chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Lot number: FA7484) at the age of 52 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 010M20A), on 16Apr2021 as dose 2, single (Lot number: 030B21A) and on 06Jan2022 as dose 4 (booster), single (Lot number: 028K21A) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included (received with in 2weeks of vaccination): GILENYA, start date: Feb2011; GABAPENTIN, start date: Jun2001; FLONASE [FLUTICASONE PROPIONATE], start date: Oct2019. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) negative, notes: I tested negative on 05Jun; (09Jun2022) positive, notes: I tested again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 29May2022 to 03Jun2022 for the treatment of COVID-19. On 09Jun2022, patient had a headache and felt a little congested, so she tested again and tested positive.
The patient stood up 1-2 minutes after the vaccine was administered and became unconscious with their eyes rolled back in the head for approximately 5 seconds. The patient also seemed to have difficulty breathing with a snoring sound. After this patient came to but would not speak and looked very pale. She was breathing well when she woke up. Paramedics were called. The patient blood pressure was very low 69/30-75/35. The patient was transported to ER to get checked out.
10-15 min. after nasal mist was administered began having difficulty breathing, extreme fatigue, dizziness, headache.  sought medical treatment 11/05/2009 diagnosed as having asthmatic reaction to vaccine. prescribed rescue inhaler & 5 day course of prednisone steroids.  emergency room visit 11/07/09 due to difficulty breathing, diagnosed w/ allergic reaction to vaccine. treated w/ nebulizer and pepcid ac for allergy.
Extreme upper extremity erythema and swelling starting within 12 hrs of vaccine admin and continuing with minimal improvement over 7 days.  No fever. No breathing difficulties. No pain.  Treated with ibuprofen 200mg tid.
Started with diarrhea the following day and has continued with diarrhea since.  This has been about 3 weeks ago.  She has tried anti-diarrhea meds and it works for awhile and the diarrhea returns.
Severe body aches; Tiredness; Muscle aches; Slight fever; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 15:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 included unspecified multivitamin, ethinylestradiol, levonorgestrel (VIENVA), pseudoephedrine hydrochloride (SUDAFED) and fexofenadine hydrochloride (ALLEGRA); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 20:00, the patient experienced severe body aches, tiredness, muscle aches, slight fever and headaches. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body aches, tiredness, muscle aches, slight fever and headaches were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
dizziness; vertigo; loss of balance; blurred vision; unsteady gait; acute urinary retention; cystoscopy; urinary catheter
flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021.  The patient received antibiotics and diarrhea medication.  The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization).   No follow-up attempts are possible. No further information is expected.
Right upper extremity deltoid area local redness and swelling measuring 4 inches across, lasted several days, no induration or infection, no fever.
Menstrual cycle ended on 3/30.  Received the 1st vaccine on 4/1. Menstrual cycle came back on 4/7. Never in my entire life have I had cycles that close together.
Erythematous, pruritic rash with mild skin thickening for 4in diameter from vaccination site. Pruritic papular rash spread to all extremities with concentrations to dorsum of bilat hands, waist, upper thighs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 22May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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: "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01May2022; CIALIS, start date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received other medication in two weeks included CRESTOR and CIALIS. Anti-viral details for COVID-19 treatment included PAXLOVID, treatment start date was on 31May2022 and treatment stop date was on 04Jun2022. Adverse event reported was relapse with adverse event start date/time on 09Jun2022 at 12:00 PM (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after 3 vaccines Pfizer 1/7/21 lot# EL3246;  Pfizer 1/28/21 lot# EN5318;  Pfizer 10/7/21 lot# FF2590
Apnea (greater than 15 seconds): repeated 'several times' per hour until admission to emergency department (approximately 3 hours) with resulting hypoxia
24 hours post vaccination, patient reports pain and redness at injection site with a radiating of redness to axilla.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-MAY-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reproted that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Donor became hot, flushed and dizzy immediately after immunization. Donor made a full recovery within 5 minutes.
Flushing/sweating, dizziness BP 113/72, HR 70, RR 14 -- > 109/63, HR 63, RR 16.  Water was given, therapeutic talk, patient layed down until he felt better.  Patient stable and released from vaccination site
redness at the injection site; swelling at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt came into pharmacy to show rash. Rash was about size of baseball w/ a dime-sized blister in it. Pt complained of burning/itching. Was referred to PCP.
