chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the second dose I had a fever and felt awful for a day; after the second dose I had a fever and felt awful for a day; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced after the second dose i had a fever and felt awful for a day on an unspecified date in 2021. It was reported that, patient had some issues with her second dose too. She got it when it first came out in Jan or Feb. (The caller thinks it was the Pfizer COVID-19 vaccine). After the first dose her arm was sore but then after the second dose she had a fever and felt awful for a day, then she was fine. The outcome of the event was unknown.  Information on Lot/Batch information has been requested.
received the 2nd dose of Shingrix 30 days after receiving the 1st one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received the 2nd dose of Shingrix 30 days after receiving the 1st one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date- 31-OCT-2023 The pharmacist reported that the patient received the 2nd dose of Shingrix 30 days after receiving the 1st one which led to drug dose administration interval too short. The reporter consented to follow up
Fatigue starting 13 hours post-injection, at 22 hours fever, chills, body aches, severe left arm pain, back pain, headache, uncontrollable shakes. Fever at 102 degrees for 6 hours despite 2 ibuprofen every 3 1/2 hours. Symptoms abated by 36 hours except fatigue- still ongoing at 43 hours post-injection
Spasms to right side of neck; short term, comes and goes.  Then resolved, per client. Client c/o spasms to Rt. side of neck.  Onsite paramedic in attendance.  Client refused to have vitals done.  Client remained in observation for another 15 mins. as requested.  Spasms resolved.  No further issues.  Client also instructed should she experience any further symptoms to seek medical attention.
2JUN about 2PM mood/irritable about 5PM; 3JUN red welt @ inject site 99-100 fever, afternoon red 3 inches down, lumpy rash; 5APR93 c/o itching sensation;
No additional AE reported.; the vaccine was inadvertently administered after expiration.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 11-MAY-2021, the patient was inadvertently vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (0.5ml, lot # T014590, expiration date was 15-APR-2021, strength and route were not reported) for prophylaxis (Expired vaccine used). No additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Myalgia, Arthralgia, Rash, ErythemaMultiform &  NauseaVomiting Narrative:  required alt ibuprofen and acetaminophen and rash appeared with hives on 1/2/2021 and Benadryl was needed
A report received from a health care professional on 02Dec02, concerning an unk number of vaccinees aged between 6-35 months who were inadvertently administered Fluvirin. On unk dates between 21Oct02 and 02Dec02, an unk number of vaccinees aged between 6-35 months were inadvertently administered Fluvirin. The vaccinees were administered Fluvirin once if they had recieved it before and twice if they had not. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300007.
Mom reports Left eye swelling and redness after receiving vaccination at 0900. Mom then called office at 1530 to report that eye swelling has improved, however is still reddened. No medications such as Benadryl have been given since receiving immunization.
This spontaneous report as received from a other health professional (registered nurse) refers to a patient of unknown age. Current conditions and medical history was not reproted. On 22-OCT-2014, the patient was vaccinated with M-M-R II injection, lot number K002036, expiry date 10-FEB-2016 for an unknown indication (dose, route and frequency were not reported). Concomitant medications were not reported. On 22-OCT-2014, the patient was administered a dose of improperly stored M-M-R II. No adverse events were reported. The outcome and causality assessment was not reported. Product quality complaint was not reported. No further information was provided. Additional information has been requested.
Burning, stinging and swelling of right arm where injections given.  Complain of swelling and difficulty in swallowing in right side of neck. Complain of tender to touch right arm. Administered EPI 1:1000 X one dose and Diphenhydramine 50 mg.
After 24 hours: soreness at injection site. After 48 hours: slight fever (99.9*F), muscle aches, and injection site soreness.
he had a COVID-19 test done but the results came back positive for COVID-19 three days later; runny nose; He got the shot without knowing that he had the virus; This is a spontaneous report from a contactable consumer (Caregiver). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Medical history included rhinorrhoea (Verbatim: Runny nose), nasal congestion (Verbatim: Congestion). The patient's concomitant medications were not reported. The patient reported he had a covid-19 test done but the results came back positive for covid-19 three days later, runny nose, he got the shot without knowing that he had the virus on an unspecified date. Patient didn't go to the hospital, had no severe symptoms, only a runny nose, didn't even have a fever or cough". Patient received first dose of Pfizer Covid vaccine on 18Apr2021, that same day in the morning he had a COVID-19 test done but the results came back positive for COVID-19 three days later. patient was originally scheduled to get second dose on 09May2021, however due to the positive COVID-19 test result he was now told he should wait 3 months to receive 2nd dose. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
didn't receive the second dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a healthcare professional as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-Aug-2016, the patient was treated at a medical facilityfor a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Syncopal episode approximately 2 minutes after last immuniation administered.  Episode lasting only a few seconds, vital signs stable - BP 120/80 & pulse 84, skin warm & dry.
