chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; bleeding all over, over and over; He has a bad rash all over his arms, his body, his legs. He has been itching, scratching and bleeding; He has been itching; Scratching; This is a spontaneous report from a contactable consumer (the patient). An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198; Expiration Date: 30Jun2021) via an unspecified route of administration in left arm on 26Feb2021 09:30 at single dose for COVID-19 immunisation. It was not administered at Military Facility. Medical history included diabetes, allergic to penicillin, and "Thyroid, he is not sure". No prior vaccinations within 4 weeks. No relevant family medical history relevant to AEs. Concomitant medications included metformin taken for diabetes from an unspecified start date and ongoing; simvastatin (Lot and Expiry: Did not really want to provide) taken for an unspecified indication from an unspecified date; glipizide (NDC, Lot and Expiry not reported since his medications were down stairs) taken for an unspecified indication from an unspecified start date and ongoing; metoprolol tartrate taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Flu Vaccine (Vaccine name: Unknown) in Oct2020, route: Injection in left arm, 4 over the past 4 years, he has been getting them once a year for that long. No additional vaccines administered on same date of the Pfizer suspect. Lot and Expiry of metoprolol tartrate was not reported since his medications were down stairs and he did not want to go get them. Looked the patient was tired (onset date unknown) and then they moved on. The patient had a rash all over on his arms, body, legs. He has been itching, scratching and bleeding all over, over and over, he had bloody t-shirts, underwear, PJ's. It was nasty. He went to the (female) doctor twice already and next Monday, 05Apr2021, he has a follow-up from the last visit. This was for the rash all over and the scratching and bleeding. Caller reported he never had a bad rash this bad in his whole life. This was the worst experience he has had in his life. It also reported it had been difficult the last 2-3 weeks with this but it has improved but, still not clear. The events occurred on 05Mar2021 between 18:00 and 19:00. No relevant tests were taken. It also reported the patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiration Date: 31Jul2021) via an unspecified route of administration in left arm on 19Mar2021 at single dose for COVID-19 immunisation. The outcome of the events was unknown.
My Sinus was closed, I could not breath for one month & a half (1.1/2). I had pressure, sinus. I had a Clot in my menstrual period, the clot was severe, it was the size of my hand, for 4 months I had different clots.
Fever; Chills; Nausea; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia) 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.   In March 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No treatment information was provided. No relevant concomitant medications were reported.   This case was linked to MOD-2021-021174 (Patient Link).
Interchange of vaccine products; 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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ3275), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm and on 09Aug2022 as dose 4 (booster), single (Lot number: 055A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jun2023, stop date: 10Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovering" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid. Clinical course: Patient started taking Paxlovid on 2nd day of symptoms and positive testing. Experienced only mild symptoms while taking Paxlovid. After the 5-day treatment, she began to experience moderate symptoms for another 10 days. She was still test positive 2 weeks after starting the Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247506 Same Patient, different drug/events;
9 hours after the shot, I started shivering uncontrollably. For the next 5 hours, in addition to the shivers, I had elevated blood pressure, a heart rate of 100bpm, a fever between 99.5 and 101. It all went away after 5 hours.
Arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant or Treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 contains No New Information. Patient declined further follow-up. Form attached.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Breakthrough case admission/ patient expired after 2 vaccines Pfizer 1/21/21 lot# EL9261;  Pfizer 2/15/21 lot# El9267
Arthralgia FATIGUE CHILLS, RUNNY NOSE, PAIN/SWELL INJ SITE Narrative:
Muscle pain; fatigue; fever; This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 at 11:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received amlodipine and experienced allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 13:30, the patient experienced muscle pain, fatigue, and fever. The patient did not receive any treatment for the events. The clinical outcomes of the muscle pain, fatigue, and fever was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Two days post vax, pt developed a 2x2 area of induration and a hematoma at vaccination site to left deltoid area. Pt treated with Westcort.
slight sinus infection; 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 SINUSITIS (slight sinus infection) 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 SINUSITIS (slight sinus infection). At the time of the report, SINUSITIS (slight sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Diffused rash; A spontaneous report (United States) was received from a consumer (patient's wife), concerning an 83 years old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and patient experienced diffused rash.   The patient's medical history was not reported. Concomitant medications were not reported.  On 09 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A), intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced adverse reaction which looks like measles. The rash just showed on his body, on his trunks, quite a bit on his back, scattered on his chest and tummy and on the anterior portion of both thighs. The patient hasn't had a fever, and it doesn't itch. The patient's wife was checking to see if this was possible late reaction to the vaccine. He has diffused rash on his back that looks like measles. The patient's wife gave her husband the treatment medication cetirizine on 25 Feb 2021. She also applied aspercreme with lidocaine on his left shoulder.   Action taken with second dose of mRNA-1273 in response to the event was unknown.  The outcome of the event, diffused rash was unknown.; Reporter's Comments: This case concerns a 83 years old, male patient, who experienced diffused rash on his body. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt recvd Engerix-B MAY & JUN91 w/no rxn; 3rd dose 13NOV91 & 14NOV91 pt devel red area @ inject site & c/o burning post vax; 15NOV91 red area spread to a 4x4 area, hard, hot & tender to touch; seen in ER 14NOV91 poss infect @ inject site;
Patient reported very sore arm,  redness, itching and swelling from shoulder to elbow lasting approximately 5 days.
Malaise; Fever; This case was reported by a nurse via sales rep and described the occurrence of malaise in a 18-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced malaise and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the malaise and fever were unknown.   The reporter considered the malaise and fever to be related to Bexsero.  Additional information was received as follows: The patient experienced malaise and fever when vaccinated with Bexsero. The reporter felt symptoms related to vaccine. The patient took ibuprofen for symptoms. This was 1 out of 2 cases reported by same reporter. The reporter did not agreed to follow up.
