chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache pain at injection site, headache Narrative:  day 1 - pain at injection site; day 2 - pain at injection site and headache; day 3 - mild pain at injection site
peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered.  No treatment received for the events.   Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
extreme pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain in the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2AO) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (extreme pain in the injection site). At the time of the report, VACCINATION SITE PAIN (extreme pain in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol every time the pain appears.   Reporter did not allow further contact
Patient awoke with dizziness and muscle spasms originating at the soles of her feet and radiating upwards throughout her body.  She also reported that she had to urinate an unusually high number of times throughout the night.  These events resolved on their own.
Fever 102 degrees, runny nose, rash (papular) on forearms and face.
Within 2 minutes of receiving vax patient experienced a bright red, swollen area that was hard and tender. There was a small amount of whitish color at the center. The patient was treated with Benadryl.
About 5 min after vaccine, after laying down walked to waiting room and sat in a chair, said he felt faint, was staring, walked him back to a room to lay down, elevated his feet, cold cloth on forehead, laid for 30-40 min, sat for 30-40 min felt better did have slight HA which improved, left with mom.
Hives; Initial information received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 58 years old female patient who experienced hives while receiving vaccine tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included fluconazole (Diflucan) and venlafaxine hydrochloride (Effexor-XR).  On 25-Feb-2008, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer (with an unknown strength, formulation, frequency, lot number and expiry date) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious hives (urticaria) (unknown latency) following the administration of tetanus toxoid.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (hives).  At time of reporting, the outcome was unknown for the event hives.
temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event; administered to patients after tempearature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 34 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion with no reported adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA and expiry date 30-Jun-2023) Suspension for injection (with an unknown strength, dose, frequency, route, administration site) for immunization.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (with an unknown strength, dose, frequency, route, lot number, expiry date administration site) for prophylactic vaccination.  On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) and On 23-SEP-2022 the patient was administered with vaccineinfluenza quadrival a-b vaccine and on unknown date administered with diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (poor quality product administered).  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events.  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 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.
I administered Covid 19 immunization and pt was waiting the 15 minutes for observation.  About 5 minutes later, companion said pt said she felt like she was going to faint. We gave her a cold pack for neck and I was monitering breathing and consciousness. Pt said she sill felt faint, was having difficulty breathing, difficulty seeing and hearing. Lips turned faintly blue so technician called 911 and I administered 1 dose of Epipen in left thigh.  A few minutes later I gave 10ml of Dihphenhydramine liquid.  EMTs responded quickly, checked pt  but symptoms resolved and she was not transported.  After event patient did say she had not eaten that morning.
Sore Arm, Little Swelling, Chills, Aching Joints, Slight Fever
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/27/2023 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 3/27/2023 ACUTE RESPIRATORY FAILURE HYPOXIA 4/10/2023 ACUTE RESPIRATORY FAILURE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/27/2023 ATHEROSCLEROSIS OF AORTA ACUTE RESPIRATORY FAILURE 3/27/2023 ATHEROSCLEROSIS OF AORTA HYPOXIA 4/10/2023 ATHEROSCLEROSIS OF AORTA
PATIENT TOO OLD FOR H1N1 FLUMIST, BUT STILL INSISTED ON GETTING IT. OKAY'D BY DOCTOR. PATIENT REMAINS HEALTHY AND NO ADVERSE EFFECTS FROM VACCINE.
pt recv vax 12AUG96 & 13AUG96 pt devel a few vesicular lesions;14AUG96 pt had approx 30 vesicular lesions;by 15AUG96 pt had devel approx 200 lesions;pt went to MD dx w/chickenpox;
Pt was given Varicella in (R) upper arm on 10/16/12. Pt the next morning noticed swelling and redness. Increasing by 10/18/12. Pt seen by Physician Asst. Pt informed to take Ibuprofen and ice. Return if worsens.
