chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO adverse event, vaccination error, patient only 17yr & 4 months old & EUA was only for 18 years of age & above.   Only reaction to vaccination was sore arm.
I don't know if this is related or not, but a couple of nurse friends said I should report it.  A day or two after receiving the injection, I developed a rash on my right hand, and a couple of days later a few spots on my left hand.  There was some itching involved with it, but I honestly can't remember when that started.  It may have been before the injection, in which case  it  wouldn't have been the cause.  Yet if something was going on, I suppose that getting  the injection could have caused it to become worse than it might have been otherwise.  As of today, (3/8/21) , I can still see traces of it, but it has calmed down considerably.  There were no other affects than its appearance and  a bit of itching,. and a bit of soreness at the injection site for a day or two.
Coughing, hoarseness, sore throat, tightness in chest, difficulty breathing.
Coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (Coughing up blood) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HAEMOPTYSIS (Coughing up blood). At the time of the report, HAEMOPTYSIS (Coughing up blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Patient had itching nose and face approximately 30 minutes after Dtap. Patient also reported itching tongue. 10 mL benedryl given. Symptoms seemed to resolve quickly however about an hour later, even after benedryl, patient then reported itching all over the body. Approx 30 minutes after that, patient reported and was seen to have severely watering eyes.  Symptoms seemed to then resolve except for small bumps and itching at injection site 2 days later.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 27-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Patient received the Pfizer vaccine on 12/26/20 and 1/16/21 so was fully vaccinated when they tested positive for COVID-19 on 9/19/21.
PATIENT CALLED THE DAY AFTER VACCINE ADMINISTRATION COMPLAINING OF A SWOLLEN ARM WITH A RASH AS WELL.HE WAS ADVISED TO TAKE BENADRYL AND TYLENOL AND GO TO THE HOSPITAL,URGENT CARE OR HIS DOCTOR.A COUPLE OF HOURS LATER PATIENT REPORTED HE WAS FEELING NO BETTER AND WAS ALSO FEELING LIGHT HEADED. HE HAD TO GO TO THE MERGENCY ROOM AND LAST I SPOKE WITH THE PATIENT'S WIFE HE WAS ON IV STEROIDS AND WAS BEING MONITORED
Pt died on 2/15/21. On 2/13/21, pt complained of muscle aches.
Had moderate swelling and redness of the left thigh (inject site) noted on the 2nd day post shots. Would not bear weight on left leg. Given shot of Solumedrol and started on Orapred x 5 days.
Reactivated HPV1, patient now has outbreak on left side of nose, same side as shot, and sore left eye, nerve pain/twinges radiating to left ear.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 12Feb2021 as dose 2, single (Lot number: EN5318), in right arm and on 02Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jan2020. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 03Sep2022 at 12:00, outcome "not recovered", described as "Rebound case of Covid with all the Covid symptoms"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Sep2022) Unknown results, notes: Rebound case of Covid with all the Covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient took Paxlovid for COVID-19 treatment from 25Aug2022 to 31Aug2022. Patient had rebound case of Covid with all the Covid symptoms. Other medication received in 2weeks. No follow-up attempts are possible. No further information is expected.
Disorientation; racing heart; lack of Appetite; loss of taste; Body felt like humming and didn't know what to do with the shot; Slept for 5 days; Strange reaction after first dose; brain fog; chills; too tired; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste) and FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were reported.  Concurrent medical conditions included Shellfish allergy (developed anaphylactic reaction).    On 21-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 DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired). At the time of the report, DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for COVID-19 last week..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided. Patient mentioned that she tested negative for COVID-19 last week. Patient mentioned that she is not taking any concomitant medications   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI follow up
Day four after receipt of COVID vaccine, Pfizer, he developed a  vesicular lesion at the injection site with underlying erythema and edema.
