chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad after second shot), ASTHENIA (Felt weak after second shot), BONE PAIN (her bones hurt for 2-3 days) and CHILLS (Chills after second shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure), Hypothyroidism and Hypercholesterolemia (High Cholesterol.).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Felt bad after second shot), ASTHENIA (Felt weak after second shot) and CHILLS (Chills after second shot). 26-Feb-2021, the patient experienced BONE PAIN (her bones hurt for 2-3 days). On 01-Mar-2021, FEELING ABNORMAL (Felt bad after second shot), ASTHENIA (Felt weak after second shot), BONE PAIN (her bones hurt for 2-3 days) and CHILLS (Chills after second shot) had resolved.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-378101 (Patient Link).
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6202), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Lot number: ew0191) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received pfizer covid vaccine and had syncopy event during the 15 minute wait period and lost conciousness for a few seconds.  He recovered and EMS was called to check him out.  They cleared him to leave with a family member.
Approximately  6 hours after vaccine, I had a headache, chills and body aches. These continued all night and got better the next morning when I took Ibuprofen. On Sunday morning, a little less than 48 hours after vaccine, I notice certain parts of  both arms were itchy. This morning, a little less than 72 hours after vaccine, I am experiencing an itchy rash in several places on my body including torso , knees and arms and legs.
One week following the 1st dose of the Pfizer Vaccine, I went to the emergency room after experiencing double vision for approximately 30 minutes, followed by prolonged dizziness. I was evaluated for a possible TIA.
Got the flu and pneumonia shot at store. That evening started to have pain in (L) arm & on Sat AM it was very sore. Was icing & taking Ibuprofen. The arm cont to swell & turn red. Monday went to the doctor & they sent him to ER. Started on KEFLEX for cellulitis. Dr states shot was low & to back of arm.
Developed pain at injection site within 1 hour. 11/16/00 AM, redness and swelling at injection site, progressively increasing with increased temperature to 99.7F. Called doctor and ordered Benadryl and cold compresses. 11/17/00, increased swelling, redness and warmness from 5" above elbow to wrist with increased temperature to 100F. Used warm compresses and Benadryl. Went to ER at 20:00 on 11/17/00. Rx'd Unisom IV, Augmentin po. 11/20/00, decreased swelling of arm. 11/21/00, decreased swelling hand.
12/3/2008 TWINRIX given. Blistery type scab 12/11/08, now has a scar barely visible and felt like had flu, muscle aches, tiredness, maybe a little fever, chills and got a cold.
Within 12- 24 hours after immunizations. patient developed fever 102, vomiting, mild diarrhea.
3JUN92 DPT/OPV/HIB recvd vax & on 14JUN eyes rolled back & pt did not respond;
Patient was given vaccine 5 days early. Patient came into store stating he was supposed to get the vaccine on 4/22. After administering the vaccine we realized his sheet said 4/27 instead of 4/22.
Persistent severe headache along with blurred vision. The headache has not resolved since a few days after getting the vaccine.
Herpes outbreak on her hands; This is a spontaneous report from a contactable nurse practitioner (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included: herpes simplex. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient had Herpes outbreak on her hands. The clinical course included: reporter (Nurse Practitioner) had her second dose of the Pfizer Covid Vaccine a week ago and got herpes simplex; got it from a patient years ago and it was breaking out on her hand. She wanted to know if she can take antiviral medication Valtrex (valacyclovir) one week after taking the second vaccine, to treat the Herpes outbreak on her hands, which she thought she could have contracted from one of their patients. Wants to know if there would be any contraindications if she takes it a week after having her Covid Vaccine. Reporter stated that she already asked her Dermatologist and Pharmacist about this, but they also don't know if she can take the medication or not. This was being reported out of an abundance of caution. The patient did not state Pfizer-BioNTech COVID-19 Vaccine. The outcome of event was unknown.  Information about Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
patient was supposed to receive a dose of Infanrix but received a dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 12th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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:13-May-2022 Reporter's comments: The patient was supposed to receive a dose of Infanrix but received a dose of Pediarix instead. The healthcare professional consented to follow-up via email. Additional Supportive Information: The patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ERYTHEMA (redness on her arm). At the time of the report, ERYTHEMA (redness on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
tested positive for Covid; tested positive for Covid; She says this was the sickest she has been in twenty years; This is a spontaneous report from a contactable pharmacist (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17May2021  as DOSE 2, SINGLE, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. On 20Sep2021, the patient reported she, her husband, and her other two daughters also tested positive for Covid. She stated this was the sickest she has been in twenty years. The patient underwent lab tests and procedures which included COVID test positive on 20Sep2021. The outcome was unknown for the events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This Amendment report is being submitted to amend previously reported information (To update narrative leadline): This is a spontaneous report from a contactable pharmacist (patient self) via the Medical Information Team.  This pharmacist reported similar events for 5 patients. This is the 4th of 5 reports.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
I had no adverse effects over the course of a couple of days. I had a slight soreness when the vaccine was given. In October I started to have stiff painful neck. I went to an urgent care where I was diagnosed with arthritis in my neck. They said I could take Tylenol if needed but they gave me a neck brace. The neck brace has helped with alleviating the pain in my neck. I wore it for a couple days then the pain disappeared. I wore it for one day then the pain disappeared again. My neck doesn't hurt at this moment, but I still don't have full motion in my neck.
