chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden onset of fatigue , Malaise, strong palor and notable change in complexion. Persistent tiredness , lack of energy, increased sleeping, diminished appetite , unusual behaviours eg. lying down after full nights sleep, rubbing head along floor repeatedly, persistent complaint of tiredness despite full night sleep. Pale in complexion, darker under eyes.
Started as one large hive on neck around 5pm. Then more and more appeared covering his back, stomach, arms, and neck by 5:30pm. Small and large raised, red bumps that are apparently itchy as he is constantly trying to scratch. Called ER and was advised to give benedryl and watch his breathing, if breathing becomes labored take to ER. If hives are still present next day take to regular physician.
sorness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sorness in arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid activity decreased (UNDERACTIVE THYROID). Previously administered products included for an unreported indication: ZOSTER (SHINGRIX) since an unknown date and INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE (FLU SHOT) since an unknown date. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3, MULTIVITAMIN ACTIVE WOMAN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), LACTOBACILLUS ACIDOPHILUS (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), CALCIUM and CLARITHROMYCIN (BIAXIN) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (sorness in arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 325 mg. At the time of the report, VACCINATION SITE PAIN (sorness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073679 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR Form received on 19-May-2021  and it mentioned patient height and weight also outcome of the events , patient contact information was updated, other relevant history was updated, concomitant medication was updated.; Sender's Comments:  MOD-2021-073679:second dose dose
The patient complains of redness, swelling, and itching over an area of 2-3" surrounding administration area and worsening symptoms of day 3 post administration.
Took the vaccine at 6:00 P.M. the night before, no side effects besides occasional dull throbbing pain Woke up at 7:30 A.M., right arm is sore and hurts to lift, experiencing chills, fever of 101.3
No adverse effects until 1/29/2021, 11:30p. itching and pain noted at injection site.  Close examination on 1/30  8:00am revealed a 5 cm diameter red  hard spot  at the injection site .  Pain was less severe but still present.
This was a J&J vaccine but I didn't see that as a choice in the drop down. My son passed away on June 5 2021.  He had severe nausea
This spontaneous case, initially received on 09-Oct-2018, reported by other healthcare professional (nurse), concerns a 27-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 09-Oct-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195244 and expiry date: 30-Jun-2018). The patient did not experience any adverse event after the vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the nurse on 31-Oct-2018: It was reported that, the patient had not experienced any adverse event after vaccination. No changes were made in the narrative.
This spontaneous report as received from a consumer refers to her husband, a male patient of unknown age. Eight years ago, in approximately October 2005, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) injection. Concomitant medications were not reported. On an unknown date (reported as a couple of months ago), the patient had a severe case of dizziness, he got shingles and a little blister by his ear. The outcome of shingles and dizziness was not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Patient was administered HPV vaccine in clinic. Waited an hour for additional examination in clinic. Patient went home and mother reported later that evening approximately > 2 hours since administration, patient broke out in a full body rash and patient felt "hot all over." Mother denied respiratory distress. Rash subsided without medication.
