chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for Covid-19 immunisation. The patients medical history was reported as none. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 01Mar2021 at 14:00 as a single dose for COVID-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 26Mar2021 at 07:00, 4 days after second dose patient experienced severe headaches for several days and severe vertigo. The patient did not receive any treatment for the events headache and vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and vertigo was not resolved at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of aphthous stomatitis in a 75-year-old male patient who received SHINGRIX (batch number B334Y, expiry date unknown) for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX. On 2nd June 2018, the 1st dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was recovered/resolved. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left deltoid. The patient reported to the pharmacist that he developed canker sores on his mouth after a dose of SHINGRIX. This case has been linked with case US2018GSK179518 (for 2nd dose), reported by same reporter for same patient.
6 hours  after the vaccination: - chills, joint pain, fatigue, fever of 38.2 degree Celsius
Swollen arm; Arm sore to touch; flu type feeling; Elevated Temperature; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 23-OCT-2023, the patient received Arexvy. On 24-OCT-2023, 1 days after receiving Arexvy, the patient experienced influenza (Verbatim: flu type feeling) and body temperature increased (Verbatim: Elevated Temperature). On 28-OCT-2023, the patient experienced swelling arm (Verbatim: Swollen arm) and pain in arm (Verbatim: Arm sore to touch). The outcome of the influenza, body temperature increased, swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the influenza, body temperature increased, swelling arm and pain in arm to be related to Arexvy.   It was unknown if the company considered the influenza, body temperature increased, swelling arm and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter reported that experiencing flu type feeling with an elevated temperature and her arm was swollen and sore to touch after getting Arexvy. The reporter did not provide lot number, expiration date or date of birth. No additional information was provided.
Initially developed sore upper L arm with gradual increase soreness by Wednesday upper arm including biceps, triceps and deltoid all redness with swelling.  Today fever noted @ 38.5
No Adverse event,  Patient turned 12 on 11/01/2021 patient received a child dose of pfizer 5-11 instead of age appropriate dose
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: hives of the face  resolved with benadryl
Severe headache, cold chills, loss of appetite, weak, fever and knot in back of right leg inhibiting me from bending my leg.  Symptoms  began about 7 to 8 hours after the shot and continued through the 2nd day. Symptoms were gone by the 3rd day.
p/vax ran fever took pt to MD for recheck;ran blood tests, dx as mono;speech was immed affected & motor skills, stumbling & stuttering;also behavioral changes; short fuse, extreme temper, disoriented, frightened over things;to neurologist Per HCP report-9/21/00 follow up phone call. Mom reports a repeat MRI will be done in 1 month. They won't know how he's doing until Thursday. Autism has been ruled out, but he's still having problems. Receives speech via EI. Mom relates that the doctors feel that patients problems are vaccine related.
No additional adverse eventswere reported; Nurse is reporting that an expired ROTATEQ was given; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On 26-APR-2022, the patient was vaccinated with one expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (Lot number reported as T034513, expiration date reported as 13-APR-2022) administered for prophylaxis (strength, exact dose, and route of administration were not provided) (expired product administered). No additional adverse events reported.
Subsequent to 2nd vax in 11/98, this pt developed fever, uveitis, and bladder infection. She was seen at either the ER or physicians office. The fever resolved and she is being treated with Cipro 500mg bid for the bladder infection. The most recent information received on 05/10/99, reports the condition of the pt as unknown.
First 48 hours, extreme swelling in arm, moved to shoulder. Within 72 hours, significant chest pain. By Tuesday (less than 96 hours), severe spikes in chest pain, couldn't walk more than 20-30 steps without severe pain. Resting heart rate is over 100 bpm, standing heart rate averaging about 120, standing for more than 5 minutes or trying to walk averages at 140+.
Swelling, induration, erythema 3x4 cm x0.5 cm height.
Patient was diagnosed with Type 1 Diabetes on 11/28/2009.  He had symptoms leading up to it for about a week prior to diagnosis.  He was very ill and was hospitalized on 11/28/2009.
