chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gross hematuria; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 at 03:45 as dose 3 (booster), single (Lot number: FK9896) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Fish" (unspecified if ongoing), notes: Known allergies: Fish; "COVID-19" (unspecified if ongoing), notes: prior vaccination. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Dec2020, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL1283, Location of injection: Arm Left Vaccine Administration Time: 10:00 AM), administration date: 12Jan2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: HAEMATURIA (medically significant) with onset 27May2022 at 15:00, outcome "unknown", described as "Gross hematuria".  Clinical course: 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 COVID vaccination. Received other medication within 2 weeks of the vaccination. Event was reported as non-serious, seriousness criteria reported as event was not resulted to death, nor it was life threatening. No prolonged hospitalization, Disabling/Incapacitating.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Mother stated baby broke out in a rash from head to toe on 6/9/18 morning. He had also finished some prednisolone approx. 4 days before receiving vaccines.
she is having itchiness; hardening on the arm of the injection; has an internal ball on the arm of the injection; Rosette on the arm of the injection; chills; she had congestion; lost her voice; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection) and CHILLS (chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills). On 14-Apr-2021, the patient experienced PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection). In April 2021, the patient experienced NASAL CONGESTION (she had congestion) and APHONIA (lost her voice). On 08-Apr-2021, CHILLS (chills) had resolved. At the time of the report, NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have concomitant medication. No treatment medication details were reported.
tightening upper back muscles/tightening upper arm muscles; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (tightening upper back muscles/tightening upper arm muscles) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Ecitalopram for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCLE TIGHTNESS (tightening upper back muscles/tightening upper arm muscles). At the time of the report, MUSCLE TIGHTNESS (tightening upper back muscles/tightening upper arm muscles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from two contactable HCP communicated to a sales representative. The two HCP reported same event for 3 non-contactable unknown patients. This case is for the 3rd patient. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to TRUMENBA on an unspecified date with outcome of unknown. The Pfizer sales representative mentioned that in the doctor's opinion the reaction was due to TRUMENBA.
Pruritic rash on stomach and back.; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 32-year-old), as dose number unknown, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included depression and seasonal allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021, the patient experienced pruritic rash on stomach and back. The event was resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included prednisone for the reported event. The outcome of pruritic rash on stomach and back was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom in clinic today requesting Hep B #2, but states child had reaction to dose #1 given 10/4/04. States child had severe headache and nausea after got home. Then developed rash on legs for 3 weeks. Still having headaches. Didn't see doctor. Instructed must have doctor clearance before getting next dose since she believes condition R/T Hep B shot.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders. No information was provided regarding the patients' historical conditions, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route of administration unknown) lot # N035937 with expiration date 18-DEC-2019 and lot #N024568 with expiration date 07-SEP-2019, for prophylaxis. All lots of VARIVAX were reconstituted with properly stored sterile diluent (MERCK). The vaccines were stored at a temperature below of -3.1C for the time frame of 1 hour and 28 minutes. There were multiple previous temperature excursions going from -9C to 8C with a duration of 53 hours and 11 minutes. The call was because of a data logger. No adverse event reported.
luer lock device was loose; Pharmaceutical product complaint; Needle stick with a contaminated needle; Occupational exposure while administering product; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 459GT, expiry date 7th June 2020) for an unknown indication. This case was associated with a product complaint.   On 6th September 2019 10:00, the patient received the 1st dose of FluLaval Tetra 2019-2020 season .5 ml. On 6th September 2019, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced accidental needle stick, occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental needle stick, occupational exposure while administering product, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The reporter stated that, the nurse was preparing syringe for administration and noticed the luer lock device was loose so she tightened the luer lock. The luer lock was again loose and she tightened it again and then administered the vaccine to a customer and as she was going to release the needle for disposal, the needle landed on her wrist, which led to accidental needle stick, occupational exposure while administering product and exposure via skin contact, syringe issue and pharmaceutical product complaint. As per the description, the luer lock device was screwed on before screwing on the needle and also after screwing the needle on because the nurse realized that the luer lock was not tight.   The product with the needle was discarded and not available for retrieval. On the 6th September 2019, the second incident happen. the nurse was preparing the injection for administration and noticed the luer lock device was loose and she screwed it back on and then tip cup with the luer lock device detached off. There was no exposure with this incident. The tip cup was not taken off. The reporter stated that the product might be available for retrieval, the nurse was not sure. The reporter consented to follow up.   Follow up information received from QA department on 25th September 2019: The conclusion of the QA statement was received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.   Upon error correction received the correction done on 29th May 2020: The classification exclude from pader was removed from the case. It was unknown if the reporter considered the accidental needle stick to be related to FluLaval Tetra 2019-2020 season.
This spontaneous report as received from a nurse refers to a 7 months 20 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Vaccine received on 2/12/21 first does Moderna.  2/20/21 buring in left arm, rash, itching and swelling.  Systems are still there as of 2/22/21
Moderna was manufacturer.  Diarrhea that lasted 3 days.  No food for first day and then crackers and water.  Days 4 and 5 still week and headache but diarrhea stopped
2 days after receiving DTAP and IPV in the left thigh, Pt began to serotest the anterior thigh. Mom noticed a large red rash on anterior left thigh and brought him in.