Swelling in right arm pit, showed up Sun morning.  Size of a tennis ball. ER doctor advised to watch and follow up with primary care. Take advil for pain.
She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised rash. It started near the injection site, then on her wrist (same arm) then on her chin, same left side. After a few more days she started getting them all over: legs, chest etc. They itch her like crazy and burn when she tries not to itch.
flu-like symptoms; maybe hematoma; warm to the touch; lymph nodes were swollen in left armpit; has a fever; soreness was till there; real red/ redness; swollen; 2.5 by 2.5 inches mass; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HAEMATOMA (maybe hematoma), VACCINATION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (real red/ redness) and VACCINATION SITE SWELLING (swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (real red/ redness), VACCINATION SITE SWELLING (swollen), VACCINATION SITE SWELLING (2.5 by 2.5 inches mass) and VACCINATION SITE PAIN (soreness was till there). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HAEMATOMA (maybe hematoma), VACCINATION SITE WARMTH (warm to the touch), LYMPHADENOPATHY (lymph nodes were swollen in left armpit) and PYREXIA (has a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (swollen) and LYMPHADENOPATHY (lymph nodes were swollen in left armpit) had not resolved, HAEMATOMA (maybe hematoma) and PYREXIA (has a fever) outcome was unknown, INJECTION SITE ERYTHEMA (real red/ redness) and VACCINATION SITE PAIN (soreness was till there) had resolved and VACCINATION SITE SWELLING (2.5 by 2.5 inches mass) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
had a positive Covid test; had a positive Covid test; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that that an 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration, on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history and concomitant medications were none. The consumer reported that her husband is due to have his second Pfizer vaccine on 10Feb2021, but he just had a positive Covid test on 06Feb2021. He tested positive after receiving the first dose of the vaccine. She asked if he still can get the second dose of the vaccine. The patient has kept in touch with his doctor while he has been recuperating. Outcome of the events was unknown.
nausea; dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting) 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 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 10/18/2000 the patient presented with a full blown case of chickenpox all over the body. The patient sought unspecified medical attention. Additional information has been requested.
I get sick when I get one; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient ) via Digital Media through social media on 23-Nov-2020 along with live follow up was received on 09-Dec-2020  .Both processed together    This case involves patient of unknown demographic who got sick when got one (illness) , while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got sick when got one vaccination (illness).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
aches; chills; High fever (103 plus) for two consecutive days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103 plus) for two consecutive days) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and PYREXIA (High fever (103 plus) for two consecutive days). At the time of the report, PAIN (aches) and CHILLS (chills) outcome was unknown and PYREXIA (High fever (103 plus) for two consecutive days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) High fever (103 plus).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2022-442218 (Patient Link).
pt recvd vax & exp pain at inject site, severe fatigue & slight t; pt exp recurrence of symptoms to a greater degree w/ 2nd dose of vax;
After 1st shot, 2 days later swollen gland in left armpit, it went away in 8 days. after the second shot it took 3 days and both armpits are swollen; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 26Jun2021 at 11:00 (at the age of 45-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 17Jul2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. 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 COVID vaccine. Concomitant medications included otc allergy medications. The patient previously took neomycin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. On 28Jun2021, after first shot, two days later, the patient experienced swollen gland in left armpit, it went away in 8 days. After the second shot it took 3 days and both armpits were swollen, went to doctor and they said to check back in 3 weeks with them and to report to Pfizer. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen gland in left armpit, it went away in 8 days. After the second shot it took 3 days and both armpits were swollen was unknown at the time of this report.
had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid after the second dose of the Moderna vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced COVID-19 (had covid after the second dose of the Moderna vaccine). At the time of the report, COVID-19 (had covid after the second dose of the Moderna vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient was suffering of deafness after having COVID.  Company Comment: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event COVID-19 (AESI) The event occurred on and unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report. The event deafness was deleted because has appeared after COVID-19 infection and no after vaccination. The case is downgrade to non-serious due there is no information in the SD supporting that is medically significant.   This case was linked to MOD-2021-377147, MOD-2021-377148 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected event COVID-19 (AESI) The event occurred on and unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report. The event deafness was deleted because has appeared after COVID-19 infection and no after vaccination. The case is downgrade to non-serious due there is no information in the SD supporting that is medically significant.
scattered reddish linear macules on abdo & back; a few 0.5 cm size whitish macules w/pinhead size papule in center w/sl erythema aorund it on legs;