chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, frequency once, dose number, route and side of administration was not reported) on an unspecified date. The patient medical history of allergies and illness at time of vaccination was unknown reported. Concomitant medication was not reported. On an unspecified date, following the vaccination, the patient experienced metallic taste. Laboratory investigation and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none.
Client received his Pfizer vaccine and 30 seconds after that, he felt faint and fell to the floor per client's mother. Mother stated he did not hit his head when he fell. Client regained consciousness a few seconds later and insisted on getting up and stated " I am fine." Client was assessed for pain, bleeding, bruising, client  stated "I am fine."  Client was transferred to the cot and assisted in lying position with feet elevate. Client stated " I feel better" and asked if he can sit up, client was given water, juice and crackers. After eating, client was transferred to a chair, client's mother went to check on him and put a mask on him. Client's eyes rolled back and started falling, client was lowered to the ground and regained consciousness a few seconds after. He complained of feeling cold and stated that his heart was racing. The EMT was called and arrived in less than 5 minutes. BP was 128/78 Heart rate was 90. Client was cleared by the EMT personnel to go home and client stated that he felt "fine."
Normal labor and delivery on 11/4/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
1 day p/vax pt exp dizziness, unbalanced, speech became slurred, incoherent;taken to ER spent the next day in hosp-ran tests to r/o stroke;final dx was rxn to shots;
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent(mother).  A 18 year-old female patient received bnt162b2 (Pfizer Covid-19 vaccine), administered in arm left(left forearm), administration date 26May2021 (Lot number: EW0183) at the age of 17 years as dose 2, 0.3 ml single and administered in arm left, administration date 03May2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Vaccines Administered on Same Date of the Pfizer Suspect, no Prior Vaccinations (within 4 weeks), no Family Medical History.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) negative, notes: on thanksgiving; (26Nov2021) positive for covid. Patient tested on thanksgiving and was negative. Then, she tested the day after holiday, 26Nov2021 with a PCR test that was positive for Covid after receiving both doses of the Pfizer Covid-19 vaccine and has come down with covid. There was no require a visit to: Emergency Room, no Physician Office.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101750087 Same reporter/drug/event, different patient
pt recv vax 5/18/99 & devel fever w/in 2hr,up to 101.5 w/swelling, redness & warmth of arm;induration subsided w/ice & DPH but swelling & redness persisted @ least until 5/21/99;edema tracked w/gravity to forearm 5/21/99;
Patient came in for office visit on 7/21/21. Patient reported a lot of muscle pains and significant fatigue since she got her COVD vaccine about 1 ½ months ago. Patient stated that she had some aches and pains prior to the vaccine but the pain was worsening after the vaccine and she felt it all the time currently. Reporting for record keeping.
A serious spontaneous report of got H1N1 and then had seizure has been received from a company representative/non health professional concerning a male child, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 23-Nov-2009; the patient received H1N1, Intranasal for an unknown indication. Within three minutes post vaccination, the patient began to seize. The patient was subsequently taken to the emergency room where the physician determined that the seizure was attributed to the H1N1 LAIV. The outcome for the reported event was unknown.
Dr. requested that these side-effects be reported. DTAP given at Left Deltoid (IM). Mother reported Left arm red, sore, had hard knot, and warm to touch but no fever and doing well otherwise.
chest pain; headache; This is a spontaneous report from a contactable consumer (patient's mother) reported for a male patient. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, on 17May2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. It was reported that her son received the Pfizer Covid 19 vaccine on Monday (17May2021), one day before reporting (reported as yesterday) on 18May2021 he had a headache and on 19May2021 (reported as this morning) he had chest pain. The outcome of the events was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Started a couple hours after I got it Chills I got really hot and really cold and shacking uncontrollable Muscle spasms couldn't hold cup without help All over body and muscles ache. Right arm was sore at the injection site Aching and tingling down arm to hand lasted about 8 hours Second day the shacking had stopped headache and body ache throughout the weekend  A week later started with headaches persistent, still to this day having headache, mainly in back of head at the left side of head going into left ear a pinching and dull pain behind left eye felt like something was poking my eye. Made appt with doctor on the the 26 on muscle relaxers and a steroid  X-ray of cervical spine MRI of brain  taking migraine medication since yesterday 06/01/2021
Patient received the third Moderna COVID vaccine in August 2021. She has had an ongoing UTI for the last 6 weeks. She also noticed shortness of breath, and low-grade fever, so she tested the covid home test, which resulted in a positive on 12/22/21. She came to the ED for dysuria, and she was admitted to the hospital on 12/23/21. She was given Meropenem, Vancomycin, and Micafungin for UTI. She was also on IV steroids while hospitalized. She was discharged home on 12/27/21.
