chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt Weak  after second shot; Could not drive after second shot; Fever after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot). On 12-Feb-2021, ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot) had resolved.            concomitant product was not provided treatment information was not provided   This case was linked to MOD-2021-292321 (Patient Link).
mom stated approx 2 days p/vax pt broke out w/itchy rash over both arms; exam showed multiple, fine pruritic papules on both deltoids; hydrocortisone cream prescribed to be applied 2x day to lesions;
A 33 year old female, with a medical history of an epidermoid tumor of the brain, received the 2nd dose of Anthrax vaccine (lot # FAV048B) pm 04/12/01. No other vaccines were given at that time. The patient received the 1st dose of Anthrax vaccine on 03/27/01 with no reaction. Concomitant medications reported were Paxil and Ortho-Tricyclen. On 04/14/01, the patient experienced induration (150mm x 150MM), edema, pruritus, erythema and heat at the injection site (left deltoid). On 04/14/01, the patient noted redness, itching, swelling and heat at the injection site. By 04/18/01, the area of induration reached 150mm x 150mm with an area (60mm x 60mm) of purple discoloration surrounding the center of the injection site. At this time, the patient began applying ice to the area four times a day for fifteen minutes. On 04/19/01, the patient was seen by medical personnel and was treated with Benadryl, po, and instructed to continue to apply ice to the area as stated above. This treatment regimen continued through 04/22/01, with symptoms steadily improving. Marked improvement was seen by the medical personnel when the patient was seen again on 04/24/01 as noted by decreasing redness, size, itching and heat. On 04/25/01, the area was nearly invisible and by 05/01/01, all symptoms had resolved.
mom reported cont crying (not high pitch) for 3 - 3 1/2 hrs starting rt p/vax; rt upper leg swelled 2 times nl size & turned red; subsided by self; mom placed cool compress on rt thigh, gave APAP & warm bath w/o relief;
Admitted to hospital June 5, 2022 with pulmonary embolism (post hospitalization for severe COVID19 April 2020 with long term post COVID issues):  symptoms-severe left chest pain and shortness of breath. Treated with oxygen and heparin, close monitoring overnight in ICU followed by 3 days in progressive care unit. Discharged on oral agent- Xarelto
Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today; Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today; Received the 1st dose of the Pfizer Covid-19 vaccine/ Received the 2nd dose of the Pfizer Covid-19 vaccine/ Received Moderna Covid-19 vaccine for 3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today), PRODUCT STORAGE ERROR (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today) and INTERCHANGE OF VACCINE PRODUCTS (Received the 1st dose of the Pfizer Covid-19 vaccine/ Received the 2nd dose of the Pfizer Covid-19 vaccine/ Received Moderna Covid-19 vaccine for 3rd dose) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine from 11-Jan-2021 to 09-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today), PRODUCT STORAGE ERROR (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today) and INTERCHANGE OF VACCINE PRODUCTS (Received the 1st dose of the Pfizer Covid-19 vaccine/ Received the 2nd dose of the Pfizer Covid-19 vaccine/ Received Moderna Covid-19 vaccine for 3rd dose). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today), PRODUCT STORAGE ERROR (Have bottle of Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 at 2pm, then placed in refrigerator/ It was administered to a patient today) and INTERCHANGE OF VACCINE PRODUCTS (Received the 1st dose of the Pfizer Covid-19 vaccine/ Received the 2nd dose of the Pfizer Covid-19 vaccine/ Received Moderna Covid-19 vaccine for 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants medications were reported. No Treatment medications were reported.  Reporter stated that the patient is immunocompromised.
Headache, Chills, Hot spills, exhaustion and feeling of unbalance. Symptoms lasted for 36 hours.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "adhd" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "immunosuppression for extra intestinal IBD symptoms" (unspecified if ongoing); "DALM w j pouch" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna". 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: Patient received other medication in 2weeks. Patient did not have any known allergies. Treatment start date was 14Jan2023 and treatment stop date was 16Jan2023.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
This non-serious spontaneous case, initially received on 29-Nov-2017 from other health professional, concerning a 6 months old male infant patient. The patient's concomitant vaccinations included PEDIARIX, ACTHIB, PREVNAR 13, ROTATEQ and OTC (over-the-counter) gas drops for an unknown indication. On 28-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195248, expiry date: 30-Jun-2018). The reporter assessed the event as non-serious. Non-significant case correction received with IRD 29-Nov-2017: The expiry date of the suspect product was changed from Jun-2018 to 30-Jun-2018. Narrative was amended accordingly.
