chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suicidal ideation; This is a spontaneous report from a contactable physician. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced suicidal ideation 10 days after vaccination in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of suicidal ideation included referral to behavioral treatment. The outcome of the event was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Suicidal ideation and the suspect drug BNT162B2 cannot be excluded. case can be reassess once additional information becomes available. 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.
Patient stated that she had appointment with oncologist and had no problem on 03/24/2021.   The night of 03/24/2021 she awoke in the middle of the night with intense pain in her lymph nodes on the side of her body that the vaccine was administered (Left Deltoid).   At first she was scared that she was having  more issues related to her cancer.    Oncologist conferred with his partner and determined this to be a common reaction to the Moderna Vaccine.    Notified the pharmacy at this point.   Was instructed to follow up with her doctor if symptoms did not improve.
bone pain; chills; headache; 99.7 temperature; sleepy; weakness; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of   in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX).    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included carpal tunnel syndrome. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome). At the time of the report, pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
stability of the Imovax vaccine once it was reconstituted. Her husband stated that the product was mixed 45 minutes prior to administration, no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves male patient of unknown age who was vaccinated with first and third doses of RABIES (HDC) VACCINE [IMOVAX RABIES] (injection, lot number and expiration date were not reported) and the second dose of RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] (lot number and expiration date were not reported) after being bitten by a bat, via unknown route in unknown administration site for post-exposure immunization. And the patient reported that the imovax vaccine was reconstituted and was mixed 45 minutes prior to administration (PT:poor quality product administered).  Medical history included Animal bite.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to deteriorated drug administered.  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at a dose of Took two Aleve. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Information has been received from registered nurse concerning a 65 year old female patient with allergies to penicillin, CIPRO, and THEO-DUR who was vaccinated with the first (lot # not reported) and second dose (Lot # 662270/1135Y) of PNEUMOVAX 23 on 11-MAR-1998 and 09-NOV-2009 respectively. Concomitant therapy included montelukast sodium (MSD), PROTONIX and SEREVENT. On 09-NOV-2009 the patient received the second dose in the right deltoid, IM at 11:00 AM and the same day at 17:00 pm her right arm started to hurt. It was red, swollen and hot. The patient put ice on the area on 09-NOV-2009. The area affected covers 90% of the upper arm. The patient has sought medical attention at office visit. Lab diagnostics studies were not performed. At the time of this report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Tenderness, slight swelling, bruising, and pain on movement of arm gradually subsided over the following week. Bruise is still visible. Stomach upset (discomfort, reflux, loose bowels) began the following day and persisted for several days. Fatigue continued for a full week.
back pain; herniated disc; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: BACK PAIN (non-serious), outcome "unknown"; INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "herniated disc".  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up
little ache; little swollen; a rash and a round circle all around the injection site; her arm hurt for the first day or two; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little ache/pain, little swollen/vaccination site swelling, her arm hurt for the first day or two,/vaccination site pain, a rash and a round circle all around the injection site/vaccination site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) little ache, little swollen.  On 2 Feb 2021, the patient experienced the event(s) her arm hurt for the first day or two, a rash and a round circle all around the injection site.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 3 Feb 2021 the outcome of event(s), her arm hurt for the first day or two was resolved. The outcome of event(s), little ache, little swollen, a rash and a round circle all around the injection site was unknown.
MILD SYMPTOMS; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild symptoms was not reported. This report was non-serious.
stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: VL-002625186) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, prev dose lot number=VL-002624736, prev dose lot unknown=False, prev dose administration date=11Feb2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 11Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 29Apr2021, outcome "recovered with sequelae", described as "stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The event "stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Facility type vaccine: Pharmacy or Drug Store. Other vaccine administrated in four weeks was influenza (high dose, quadrivalent on 27Sep2022), Pneumococcal conjugate PCV20, polysaccharide CRM197 conjugate on 27Sep2022. Other medications received in two weeks. Adverse event: stroke on 29Apr2021, ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. 4 days hospitalization, patient recovered with lasting effects, treatment received AE: emergency treatment for stroke. No covid prior vaccination and no covid tested post vaccination. No known allergies and other medical history: rheumatoid arthritis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026438 same product, patient, and event, different dose;
Tenosynovitis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 83 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Jan2021 (Lot number: EL3247) at the age of 83 years as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 12:30 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFIB" (unspecified if ongoing), notes: Other medical history: AFIB, HTN,; "HTN" (unspecified if ongoing), notes: Other medical history: AFIB, HTN,; "allergies: Penicillin" (unspecified if ongoing), notes: Known allergy: PCN. The patient's concomitant medications were not reported.  The following information was reported: TENOSYNOVITIS (non-serious), outcome "not recovered", described as "Tenosynovitis". The event "tenosynovitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tenosynovitis.  Additional information: Vaccination facility type is hospital. No vaccine received prior to 4 weeks.AE treatment: Steroids, seen Rheumatologist. The patient did not reported COVID prior vaccination and did not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter.   Information about Lot/Batch number has been requested.