Presented on sick call on 19 Feb with CC: disoriented, hallucinating and bowel and urine incontinent.  Admitted to medical center on 20 Feb.  Intubated in ICU.  Given IV Solumedrol x 4 days.  IVIG started in late Feb 08 (after 2/26/08) with marked improvement after course of IVIG.  Discharged to rehab around 12 Mar 2008.  7 May 2008, Neurology Note: Patient seen briefly on follow-up.  Patient is doing well.  Patient had repeat MRI brain, c/t-spine yest - showed near-resolution of intracranial signal abnormalities; there appear to be 2 small residual facl, L frontal, but the signal abn in the medulia, pons, thalamus have essentially resolved; in the c-spine, the prior C4 5 lesion is much less pronounced, with 7 some residual signal abn.  The MRI fits with patient's marked clinical improvement.  No new recommendations.  Note from 27 May: Multiple fluctuating neuro deficits, problem with pain perception.  8/8/08 Medical records  & vax records reviewed. FINAL DX: acute demyelinating encephalopathy Records reveal patient experienced purulent cough w/post-tussive vomiting x 3 wks on 2/13 w/fever 101.2, nasal congestion & discharge, myalgias, chills, night sweats, HA, reduced oral intake.  Dx w/pneumonia & tx w/IM & oral antibiotics.  Improved until 2/19 when again spiked fever 103.5, found disoriented, delerious, hallucinating, incontinent of bowel & urine.  Exam at that time revealed  rales/crackles.  Next note is for 5/7/08 Neuro clinic where MRI of brain & c&t-spine revealed significant improvement but pt w/residual deficits.  12/22/08 Received hospital medical records of 2/19-3/12/2008. FINAL DX: acute demyelinating encephalomyelitis; dysphagia; deconditioning Records reveal patient experienced altered mental status, lconjunctival injection, bilateral rhonchi, oss of bladder & bowel control, unsteady gait, dizziness, fever.  Had been treated for pneumonia 2/13.  Admitted ICU.  Neuro, Optho, ENT consult done.  Tx w/IV antivirals.  Transferrd to higher level of care.  Intubated x/1 week.  Developed esotropia, LUE superficial vein clot, hematuria, right vocal cord paralysis.  Tx w/tube feedings, steroids & IVIG x 3.  Received PT/OT/ST & was able to use rolling walker by d/c to inpatient rehab hospital.   Follow-up: Lost to follow-up since June 2008. Last clinical evaluation while in military(a Hache) - June 06. Pt had multiple labs done. Please call if results are not accessible to you.
developed tinnitus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "developed tinnitus".  Additional Information: The patient received 1st Pfizer vaccine dose on 12Jan2021 and developed tinnitus. Patient had previously reported to VAERS and Pfizer. Patient is calling today about getting the 2nd dose. Patient needs a confirmation about does she need to repeat the first dose due to the length of time between dose 1 and 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythematous indurated area on left deltoid started approx 24 hrs post meningococcal immunization. Improved 7/28/14, but still itchy w/sl. erythema.
Symptoms continued and worsened following the second vaccination.; Achenbach Syndrome; painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally; painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally; This is a spontaneous report from a contactable physician. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) in the right arm on 21Mar2021 at 14:00 (at the age of 65-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) in the right arm on 12Apr2021 at 15:00 (at the age of 66-years-old); both as a single dose for COVID-19 immunisation. Medical history included smoldering multiple myeloma, hyperlipidemia, hypertension, hepatitis c ((treated and cleared in 2019), sickle cell trait, stroke and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem hydrochloride (CARTIA XT), clopidogrel bisulfate (PLAVIX), docusate sodium (COLACE), ferrous sulfate (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR) and unspecified multivitamins; all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) for unspecified indication from unknown date and experienced drug allergy. On 25Mar2021, about 4 to 5 days after first vaccination, patient developed painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally. The patient saw a hand specialist and was diagnosed with Achenbach Syndrome. The symptoms continued and worsened following the second vaccination. The patient never had similar symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally, Achenbach Syndrome, symptoms continued and worsened was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Immunization given on 12/5 at 5 PM. Friday morning 12/7 noticed face and ears swollen, red, and itching, also both arms. No actual rash. No difficulty breathing or swallowing. Advised to go to ER or urgent care but patient decided not to go.