Cold sensation down her right arm; Began "seeing stars"; Metallic taste in her mouth; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received the first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EJ1685, intramuscular at the right arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination.   On 21Dec2020 09:00, the patient experienced cold sensation down her right arm, began "seeing stars", followed by a metallic taste in her mouth. The patient was not hospitalized for the events but required emergency room/department or urgent care visit. The patient did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. It was unknown if the patient has received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
PATIENT STARTED NOTICING PAINFUL SYMPTOMS RIGHT AWAY, SHE FELT BONE PAIN AROUND THE INJECTION SITE, FELT FEVERISH, AND THE RASH SIZE OF A FIST STARTED FORMING 2 DAYS AFTER. ALSO NOTICED SWELLING ON THE INJECTION SITE. Told the patient to apply cortisone cream and take benadryl, if symptoms persist told her to go seek medical attention.
severe left sided headache near eye; burning sensation throughout my body; severe ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 25Mar2021 at 09:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity, vertigo, IBS and SVT. The patient did not take any concomitant medications within two weeks of vaccination. The patient was allergic to latex and cayenne pepper. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 09:35 (within first 5 minutes post-vaccine), patient experienced burning sensation throughout body which resolved; severe left sided headache near eye on 25Mar2021 at 09:45; and 3 days later, on an unknown date in Mar2021 severe ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events burning sensation was not resolved (also reported as resolved on an unknown date), while of headache and ringing in ears was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
headache; fatigue; pain at the injection site; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The reporter mentioned that the patient received the COVID-19 vaccine series. The patient experienced headache and fatigue after the second injection (same day) and pain at the injection site, all on unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information on the lot/batch number could not be obtained.
Fainted for the first time ever. Light-headed, fuzzy and woozy, and fainted while standing outside on the grass, viewing a performance.
pt devel pain @ inject site w/redness & swelling w/in 1 hr of vax; had low grade temp; p/3 hrs devel emesis w/t103.5; pt lethargic admitted for altered mental status observation-no sz;
BRUISE ON THE LOCATION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not infected with covid-19 infection. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received first booster, dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received second booster, dose 3 with Non-company suspect vaccine covid-19 vaccine (unspecified manufacturer), (Dose number in series 3), (form of admin, route of admin, and batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient experienced bruise on the location (Injection site bruising) (Dose number in series 3). It was reported as "I got the shot and the boosters and nothing bad happened. Yeah, it felt like a bruise on the location, no big deal. I also didn't get Covid" The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine was not applicable. The outcome of the bruise on the location and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Pain at injection site; Small redness at injection point; after 12 or 13 hours fever; Chills; they cannot sleep actually because of the chills; This is a spontaneous report from a contactable consumer (patient). This is the second case out of the two cases.  A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknow), via an unspecified route of administration, administered in right arm on 14Apr2021 at 10:00 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history reported as none. The patient concomitant medications were not reported. No any past drug history reported. On Apr2021, 3 to 4 hour of vaccination, the patient had pain at injection site, just a small redness in injection point, after 12 or 13 hours fever and they cannot sleep actually because of the chills. The patient underwent lab tests and procedures which included on Apr2021 body temperature: 101.3 (unit not reported). Outcome of the events was unknown for all.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
The pt experienced hives, swelling of the face and wheezing. Treated with epinephrine, prelone, Benadryl, admitted to the hospital.
Coughing; Not able to eat; Severe pain in hip, joints, and back; Vomiting; Headache; Chills; Severe pain in hip, joints, and back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing), FEEDING DISORDER (Not able to eat), BACK PAIN (Severe pain in hip, joints, and back), VOMITING (Vomiting) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016N20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Very high after vaccine- increased medication.) since 2000, Asthma (Increased coughing- steroid treatment) since 2007, Penicillin allergy, Drug allergy (Demarol), Drug allergy (Keflex.), Drug allergy (Diltiazem), Drug allergy (Rymed) and Drug allergy (Clonidine). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Asthma, CARVEDILOL and HYDROCHLOROTHIAZIDE for Blood pressure, CARBIDOPA for Restless legs, CALCIUM for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Severe pain in hip, joints, and back). On an unknown date, the patient experienced COUGH (Coughing), FEEDING DISORDER (Not able to eat), BACK PAIN (Severe pain in hip, joints, and back), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, COUGH (Coughing), FEEDING DISORDER (Not able to eat), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown and BACK PAIN (Severe pain in hip, joints, and back) and ARTHRALGIA (Severe pain in hip, joints, and back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-032910 (Patient Link).
Feel hot and cold; Fever; Headache; feel tired; feel like will vomit; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit). At the time of the report, BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concominant medications were not reported.  Treatment information was not provided.
Rash and itching developed within 10 minutes; administered oral Benadryl. Anaphylaxis at 45 minutes; administered 1 EpiPen at 45 minutes, 1 EpiPen at 50 minutes. Anaphylaxis subsided until 2 hours post-vaccination; administered an additional 2 EpiPens and an additional dose of oral Benadryl. Anaphylaxis did not return. Rash and itching were gone by hour 6 post-vaccine. Fever, chills, sore throat, anorexia, and lethargy developed 12-16 hours post-vaccine. Changes in sense of taste and smell developed 36 hours post-vaccine (could be related to seasonal allergies).
Received shot at 3:30 on Friday afternoon. By Friday evening, my eyelids were very red, scaly, swollen and itchy. By Saturday morning, the redness and swelling were below my eye as well.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 05-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Increased Heart Rate, Increased Blood Pressure, Tingling of bottom lip, chin and cheeks, hand tremors, rapid breathing.
Breakthrough case admission after three vaccines Moderna 1/8/21 Lot# 012L20A;  Moderna 2/5/21 Lot# 012L20A;  Moderna 11/23/21 Lot# 012H21B