chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster dose; When I get really relax my heart starts beating up; fast heart beat; I urinate; I get frequent urine; I have no control over it; it's is basically at night not so much during the day; Dizzy; Shortness of breath; but stated he went to ER twice for congestion but he is better now.; This is a spontaneous report from a contactable consumer. This consumer reported that, A patient of unspecified age and gender received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization and took second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient takes booster dose and patient get really relax his heart starts beating up; fast heartbeat, patient urinate; get frequent urine; have no control over it; it's basically at night not so much during the day, dizzy, shortness of breath, but stated he went to er twice for congestion, but he is better now. It was reported that patient had the booster shot then having side effects. When patient get really relax patient heart starts beating up. The biggest problem patient urinate mean get frequent urine. Patient have no control over it, it's is basically at night not so much during the day. Patient feel dizzy, shortness of breath and fast heartbeat. On an unspecified date. the patient underwent lab tests and procedures which included heart rate: increased. The outcome of the event but stated he went to ER twice for congestion but he is better now recovering and for the other event was unknown.  Follow-up attempts have been completed and no further information is expected.
BODY ACHES; COUGH; NASAL CONGESTION; SNEEZING; CHILLS; WEAKNESS; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced body aches. On 17-OCT-2021, the patient experienced cough. On 17-OCT-2021, the patient experienced nasal congestion. On 17-OCT-2021, the patient experienced sneezing. On 17-OCT-2021, the patient experienced chills. On 17-OCT-2021, the patient experienced weakness. On 17-OCT-2021, the patient experienced tiredness. On 17-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, body aches, weakness, cough, tiredness, nasal congestion, headaches, and sneezing. This report was non-serious.
administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml ); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) in a 41-year-old female patient 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 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. Patient did not report any adverse effects post vaccination
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative; Unknown results, notes: I had tested negative after the 5th day of initial testing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course received on 12Jul2022: stopped taking the meds on the third day because patient kept gagging at night from the metallic after taste and had tested negative after the 5th day of initial testing. 3 days after stopped taking the meds and relapsed with different symptoms (congestion, sneezing) and wondering if it is because patient did not finish the whole treatment or because that is one of the side effects. Patient was fully vaccinated and double boosted. Adverse event started on 11Jul2022, patient was not recovered. Its unknown that any treatment for adverse event was received. Patient is allergic to Penicillin and other medical history includes asthma. Anti viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 05Jul2022, Treatment stop date: 07Jul2022, Lot number: 609422, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; dose 5 (booster); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), outcome "unknown", described as "dose 5 (booster)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative test obtained after 4 days; Positive, notes: In daily testing tested again faintly positive after Paxlovid final dose taken. Symptoms fully re-occurred, with strongly positive rapid test 4 days after final Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date: 18Sep2022, Treatment Stop Date: 23Sep2022.  Paxlovid rebound. Symptoms improved within 3 days and negative test obtained after 4 days. In daily testing tested again faintly positive after Paxlovid final dose taken. Symptoms fully re occurred, with strongly positive rapid test 4 days after final Paxlovid dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue, myalgias/arthralgias, and vasovagal syncope within 24hrs of immunization; also developed local redness, induration, warmth, and soreness of the R deltoid injection site  within 24hrs of immunization; symptoms seemed to be improving at the time of evaluation 48hrs post-vaccination
I was up all night scratching my head; This is a spontaneous report from a contactable consumer(patient). A 54-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 03Feb2021 15:00 as unknown, single for covid-19 immunisation.  Medical history included allergy to allergic to fire ants from an unknown date and unknown if ongoing and Penicilin drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within a timeframe of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient was up all night scratching her head on 03Feb2021 23:00 further she described just like when I took penicillin (which I am allergic to).The outcome of event is recovering. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Flu like symptoms for 3 days, then continue loss of appetite, weakness, so much so that on April 5, 2021, I was taken to the emergency room for immediate treatment.  The hospital then discovered 2 pulmonary embolisms (blood clots), one in each lung and pneumonia.  At this time, I was extremely weak and in major physical stress.  NOTE:  I do not have a history of ever having blood clots.
Pt reports < 12 hrs of receiving Hep B vaccine felt flu like symptoms without fever. Leg weakness, body aches.
24FEB high fever 103 treated w/APAP; 25FEB t105.2; 26FEB t105.6 had sz 3PM last about 1 1/2 min; taken to ER; mom stated that MD felt that episode not vaccine related; pt doing well presently;
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 75 year old male patient with no pertinent medical history or drug reactions or allergies. On 11-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007825, expiration date 13-JAN-2016) intramuscularly (dose not reported). There was no concomitant medication. The pharmacist reported that the patient called the pharmacy on 12-NOV-2014 to report that the "should(er)"/(the place) that he received the vaccination was sore. The patient was advised to treat the soreness with "ice, as needed." There was no lab test performed. At the time of reporting, the outcome of event was reported as recovering/resolving. The patient sought medical attention via calling the pharmacist. This is one of several reports from the same reporter. The pharmacist requested lot check for the PNEUMOVAX 23 (lot # K007825, expiration date 13-JAN-2016). Additional information has been requested.