Got really disoriented; Nose was gushing blood for an hour and half; Felt horrible and horrific; Couldn't breath; Nose was blocked; Felt ill for 2weeks,Feels like she's not right till today; Will not receive second dose; Headache; Fatigue,extremly tired; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Got really disoriented), EPISTAXIS (Nose was gushing blood for an hour and half), FEAR (Felt horrible and horrific), DYSPNOEA (Couldn't breath) and NASAL CONGESTION (Nose was blocked) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Got really disoriented), EPISTAXIS (Nose was gushing blood for an hour and half), FEAR (Felt horrible and horrific), DYSPNOEA (Couldn't breath), NASAL CONGESTION (Nose was blocked), ILLNESS (Felt ill for 2weeks,Feels like she's not right till today), PRODUCT DOSE OMISSION ISSUE (Will not receive second dose), HEADACHE (Headache), FATIGUE (Fatigue,extremly tired) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DISORIENTATION (Got really disoriented), EPISTAXIS (Nose was gushing blood for an hour and half), FEAR (Felt horrible and horrific), DYSPNOEA (Couldn't breath), NASAL CONGESTION (Nose was blocked), ILLNESS (Felt ill for 2weeks,Feels like she's not right till today), PRODUCT DOSE OMISSION ISSUE (Will not receive second dose), HEADACHE (Headache), FATIGUE (Fatigue,extremly tired) and MYALGIA (Muscle pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications reported.
p/vax pt exp redness, warmth, induration, swelling at inj site;
Have very very STRONG reason to believe that I have undiagnosed MCAS and each dose has triggered a flare. 4 hours after first dose - severe nausea, diarrhoea, fainting: episode lasted about 15 to 20 minutes. 24 hours after second dose - headache, chest tightness, dizziness, stuffy ears, inflammation, throat tightness, lasting about one hour or less. Possible mild lingering symptoms.
Within 2 hrs of DTaP, IPV, flu vaccine child became lethargic, whiney, inconsolable with forceful episode of emesis.
Immediately felt cramping in my abdominal.  Minutes later my feet and legs went numb, following ringing in my ears. I began to sweat and needed to lay down. My throat began to tighten and swallowing became difficult.  I was closely monitored for about 30 minutes, as my symptoms started to lessen.  It?s two days later and the cramps and weakness/ numbness are still there.
At 246pm - Pt alerted the nurse he was felling nauseous. Pt was assisted to wheelchair and to private area.Pt was pale and diaphoretic, pt vomited 3 times. 252 pm     BP 100/80 HR 75 02- 100% Resp 20  Pt states he feels much better after vomiting.  256pm- Pt color and skin returned to WNL after vomiting. BP  110/60 Hr 68 resp 18 02 100%  303pm-  BP 110/72 Hr 58 02 99% Resp 16  Pt states he smoked marijuana and ate food prior to arrival , and that he had similar nausea after first dose but did not vomit the first time because he did not have anything to vomit. Pt states he also has hx of social anxiety.   308pm-  O2 - 99%  resp 16 HR 68  Pt mother in parking lot to transport pt home.  Pt states he feels better and is ready to go home. Pt feels good upon standing and standing VSS -  BP 110/77  HR 68 02 sat 99% resp 18  Reviewed discharge instructions with pt and to call emergency responders or go to nearest ED if symptoms worsen. Pt was provided vsafe flyer. Steady gait exiting clinic.
2" area of redness/itching on arm at injection site, developed 2 days, post vax.
Patient had COVID diagnosed and treated as outpatient on 12/24.  She developed SOB with the infection and this persisted afterwards and did not resolve.  She received first dose of Moderna vaccine and next day had fevers, myalgias, shortness of breath and hypoxia. She is now admitted to our facility with bilateral diffuse ground glass opacities and is severly hypoxic on high flow nasal cannula.  She also has hemoptysis. procalcitonin is negative; BNP is normal; troponin normal.
I woke up in the middle of the night with severe pain of my tongue and noted many ulcers on both sides of my tongue and had severe pain of my tongue that lasted about 4 days of severe pain making it hard to eat or drink or talk then started to slowly get better.  In addition I had diffuse achiness of my joints and muscles and was very fatigued for about 4 days and then slowly improved.  It took at least 8 days to feel back to normal but even after 2 weeks some ulcers of the tongue remained.
