chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; hot rash on chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and RASH (hot rash on chest and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache) and RASH (hot rash on chest and neck). The patient was treated with PARACETAMOL (TYNELOL) on 19-Apr-2021 for Headache, at a dose of 1 dosage form. On 20-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (hot rash on chest and neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant was provided
Chest tightness and anxiety centered around the heart lasted from October 1, 2021-October 19, 2021. The sensation presented as a constant, low-grade sensation of chest tightness and anxiety from when I woke up until I fell asleep. I experienced nightmares almost every night. The sensations of chest tightness and anxiety did not inhibit me from working or going about my day, despite the fact that I felt both constantly. The sensations stopped on October 19 when I got my second Moderna dose (lot #011F21a ). I experienced a fever, chills, headache, and tiredness on October 19-20, 2021, but I didn't feel any chest tightness or anxiety on those days. The sensations of chest tightness and anxiety started again on October 22, 2021 and lasted until October 26, 2021. They recurred November 14-17, 2021, December 2-4, 2021, and December 16-18, 2021. My pulse and blood pressure, when measured during these periods, have been normal. I discussed these symptoms with my practitioner on November 4, 2021 as part of my physical exam. Dr. gave me an EKG and a GAD-7(generalized anxiety disorder) assessment . After the EKG showed nothing and I scored a 3 on the GAD-7, Dr. "reassured patient that his chest tightness was likely secondary to anxiety" and he "advised patient that his anxiety may have been cyclical and worsening due to his chest tightness (which was likely secondary to his anxiety." I declined a referral to a psychologist and agreed to follow-up with Dr. in 6 months or earlier if conditions worsened.  Since November 4 my conditions  haven't worsened, but they have recurred on November 14-17, December 2-4, and December 16-18. Until I took the Moderna shots, I had absolutely no history of anxiety or chest tightness whatsoever, and no history of any kind of mental disorders. I've had no history of any health problems of any kind until this.
COMPLAINED OF HEADACHE LASTING LONGER THAN 24 HOURS.  EVALUATED IN THE EMERGENCY ROOM AND THEN REFERRED TO LOCAL MEDICAL PHYSICIAN. PRESCRIBED IM AND ORAL MEDICATION.
no med records received on this patient, he died at home; had a positive COVID test on 4/29/21; per death certificate, pt had "recent COVID infection" listed as a condition contributing to death
Received second Pfizer vaccine for COVID 19 on 3/17/21. On 3/19/21 client lost vision in left eye  3/24/21 Client saw Dr who referred client to Dr in Opthamology  Client started on Prednisone 20 mg 4 daily. He has been referred to clinic 5/12 appt Dr states Pt has had = 15 TIA's/CVA Prior to vaccine - over Several years. Possible TIA again -
Case previously recorded as MA2009-5229. Initial case report received from a physician, via Novartis Medical Communication on 20 NOV 2009. A 14 month-old male patient was vaccinated with S-OIV FOCETRIA (batch no. 102124P1, expiration date 31 MAR 2010) i.m. on 13 NOV 2009. No adverse event was reported. MedCom reference no: NA09-008308.
Mistakenly given a Pfizer booster vaccine to the patient who is 16 years old
Pt inadvertently recvd Influenza vax IV in place of Ativan inject; 3-4 days p/recving vax, pt devel pustular, maculopapular rash more dense on face & neck, & less dense on upper arms, shoulders & chest; pt felt feverish; dx viral exanthema;
accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022; accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022) and PRODUCT STORAGE ERROR (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022 at 10:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Mar-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022) and PRODUCT STORAGE ERROR (accine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 degreeC thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix-B). On 10 November 2004, the patient received the 1st dose of Engerix-B in the left arm (lot ENG5595BC-incorrect lot number). At an unspecified time following the first administration of Engerix-B, on 10 November 2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 10 November 2004. The nurse reported that, "the vaccine had just been removed from the refrigerator prior to the injection and it was cold." The nurse considered the injection site reaction to probably be related to vaccination with Engerix-B.