Sinus problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "Sinus problem".  Additional information: Patient had the first dose on 26Mar2021, scheduled her second dose on 15Apr2021 and patient had sinus problem which started last Sunday and caller wants to know if it is okay for her to have her second dose even though she had a sinus problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID arm right arm; Rash at injection; diarrhea; abdominal discomfort; swollen lymph nodes mainly under the right arm pit/ swollen lymph nodes also under left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal discomfort), LYMPHADENOPATHY (swollen lymph nodes mainly under the right arm pit/ swollen lymph nodes also under left arm pit), HYPERSENSITIVITY (COVID arm right arm) and VACCINATION SITE RASH (Rash at injection) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AR1A) for COVID-19 vaccination.     The patient's past medical history included Arrhythmia (mitral valve leak that causes the arrhythmia). Concurrent medical conditions included Drug allergy (Sulfa) and Drug allergy (Sensitive to Polyethylene Glycol.). Concomitant products included ATENOLOL.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal discomfort) and LYMPHADENOPATHY (swollen lymph nodes mainly under the right arm pit/ swollen lymph nodes also under left arm pit). On 03-Apr-2021, the patient experienced HYPERSENSITIVITY (COVID arm right arm) and VACCINATION SITE RASH (Rash at injection). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (abdominal discomfort), LYMPHADENOPATHY (swollen lymph nodes mainly under the right arm pit/ swollen lymph nodes also under left arm pit), HYPERSENSITIVITY (COVID arm right arm) and VACCINATION SITE RASH (Rash at injection) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt rcvd vax; pt exp slight reaction & itching; pt devel rash on arms,legs & sides; pt neg for anti-HBs; when pt rcvd 4th dose of vax; subsequently lab evaluation was pos for anti-HBs;
Patient asked to remain within store for at least 15 minutes prior to vaccination.  About 5 minutes after vaccination, it was brought to pharmacists attention that patient had felt light-headed, sat down  in a chair  which proceeded to syncope.  Patient's mother stated her eyes rolled back and she began to shake for a few seconds before coming to.  Patient asked to lay down and was placed in opposing chairs until EMT service arrived.
Vaccine was administered after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees F low on 31-Mar-2021. The BUD date and CDC expiry date was reported as 22-Sep-2021.   No treatment medication was reported.  This case contains information for the eleventh of 45 patients described by the reporter.
Fainting episode; elevated lower extremeties, applied cool compress, VS checked and stable, resp even and unlabored. Pt responded to verbal stimuli @ 30-45 seconds after fainting. Pt given crackers, and hydrated with powerade.  Incident lasted from @12:04 to 12:08.Pt remained in clinic until 12:30pm. A & O x 3 steady stable gait upon ambulating out of clinic without assistance. Resp even and unlabored.
patient went to the ER later on in the night from abnormal heart rate (high), in teh 140s.
I never have a late period, but I was meant to start on the 9th - one week after shot one. Now, 6 days later (and a confirmed negative pregnancy test), I still have not started my period. This is abnormal for me.
Feet numbness/ continue to have numbness of both feet; finger tingling begins/continue to have tingling in both hands; extreme  fatigue; Shortness of breath; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite), HYPOAESTHESIA (Feet numbness/ continue to have numbness of both feet), PARAESTHESIA (finger tingling begins/continue to have tingling in both hands) and FATIGUE (extreme  fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergy to Penicillin).   On 17-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme  fatigue). On 02-Apr-2021, the patient experienced HYPOAESTHESIA (Feet numbness/ continue to have numbness of both feet) and PARAESTHESIA (finger tingling begins/continue to have tingling in both hands). At the time of the report, DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme  fatigue) outcome was unknown and HYPOAESTHESIA (Feet numbness/ continue to have numbness of both feet) and PARAESTHESIA (finger tingling begins/continue to have tingling in both hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Favorable/ Normal. In 2021, SARS-CoV-2 antibody test: positive (Positive) Positive but patient believed to have exposed before dose 2.         It was reported that the patient was tested positive for COVID-19 antibodies, also reported that it might be before dose 2 No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-229613 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received and contains significant information updated batch/lot number of vaccine On 26-Jul-2021: Follow-up received and contains no new information. On 10-Aug-2021: Follow up received and updated outcomes of events and lab data.