3RD DOSE MODERNA COVID VACCINE GIVEN 12/1/21, #011F21A; pt admitted on 9/9/22 after recent hospitalization for AHRF; pt had nausea, vomiting, weakness and confusion; sepsis with septic shock; underlying acute colitis; pneumonia; AKI; Atrial Fibrillation; 9/16/22 pt had a positive COVID test; given Molnupiravir and ABX; pt's condition deteriorated; poor prognosis; DNR; pt passed away in PRIVACY.
pt recv vax & devel hives which covered approx 100% of body from head to toe;
This spontaneous report was received from a female patient of unknown age. On an unknown date the patient was a dose of vaccinated with ZOSTAVAX (dose, route, indication and lot # not reported). On an unknown date the patient developed shingles after receiving the ZOSTAVAX vaccine. The outcome of shingles was unknown. Additional information is not expected.
Shortly after getting flu shot at our drive through clinic, patient developed swelling and watering of eyes, facial swelling, coughing, wheezing and chest and throat tightness.  She administered her EpiPen and symptoms all resolved within one hour.  The following day, she woke up with hives and severe itching body wide, this resolved 30 minutes after taking oral bendadryl.
Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/16, Pfizer, dose #2 08/15 pt cc: cough, diarrhea, rhinorrhea, congestion, dyspnea exposure: unknown 08/18 COVD swab, result: detected 08/18 SARS-COV-2 Variant Sequencing result: pending 08/18 CXR impression: 1. No radiographic evidence of acute cardiopulmonary disease. 2. Interval placement of spinal stimulator. 08/18 pt admit to ED cc: R foot pain, L hip pain, cold symptoms dx: COVID+ LOS: 1 DAY
A non-serious spontaneous report of influenza type B was received from a consumer concerning a four year old female, subsequent to FluMist. The patient's past medical history and concomitant medications were not reported. The patient received FluMist on 14-Sep-2009. On 16-Sep-2009 the patient developed a running fever of 101.9 with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome and causality of the event were not reported.  All follow-up attempts have been made per company SOPs.  No further information is available. 19-Feb-2010.
allergic reaction bump at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication was not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient had allergic reaction bump at injection site. The clinical outcome of the event allergic reaction bump at injection site was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm 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) and as dose 3 (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) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Bounce back of positive COVID after 2 days of negative test; (Dec2022) Positive, notes: Bounce back of positive COVID after 2 days of negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Bounce back of positive COVID after 2 days of negative test.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
DVT Right leg.  Mid Femoral Vein all the way down to mid Calf past triforcation and superficial gastroc.
Pain, itching, severe swelling in entire back side of forearm, skin discoloration (red at first now skin is darkened in the same area as swelling); symptoms lasted over 7 days. Took BENADRYL with no relief but BENADRYL cream helped with itching. Nothing helped with swelling. Small painful blister at left side of waist lasting 1-3 days.
p/vax pt devel five lesions on stomach, chest & back;pt sought unspecified medical attention;
Took two doses of Vivotif which were not stored correctly; Spontaneous report received on 28JUL2020.  A male consumer reported that he "took two doses of Vivotif which were not stored correctly" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer started Vivotif and he took only two viable doses around three weeks ago. Later, he took two remaining doses of Vivotif which were not stored correctly and he wanted to know if Vivotif was still viable after a temperature excursion exceeding 50 degree Fahrenheit for 2 to 4 days. He did not have the lot number. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took two doses of Vivotif which were not stored correctly (Incorrect product storage). This consumer took other doses correctly but took the remaining doses where the Vivotif was exposed to temperatures exceeding 50 degrees Fahrenheit for 2 to 4 days. Vivotif should always be stored in refrigerator at the recommended temperature. Considering the case information, the causality of incorrect product storage is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took two doses of Vivotif which were not stored correctly (Incorrect product storage). This consumer took other doses correctly but took the remaining doses where the Vivotif was exposed to temperatures exceeding 50 degrees Fahrenheit for 2 to 4 days. Vivotif should always be stored in refrigerator at the recommended temperature. Considering the case information, the causality of incorrect product storage is assessed as not applicable to Vivotif due to the nature of the event.
heavy menstrual bleeding Menarche 7/12/21 in this 14 year old patient. Light bleeding 3 days duration. Next cycle started 8/31/21, Covid vaccine #1 9/1/21. Then bleeding became heavy, lasted through 9/17/21. No bleeding 9/17 - 9/21/21. Received Covid vaccine #2 on 9/22/21.  Menstrual bleeding resumed on 9/22/21, dark spotting for 1 week, then heavy bleeding which still continues as of 10/11/21 Never any pelvic cramping or pain.