severe headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) and ARTHRALGIA (joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (severe headache) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (severe headache) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
extreme fatigue; fever/Fever is jumping from 100 to 104; Sick; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included spleen removal 25 years ago. The patient's concomitant medications were not reported. The patient reported that he has a fever, and extreme fatigue on an unknown . The patient had the shot Tuesday morning, on an unknown, he meant hours kept me sick. Fever was jumping from 100 to 104 and asked for data regarding people like him that do not have a spleen and their experience with the Pfizer shot. The patient underwent lab tests which included body temperature jumping from 100 to 104 on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Numbness in hands; fatigue; muscle pain; joint pain; headache; fever (102.5 deg F); nausea; chills; This is a spontaneous report from a contactable consumer (Patient herself).  A 34-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0183), via an unspecified route of administration, administered in Arm Left on 17Jun2021 10:30 (at the age of 34-years) as dose2, single for COVID-19 immunisation. Medical history included asthma, Known allergies: Allergic to ibuprofen, codeine, nuts, seeds, spices. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT); fluticasone furoate (AVAMYS); fexofenadine hydrochloride (ALLEGRA)- all taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Lot number: EW0173), via an unspecified route of administration, administered in Arm Left on 27May2021 10:15 am as dose1, single for COVID-19 immunisation. On 17Jun2021 12:30, the patient experienced numbness in hands, fatigue, muscle pain, joint pain, headache, fever (102.5 deg F), nausea, chills. The patient underwent lab tests and procedures which included body temperature: 102.5 deg Fahrenheit on unspecified date. Treatment received with Tylenol as a result of events. The outcome of events was resolving.  Information on the lot/batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
25JUL91 pt recvd Engerix-B vax & 26JUL91 devel a h/a that lasted 2 days & resolved w/out treatment; 12SEP91 recvd 2nd dose of Engerix-B & devel h/a that was less severe that te previous h/a;
Triggered photo sensitive migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "History of migraine" (unspecified if ongoing), notes: History of migraine; "unknown gastrointestinal illness" (unspecified if ongoing), notes: unknown gastrointestinal illness. The patient's concomitant medications were not reported. Past drug history included: Topomax, reaction(s): "Allergies: Topomax", notes: Topomax. The following information was reported: MIGRAINE (non-serious) with onset 20Oct2021 08:00, outcome "recovered" (2021), described as "Triggered photo sensitive migraine". Therapeutic measures were taken as a result of migraine.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and taken over the counter Ibuprofen as treatment medication. The prior to vaccination and since the vaccination she did not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very fatigues, headache, nausea, intermittent chills, vomited once.
Pt fine at administration but while at checkout had a syncopal episode. Pt hit head and chin at time of fall. Provider notified, legs lifted, BP monitored. Observed in office for 30 mins.
9 days after receiving first injection a red rash (not itchy) appeared at injection site that was warm to the touch, swollen and tender. 10 days after injection the red rash (not itchy) is slightly larger, still warm to touch, swollen and tender.
pt c/o pain & weakness in both thighs, progressed to both calves & worsened every evening;also had low grade 100 oral temp;seen by MD;
Rash at site of injection  L arm Generalized rash on body Urticaria
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Delayed skin reaction about 1 week after the vaccination - it looks like a rash that covers approximately half of the upper arm, local to the injection site. The injected arm was sore around the  deltoid area and the left armpit lymph node was tender, but was not visibly swollen.
Pt recvd vax & 3-4 days later exp severe constant nausea, abdo pain, diarrhea, h/a, joint soreness, fever, noc sweats & extreme weakness & fatigue;
On 4/25/04 patient experienced swelling in left arm, no rash, no itch. On 4/26 pt. had fever of 101 but no fever since that date. On 4/27 rash (4 bumps like pimples) on left shoulder just above injection site. Shoulder still swollen and now red. Patient also describes pimple on left side of nech and left cheek.
