chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
No adverse event, but was given to a patient under the FDA-approved emergency use age limit (patient is 15 years old, age limit for Pfizer COVID-19 vaccine is 16 years or older).
Did not convert; vaccinee "did not convert" following a  series w/Engerix-B (dosing schedule - 0, 1, 6).
Rush of hot flash through chest and throat.  Rested until subsided for at least 10 minutes. At 30_35 minutes had a rapid fluttering in my chest.  Once home 45 minutes after shot my wife who is a medical aide checked pulse at 130bpm.  4 hours after shot down to 104bpm
HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Patient arm was swollen, red & sore. Pt was taken to ER over the weekend & treated with IVs. Called pt 10-19-11 everything is fine.
Called hospital call ceneter. Pt c/o severe body pain/joint pain, also stated yes to constant and extreme dizziness and feeling weakness since yesterday after she got her J&J covid vaccine appt on 5/26/2021 . recommended pt to go to nearest ED /Call 911. Pt stated she will go to ED  Pt speech clear, AO X3.
On Monday I had a tickle in my throat and by the evening I had a fever off and on. My fever was 101.0. I had to stay home the rest of the week from work. Lasting coughing for many weeks. I haven't recovered from my cough. The cough was so bad that my ribs was hurting.  By the tenth day I was testing negative.
their upper arm was painful.; achy on the arm of the vaccine, their upper arm was painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, DILTIAZEM, LOSARTAN, ROSUVASTATIN, OMEPRAZOLE, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.). At the time of the report, PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
On 09/20/2000 the patient developed varicella. It was noted that she was febrile and had pox on her left leg, trunk and right arm. Prescription drug treatment was not required for the patient's experience. Subsequently, the patient recovered. No further information is available.
temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes; sore arm; headache; ache all over; stiff neck; sweats; chill; too tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "GI issue". Vaccination history included: Bnt162b2 (First dose), for covid-19 immunisation, reaction(s): "pain"; Flu vaccine (4-5 years ago), for immunisation, reaction(s): "very sick". The following information was reported: HYPERPYREXIA (medically significant) with onset Feb2021, outcome "unknown", described as "temperature all over the place/temperature is fluctuating a lot from 109 to 99.6 to 99.8 within 20 minutes"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "ache all over"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Feb2021, outcome "unknown", described as "stiff neck"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chill"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "too tired". The patient underwent the following laboratory tests and procedures: body temperature: (Feb2021) fluctuating a lot from 109 to 99.6 to 99.8, notes: within 20 minutes. Therapeutic measures were taken as a result of hyperpyrexia, pain in extremity, headache, pain, musculoskeletal stiffness, hyperhidrosis, chills, fatigue (patient took Tylenol).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient awake with itching half dollar sized red area at site of injection.  Advised to see provider if progressed itching or hives, or shortness of breath.  04/23/2003.
Hot tingly in face, red splotch across cheeks and nose, swollen face on left side (shot was in right arm), lightheaded
p/vax 9JUN93 pt exp severe inject site react (severe pain & swelling) of thigh; also had unconsolable screaming for several hrs; seen in office 10JUN93; APAP was administered post dose; pt recovered;
Immune system is compromised; Had a stroke after both doses of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immune system is compromised) and CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immune system is compromised) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in December 2021 to sometime in December 2021 due to CEREBROVASCULAR ACCIDENT and IMMUNODEFICIENCY. The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, IMMUNODEFICIENCY (Immune system is compromised) had not resolved and CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) outcome was unknown.            Concomitant medications were not provided by the reporter. Patient stated that she was ok and did not had any deficit. Company Comment: This is a spontaneous case concerning a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI Cerebrovascular accident and the unexpected serious event of Immunodeficiency. The event Cerebrovascular accident occurred approximately 8 months 19 days after the second dose of mRNA-1273 vaccine. The patient required hospitalization for 3 days. She was treated with physical therapy and stated that she did not have any deficit. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization and important medical event.; Sender's Comments: This is a spontaneous case concerning a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI Cerebrovascular accident and the unexpected serious event of Immunodeficiency. The event Cerebrovascular accident occurred approximately 8 months 19 days after the second dose of mRNA-1273 vaccine. The patient required hospitalization for 3 days. She was treated with physical therapy and stated that she did not have any deficit. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization and important medical event.