Immediate swelling of lymph nodes. Pain continued in arms. Several months later developed nerve attack in arm which has not gone away. Nerve damage in right shoulder that radiates down the arm and causes numbness and tingling in hands.
Sore throat; Headache; Something sharp going down her leg and it felt like it was in the area of the vein; Abdominal pain; It is rawish and hard to swallow; Her throat felt scratchy when she laid down; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper right arm on 03Feb2021 12:35 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation (reported as "her health. She has a heart condition and is scared to get COVID"). Medical history included heart condition (Verbatim: heart condition/caller states she doesn't know what her heart condition is), blood cholesterol abnormal, blood pressure abnormal. Concomitant medications included irbesartan (AVAPRO) taken for blood pressure abnormal (she has been on it for some time); evolocumab (REPATHA) taken for blood cholesterol abnormal (been on it a year. She gave herself a shot yesterday), two heart pills and a blood pressure pill.  The patient previously got flu shot back in November. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None.  Prior Vaccinations (within 4 weeks) was No.  The patient experienced sore throat on 04Feb2021 with outcome of not recovered (reported as worsened), headache on 04Feb2021 with outcome of not recovered, something sharp going down her leg and it felt like it was in the area of the vein on 04Feb2021 with outcome of recovered, abdominal pain on 04Feb2021 with outcome of recovered, it is rawish and hard to swallow on 04Feb2021 with outcome of not recovered, her throat felt scratchy when she laid down on 04Feb2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body height: 152.4 cm on an unspecified date, weight: 165 lbs on an unspecified date.   The clinical course was reported as follows: She went and had the vaccine. She got a horrible sore throat. It is rawish and hard to swallow. She had a headache last night (04Feb2021). When she laid down last night it felt like something sharp going down her leg and it felt like it was in the area of the vein: it happened through the night off and on. It hasn't done it today (05Feb2021). She had abdominal pains really bad yesterday(04Feb2021). She didn't have a sore throat prior to the vaccine, so she is sure it is related. Her throat felt scratchy when she laid down. Today (05Feb2021) it has been raw.  She has not wanted to eat, but she took her medicine. The headache was just dull at the time of reporting. She had only got the first dose. She only got a sheet with the side effects. 24Feb2021 was when she gets the second. No Emergency Room and Physician Office required. The sharpness down her leg was gone. Other than her throat and dullness in her head she was doing ok. Caller declined to be transferred to a facility. She states she was just going to gargle with warm salt water.
Started to experiment COVID-19 like symptoms the next morning after I received the vaccine. The symptoms included headache, nausea, muscle aches, joint aches, fatigue, fever, and chills.
On 07/05/2000 the pt presented to the medical center with joint pain for four weeks, edema in fingers, and tenderness . No family history of lupus or rheumatoid arthritis. On 11/01/2000 follow-up at the center-above symptoms resolved. Also reported syncopal episode two times. Referred to cardiologist for evaluation. On 11/29/2000 follow-up states that the symptoms resolved.
Cough; Chest Congestion; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), CHEST DISCOMFORT (Chest Congestion) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). On 02-Mar-2021, the patient experienced COUGH (Cough) and CHEST DISCOMFORT (Chest Congestion). At the time of the report, COUGH (Cough), CHEST DISCOMFORT (Chest Congestion) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-049529 (Patient Link).
pt recvd vax;hands itch intensely,severe abdo pain followed by diarrhea,v x 2;became pale & clammy;tongue & lips began to swell & throat seemed to be narrowing; to er;later sxs subsided;adm decadron LA,DPH given;
pt recv vax & 1 to 2min p/vax pt exp a vagal response in which fainted or passed out;
Patient presents with fever for __1__ days with  Tmax of ___103.4___. Parents gave antipyretic with improvement in fever.  Last  ibuprofen    _1____ hours ago. Associated symptoms include: _Y__ watery eyes* _Y__ body aches* (excessive crying/fussiness) _N__ Sore throat _?__ Headache* _N__ Vomiting _N__ Diarrhea _N__ congestion of the nose _N__ cough** _N__ wheezing**    _No__ recent travel   _No known__ sick contacts   PE shows 101.5 fever in child whose exam is remarkable for posterior cervical and posterior occipital lymphadenopathy bilaterally without meningismus and some scleral injection with watery eye discharge and rhinorrhea. No rash and otherwise normal exam.
Red, inflamed, itchy area about the size of a hand below the upper arm vaccination site, above the elbow.
Have had a 100.6 temp most of time since Friday the 5th  , reduced to 99 for the last 3 days , extreme fatigue, unsettled stomach. Still have 99 fever  5 days out ( Tuesday).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
pt recv vax 23APR96 & 23DEC97 pt devel chickenpox;