I had lung congestion; I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID; I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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 31Mar2022, outcome "recovered" (2022) and all described as "I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID"; PULMONARY CONGESTION (medically significant) with onset Apr2022, outcome "recovered" (2022), described as "I had lung congestion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Saturday I had a positive antigen test again; (05Apr2022) Positive, notes: still testing positive in an antigen test; (unspecified date) Negative, notes: Thursday evening was the first time I tested negative; (31Mar2022) Positive, notes: I tested first positive for COVID; (17Apr2022) negative, notes: I finally tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, pulmonary congestion.  Clinical course: Paxlovid Rebound: On 31Mar Patient tested first positive for COVID. Patient started Paxlovid same evening. On Tuesday morning 05Apr patient completed my Paxlovid but was still testing positive in an antigen test. Thursday evening was the first time patient tested negative. Saturday patient had a positive antigen test again. Monday patient had lung congestion. Tuesday patient started second course of Paxlovid that finally cleared the infection. Sunday 17Apr patient finally tested negative and it has remained that way. Patient had 3 Pfizer shots in 2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium
pharmacist failed to fill out the patient's VAR form instead just writing "same info" on mom's var
After several hours, patient's arm started swelling like a golf ball, continued to increase.  Then his head started swelling all over as if he was beat up.  His arm continued to swell after cold compresses.  I called his physician (on call) & spoke w/ person who instructed me to alternate w/ Motrin & Benadryl along with the cold compresses.  The nurse monitored via phone every 3 hours. After about 3 days, swelling had decreased but it took 1 week before all symptoms of swelling, fever & irritability went away.
following  COVID booster on 10/28- patient developed abdominal pain, flank pain, urinary retention and constipation.  imaging showed possible mild infrarenal aortitis. now with increasing CRP and worsening leukocytosis . patient also with progressive generalized pain, more on the bilateral lower extremities, hand/joint pain. has abnormal UA - but suspect due to presence of foley/colonization and not true UTI. being empirically treated with antibiotics so far, I think work up suggestive of inflammatory process. vasculitis work up has been negative to date-including ANA/ANCA, complement levels
Vaccinated on 12/18/2020 and 1/8/2021. Tested positive for COVID-19 on 6/1/2021 after symptoms started 5/31/2021 and known exposure on 5/27/2021. Was advised to report on this site.
Tinnitus; Ongoing fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. On 01May2021, the patient experienced tinnitus and fatigue which was ongoing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event tinnitus and included tinnitus therapy and hearing treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and ongoing fatigue were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
From the itchy ankles it progressed to first mild itch and then hives on upper torso and arms by day four and has  continued to less and less until today. Accompanied by headache and mildly upset stomach. it's now 10/31/2016 and I have yet to recover fully.
Patient presents in fulminant liver failure. Per GI team documentation: "We do not have an etiology for this acute liver injury.  The differential diagnosis includes drug-induced liver injury, acute viral hepatitis, ischemic hepatitis, autoimmune hepatitis and indeterminate.  Acetaminophen and salicylate levels are negative.  Alcohol level is negative.  Although patient does abuse alcohol on a daily basis, her presentation is not consistent with acute alcoholic hepatitis.  Serologies have been sent to evaluate the differential diagnosis and other potential causes of acute liver injury.  Liver imaging including Doppler ultrasound does not reveal any abnormality and there is no evidence of chronic liver disease."  We have found four case reports of hepatitis/autoimmune hepatitis related to mRNA vaccines. We have additionally had a case of fulminant liver failure in our community a few months back of which no other etiology was identified other then mRNA vaccine. Because of such, and with no other identifiable cause, we are concerned her acute sudden liver failure was vaccine induced.