This spontaneous report was received from a healthcare worker who on 17-AUG-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL (route unknown) (lot # H009826, expiration date on 11-FEB-2014). On 17-AUG-2012, the patient developed a redness reaction behind the arm and across the chest. The patient was taken to an unspecified hospital for an unspecified amount of time and was given unspecified antibiotics to treat the event. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX 23. Additional information has been requested.
A report was received from a health care professional on 11/10/03 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 11/4/03. On 11/4/03, the vaccinee received a single dose of Fluvirin 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
stomach upset; Nausea.; Cold sweats; Chills; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program Support. A male patient (consumer's son) of an unspecified age received bnt162b2 (Pfizer Covid 19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE  for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stomach upset, nausea, cold sweats and chills. Outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.
Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 032B21A) for COVID-19 vaccination.     No known drug allergies were reported. It was unknown if patient ever have tested or diagnosed COVID positive.  The patient's past medical history included Jaundice on 29-May-2019, Ureteropelvic junction obstruction on 16-Oct-2019, Ureteropelvic junction stone on 16-Oct-2019, Fever on 13-Jul-2020, Abdominal pain on 16-Sep-2021, Upper abdominal pain on 08-Nov-2021 and Bacteremia on 08-Mar-2021. Concurrent medical conditions included Hyperlipidemia since 11-Mar-2009, Prediabetes since 24-Apr-2018, Metastatic carcinoma since 29-May-2019, Colon cancer stage IV since 13-Jun-2019, Hyperglycemia since 13-Jun-2019, Type 2 diabetes mellitus since 13-Jun-2019, Metastatic colon cancer since 03-Dec-2019, Ileus since 08-Dec-2019, Perihepatic abscess since 16-Jul-2020, Pancreatitis since 09-Aug-2021, Duodenal ulcer since 17-Sep-2021, Failure to thrive since 16-Sep-2021, Malignant neoplasm of ascending colon since 16-Sep-2021, Protein-calorie malnutrition since 17-Sep-2021 and Sepsis since 11-Nov-2021. Concomitant products included INSULIN for Type 2 diabetes mellitus.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2022-539688 (Patient Link).
Vaccine expired 07/12/2022, 3 days earlier.  Pfizer was notified and they said they have data for stability 2 days past expiration date.  Form submitted to Pfizer to determine if suppliers have more stability data.  Doctor does not recommend revaccination.. Parent notified.
Described as a "minor thing" and pointed at arm; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient described as a minor thing and pointed at arm on an unspecified date. The event outcome was reported as recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Soreness in upper right arm around injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 25Feb2021 at 13:15 (at the age of 63-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 vaccination. On 25Feb2021 at 22:00, the patient experienced soreness in upper right arm around injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in upper right arm around injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22 months old female patient who experienced vaccine expired 10 days ago, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2018, the patient received a 4th dose 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5065AA, expiry date- 08-Oct-2018 via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for vaccine expired 10 days ago. 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.
Pt reported a HA and had stroke-like symptoms including altered mental status, aphasia, RUE weakness. He had multiple imaging studies, labs and a craniotomy with biopsy. He was hospitalized x 12 days, then discharged to a rehab facility and is being discharged home today (5/7/21).
positive for COVID 8/8/21 ED on 8/9 feeling could not get warm, dx sepsis most likely d/t COVID -19 moved to ICU pt expired 8/12/21
Woke up feeling tired with mild body aches. Chills began at 10AM and lasted four hours.  When the chills stopped the headache began and felt like a vise on the side of my head. Advil helped a little. The aches and headache continued until approximately 11PM the same day. Then suddenly everything faded away.   This episode felt very similar to an illness I had in November 2019 when I also had a bad cough that lingered for four weeks. This was a month before the first public reports of COVID.   The headache during both events is so distinct. I have never felt anything else like it.   During the post 2nd dose of vaccine event I needed only a few tablets of Advil to control the headache and body aches. I drank plenty of water and rested. My appetite was not affected and I was able to rest and sleep. Overall the event last approximately 12 hours and disappeared as quickly as it began.