Started having tinnitus & thought it was related to shot. Went to PCP-no treatment given.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23, 0.5 ml (lot number and expiry date unknown) and (dosing regimen and frequency unknown) and AFLURIA (lot number and expiry date unknown) and (dosing regimen and frequency unknown). On an unknown date the patient developed soreness, swelling and redness at the injection site, although it is unclear which one, which then developed a pustule that traveled down the patient's arm. The field employee could not specify how far down the arm the pustule traveled or how big this lesion was. It was reported that the patient sought medical attention and visited a pharmacy. The pharmacist told the field representative that she recommended MOTRIN (manufacturer unknown) and BENADRYL (manufacturer unknown). The patient has not followed up with the pharmacist. No lab diagnostics studies were performed. The outcome of redness at the injection site, soreness at the injection site, pustule and swelling at the injection site was reported as not recovered. The relatedness of the events to the therapy with PNEUMOVAX23 and AFLURIA was unknown. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Patient's arm became red, swollen and sore. States arm puffed up from shoulder to elbow. Went to doctor on 11/10. Rx was Vicodin, Benadryl and Ibuprofen. Swelling worsened on 11/11; went back to doctor with complaints of decreased appetite, low grade fever, arm hot. States getting better today. Swelling starting to subside.
took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart; took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart which they said came out to be a virus; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history included lost her taste and had a low grade fever. Concomitant medications were not reported.  This patient reported for a day and a half she lost her taste and had a low grade fever. So she went the next week (date unspecified) and was tested 2 times and came out negative (clarification of test type not provided). So on 09Jan2021 she got her first dose of the vaccine. On 14Jan2021 she ended up in the hospital with fluid on her heart which they said came out to be a virus. Outcome of the event was unknown.She was due for her second dose of the vaccine on 30Jan2021. Patient called to ask if she should or should not still get the second shot as scheduled. Information about batch/lot number has been requested.
still not feel normal; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (still not feel normal) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (still not feel normal). At the time of the report, FEELING ABNORMAL (still not feel normal) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. Patient reported that it has been 4 days since the first shot and still feeling abnormal.
I have more severe pain in all of my joints everyday all of the time. We tried a nerve pain killer which made me too sick so I couldn't take it and it wasn't working anyway. We are trying a different medication to see if it works.
had a terrible reaction; had COVID in november; had lymph node pop up under the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, COVID-19, and LYMPHADENOPATHY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, COVID-19 and LYMPHADENOPATHY. At the time of the report, VACCINATION COMPLICATION, COVID-19, and LYMPHADENOPATHY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications was provided by the reporter.  Patient experienced Lymph node under the arm, while patient had COVID in November and had a terrible reaction, patient received the COVID -19 vaccine 3 months before.  No treatment medications was provided by the reporter.  This case concerns a patient with unknown age and gender, with no reported medical history, who experienced Non-serious, Unexpected AESI event of Covid 19 which occurred on an unknown date, with an unknown dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine) is not affected by this report.
PATIENT RECEIVED FIRST DOSE ON 08-19-21 AND SECOND DOSE ON 09-09-21 (21 DAYS APART)
pt recv vax 28APR97 & 13MAY97 pt learned was pregnant (LMP 14APR97);pt exp a spontaneous abortion;
Patient received .3 ml of Pediatric Pfizer (orange cap).  No  adverse events noted.
Information has been received from a registered nurse concerning her daughter who on an unknown date was vaccinated with a dose of GARDASIL. The patient was experiencing severe headaches. No further information is available.
Narrative: COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/09, Pfizer, dose #2 08/20 COVID swab, result: detected 08/20 pt cc: exposure: unknown 08/20 SARS-COVD-2 Variant Sequencing result: pending
fatigue; fainted; shaking; arm cold (felt like ice); red spots on forehead; chills; A spontaneous report was received from a consumer's relative concerning a 21-years-old, female patient who received Moderna's COVID-19 Vaccine, and experienced fainting, shaking, cold arm, red spots on forehead, chills and fatigue.   The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 28 Jan 2021, the patient experienced fainting, shaking, cold arm, red spots on forehead, and chills. Reporter stated that no treatment drugs were prescribed for the events. A complete blood count and an electrocardiograph was performed (results not provided).  On 29 Jan 2021, the patient experienced fatigue.  Action taken with second dose of mRNA-1273 in response to the events was not provided.    The outcome of the events fainting, shaking, cold arm, red spots on forehead, chills and fatigue was not provided.; Reporter's Comments: This case concerns a 21-year-old female patient, who experienced a serious  event of syncope and non-serious events of tremor, feeling cold, rash macular, chills and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Tinnitus, bilateral. I have not been seen by a healthcare professional regarding this matter. Tinnitus seems to be worsening. No other symptoms. Seeing a physician in May.
