chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site red, hot, swollen hours after injection. Next day HA, nausea, chills/sweats, loss of appetite, weakness, fatigue, light-headedness. Advised fluids, rest, ibuprofen and TYLENOL. 5/25 fever of 102.4.
Patient felt flushed and her skin turned red on the chest, face, and arms. She felt dizzy and nauseous.
At approximately 6:20pm on 03/30/2021 patient during 30 minute observation (high risk due to immunosupression) had dizziness without syncopy. On assessment at 6:20 PM  HR:121, BP:102/70 R:18 O2:99%, patient was AA&Ox4, answered questions correctly. 6:30 HR:83, BP:90/70, R:18, O:99%. Patient states: "I can not drink water." Patient appeared less alert and hard to rouse, Transportation to ER was advised repeatedly. Mother stated: "I don't want to take her to ER, because it is too dangerous for my daughter because she is on steroids. We have been in ER 3 weeks ago due to migraine and they check all labs." Mother refused to call 911 and said she would transport the patient to ER of Hospital.
adult patient received a dose of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 26th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Medical assistant reported that, an adult patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
nosebleed; chills; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (hospitalized for 5 days and had blood clots in his lungs.) in November 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment has not provided. The patient's concomitants has not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Headache that feels like I drank hard alcohol (which I don't) and have a bad hangover starting the morning after the vaccination and it has not stopped after 14 days. Leg pain is off and on which feels heavy and with shooting pain.
Product Storage Error; Flu Like Symptoms; Muscle ache on entire body; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the patient experienced flu like symptoms and generalized muscle aches. On an unknown date, the outcome of the flu like symptoms and generalized muscle aches were recovered/resolved and the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the flu like symptoms and generalized muscle aches to be related to Shingrix.  Additional case details were provided as follows: The patient was administered a frozen dose of Shingrix vaccine in her left arm, which led to incorrect storage of vaccine. She experienced flu like symptoms and muscle ache on entire body for about 3 days.  The patient had reported this event to her physician. The patient did not consent to follow-up. No further details were provided.
Patient received RSV vaccine on 10/10, then on 10/20 for routine visit, platelet value was 6. Repeat platelet count was 6.  Suspected immune thrombocytopenia due to RSV vaccine due to timeframe and no other identifying causes.  Prior platelet levels from a visit month before was 132. Prior monthly values were 166, then 148, and 132 without count check in between.   Patient was admitted to the hospital and treated with dexamethasone 40 mg x 3 days + IVIG 1g/kg x 2 doses. Platelet count subsequently improved to 25 on 10/21/23 after treatment, with most recent platelet count of 74 on 10/27.
w/in  2 hrs of vax pt devel severe hive react which persisted for 48 hrs; DPH administered during this entire period every 4-6 hrs as recommended by MD; breathing appeared to become labored @ one point & almost rushed to ER site swollen; t
Fever; Chills; Tired; This is a spontaneous report from a contactable consumer or non health professional. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills and tired. Outcome of the events were unknown.  Information on the lot/batch number has been requested. No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Covid Arm. Red rash of about 3 inches in diameter a few inches below injection site. Now yellowing is appearing on the edge of one side of the rash.
Blood pressure 130/99 Pulse 129 Severe headache Back pain Nerve pain
Patient arrived for COVID-19 vaccine (Moderna vaccine). Patient was underdosed given 0.05mL, waited for 15 min and then left and no acute reactions were noted. Leadership was notified. Patient was brought back later for accurate dosing. No adverse event noted
Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the arm left on 10Apr2021 at 08:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Pregnant at the time of vaccination was reported as unknown. Concomitant medications included estradiol (ESTRADIOLO), progesterone (MANUFACTURER UNKNOWN) and chlorpropamide (CHLOMIDE) for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the arm left on 20Mar2021 at 08:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. 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 10Apr2021 at 22:30 the patient experienced Dizziness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event Dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chills, nausea and injected limb mobility decreased. On an unknown date, the outcome of the chills, nausea and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, nausea and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The patient received a dose of SHINGRIX on right arm. The reporter stated that for a while, the patient could not lift her right arm above her head. The patient did not have any additional information. The patient did not consent to follow up.
allergic type reaction with extreme pruritis, redness and swelling beginning in scalp and spreading to face, arms, trunk and back
Chills and Fever at 12-24hrs Months following - positive COOMBS, high liver enzymes and reactivation of epstein barr virus.