Covid-19 virus test positive; Alzheimer's disease; anxiety; This spontaneous case was reported by a nurse and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was unknown if the patient was taking any over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination.  Concurrent medical conditions included Drug allergy (Niacin), Drug allergy (Oxybutin) and Type 2 diabetes mellitus (no recent change in condition status) since 14-May-2021.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) (seriousness criterion medically significant) and ANXIETY (anxiety). On 16-Feb-2022, the patient experienced COVID-19 (Covid-19 virus test positive). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) and ANXIETY (anxiety) had not resolved and COVID-19 (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment drug information was provided. Company comment: This spontaneous case concerns a 91-year-old male patient, with current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) unexpected event of DEMENTIA ALZHEIMER'S TYPE (among other non-serious events), 2 days after the third dose of of mRNA- 1273 vaccine. No further clinical information was available for medical review. Patient´s age and previous Type 2 diabetes mellitus could be risk factors for the event. The benefit-risk relationship of mRNA- 1273.214 vaccine is not affected by this report.   This case was linked to MOD-2022-665372, MOD-2022-674143 (Patient Link).; Sender's Comments: This spontaneous case concerns a 91-year-old male patient, with current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) unexpected event of DEMENTIA ALZHEIMER'S TYPE (among other non-serious events), 2 days after the third dose of of mRNA- 1273 vaccine. No further clinical information was available for medical review. Patient´s age and previous Type 2 diabetes mellitus could be risk factors for the event. The benefit-risk relationship of mRNA- 1273.214 vaccine is not affected by this report.
21JUL pt recv vax 23JUL97 stated afternoon sudden abd cramping then diarrhea x2, sl loss of appetite, sl sore throat;24JUL97 feeling better but tired then 25JUL97 better no diarrhea but feeling tired;temp on 17JUL97 but no diarrhea or GI sx
Arm got red/Consumer confirmed redness is at site of injection; This is a spontaneous report from a contactable consumer (patient). A 81-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm on 06Mar2021 (at the age of 81 years old) as single for covid-19 immunisation. Medical history included patient was very sensitive. When patient got the pneumonia shot, patient also got redness but it run away. The patient's concomitant medications were not reported. The patient previously received pneumonia shot and experienced redness. The patient wanted to say patient got the Pfizer shot a week ago and patient was fine. Patient had no side effect at all. Then on 06Mar2021, Saturday, a week later all of sudden arm got red. Patient don't have any pain. Patient don' t have any side effects. It feels fine but the redness would not go away. The concern was redness would not go away. Patient had no pain. Patient tried to take the temperature at it, it does not have the temperature but just the redness would not go away and the next Saturday, not this week but 27th of March, patient due for another injection and patient don't know whether patient should have it or not. Patient don't know whether this redness doesn't mean anything because patient didn't get any effect when patient first got the shot. Patient don't know what to do? The next day patient had no redness. The first day that patient had the vaccine patient had redness and then the next patient took a Tylenol(treatment) and the next day on 07Mar2021, patient had no reaction at all. Redness and everything were fine. Then on the 13th, the following Saturday from the vaccination arm started to get red. Patient confirmed redness was at site of injection. The patient underwent lab tests and procedures which included body temperature: it does not have the temperature. Therapeutic measures were taken as a result of Arm got red/Consumer confirmed redness is at site of injection with tylenol. The outcome of event was recovered on 07Mar2021.  No follow-up attempts are possible. No further information is expected.
Began to have sx the evening of injection and was unable to come to work the next day d/t sx. Myalgia, Arthralgia and weakness.
red spot @ inject site, soreness, flu-like sx, fever 102 degrees, blurred vision, dizzyness;
2 females recvd 1 dose of Engerix-B 5MAR92 from the same lot#; exp night sweats which started w/in 4 days of receiving 1st dose;
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23, 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 200, 24, 132 and 352 hours and the lowest recorded temperature reported were 32, 33, 34, and 29 Fahrenheit (F) (0, 0.555555556, 1.111111111 and -1.666666667 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Not able to run because of knee pain; Not able to run because of knee pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 025B21A) for COVID-19 immunisation.     Concurrent medical conditions included Arthritis (Patient had a history of arthritis joint.).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, 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 experienced HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain). At the time of the report, HYPOKINESIA (Not able to run because of knee pain) and ARTHRALGIA (Not able to run because of knee pain) outcome was unknown.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Patient was a known avid runner. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-191152 (Patient Link).