At my last doctor's appointment, it was discovered I was having high bouts of blood pressure. I have never had these issues before in my life. I was sent to a follow-up clinic and the placed me on a low dose medication. I was having high readings back-to-back, to high for MR 158/98; 159/90 and so. I now have to monitor my blood pressure every day, and I have a follow up appointment in April, to see if this medication is helping and how long I'm going to be on it.
just to make my next shot my first shoot was 4/28/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-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 PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment medications were reported.   Reporter did not allow further contact
Fine red, raised rash, itching, muscle/joint pain, fatigue. Rash was not only at injection site but arms and knees.
Redness, swelling approximately 3.5" area surrounding injection site, warm to touch. Advised ice to site.
Occasional itching in days following vaccine, today (7 days later) injection site is very itchy, red, inflamed, raised. Approx. 4" by 6" patch. Applied cold compress and swelling slowly subsided
Very high Blood Pressure that was fluctuating but not lowering for several hours.  Sent to ER after 1.5 hours at the clinic.  No treatment given at ER, Bloodwork, urine, and ECG all normal with no indication of any type of organ damage resulting from uncontrolled High Blood Pressure.  Sent home after 3 hours with blood pressure of 179/95 and pulse rate of 104 with recommendation to monitor blood pressure and follow up with primary care.  By Feb 13 blood pressure became normal and has stayed in the normal range.
Itchy at injection site; Skin bumps at injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 07-FEB-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced injection site itching (Verbatim: Itchy at injection site) and injection site papule (Verbatim: Skin bumps at injection site). The outcome of the injection site itching and injection site papule were unknown.   It was unknown if the reporter considered the injection site itching and injection site papule to be related to Shingrix.     It was unknown if the company considered the injection site itching and injection site papule to be related to Shingrix.   Additional Information: GSK receipt date: 06-Apr-2023  The patient developed itchy skin bumps at the injection site. The reporter consented to follow up.
This case was reported by a nurse practitioner and described the occurrence of change in level of consciousness in an adult male subject who was vaccinated with hepatitis A vaccine (manufacturer unspecified for prophylaxis. Concurrent medical conditions included hepatitis C. He had recently completed treatment with interferon. The subject reported that he received the 2nd dose of hepatitis A vaccine unknown several years ago. At an unspecified time after vaccination with hepatitis A vaccine, the subject bled profusely from the injection site and experienced changes in his level of consciousness. The events resolved on an unspecified date. The reporter could not verify that the subjects bleeding and change in consciousness actually occurred after his second dose of hepatitis A vaccine. This case was assessed as medically serious by manufacturer (OMIC).
She was admitted at hospital on 3/9/21-3/11/21 due to ischemic stroke which she received TPA and mechanical thrombectomy for L MCA M1 occlusion. Her symptoms include aphasia, R facial droop, R side weakness. Patient report no residual deficits.
Itching started at the site where the shot was given, swelling, warmth, and redness around the injection site.
3/9/21- chills muscle aches, joint pain, tired for about 4 hours 3/10/21-4:00 pm- chili?s, joint pain, aches, headache, fever-99.8
2 weeks after my 1st dose, I began to get shooting electrical pains in my nervous system, tingling, bug crawling like sensations, and general inflammation everywhere. It felt as if the spike protein was attacking me relentlessly. The symptoms started to stop for a few days or a week at a time and came back for a few days, then went away again. As of 1 week ago (3 months later)- I now have little to no symptoms. I did not seek any treatment "officially." I used energy, frequency, and vibrational medicine. I used bio-resonance machines, radionics, etc..I believe in holistic/natural treatments. I only got the vaccine out of employer coercion. Big mistake.
On 4/15/21 I collapsed on the floor. I hit my head on the side of the bed. I called 911. I was taken to hospital. I was told that I had lost sinus rhythm in my heart twice. I have no history of heart issues and get checked yearly because I?m diabetic. I stayed in the hospital for 3 days to be observed and followed up with an at home heart monitor. There were no findings as to why this happened. I had my 2nd vaccine shot a few days later and had no additional cardiac issues. I still need to follow up with neurology reguarding my head injury. I have right temporal lobe damage. I am not sure if this is temporary or permanent.
Hard lump approx 1 inch Red circular skin blotch approx 2 inches Severe itching At injection site Duration 3 days Took OTC Allegra from 1 hour prior to vaccination through day 4 post vaccination  On day 2 - mild fever, nausea, headache lasting 4 hours.
This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Numbers: UNKNOWN) via unspecified routes of administration in the left arm on unknown dates for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown dates, the patient had a migraine after the first and the second doses. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with an unspecified medication. The clinical outcome of the event migraine after the first and the second shots was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : -PFIZER INC-202101555991 similar report from same reporter.