Patinet presented to the Emergency Department with burning chest pain radiating from the center of his chest 1 day post receiving his second dose of the Pfizer vaccine. Elevated Troponin (16498) and Creatinine Kinase (1187). Patient being treated for vaccine induced cardiomyopathy.
Pfizer Vaccine lot #30135BA was affected due to out of temperature range. No adverse reactions from patients.  132 patient's affected.
Nausea, dizziness, headache, neck and shoulder pain.   No treatment,  was told to report these symptoms.
7.5 cm x 6.5 cm circular erythematous cellulitis to right upper arm.
I received the 1st shot with no issues.  After receiving the 2nd does I started with a lump in my armpit.  After a week it went away.  I then got a flu vaccine in Oct. and the lump came back.  It was a painful lump.  I went to my doctor several times, had blood work done and a mammogram.  All came back fine.  I had the lump for about 8 weeks.  I then got Covid the first week of Jan. and the lump came back.  It lasted about 8 weeks and is now gone.
Minor headache day after vaccine.  pain in left upper teeth 2 days later, subsided after 1 week.  2 weeks after the vaccine, on April 4th, patient had severe thunderclap coital headache, and has had mild headaches (possibliy stress induced) since.  MRI/MRA showed only empty sella, which is likely incidental.
8 hours after vaccine TDaP and MCV4 pt woke with painful itchy and red legs. Then ear lobes swollen and red (L) arm itchy and red. This am swelling at vaccine site (L) arm.  (R) cheek redness.
Redness and swelling to injection site. Injection site anterior right thigh. 10 x 12cm indurated. Pt Rx Orapred.
Itchy arm rash at injection site that appeared a week post injection; Itchy arm rash at injection site that appeared a week post injection; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6208) via an unspecified route of administration in left arm on 13Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. 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 was not been tested positive for COVID-19. On 21Mar2021, the patient experienced itchy arm rash at injection site that appeared a week post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported event. The clinical outcome of the event itchy arm rash at injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
pt recv vax 26OCT95 & platelet count was 153K;29DEC day of prev vax platelet count 49K;pt was subsequently sent to hematologist & dx w/aplastic anemia;
pt got second pfizer covid vaccine(12:53pm) (no problems with first one), while she was during her post-vaccination wait, she looked at her arm and noticed hives (1:15pm)  gave her 10mls of benadryl  she waited 20 more minutes and left
Nausea; Body ache; low energy; Discomfort in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Body ache), ABDOMINAL DISCOMFORT (Discomfort in the stomach) and ASTHENIA (low energy) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-1903, the patient experienced ABDOMINAL DISCOMFORT (Discomfort in the stomach). On 25-Jan-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Body ache) and ASTHENIA (low energy). At the time of the report, NAUSEA (Nausea), MYALGIA (Body ache), ABDOMINAL DISCOMFORT (Discomfort in the stomach) and ASTHENIA (low energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
A nurse reported that a 9 month old female received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 5/23/00. The infant had a runny nose at the time of IZ. On 6/3/00, the infant developed a measles-like rash on her chest and back. The rash persisted on 6/5/00 and the infant was seen by the physician, who did not prescribe any treatment.
Tinnitus in left ear, no other known etiology per otolaryngologist, unchanged and unresolved as of 04/24/2023.
