe the feeling is that it felt as if my arms were 'asleep'.  The pain continued to worsen in my shoulders and neck and my grip strength deteriorated quickly.  The pain continued to be sharp and I was unable to find any relief as it spread to my chest, lower back and abdomen.  The pain was intense and quite severe (as an aside, I generally have a high tolerance for pain having played soccer through a torn ACL and multiple fractures).  This pain was sharp, constant and all-encompassing of my upper body.  I was also experiencing intermittent periods of chills. In an effort to find relief I paced my basement and tried stretching out my upper body.  Unfortunately, nothing seemed to help the pain and sitting and laying were extremely uncomfortable.  Thus, I spent the next 3.5 hours or so pacing my basement trying to get my mind off the pain.  At around 4:00 AM the pain had moved past its peak and was beginning to lessen a bit.  Slowly, but surely, the pain became more tolerable and around 5:30 AM I was finally able to lay down and fall asleep.  Around 7:00 AM I woke up on the couch with my clothes soaked through, almost as if a fever had broken or something. Today I am sore all over my upper body, but don't really have any pain to speak of.  I feel 'off', but I'm guessing that has more to do with lack of sleep than anything.  I am definitely dehydrated today as indicated by my headache and urine color. I have received a flu shot in each of the past four years.  This is the second time I have had a 'reaction' to the immunization.  Two years ago after receiving my flu shot I came down with chills, aches and fever almost exactly six hours after the shot was administered.  Interestingly, it seems it took exactly six hours for me to experience a reaction this year as well.  The other two years I received a flu shot I had no adverse reaction to speak of.