chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had no taste. It was like when I had Covid, but it was different.; I have sections of mouth that have sores; On the bottom of my mouth I see, like a red line; fever of 102°F; headache; I was nauseous; My arm, it hurt so much; My arm was like it was paralyzed, I could barely move it - it hurt so much; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (My arm was like it was paralyzed, I could barely move it - it hurt so much), AGEUSIA (I had no taste. It was like when I had Covid, but it was different.), STOMATITIS (I have sections of mouth that have sores), ORAL MUCOSAL ERYTHEMA (On the bottom of my mouth I see, like a red line) and PYREXIA (fever of 102°F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 26-May-2021.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (My arm was like it was paralyzed, I could barely move it - it hurt so much), PYREXIA (fever of 102°F), HEADACHE (headache), NAUSEA (I was nauseous) and VACCINATION SITE PAIN (My arm, it hurt so much). On 27-Sep-2021, the patient experienced AGEUSIA (I had no taste. It was like when I had Covid, but it was different.), STOMATITIS (I have sections of mouth that have sores) and ORAL MUCOSAL ERYTHEMA (On the bottom of my mouth I see, like a red line). The patient was treated with ETHANOL, THYMOL (LISTERINE ANTISEPTIC) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (My arm was like it was paralyzed, I could barely move it - it hurt so much), AGEUSIA (I had no taste. It was like when I had Covid, but it was different.), STOMATITIS (I have sections of mouth that have sores), ORAL MUCOSAL ERYTHEMA (On the bottom of my mouth I see, like a red line), PYREXIA (fever of 102°F), HEADACHE (headache), NAUSEA (I was nauseous) and VACCINATION SITE PAIN (My arm, it hurt so much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, Body temperature: 102°f (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Patient has used sea salt for the treatment.; Sender's Comments: This case concerns a 65 year-old, female patient with no relevant medical history, who experienced the non serious unexpected adverse event of special interest of Ageusia. The event occurred approximately 3 days after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
VOMITING, CHILLS, MUSCLE PAIN, FATIGUE FOR 24 HOURS
COVID-19 virus test positive; COVID-19 virus test positive; Stiffness; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233732-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and intramuscular, administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "COVID-19 virus test positive"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "Stiffness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and  DRUG INEFFECTIVE , COVID-19 , MUSCULOSKELETAL STIFFNESS   cannot be completely excluded.
"COVID arm"; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness). On 19-Feb-2021, VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness) had resolved. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Patient was scarred to take the second dose and therefore she decided not to take it.   Concomitant products included were blood pressure meds ,cholesterol meds. Treatment included antihistamines and "put ice on it".; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left facial numbness lasted for the remainder of the day and the day after; Left arm soreness; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (at the age of 33-years-old) as a single dose for covid-19 immunization. Medical history included in vitro fertilisation from an unknown date and unknown if ongoing (undergoing egg retrieval 2 weeks prior). Concomitant medication(s) and received within 2 weeks of vaccination included vitamin d; minerals nos, vitamins nos (PRENATAL PLUS); fish oil; dexamethasone; doxycycline hydrochloride (DOXY-1). The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 15:30, the patient experienced left facial numbness lasted for the remainder of the day and the day after. Left arm soreness and general malaise lasted for 36 hours after the initial vaccination. The patient did not receive any treatment. The events were reported as non-serious. Outcome of the event was recovered on an unspecified date in 2021, at the time of this report. Device Date was 17May2021. No further information expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On 16-FEB-2015, these patients were vaccinated with improperly stored doses of ZOSTAVAX injection 19400 plaque forming units (PFU) (lot# K021953 with expiry date: 10-FEB-2016; strength, dose and route of administration unspecified). No co-suspect and concomitant therapies were reported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
6:00 am I experienced a minor Vasovagal episode. I felt my blood pressure drop, I went a little cold, I got a little dizzy, and my stomach gurgled. I lay down on the couch for only 1 minute. I suddenly felt the need to have another bowel movement (since I'd already had a healthy one about 30 minutes prior). I got up and went to the bathroom and had another BM, this time really soft, but a substantial amount. As soon as I got up from the toilet, I felt better. However, it is now 3:50 pm, and I have been a little tired all day. My muscles have been achy (especially the back of my neck), and I have had very little appetite. I have drunk 2 bottles of water, and I only ate half a PBJ for lunch.
COVID-19 BREAKTHROUGH: 33 y/o female presents to the ED with the CC of Cough and CP x days. Patient with no PMH presented to the ED due to worsening Cough and CP x days. Pt states that about 3 week her daughter started to have URI symptoms after returning from Daycare. Pt states that she started to have Fever, Chills, and Hoarse voice. Pt states that her symptoms continued to worsen hence she went to hospital 5/2, pt states that she was diagnosed w/ Seasonal allergies and Rx Steroids. Pt states that she continued to worsen and had N/V. Pt c/o cough and CP. Pt denies any SOB. Pt denies any fever but c/o chills.
Hyperacusis, Tinnitus, Head Pressure, Neck Pain, Dizziness, Jaw Pain, Gum Pain, Ear Fluttering, Ear pain.  Started on 4/17/2021
Pfizer-BioNTech COVID-19 Vaccine EUA Patient is a 37 year old female who presents with dyspnea and myalgias following her second COVID vaccination today. Patient denies any history of vaccine associated reactions. After her first dose of the COVID vaccine she had fever, chills and myalgias as well as some sensory changes to the left arm. These symptoms lasted for around a day before resolving. Today, she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain is moderately severe and worse with deep inspiration. Patient also having back aches and feeling clammy. Patient re-presented to the vaccine site and was brought to the emergency department for evaluation.  Patient received acetaminophen 1000mg orally, ketorolac 15mg IV, and lactated ringers 1000ml IV and was discharged.