Did not feel well; Receiving Rabavert in her tendon rather than deltoid; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert with an associated reaction of therapeutic response decreased (for tolerance to the past dose, refer case US2020AMR232591). Concurrent medical conditions included animal bite (possible bat bite). Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 9th November 2020, less than a day after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced feeling unwell and vaccine administered at inappropriate site. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   Additional details were provided as follows: The age at the vaccination was not reported. The patient received RabAvert was post exposure prophylaxis. Possible bat bite on 28th October 2020. The patient received  Rabavert in her tendon rather than deltoid and said she did not feel well afterwards, which led to vaccine administered at inappropriate site. The nurse said there was no blood after the shot. It took 30 minutes for the nurse to get the doctor's signature. Once she got the vaccine the patient thought she should start feeling bad, like it could mimic rabies, but was still feeling well. The reporter declined to provide contact information and further details for adverse event report.  It was unknown if the reporter considered the feeling unwell to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232591:same patient
Information has been received from a lawyer regarding a case in litigation concerning a 76 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2011, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 10-JUL-2012, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Client came into the health dept on 11-24-21 to receive her 2nd dose of the children Pfizer vaccine, however, it was discovered on  11-24-21 that she actually received the adult Pfizer vaccine (0.3 ml) instead of the children Pfizer vaccine (0.2ml). Spoke with mom to inform her of the medication error on 11-24-21 and she and the client stated there were no adverse events noticed the day she received the adult Pfizer vaccine on 11-3-21 or after.
Pt recvd Engerix-B & exp lightheadedness, dizziness which resolved; sx were not anaphylactic-like;
experienced shingles about a week and a half later; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   The patient's past medical history included shingles.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shingles about a week and a half later. The patient had a history of shingles as well. The patient had notified the doctor but no treatment has been recommended.
Tested for Covid, Nasal Swab: postitve (18OCT2022); Tested for Covid, Nasal Swab: postitve (18OCT2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: FN6204), in left arm, on 16Apr2021 at 12:00 as dose 2, single (Lot number: FP2533), in left arm, on 29Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 16Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history (no known allergies). The patient took concomitant medications (Probiotic). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Oct2022, outcome "unknown" and all described as "Tested for Covid, Nasal Swab: postitve (18OCT2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201398220 Same reporter/patient, same drug/different dose, different AE;US-PFIZER INC-202201397769 Same reporter/patient, same drug/different dose, different AE;
Patient had swelling from armpit to elbow. Patient stated prescriber placed them on an antibiotic.
Mother returned with pt to clinic on 8/25/2003, stating that pt was unable to bear her weight on her right leg. Pt did not run a temperature, there was no redness or swelling to any vaccine sites or bruising noted. Mother states she took patient to Dr out of country on 8/25/2003 and he gave the pt "something for inflammation", she also states she has been applying something "similar to" "Vicks Vaporub" to the injection sites. Xrays to femur were done on 9/02/2003. Results show no fracture identified. No bony destructive lesions present. Mother was advised since Day 1 to apply cool compresses on day of vaccination and warm the next day, to make sure she gave pt Tylenol or Tempra for fever and pain and to make sure that pt was mobile as much as possible. Pt has an appointment pending with a neurologist as of 9/10/2003.
Client experienced syncopal episode approx. 20 mins after receiving vaccine. Acc. to EMT observer, client was "in and out of consciousness for about 2 minutes." After this time, client was AOx3. V/S taken @ 9:44am BP 118/64 HR 85 RR12 O2 96. Client's mother was present and reported that syncopal responses are common for client after vaccines/blood draws and did not appear concerned. Client also stated this often happens after needles. Client was advised to remain for an additional 30 mins. V/S @ 9:53am: BP 122/70, HR 81, 02 98, RR 16. V/S @ 10:01 BP 118/72, HR 68, O2 96. V/S @ 10:12am BP 116/74, HR 70, RR 16, O2 98. V/S @ 10:24am BP 122/74, HR 76, O2 98, RR 16. Approx. 10:25am, client reported feeling safe to walk to car. She left site accompanied by mom, unassisted, and with a steady gait. Mom stated she would be driving them home.
PATIENT WAS SUPPOSED TO HAVE RECEIVED A SHINGRIX ZOSTER VACCINE, AND INSTEAD GOT A DOSE OF PREVNAR-13, WHICH WAS PREVIOUSLY ADMINISTERED 09/17/2015.
Dark purple bruise, 1.5?x2.5?, and swelling appeared about 1 hour after vaccination 6? below injection site. Red, diffuse rash  appeared above and beside bruise 2 days later.  Bruise and rash still present at day 4.
After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2022 and was forwarded to Moderna on 14-Jul-2022.     This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack /After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) (seriousness criteria death and medically significant). The reported cause of death was after the second dose of the moderna covid-19 vaccine the person's relative suffered a fatal heart attack.. It is unknown if an autopsy was performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack.
Information has been received from a physician who heard from another physician concerning a female (from a gymnastics class) who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced tingling in her lower extremities. The outcome of the patient was not reported. This is one of the several reports from the same source. Additional information has been requested.