Child observing sibling receiving vaccinations sibling anxious and crying. 10 min prior child had received a TB skin test and Varicella vaccination. Child began to c/o not being able to see. Mother noticed child pale and beginning to faint. Assisted child - ammonia inhalant used, vital signs taken. Orange juice given and cool towels placed on neck and forehead. Child awake and talkative. Evaluated by Dr. pt. reported being anxious about brother getting shots. PBL and presyncopal episode. Advised to follow up today with PMD for further eval.
Initial solicited report received on 08 June 2016 from a consumer participating in the study. This case involves a 30 year old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), the subject reacts to prescriptions. The outcome of event reacts to prescriptions was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
diarrhea and abdominal pain, ongoing for 24 hours so far, not severe enough for treatment at this point
26 y.o female who c/o feeling of dizziness and nausea - aprox 30 minutes after getting second dose of HPV vaccine. Reports did had anything to eat today and at luch time (12 noon) got dizzy again with chills, nausea and feeling heart racing with tingling from head to toes and headache Pt was given 1 tab of Meclizine 12.5 mg was resting for 20 min and reports feeling a little bit better. No focal neurologic deficits.
Dizziness, double vision, Rt mid brain stroke, third nerve palsy, begin shortly vaccine, hospitalization began 04/03/2021
Swollen at the injection site; This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was swollen at the injection site. The outcome of the event, 'swollen at the injection site', was unknown.  No follow-up attempts are possible. No further information is expected.
Persistent (i.e., 24/7 but fluctuates in degree of severity) chest pain (believe it was more concentrated in center of chest early but appears to have migrated a bit to upper left side of chest) dating back from around the time of vaccinations (did not immediately connect the two - and only perhaps linking the pain to the vaccinations now as a result of seeing publicity about the potential for heart inflammation - as pain was very mild early on).  Have taken some anti-heartburn OTC medication at medical professional's direction, but that has not been an effective solution as pain has continued.  Not overwhelmingly crippling pain, just persistent and concerning.  Have not had a chance to see a specialist for full-blown evaluation/diagnosis yet.
12/17/12 Pt had pneumonia shot x 1 day ago. Pt c/o pain, redness at injection site and difficulty moving her arm (L). Pt was seen in ER 12/20/12. Pt seen 12/26/12 f/u - symptoms improving.
The patient was getting COVID despite of having had the Covid vaccine.; The patient was getting COVID despite of having had the Covid vaccine.; This is a non-interventional study report from a marketing program name not available received from a non-contactable consumer.   A 64-year-old male patient (Age at vaccination 64 years) received BNT162B2 (BNT162B2), intramuscular, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history includes psoriasis. Concomitant medication included risankizumab (SKYRIZI [RISANKIZUMAB]) taken for psoriasis from an unspecified start date and ongoing. It was reported that the patient was getting covid despite of having had the covid vaccine on 05Aug2021. The events were reported as serious-medically significant. Outcome of the events was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events( Drug ineffective, Covid19) and the administration of the vaccine cannot be excluded.
Extreme heavy uterine bleeding 8 weeks, ultrasound confirmed blocked falopian tubes
Rash - about 4 inches wide - warm to touch with small central bump - noticed to be getting worse 8 days after vaccination - pt referred to PCP.
Patient received vaccines in right thigh on 1/25/13. On 1/27/13 she was seen in the ER for left leg pain and sent to another facility for further evaluation of leg pain.