Red and swollen left arm at administration site of DTap. Low grade fever that night. Complained of headache and vomitting x1. Using motrin and ice packs. Referred to medical care. Arm still warma and swollen in AM. No fever. Took to er. Was started on antibiotic. Remained afebrile. Was to come in and fill out report and release forms. No further contact from parent.
Patient was given flu vaccination in right deltoid and waited 10 min in vaccination area. After 10 min, patient noticed hives and swelling around his mouth with associated lip swelling. Patient was not experiencing shortness of breath, throat closing, or throat irritation at the time of reaction. Patient was transported to nearby clinic and evaluated. He was given Salumedrol and Benadryl and began to improve. Patient was sent home in stable condition.
PATIENT WAS GIVEN MMRV COMBO INSTEAD OF MMR AND VARICELLA SEPERATE
patient received Janssen booster vaccine and immediately felt lightheaded, feeling of wanting to throw up, dizzy. pharmacist measured blood pressure reading and it was low, paramedics evaluated patient told us it was most likely due to anxiety
Myalgia, Fever, NauseaVomiting, injection site tenderness Narrative: Per nursing report: "she received her 2nd dose of Moderna vaccine on 9/1/2021 and now [9/2] with adverse symptoms of body aches, fever, injection site tenderness, nausea and vomiting."
Patient died of a sudden heart attack at age 70, just 2 months after receiving his 2nd dose of the vaccine. His parents lived well into their mid-eighties and patient spent the last 17 years of his working years as a door to door, getting lots of cardio exercise every day. At the time of his death he was a very low stress person and taking good care of himself.
04jun90 pt vax 2nd hepta B. in jun90 pt ex swollen arm.
Itchiness; Rash on back and sides below rib cage; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and RASH (Rash on back and sides below rib cage) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PRURITUS (Itchiness) and RASH (Rash on back and sides below rib cage). On 26-Jan-2021, RASH (Rash on back and sides below rib cage) had resolved. On 31-Jan-2021, PRURITUS (Itchiness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti-itch lotions (calamine) and lotion for dry skin.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information was received on 22-Apr-2021.Treatment medication included.
Information has been received from a physician concerning a 14 year old female patient with no medical history or drug allergies reported, who on 27-JUL-2007, 02-SEP-2007 and 06-FEB-2008 (3rd dose also reported as 27-JUL-2008 administered intramuscularly) was vaccinated with the first, second and third doses of GARDASIL, respectively.  There was no concomitant medication.  In August 2007, after the physician reviewed the patient's past medical history, he noticed that the patient experienced bloody stools in the beginning of August 2007 after her first dose of GARDASIL.  On 04-JAN-2008 the patient saw her physician and stated that she was experiencing constant fatigue and tiredness.  A blood test was taken and showed that the patient was anemic.  The patient was diagnosed with ulcerative colitis and was hospitalized on 08-MAY-2008 (the number of days spent in the hospital were unspecified).  At the time of this report the patient has not recovered.  No product quality complaint was involved.  Ulcerative colitis was considered to be disabling.  Additional information has been requested. 6/20/08-records received for DOS 5/7-5/12/08-DC DX:Ulcerative colitis. Blood in stools. Admitted for a flare with worsening bloody stools and crampy  lower abdominal pain over past 2-3 weeks.Emesis, diminished urine output.  Diagnosed with ulcerative colitis 2/08. Began having blood in stool in 7/07, hid her symptoms, determine to be anemic.
Initial report received on 27 August 2012 from an investigator. A male subject (age not reported) who was a non-smoker with no past medical or surgical history, and who had not been taking any concomitant medications, had received ACAM2000 (route, site and date of administration not reported). On 12 April 2011, an unspecified amount of time after receiving the vaccine, he had normal central laboratory Troponin I levels (<0.10 ng/mL), a normal ECG and positive Rapid Troponin I levels. A repeat test was normal (date not reported). An event outcome was not reported. Additional history noted alcohol consumption 2-4 times per month (two drinks per day). Consumption of five drinks or more on one occasion was reported as monthly or less, with consumption of one drink reported in a typical week. The subject had never taken topical steroids to treat an eye problem or disease, and he was not allergic to any medications. According to the investigator, this event was possibly related to vaccination with ACAM2000 and was considered an Other Important Medical Event. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Injection site soreness; Redness; Body aches; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema, general body pain and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, general body pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient date of birth was reported as 26th December. The age at vaccination was not reported. The reporter stated that, after vaccination with dose of Shingrix experienced injection site soreness, redness, body pain and fatigue. The reporter consented to follows up.