Patient currently experiencing pain, swelling, redness and itching covering 3/4 of her left arm. She started taking ibuprofen on 09/28/2018 for pain and swelling. Symptoms continued to worsen. Patient starting BENADRYL 50mg every 6 hours on 09/29/2018. Will contact doctor if reactions continues to worsen.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2008, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a hospital for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The causality was related.
mildly faint, heavy, mild urticaria. Evaluated be EMS-Cleared
I received my 4th vaccine shot on 4/18/2022.  I began to feel COVID symptoms on 5/12/2022, which became worse over next several days.  Symptoms included:  sore throat, ear stuffiness, congestion, runny nose, extreme fatigue, cough, fever, chills, sweating, eye watering, and blurry vision.
diarrhea; loss of appetite; feeling sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), MALAISE (feeling sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), MALAISE (feeling sick) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), MALAISE (feeling sick) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
pt recv vax & devel a pruritic rash around neck;rash was more dense on lt side;also devel sl induration & rash @ the site of vax;tx w/DPH & calamine lotion & recovered;
Pt recvd vax on 29APR92  & exp severe h/a & visual blurring;
R09.02 HYPOXEMIA 4/30/2023 GALLBLADDER CANCER R09.02 HYPOXEMIA 4/30/2023 SHORTNESS OF BREATH R09.02 HYPOXEMIA 4/30/2023 LIVER ABSCESS R09.02 HYPOXEMIA 4/30/2023 PLEURAL EFFUSION
pt was admitted back to the hospital on june 9 2021. pt also was entered in the emergency room for about a week an a half and with flare ups, no specific dates provided but it may have been due to pt getting a covid 19 shot. pt switched to entyvio but symptoms are still the same and is in the process of getting switched back to humira. no further details provided.
Date and time adverse event started: 3-24-21 noon felt bad, 120-140 HR. took tylenol prior to call. HR currently 115. 100.3Temp.  recommended tylenol,ibuprofen, naproxen to keep high fever at bay as well as lot of fluids to keep hydrated, and rest. Informed them fever can cause tachycardia but tachycardia alone would be a bit more concerning. Had spouse check HR & temp while on the call. Wife stated a HR of 115 and temp of 100.3F after taking 1g of tylenol an hour prior to call. informed her the HR is improving likely from a higher temp prior to medication. Advised this can be managed at home. Informed them of concerning symptoms associated with the tachycardia such as but not limited to SOB, CP, disorientation. both verbalized understanding.
steady increase of significant tachycardia accompanied with shortness of breath and intolerance to heat throughout the past several months, dizziness and tunnel vision upon standing
Felt cold all of the sudden after working out; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold all of the sudden after working out) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pityriasis rosea (been using Steroid cream since then) since 04-May-2021.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced FEELING COLD (Felt cold all of the sudden after working out). At the time of the report, FEELING COLD (Felt cold all of the sudden after working out) outcome was unknown.            Concomitant medications included  multivitamins as supplement.  Treatment information included Steroid Cream for rashes, recommended by the dermatologist.   This case was linked to MOD-2021-251531 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Non-Significant follow-up received and included patient denies consent.
On Friday 08/10/12, patient started to experience oliguria told mom 8/15/12. Visited PA on 08/16/12. UA came back clear. Started on Antibiotic & Tamsulosin 8/17/12. By 8/19/12, symptoms subsided & medication stopped.
Information has been received from a consumer concerning his daughter a 27 year old female with no pertinent medical history and no allergies who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). In March 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). In early June 2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. Middle to late in June 2008, the patient began to experienced a burning sensation in the area of her bladder when urinating and she had a more frequent need to urinate than usual. Originally her physician treated this as an urinary tract infection and more recently she was diagnosed as having an overactive bladder. Blood tests and urine sample tests were performed. At the time of this report there was slight improvement. No further information is available.
Patient told me today that the day after her flu shot she woke up dizzy and coughing non-stop for 4 hours straight. Then both side effects stopped. She told me this happened once before after a flu shot.
On 4/21/2021 I experienced dizziness and nausea upon rising from bed, and later rising from toilet, and picking up something off floor. It felt like the whole room was swirling about me. I spent the day resting but found laying down brought on the symptoms. On 4/22 and 4/23 I have tried to rise slower and continue to experience nausea, dizziness, vertigo and have had the symptoms while laying in bed unmoving as well as when arising from bed. I am fearful of walking unsteadily and have used my cane [for my arthritis which doesn't require it now]- for safety sake.