Swelling at injection site with a 2" diameter; Swelling at injection site with a 2" diameter with itching; Swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on an unknown date in 2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. On 14Oct2021, the patient experienced swelling at injection site with a 2" diameter with itching and swelling. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection site with a 2" diameter with itching and swelling was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a female patient. On an unspecified date in 2012, the patient received an influenza vaccine (manufacturer and batch number not reported) in the left arm. On an unspecified date, the patient developed left shoulder adhesive capsulitis. Outcome was unknown. Linked to 2014044809.
pt recv vax 24OCT95 & w/in 3hr devel nausea, vomiting, stomach cramps, diarrhea;sx lasted during the noc;pt recovered;
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound-COVID symptoms returned) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F211A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-Apr-2022, the patient experienced COVID-19 (Rebound-COVID symptoms returned). At the time of the report, COVID-19 (Rebound-COVID symptoms returned) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, SARS-CoV-2 test: tested positive in antigen test (Positive) Rebound-COVID symptoms returned, tested positive in antigen test. Device date : 27Apr2022. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient taking other medications or products within 2 weeks of starting COVID-19 treatment but unaware of the name. The patient also previously received a unknown COVID-19 vaccine. The patient had a Rebound-COVID symptoms returned, and found positive in antigen test. The device date 27-Apr-2022. No treatment drug details was reported. Company comment: This is a Spontaneous case concerning a 67-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 5 months and 16 days after the administration of a dose of the mRNA-1273 vaccine (of an unknown dose and scheme of vaccination). Relevant test was performed: COVID-19 antigen test positive. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious. Sender's Comments: This is a Spontaneous case concerning a 67-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 5 months and 16 days after the administration of a dose of the mRNA-1273 vaccine (of an unknown dose and scheme of vaccination). Relevant test was performed: COVID-19 antigen test positive. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.
Achy; Tired; Nauseated; Joints felt like pins and needles; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles) and PYREXIA (Slight fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient stated that she had COVID-19 between thanksgiving and Christmas.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
Developed rash within 25 hour after vaccine admin. Papular rash over Bilat arms/Trunk. no SOB no cyanosis. went to ER and received prednisone and Benadryl. Rash is resolved. Nml appetite
Robust take ? Pulse 92, Resp 20, BP 160/72, Temp 97.4, PSO2 96% Rash anterior/posterior head to toe. Alert and oriented-transported to ER.
on 2/12/21 at an offsite COVID 19 vaccine clinic between 1-3 pm pt was administered second dose of COVID19 Moderna vaccine and shortly after experienced what seemed to be a catatonic seizure. EMS was called by a staff member immediately. Rph's on site tended to pt immediately monitoring pulse and breathing . seizure lasted approximately 1-2 minutes. Was resolved upon EMS arrival, EMS encouraged/recommended to take pt to hospital . Patient refused to go to hospital . EMS asked pt a few questions that she answered correctly then EMS had pt sign- waiver declining to go to hospital even if it resulted in death. At end of clinic 3pm., when we were leaving pt was very aware and talkative.   Patient does have history of seizure disorder that is controlled with medication. Per the pt, she is currently taking depabote.  Pt did not have any reaction with first dose on COVID 19 moderna vaccine administered on 1/15/21.
Patient reported "normal" sore pain at the injection site for 2-3 days after the injection. 2-3 days after that, black brusing appeared and stayed through the day the incident was reported (9/21/2020). Patient stated the area was very dry, after being questioned/examined by multiple pharmacists it was presumed a localized topical reaction. No intense pain or swelling reported.
Fever to 100.4, chills and related shivering, body aches, muscle pain, joint pain particularly in knees, fatigue, occipital neuralgia
Development swelling of eyes and urticaria 5 mins after administration MMR, DTap, IPV.