Information has been received from a consumer, concerning her 17 year old son with a penicillin and CECLOR allergy, sulfonamide allergy, drug hypersensitivity to FLUVIRIN (involving an anaphylactic reaction, 02-OCT-2007), latex allergy, and multiple food allergies, Concomitant therapy included ZYRTEC.  On an unspecified date prior to scheduled vaccination with VARIVAX, her son's skin "flared up and became red" when a small amount of the vaccine was injected under the skin to determine if he was allergic.  Due to the response to the allergy test, her son was not given a full dose of the vaccine.  No further information was available.  The patient had a history of a positive allergy skin test when exposed to PNEUMOVAX 23 (WAES # 0711USA03586).
can't breathe as easily as before receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breathe as easily as before receiving the vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPNOEA (can't breathe as easily as before receiving the vaccine). At the time of the report, DYSPNOEA (can't breathe as easily as before receiving the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.   Reporter did not allow further contact
11-2 ER visit, URI - chest complaints. 11-4 ER visit, Decreased appetite - general weakness. 11-7 ER visit, Fell twice - could not get up.
Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 at 09:45 AM (at the age of 50 years old) (Lot Number: ew0162, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history included chronic atopic dermatitis, mild asthma, sulfa allergies, latex allergies, allergies of peanuts and almond, banana peel allergies, allergy to tomatoes, sesame allergy, and shrimp allergy. Concomitant medications included dupilumab (DUPIXENT); hydroxyzine hcl; and ibuprofen. The patient experienced metallic, numb sensation on end of tongue and Bell's palsy on 23Apr2021. The events resulted in emergency room/department or urgent care visit. The patient received prednisone and valacyclovir as treatment for the events. No other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Known allergies : Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: Other medication in 2weeks reported as no. It was reported that Paxlovid was used as treatment for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 63-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included ADVAIR unknown for asthma. The patient's past medical history included hypertension, premature ventricular contractions and gastrooesophageal reflux disease. Concurrent medical conditions included drug allergy (FORADIL, CELLCEPT and ACTEMRA). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and ADVAIR at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and ADVAIR, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reactions to be related to Seasonal Influenza vaccine and ADVAIR. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have any relevant family history. The patient did not have any relevant drug history and history of drug or alcohol abuse.
Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Lost vision (one eye)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain tumor and Brain tumor operation (Removed when patient was 18).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS UNILATERAL (Lost vision (one eye)) outcome was unknown.            Concomitant medications were not provided. Treatment information includes steroids.  Patient was hospitalized for couple of weeks and no doctors could point out the causes. They said they can do nothing and gave patient steroid and asked them to go home. Reporter knew some people who had experienced same issue after 3-6 months of taking second vaccination. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with clinical history  of Brain tumor removed who experienced the unexpected event of BLINDNESS UNILATERAL  The event occurred unknown days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-423102, MOD-2021-423139, MOD-2021-423152 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with clinical history  of Brain tumor removed who experienced the unexpected event of BLINDNESS UNILATERAL  The event occurred unknown days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
515 Child not breathing at home - brought to ED by POV. 525 Arrived in ED, full arrest at that time. Vitals monitor. 0544 ETT placed, Epi. 11/3/08-records received from ED for DOS 10/25/08-presented to ED dyspnea, unresponsive ventricular fibrillation. At home acutely SOB  6/23/09-death certficate and autopsy report received-COD Status asthmaticus. Lymphocytic bronchitis.
pt recvd vax & devel terrible headache, nausea, vomiting, achy muscles, tired; arm felt heavy but often like that;
At the end of the clinic, healthcare staff noticed a gray particle inside of the Moderna vial. It is unsure whether it is part of the rubber stopper or if it is a foreign material. After monitoring the patient for over 15 minutes, there were no adverse signs or symptoms.
Increased blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increased blood sugar) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Increased blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Increased blood sugar) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant and treatment medications were not provided by reporter.
11-12-06 11:00 AM - MOM NOTICED T.102.7. LIGHT PINK PINPOINT SPOTS ON ABDOMEN. BY THE AFTERNOON, THE SPOTS HAD SPREAD TO HER BACK. T.>102 DEGREES WITH MOTRIN. 11-13-06 RASH IS NOW ALL OVER HER BODY EXCEPT HER ARMS AND UPPER FACE.T.102.6. THE RASH NEVER DID ITCH NOR IS IT RAISED.