Pericarditis; This is a spontaneous report from a male nurse (patient) reported for himself. A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration, administered in Arm Left on 12Jan2021 at the age of (30-years-old) as dose 2, single for covid-19 immunisation. Medical history included patient was diabetic diagnosed 31 years ago from an unknown date and unknown if ongoing diagnosed 31 years ago. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140) via an unspecified route of administration, administered in Arm Left on 22Dec2020 as dose 1, single for covid-19 Immunisation. It was reported that on 14Jan2021 patient had developed pericarditis 2 days after getting the second dose. He does not had any pre-existing heart conditions. The patient was hospitalized for pericarditis from 14Jan2021 to 18Jan2021. On an unspecified date the patient underwent lab tests and procedures which included EKG which was showed that tombstone. The patient was recovered from the event on 15Jan2021.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of pericarditis 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.
got COVID; got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 23Dec2022, outcome "unknown" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: 4 COVID doses and last was bivalent and got COVID on 23Dec2022 then plus Ag 24Dec2022 after gym mild symptoms cough and congestion. COVID prior vaccination was not Unknown. Patient tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300004020 same  patient/reporter/dose, different dose/event;
Fever  and swelling at the injection site for 8 days along with joint stiffness in my legs, arms and hands for 5 days.
Patient was part of a pediatric COVID school clinic, consent from was sent to the school nurse by parents, nurse stated that this is the first shot of the two series for pediatric Pfizer and that was notated on the consent form, patient received the correct pediatric dose at the correct injection site on 12/3/21 upon verification from the school nurse. Nurse then contacted pharmacy stating that there was a miscommunication with the patient's mother and she wasn't informed that he already received his first shot of the pediatric COVID a week earlier! checked on patient and nurse stated that he didn't suffer any side effects except for a little headache on the day after the shot and had subsided later on.
Really high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Really high fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Really high fever). At the time of the report, PYREXIA (Really high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: high (High) High.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Case number PHEH2016US030620, is an initial spontaneous report received from other health professional (other health care professional) on 18 Nov 2016. This report refers to a 54 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) on an unspecified date. On 17 Oct 2016 (after vaccination), the patient experienced pain in arm (injection site). It was reported that when the patient moved left arm, she had pain in upper area. The outcome of the event was condition unchanged. The event was reported as non serious. The causality of the event was not reported.
FIRST PATIENT OF THE DAY, AND THOUGHT A NEW VIAL WAS OPENED. UNFORTUNATELY IT WAS FROM THE PREVIOUS EVENING, AND 5 HOURS AFTER THE BEYOND USE TIME. WE CALLED PATIENT BACK IN AND RE-ADMINISTERED THE VACCINE WITH A FRESHLY OPENED VIAL AS PER PROTOCOL.
pt recv vax & exp flu-like sx w/chills, fever, nausea, stiffness in joints; No further details were provided;
Apnea x 3 - patient intubated.  10/16/07 Reviewed vax records from pcp which confirm RO lot # as reported.  11/30/07 Reviewed hospital medical records which reveal patient experienced crying inconsolably, irritability, feeding, vomiting, arched back, stiffened & mottled then went limp & pale.  Became alert again then episode recurred.  Taken to outlying ER where had several more episodes & was bradycardic.  Then experienced cardiopulmonary failure.  Intubated & resuscitated.  Transferred to higher level of care.  Admitted 10/10-11/02/2007.  Patient had been exposed to stomach virus within 2-3 wks prior to admit. Immunology, neuro, opthalmology consult done.  Received blood transfusion & apparently had reaction.  Developed ARDS & had bilateral chest tubes placed.  Felt to have poor visual fixation & likely damage to optic pathways & poor head control.  Was to be followed by opth & developmental outpatient clinics. FINAL DX: no d/c summary available.  Immunology dx: Hypotonic-hyporesponsive episode s/p non-immune mediated adverse vaccine reaction, likely acellular pertussis component. Per 60 day follow up: She has permenant brain damage. Her brain has atrophied, she has extensive damage to her cortex & occipital lobe. 1/12/2010 She still and will always have brain damage.. She is 17 months old and still cannot sit up, crawl, stand and walk.
Child was screaming an crying uncontroably, (very unlike him). Would not allow to be picked up, would not eat or breastfeed. Would not sit up. Would not move anythig from waist down, (even when sleeping- which is very unlike him considering he rolls around a lot), called dr and was advised to give children's Motrin at 8pm and to call back if nothing changed. Nothing changed so called dr back and was advised to take child to ER. Went to ER around 2am. Same symptoms this whole time (from 5pm-2am). Was seen by a Doctor in ER around 3am and symptoms seems to go away.