fever 101 w/Ibuprofen q 4hr, hot hard lump 2"x2" @ site, weakness in arm 24hr p/shot;dizziness flu like, muscle soreness intense into shoulders & neck;gen soreness all over;all sxs better today;out of breath last noc 25SEP;
I woke up with stomach pain and diarrhea and dry heaves. I took some tums and sparkling water. I have flu like symptoms and chills. I have congestion.
RECEIVED 3RD BOOSTER DOSE OF JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date in MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient previously received first booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient previously received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. The drug was associated with Off label dosing frequency (Off label use) (dose number in series 3). The patient received additionally third booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 4) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-SEP-2022 for covid-19 prophylaxis which was associated with Off label dosing frequency (Off label use). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-SEP-2022, the patient received 3rd booster dose (Off label use) of JANSSEN COVID-19 VACCINE (dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received 3rd booster of JANSSEN COVID-19 VACCINE was not reported. This report was non-serious. This case, involving the same patient is linked.
Welt; Red itchy Welt on right cheek; Pin dot size bumps on her neck that got itchy and hot; Little bumps on her forehead; pin dot size bumps on her neck; Felt tingling sensation like she had vapor rub n her; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt tingling sensation like she had vapor rub n her), RASH (Little bumps on her forehead; pin dot size bumps on her neck), RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot) and URTICARIA (Welt; Red itchy Welt on right cheek) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (Felt tingling sensation like she had vapor rub n her). On 25-Jan-2021, the patient experienced RASH (Little bumps on her forehead; pin dot size bumps on her neck). On 26-Jan-2021, the patient experienced RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot). On 27-Jan-2021, the patient experienced URTICARIA (Welt; Red itchy Welt on right cheek). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 28-Jan-2021, URTICARIA (Welt; Red itchy Welt on right cheek) had resolved. At the time of the report, PARAESTHESIA (Felt tingling sensation like she had vapor rub n her), RASH (Little bumps on her forehead; pin dot size bumps on her neck) and RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Extreme pain in total arm, not just the vaccination site, redness and swelling in whole arm, low energy and felt lethargic, chills the day after vaccine. The extreme pain, redness and swelling continued for 3 additional days. Moderate pain continued for 2 more days.
This spontaneous report as received from a medical assistant refers to a 23 years old female patient with penicillin allergy and unspecified sexually transmitted disease. The patient was intramuscularly vaccinated at left deltoid with first dose of 0.5 ml GARDASIL (Lot# reported as 0636AE, Exp date 09-JAN-2015) on 08-AUG-2012. No other co-suspects were reported. Concomitant medications included NUVARING, flaxseed oil, biotin, Vitamin B-12, fiber (unspecified) and doxycycline (to treat sexually transmitted disease). The medical assistant reported that the patient experienced pain at the injection site on 08-AUG-2012 when she received the vaccine. The medical assistant then spoke to the patient on 10-AUG-2012 and the patient said she was experiencing less pain. On 13-AUG-2012 the patient said her arm was "hurting more". The medical assistant spoke with the patient again on 15-AUG-2012 and the patient said she was experiencing severe pain of her arm and she cannot move her arm. There was no redness and no warmth. The patient had sought medical attention via calling office. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Pain at the injection site, severe pain of her arm and she cannot move her arm were considered to be significant disability or incapacity by reporter. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored PEDVAXHIB intramuscularly (strength reported as "7.5 mcg", lot # K015463, expiration date: 09-JUL-2017) for prophylaxis. No adverse effects were reported. It was stated that vaccination with PEDVAXHIB was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA008360: US-009507513-1611USA012030: US-009507513-1611USA012031: US-009507513-1609USA010831.
