chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed blood blisters in his mouth; hemorrhagic reaction; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), dose 1 via an unspecified route of administration on Dec2020 (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that, patient stated that he is hoping he is talking to the right person; that he had already talked to somebody else. He states that he got his first dose of the Pfizer BioNTech Covid-19 vaccine in DEC2021, and had a hemorrhagic reaction, that it is not bad enough to be in the hospital. States that he has heard there have been instances where that has happened, even one person that died in his city (withheld), and that it was in the newspaper. Reports that 2 or 3 days after his dose, he developed blood blisters in his mouth.  It didn't go beyond that, and they resolved. About 2 weeks later, the same thing happened. The same thing happened about 3 more times, sporadically, but hasn't happened again in the last 5 months. States he has never had that happen before the vaccine. He did not get the second dose. He reports that he is being pressured at work to be fully vaccinated and is extremely uncomfortable with that; he is afraid of a worse hemorrhagic situation that could hospitalize or kill him. He is asking, what is somebody like him supposed to do about that. The reporter assessed the seriousness as non-serious. The outcome of the event developed blood blisters in his mouth was recovered on an unspecified date of 2021 and outcome was unknown for other event.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182128 similar report from same reporter
6 mos pt vax /w MMR/DTP/OPV 26Oct81,next morning pt experienced 1st seizure,subsequently experienced numerous seizures, treated /w anti convulsant drugs,seizure disorder not controlled &has mental retardation &physical handicaps.
7/11/06 Dtap IM left thigh, varicella SQ right thigh. 7/22/06 site of immunization right thigh with vesicles, mom brought child to ofc. 07/24/06 Rash all over, child taken to urgent care.
pt recv vax 1AUG98 & 24hr later pt exp joint aches, fever & erythematous mildly raised wheels;pt sought unspecified med attention;
This currently 81 year old female patient, with no known medical history, and no known medical conditions reports adverse events with Fluzone HD 2012-13 prefilled syringe. The patient had no other vaccines 4 weeks prior to Fluzone. The patient received the Fluzone HD 2012-13 on 11Oct2012 at 12:40 pm to prevent flu. The patient called the pharmacy on 14Oct2012 in the am to report adverse events with the flu shot. The patient stated on 11Oct2012 in the PM she was sleepy, had no energy for the rest of the day after getting the flu shot. The patient also reports that the night on 11Oct2012 she had chills and restless sleep. On 12Oct2012 the patient reports no measurable fever and the patient developed a cough with sputum. The patient described the sputum as having little or no color. On 13Oct2012 the patient reported having diarrhea. As of 14Oct2012, the patient has not seen her primary care provider for her described events. As of 16Oct2012, the outcome of all the patient described events are unknown.
Significant - along (R) posterior/radial upper ext for swelling, erythema and mild tenderness lasting > 4 days since injection.
adult patient was given the undiluted pediatric dose.  The dose given is still 30 mcg in 0.3 ml.
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 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), 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 included: "Asthma" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days 12 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment (Paxlovid), treatment start date was 23Sep2022, treatment stop date was 05Oct2022 and indication was treatment of COVID-19. Other medication in 2weeks reported as yes.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA Redness, itching, swelling and heat in innoculation area.  Concern as it did not show up until one week after innoculation .  Started at site and then traveled down arm.
About 20 minutes after receiving hep A vaccine #2, in Right deltoid, patient develolped red spots, "pencil point" on bilateral arms and legs without any other reported complaints.  Patient alert and playful. No respiratory distress reported.  Advised to see primary care physician and will follow-up with parent 7/3/08.
Patient passed out approximately 10 minutes after getting her shot. She was given a bottle of water (by her spouse). EMS was called and evaluated patient. She declined further care and left with her husband once she felt better.
Next day patient called to report severe pain to R upper arm, radiating to neck area. Came in to be seen by provider. Received Toradol 60mg IM injection to gluteal area. Pt very sore, no erythema, no drainage from site seen, no fever. Guarding area and complained of much pain when moving arm. Followed up with patient next day and had less soreness and advised to take over the counter Tylenol or Motrin.