Extremely high fever (104/105)  that only slightly went down for approximately 40 hours. Never dipped under 100  Fatigue  Chills  Body ache  Headache  Loss of appetite  Shortness of breath
Pregnancy  termination at 18 weeks due to un-survivable . OTC Deficiency as carrier diagnose during permanency and cause of loss.
swelling and redness at the injection site; swelling and redness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EN5318), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2, Lot: EN5318), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "high fever", "shaking", "extreme chills", "extreme fatigue", "she couldn't move", "COVID-19"; BNT162b2 (Dose: 3, Lot: 30130BA), administration date: 30Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "swelling and redness at the injection site", "swelling and redness at the injection site", "COVID-19"; Shingles vaccine (shingles vaccine), for Immunization, reaction(s): "localized reaction". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2022, outcome "unknown" and all described as "swelling and redness at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The NDC number was unknown for all doses unknown. Additional Vaccines Administered on Same Date were not for the last 2 doses, reported stated it is hard to remember she had so many immunizations this year. She doesnt think so but she is not 100% certain. On 30Sep2021 she could have gotten the flu shot that day, but she doesn't know for sure. Adverse Event (AE) Details was Not Provided. She was not Prior aware of Vaccinations within 4 weeks. Reporter then stated that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. States she had a localized reaction as well, attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Patient's Medical History was unknown, can't think of anything. About Family Medical History reporter stated that the only thing she can think is that her half-brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So, it wouldn't affect her she doesn't have the markers for that. The patient tested positive for COVID after having all 4 doses.
Vertigo symptoms began approximately 12 hours after booster shot was received.  No symptoms with laying down but severe spinning/off balance sensation accompanied by nausea when upright/walking. Parents tried Tylenol with no improvement. One dose of Dramamine was not helpful. Ibuprofen seems to help some.  Sx continue over a week later.
Fluarix administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30-JUN-2023) for prophylaxis.   On 22-AUG-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 22-AUG-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Fluarix administration of expired dose).  The outcome of the expired vaccine used 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 Information: GSK Receipt date: 23-AUG-2023 A reporter reported that a patient received on August 22nd 2023 a dose of expired Fluarix which led to expired vaccine used.  The reporter wanted to know the patient should be re vaccinated. The reporter did not consent to follow-up.
Headache, Myalgia, chills, temperature, soreness at injection site Narrative:  Other Relevant History:
In October 2022 I became severely anemic, and I had to receive 5 infusions.  I had become breathless with a rapid heartbeat and exhaustion.  I went to the emergency department.  The infusions began in January 2023 and ended in March of 2023.  I am now taking iron supplements and I feel much better.  We are unsure why I became anemic.
NEXT DAY INDURATED SITE, SLOW PROGRESSING (OVER 48 HRS)ITCHY RASH, RED RAISED PAPULES ON MODERATE TENDER PINK BASE, 2-5MM ON CHEST AND AXILLA, NON-CONFLUENT, NO PATTERN WITH ELEVATED BP, DRY ITCHY EYES AND OVERALL DRY SKIN TREATED WITH ORAL BENADRYL IN ER, RELEASED AFTER OBSERVATION.
The pt developed swelling, slight erythema and heat; treated with cold compresses and elevation.
Approximately 15 minutes after receiving vaccinations (after leaving clinic site) she became pale, weak and had difficulty walking. She recovered completely after resting awhile.
covid arm; shot site itches; shot site is red; shot site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The event outcome was updated.
Within 4 hours she developed localized erythema, swelling and apparent pain in the right thigh, extending up to the inguinal crease and down to the knee. She was unsettled and fussy, but had no generalized rash, no vomiting or respiratory distress. She had no known fever, but was treated with several doses of Tylenol.
Information has been received from a nurse practitioner concerning a 30 year old female patient who on 15-OCT-2009 received her first dose of GARDASIL (dose and lot number not reported). According to the reporter, the patient called the office to report that her hair is falling out. The patient was scheduled to be seen in the office on 10-NOV-2009, but she failed to keep the appointment. The outcome for the patient's hair falling out was unknown. Follow up information has been received from the nurse practitioner concerning the 30 year old female patient without any illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions reported, who on 15-OCT-2009 received her first dose of GARDASIL, intramuscular route (lot #661846/1312X). No other known vaccines administered. The nurse practitioner reported that the patient called the next day after the vaccination and she reported that she was losing her hair after shot. the patient was to see a dermatologist. (The reporter felt that secondary unlikely caused by GARDASIL). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Two days post vax, she developed an injection site reaction with induration, the injection site reaction affected a 12-cm area.
Slight chills, slight fever but not sweating, overall tiredness, sore muscles all over, slight headache. Symptoms got better after I got up in the morning but I stayed tired all day, sleeping on and off. Felt back to normal getting out of bed the very next day, today 7/29/2018.
Seizure, patient was laid on exam table, fan placed in room, provider notified, parent was called. Provider stayed with patient, symptoms lasted 30-45 seconds. patient was observed for 15 minutes.
received first dose in late December and I'm pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In December 2020, the patient experienced EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant). In December 2020, EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
Epiglottal swelling, pruritis, tachycardia, SOB, EPI 0.3 IMx3 Solu Medrol 125mg IM IV O2, Zyrtec 10 mg + response to anti antiphlactic meds.
pt recvd vax; devel severe irritation at site of inject;swelling & hot to touch;rash on neck, face & back;