Patient states that at 4:30pm on 01/17/22 the lip of her mouth begun to swell and at 7:49 pm she arrived at the emergency room of Doctors where she was administered Solumedrol- and BENADRYL, patient was discharged.
RT ARM, REDDENED AND SWOLLEN, WARM TO TOUCH. 9CM LONG, 7CM WIDE
Patient reports she felt a suddent increase in the noise in her ears.  She had baseline tinnitus, but it suddenly became loud and high pitched in both ears.  She also had a sensation of a tremor throughout her body and a feeling of hypersensitivity.  She reports fatigue and unintentional weight loss of 3lbs since the event.
Day after Shot:  Complete Body Aching; Fever; Vomiting; Fatigue; Sore Arm
This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 08:15 (lot number: EW0162) at the age of 65 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included PKD (Polycystic kidney disease), hypertension, enlarged prostate, meningioma, swollen retina, and allergies to ace inhibitors. Concomitant medications received within 2 weeks of COVID vaccination included eplerenone; tamsulosin; metoprolol; amlodipine; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 23Mar2021 at the age of 65 years old for COVID-19 immunization (product=COVID 19, Brand=Pfizer, lot number=ER8732, administration time=08:15 AM, dose number=1, vaccine location=Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. According to the patient, he experienced "severe visual distortion starting two days after second shot (15Apr2021 at 08:00 AM). Blurriness and extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked. The severe distortion lasted 2 1/2 weeks, however my vision is still blurry in my right eye. All effects were in the right eye." The events resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included angiogram: unknown results on 2021, and 3 scans of the eyes: unknown results on 2021. The patient has not recovered from "blurriness/vision is still blurry in my right eye". The patient recovered from "severe visual distortion starting two days after second shot/extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked" on May2021.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-MAY-2016, the patient was vaccinated with PEDVAXHIB (lot # L038502, expiry date: 07-AUG-2018) (route of administration: intramuscular) and ROTATEQ (lot # L027070, expiry date: 07-MAR-2017) (route of administration: oral) that were improperly stored. The vaccines were stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt reported tongue swelling 92% 02 RA, throat itches, given Zyrtec 10mg, PO @1400.  pt given Benadryl 50mg IM, 14:12  02 93% RA, placed o2 2L via nasal canula, 14:21 Pt reports feeling better.   BP 128/71, HR 67 02 99% RA.  Pt dc home stable.  Pt has a partner with her to drive.
Approx 15 lesions - papules/macules, vesicles. DX varicella
roughly 2 weeks after the vaccine started to have a ulcerative colitis flare after being in remission for over 1.5 years.
Information has been received from a nurse practitioner concerning a patient who on approximately 21-APR-2009, "last week," was vaccinated with the third dose of RECOMBIVAX HB (lot number, site and route not reported). The patient's injection site developed into a dense hardness area. According to the patient, some of the vaccine might have been leaked out from the site. The outcome of the event was not reported. No further information is available.
Patient complained of dizziness, nausea, felt like she was "drowning," BP 181/110 elevated, redness, diaphoretic. Patient refused to lay down. Given juice, water, snack, Continued to monitor vital signs. Contacted EMS.
Severe pain that has not gone away since the injection.  The pain wakes me up at night.  I also feel a weakness that makes dressing difficult and using the arm for lifting items.
6x7cm  area of erythema (papule) mild swelling and warmth. Non tender. No appreciable abscess. Suggested Motrin PRN and cold compresses.
Patient developed a swollen arm following receiving a vaccination, which then progressed overnight with more swollen. The arm is described as hard, visibly swollen and hot to touch. Patient says it is limited to the right arm with no system effects, not effects on breathing. Patient will be following up with MD today.
8-10cm erythema, swollen area.  Prescribed steroids and Augmentin.