3 patients received expired second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache (11:00 pm), shivering, night sweat (2:00 - 5:30 a.m.) Treated with ibuprofen @ 6:30 a.m. Mild headache returned at 6:00 pm but side effect, besides sore are at the site of the injection.
Patient received first dose of Moderna COVID-19 vaccine on 7/15/21 at approximately 0900 by this RN. Patient reported NKA or conditions that may contraindicate receiving vaccine. After vaccine administration, patient was observed by this RN for fifteen minutes. Prior to leaving patient stated he felt fine and appeared to be in no apparent distress upon departure. At approximately 15:30, patient called stating he had been experiencing blurred vision since approximately "10:30 or 11:00 that morning" and wonders if he should seek medical attention. This RN encouraged patient to seek immediate medical attention. Patient reports a chronic medical condition  called Keratoconus. Patient denies any other medical problems or allergies. Patient states he will seek immediate medical attention at the local ER or an urgent care. Patient encouraged to call back if needed by this RN.
vomiting; Stomach ache; low grade fever (99F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Nov2021 18:45 (Lot number: FL0007) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 21Nov2021. Vaccination history included: Comirnaty (1st dose, Time: 17:15, Lot Number: FK5127, Route: Intramuscular, Anatomical Location: Right Arm), administration date: 09Nov2021, when the patient was 7 years old, for COVID-19 immunization.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 30Nov2021 13:30, outcome "unknown", described as "Stomach ache"; VOMITING (non-serious) with onset 30Nov2021 15:00, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 30Nov2021, outcome "unknown", described as "low grade fever (99F)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Relevant tests and Specific Relevant tests for thromboembolic events with thrombocytopenia were None. Upon temperature check, patient had a low-grade fever of 99F on 30Nov021.  Follow-up attempts are completed. No further information is expected.
Flu Vaccine given on 11/09/2005. Skin reaction on 11/11/2005, beginning on trunk, face, limb, edema of lips, hands, feet. Afebrile, no itching. Saw PMD on 11/11/2005 and ER visit on 11/ 13/2005. Additional PMD visit 11/14/2005 for bloodwork.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild
Patient took 25mg Benadryl x 2 doses prior to immunization. Patient developed prickly sensation all over body, blotches like first vaccine.  Per patient report at this time patient got rashes and hives for three weeks after first vaccine.  Patient took another 25mg of Benadryl during time in observation and immunization clinic. Patient instructed to go to ED if symptoms worsen.
Herpes, high BP, palpitations, high fever, nausea, diarrhea, cough, fatigue, headache,congestion,no appetite,swollen glands, stomach ache
Bleeding left arm from Dialaysist-fistula site-pressure applied-redness-family to transport to hospital. BP-158/82
large irritation to skin to upper right arm. An area that is approximately 10 cm x 10 cm is red and inflammed
Covid19 Pfizer 12 and up was given and was expired on 11-7-22.   No reaction.
Woke up today - 1 week after vaccine with generalized urticaria and hives, took BENADRYL with relief. Has has same reaction in past.
Fever, bone aches, stiff painful arm, chills- Motrin for two days I took Motrin and stayed in bed and slept. Facial red rash started 6 days after vaccine and I began to develop red bumps and thickening of the facial skin.
extra of ACTHIB that was administered/administration of an extra dose with no reported AE; Initial information was received on 26-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 7 months old female patient who reported that extra of vaccine hib (prp/t) vaccine [ACT-HIB] that was administered/administration of an extra dose with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR); and DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix).  On 26-Apr-2023, the patient received a dose 5 of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ756AA, Expiry date :12-Aug-2023) (with unknown strength) via intramuscular route in the right thigh for Immunization.  On 26-Apr-2023 the patient developed a non-serious event of extra of acthib that was administered/administration of an extra dose with no reported ae (extra dose administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event extra of acthib that was administered/administration of an extra dose with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dizziness and nausea started within 20 minutes after receiving vaccine.  As of 4/26/2021 I am still experiencing these symptoms.