I had the shot on a Wednesday. Thursday and Friday I felt a little achy and cold but Saturday I woke up with pain under my right clavicle (almost like post surgery gas pain). It has not gone away and is not relieved with ibuprofen.  I also have weakness/numbness in my right arm and it feels crampy and uncomfortable. Today is day 8 since my shot.
Within a month my blood pressure was elevated. Diastolic numbers were considered high. I had some previous high blood pressure incidents, but stress related and not consistent like this. I let my doctor know and she did not think it was related to the vaccine but there is no other explanation I can think of for a sustained diastolic reading of 90+. She prescribed a 10mg dose of Lisinopril which has reduced the systolic numbers, but the diastolic numbers remain high. I have a healthy lifestyle - lots of cardio exercise, routine weightlifting and yoga, my diet is good. To this day, my blood pressure remains high despite over a year on blood pressure medication. I think this needs to be reported as a possible side effect from the vaccine.
Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 14Mar2021 15:45 (at the age of 64-year-old) (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (ESTER C) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that site on her left arm after the COVID vaccine became warm to touch, red, and very itchy on 15Mar2021 10:00. Therapeutic measures were taken with Benadryl 4 times per day, ice on area, hydrocortisone. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving 3rd and last vaccine, turned pale and became limp while sitting on exam table. Had her lay down and was OK with seconds although still pale. BP 118/70. Checked by doctor. Left office after 20 min and appeared fine.
Pt presented to pharmacy on 10/22/15 on/about 1300 hrs - with left arm redness around injection site - warm to touch, itchy and circular in nature - pt noticed on 10/21/15 area has reddened since.
After giving Hepatitis A vaccine #2, I was placing the bandaid and looked at pt who head started to lean back and eyes was starting to roll and pt mouth was opening wide. Called pt name no response opened door and called for DR. Dr. came and stated call 911. I put arm under pt shoulder and under chin for pt would not hit head on desk. Pt was having a vago response and became very tight. Other Dr.'s and nurses arrive. Pt slowly started coming out and then we were able to put pt on bed. Blood pressure, pulse was monitored. EMS arrived then it was canceled. Dr. stayed with pt for about another 20-30 minutes. Pt left walking on his own. Per Dr./RN The patient had a seizure that was caused by his vasovagal reaction. The vasovagal episode triggered the seizure.
Pt tested positive for Covid 19 on 03/29/2021 and 04/09/20221
spontaneous Intraparenchymal hemorrhage; flaccid on right side; aphasic; anisocoria; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Gray Cap-PFIZER BIONTECH 0.3ML IM, Without Preservative), on 03Jun2022 at 16:15 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history included: "a.fib." (unspecified if ongoing). Concomitant medication(s) in two weeks included: ASPIRIN [ACETYLSALICYLIC ACID]. No other vaccine in four weeks.  No COVID prior vaccination. COVID not tested post vaccination. No known allergies. The following information was reported: ANISOCORIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal"; APHASIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "aphasic"; HYPOTONIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "flaccid on right side"; HAEMORRHAGE (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "spontaneous Intraparenchymal hemorrhage". The events "spontaneous intraparenchymal hemorrhage", "flaccid on right side", "aphasic" and "anisocoria" required emergency room visit. AE resulted in: Emergency room/department or urgent care. The patient date of death was 10Jun2022. Reported cause of death: "Intraparenchymal hemorrhage". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events spontaneous intraparenchymal hemorrhage", "hypotonia", "aphasia" and "anisocoria" and the suspect drug BNT162B2 cannot be excluded.  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.; Reported Cause(s) of Death: Intraparenchymal hemorrhage
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 17-Nov-2021.
Swelling at the injection site; Heat at the injection site; Pain at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 10 years before the date of reporting).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient got the original shingles shot almost 10 years ago. It turned out only about 30 percent effective. The patient got the Shingrix shots, it was 2 shot deal and had a higher rate of effectiveness. After vaccination, the patient had swelling, heat and pain at the injection site. The patient hope that he/she feel better soon and would check with doctor about whether or not other should get the newer vaccine. Additional Supportive Information: This case was linked with case US2022AMR076126, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076126:Same reporter.
Patient states that she felt fine, but at about 11 PM she woke up shivering uncontrollably. She felt fine other than that, and no issues with extremities, but her core was shivering. It was bad enough it kept her up until 4 AM when she took a sleeping pill. At 6 AM she woke up with no shivering but all her muscles were very sore.
4-29 had itchy bumps on site of vaccine. 4-30 had about 2 inch round, itchy welt. 5-1 went away on its own, no treatment.