I woke on  the 27th and I was bleeding  considerably. I did not seek medical care for that particularly but it was challenging. I contacted Dr. because my depression worsened to the point where I was having thoughts of suicide and needed additional medication to manage it. I was placed on Wellbutrin in addition to the other medications. I had 2 more very heavy periods but eventually it became more normal. The Wellbutrin helped to mitigate the other symptoms. No medical or laboratory test were completed. I do believe that I have completely recovered with taking the additional medication.
Emesis started at dinner time 11/05/2005, gassy and abdominal pain evening of 11/05/2005. Increased nasal symptoms, sneezing on 11/07/2005.
After he went to bed the same day he received the vaccine, his upper and lower arm swelled up and was red. During the day the fluid would dissipate and then swell up again during  the night. After the 4th day, the swelling dissipated and after 7 days he was back to normal. At one point, he had a swelling in his lower arm the size of a small potato under the skin.
05sep90 pt vax hepta B. 11sep90 pt ex fatigue, malaise, abdo cramps, rash, itching, myalgia and fever. sx resolved
Flu like symptoms the day after vaccination. Including severe headache and bodyaches.  The following symptoms started about four days after the vaccination? Severe headaches, shortness of breath, difficulty breathing, abdominal pain.
Knee issue if immobile for extended period of time have a severe amount of pain and difficulty moving. I need several minutes to move around. Like if the knee had locked. Never had this issue until after second dose. Fatigue tied to my knee.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUN-2015, the patient was treated by a physician for a vesicular outbreak, for the diagnosed of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed LIDODERM for management for his 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-DEC-2014, a dose of VARIVAX (Merck) (lot#, strength, dosage, frequency and route unknown) which was expired on 30-NOV-2014 was inadvertently administered to the patient. No adverse effects were reported. Additional information has been requested.
Moderna COVID?19 Vaccine At approximately 1630 Friday, 12FEB2021, I noticed injection site redness measuring a diameter of approximately 1 inch. By 2230, the redness had increased to approximately 2 inches and a knot had formed at the injection site measuring approximately 1 inch in diameter and 0.25 inches in height.
two hours after the vax her right eye swollen up, face was very itchy and cant feel tongue, teeth or lips
mom reports episode of crying non-stop for 6 to 8hrs; cry was shrill per mom's account
chest pain with deep inspiration while laying down that started the evening of the shot.  Continued for 24 hours.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 8-year-old female patient who received KINRIX (batch number T7E4A, expiry date 2nd June 2020) for prophylaxis. On 6th November 2018, the patient received KINRIX. On 6th November 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The vaccine administration facility was the same as that of primary reporter. The patient inadvertently received KINRIX at an age of 8 year, which led to inappropriate age at vaccine administered. The healthcare professional consented to follow up. Follow up information received from other health professional on 21st December 2018: This case US2018203449 was identified as duplicate of case US2018230982. The case US2018230982 will be deleted and all the future correspondence will be added in the present case which stands as case of record for this patient. The duplicate case contained the following additional information: The patient received KINRIX vaccine on an unknown arm. Less than a year after receiving KINRIX, the patient experienced injection site redness. However, the reporter was unsure if it was in the arm vaccinated with KINRIX. It was unknown if the reporter considered the injection site redness to be related to KINRIX. The reporter consented to follow up.
Intense pain with tingling and numbness through left arm and hand immediately upon administration. I immediately told the administrator who informed me that happens sometimes and suggested I move my arm around. Three minutes later, I experienced a vasovagal syncope without losing consciousness and received medical attention from on-site paramedics. The paramedics monitored me and I left the event approximately 25 minutes later. The arm pain subsided after a few minutes and my blood pressure and heart rate had returned to normal about twenty minutes later. I did not receive further medical attention.
This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # L048848 with expiry date 09-AUG-2018 and lot# M018625 with expiry date 11-AUG-2018) (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were rerpoted in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Temp 104.1 after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temp 104.1 after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temp 104.1 after vaccine). At the time of the report, PYREXIA (Temp 104.1 after vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.1 (High) 104.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.  No further information is expected at this time.