Resting heart rate went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. Known allergies were reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Apr2021 at 12:00, the patient experienced resting heart rate which went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM. This was continued on and off for five days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event of resting heart rate went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
incoherent; really weak.; nauseous; fever; vomiting; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves afemale patient who experienced incoherent, really weak., nauseous, fever and vomiting, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included menactra when she was 11 but did not have any reaction. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a Booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious incoherent, really weak.(asthenia), nauseous (nausea), fever (pyrexia), vomiting following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No lab test reported.  Final diagnosis was vomiting, fever, nauseous, really weak. and incoherent.   Patient was taken to hospital and given IV fluids and a anti-nauseous medication. Patient stated that she thought she was given an antiemetic but she stated that she didn't know that 100%.  The patient outcome is reported as Unknown for the events..  Information on the batch number was requested:
Severe headache starting about 8-10 hours after vaccination and lasting about 30 hours  Vomiting- starting about 8 hours after vaccination, lasting about four hours  Shivers/aches/chills/sweats first night after vaccination. Extreme fatigue lasting two days after vaccination.
Menstruation changed dramatically. Shorter and heavier periods. Went from 4 days to 2 days. Went from very light to very heavy. I never had pms pain prior to the vaccine and now a few hours before menstruation starts I am up all night with agonizing stomach pain.
The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information was not given.
People being treated in hospital for COVID with both vaccines given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (People being treated in hospital for COVID with both vaccines given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (People being treated in hospital for COVID with both vaccines given) (seriousness criterion hospitalization). At the time of the report, COVID-19 (People being treated in hospital for COVID with both vaccines given) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Company Comment : This is a case of unspecified number of patients of an unknown age and gender who experienced serious unexpected event of special interest COVID-19. Temporal relationship cannot be determined as start date of the event was not provided nor vaccination dates. The event occurred following the second dose with the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. Very limited information regarding the event has been provided at this time. Outcome of the event was unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This is a case of unspecified number of patients of an unknown age and gender who experienced serious unexpected event of special interest COVID-19. Temporal relationship cannot be determined as start date of the event was not provided nor vaccination dates. The event occurred following the second dose with the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. Very limited information regarding the event has been provided at this time. Outcome of the event was unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Swollen painful lip, rash. Pt took Benadryl. I suggested going to doctor but daughter told me today she refused but will encourage her to go again tomorrow.
Started with nasal irritation, then sore throat. Within 24 hours after onset of symptoms, Sore throat turned severe along with itchy eyes, runny nose, and heavy white mucous congestion. Aches and slight fever came a day later.
Patient reported feeling "lightheaded" after FLUVIRIN injection. After 10minutes she felt "better" and needed to leave. We called her @ 9am the next morning and she said she was "back to normal" after eating dinner.
feels "bad"; vomiting; nausea; Less than 21 days between vaccine administrations; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations), FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations). On an unknown date, the patient experienced FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations) had resolved. At the time of the report, FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: decreased (abnormal) Lost 5 pounds..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient had experienced-Delayed reaction after taking the COVID-19 vaccine.
Information has been received from a physician concerning a female (age unknown), who , on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, almost immediately after receiving the vaccination, the patient became very lightheaded. The patient became no lightheaded that she had to be held up by her mother, but did not faint. The patient did not seek medical attention. The patient recovered within five minutes after vaccine administered. No product quality complaint was involved. Additional information has been requested.
24 hrs. after vaccine: HA, lethargy, lograde T, lower respiratory sx progressing deep, dry cough. Lo-grade T cont x 8 days. Cough persisted x 3 wks. Like a "cytokino storm. " &. Wheezing with exercise/bronchoconstriction.
Dizzyness, lightheaded, sense of instability and balance issues, disoriented, difficulty to focus or concentrate. Feeling of swaying while sitting or standing still, fatigue.