This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time.  Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
optical migraine; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine (optical migraine). Concurrent medical conditions included Pollen allergy, Dust allergy, Egg allergy and Dairy intolerance. Concomitant products included PARACETAMOL (TYLENOL), DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM), DIAZEPAM (VALIUM), RALOXIFENE HYDROCHLORIDE (EVISTA), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]), BIOTIN, POLYCARBOPHIL CALCIUM (FIBER), CYANOCOBALAMIN (VIT B12) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache). At the time of the report, OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-109782 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109782:MOD21-055918
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe
Expired Bexsero used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39ab, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 27-Sept-2022 Reporter's comment: Nothing was reported. The reporter consented to follow-up with prescriber. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Weakness-chills-hot/cold flashes-fever as high as 102-Sore muscles-Fatigue-Sweating-Dizzy-Nausea-Headache-Light headed-brain fog-felt faint-drained physically- This all last about 12-20hours-still a week later still feel fatigued and tired all the time, don't really have any energy
temperature excursion due to the refrigerator door being left opened with no reported adverse event; patients administered TUBERSOL post excursion with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 35 years old female patient who had temperature excursion due to the refrigerator door being left opened of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and Tuberculin test [Tubersol] with no reported adverse event and was administered Tuberculin Test [Tubersol] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The suspect diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] Suspension for injection pertains to batch number: unknown (strength, dosage, route of administration, expiry date and administration site: unknown) for prophylactic vaccination. The batch number is requested.  On 26-Jul-2022, the patient received a dose of Tubersol (tuberculin test) Solution for injection with lot number: C5841AB and expiry date: 17-Jun-2023 at a dose of 0.1 mL total via intradermal route on Left Forearm for (strength: unknown) Tuberculin test.  On 26-Jul-2022, the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and Tuberculin test [Tubersol] were exposed to temperature at a high of 21.2C out of range for 8 hours (temperature excursion) due to the refrigerator door being left opened with no reported adverse event (product storage error) (Latency: Same day).  On 26-Jul-2022, the patient received a dose of tubersol post excursion with no reported adverse event (poor quality product administered) (Latency: Same Day) following the first dose intake of Tuberculin Test.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown    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.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 03-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K019388, expiration date 20-FEB-2016) (route, strength and anatomical location were not specified). There was no concomitant medication reported. No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Patient rec'd Moderna  vax 3/14/22 @ 1400. Symptoms occured 3/15/22 @ 1530. Symptoms reported are "high fever (102.5F) and fainting."  Patient did not receive medical care after fall.  Patient self medicated with "Tylenol and went to bed."  Patient reported incident at Oncology clinic 3/17/22 feeling "mostly back to normal:.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD underwent a temperature excursion. On 21-AUG-2014, the patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Redness and swelling 2 x 2 1/2" left thigh site injection. Redness and swelling 1 x1" right thigh site of injection.
Pt recv vax & exp "spacing out,staring into space & jerking movements of his head while walking".No fever. 05Nov97 pt exp 101t. 06Nov97 "child seemed fine".
Pt states after receiving 2 COVID Vaccines and 2 booster all of which were Pfizer vaccines she has developed neuropathy in her feet and legs and now also in her arms she states that this has steadily gotten worse over the past few months.  She did also have COVID and I am not sure if this is related to the vaccines or from her COVID history, Auto Immune Disease, history of Fibromyalgia or other. Nevertheless the patient is convinced that it is related to the vaccines and so I am reporting to VAERS.
Localized erythema, swelling to left upper arm and shoulder. No difficulty breathing, no hives.
Immense chronic fatigue; Brain fog; Shortness of breath; Felt that I would faint; Chronic migraines that lasted for six months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: ER8730) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Carrots, Celery and Peas" (unspecified if ongoing), notes: Verbatim: known allergies: Carrots, Celery and Peas; "Known allergies: Peaches and Cantaloupe" (unspecified if ongoing), notes: Verbatim: Known allergies: Peaches and Cantaloupe. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: Apr2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (disability) with onset 27Apr2021, outcome "recovering", described as "Chronic migraines that lasted for six months"; FATIGUE (disability) with onset May2021, outcome "recovering", described as "Immense chronic fatigue"; FEELING ABNORMAL (disability) with onset May2021, outcome "recovering", described as "Brain fog"; DYSPNOEA (disability) with onset May2021, outcome "recovering", described as "Shortness of breath"; DIZZINESS (disability) with onset May2021, outcome "recovering", described as "Felt that I would faint". The events "chronic migraines that lasted for six months", "immense chronic fatigue", "brain fog", "shortness of breath" and "felt that i would faint" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results, notes: Blood workup; magnetic resonance imaging: (2021) unknown results, notes: MRI scans. Therapeutic measures were not taken as a result of migraine, fatigue, feeling abnormal, dyspnoea, dizziness. Clinical course: Within a week of the second dose, I started having. A month after the second dose, I began experiencing. I was essentially disabled and could not live my life as I did before. I went to several doctor and they could not diagnose anything. I have never tested positive for COVID. These effects only began to go away six months after the second dose. Patient did not take any other vaccine in four weeks. Patient did not have Covid -19 prior to vaccination and did not taken Covid-19 test after vaccination.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Patient developed pain in the same distribution as her previous episode of shingles which was sevral years ago.
During administration, dose leaked out from the side of BD Integra syringe due to a faulty syringe. I couldn't determine how much of the dose was administered. Per CDC recommendation, offered additional full dose to ensure patient is adequately protected. Patient accepted the recommendation and another dose was administered to the left arm few inches away. Patient reports no reaction to previous vaccinations. Counseled patient to stay hydrated and take tylenol around the clock if develop any symptoms.