Patient experienced dizziness almost immediately and neck/throat pain after about 5 minutes that progressed to voice changes/raspiness before 50mg of liquid benadryl was administered.  10 minutes after benadryl the patient's voice had returned to normal and she felt much better.
Fever, chills, myalgia, arthralgia, "bone pain," fatigue, nausea, vomiting, headache
Information has been received from a health care worker concerning a 23 year old male patient who on an unspecified date at some time in the past might had been vaccinated with a dose of MMR II now had mumps. At the time of the report the patient's status was unknown. Additional information is not expected.
Burning Mouth Syndrome?   My mouth, throat, and lips are on fire.   I thought it was related to GERD/LPR (and perhaps it is), but I was speaking to a colleague about it today, and she mentioned that her sister was having similar issue post vaccine.   I have not been to see doctor yet--b/c I don't even know what they could do.  There are no visible signs--no redness or anything.   Honestly, it seems unlikely that vaccine could STILL be causing this two months out, but I'm just wondering if any other people have reported.
FIFTEEN MINUTES AFTER VACCINE, PT. STARTED SWELLING AROUND THE LIPS AND THROAT. PARENTS GAVE PT. BENADRYL HOWEVER SWELLING DID NOT GO AWAY. PT. WAS TAKEN TO ER AND SEEN BY DR. AT MEDICAL CENTER ER.  PT GIVEN 20MG OF PREDNISONE AND A RX IF NEEDED.  ER VISIT ON 8/17.
HYPOXIA 3/21/2023 DIVERTICULITIS OF SIGMOID W PERFORATION
passed out; very sick; got a floor burn on face; must have been allergic; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.   This case involves a patient (unknown demographics) who passed out (loss of consciousness), got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 1982, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1982, the patient passed out (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date in 1982, the patient got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient had to get stitches in his lip.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented case concerns a patient (unknown demographics) who suffered from loss of consciousness, illness, burning sensation and hypersensitivity after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2023 at 15:00 as dose 4 (booster), single (Lot number: 049621A), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Aug2023 at 10:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Positive, notes: Positive COVID 19 Antigen Test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
In bed for two days after first dose; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mononucleosis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired). At the time of the report, BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided
Rt foot had a walnut size lump on the big toe joint, toes were black, significant swelling on sole of foot. Smaller lumps began to appear, spread to left foot. Knot and redness at injection site. Went away with Benadryl , Zyrtec and Epsom salt bath. 2nd day, school called to say rash and swelling were on hands and face. Fingers were black. face was more swollen on rt side with rt eye almost swelled shut. Treated again with Benedryl and Zyrtec. 3rd day, slight swelling in face, hives on arms, hands and hips.
Low grade fever, pain in entire arm where shot was administered, and swelling and hardening of injection location. Antibiotic and warm compresses was given.
Patient brought in the clinic in the afternoon of April 8, 2009 for check-up and immunization.  He had mild congestion only, vital signs were normal, gaining weight, no previous medical problems.  Patient was given Pentacel, Hep B, Prevnar and Rotateq.  The next day, in AM patient was brought to local ER apneic and pulseless.  Patient pronounced dead at about 11:21AM.  8/17/09 Autopsy Report states Probable cause of death: Undetermined. Manner of death: Undetermined. Report additional notes: Preliminary Autopsy Findings - 1. Normally developed infant with height and weight at the 75th and 50th percentile respectively. 2. Rare thymic and epicardial petechia. 3. Bilateral lungs with small perivascular chronic inflammatory collections. 4. Pulmonary hemorrhage. 5. Microscopic mitral valve hemangioma. 6. Negative toxicological, microbiological, and neuropathology evaluations.  Other Significant Conditions - Co-sleeping with adult(s), new sleep environment, childhood immunizations within 48 hours of death.  4/17/09 Received ER medical records of 4/9/09. FINAL DX: cardiopulmonary arrest Records reveal patient experienced unresponsiveness, asystole, EMS started CPR & unableto intubate.  In ER, remained unresponsive w/fixed pupils, abd distention, pale & possible dependent lividity of back.  Intubated in ER but resuscitation efforts were unsuccessful.