chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
confused with that Lot number; the lot number that was recorded in his vaccination card was "very unusual"; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 73 year-old male patient received bnt162b2 (COMIRNATY), administration date 07Oct2021 (Lot number: 30145BA) 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: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused with that Lot number"; PRODUCT LOT NUMBER ISSUE (non-serious), outcome "unknown", described as "the lot number that was recorded in his vaccination card was "very unusual"".  Additional information: Caller stated that he has a 73-year-old, male patient who had a reaction to the Pfizer BioNTech COVID-19 vaccine that he received on 07 OCT 2021 at a Local Pharmacy in which the lot number that was recorded in his vaccination card was "very unusual". Caller stated that the lot number was "301458A" and does not have the information on the expiration date of the vaccine for that lot number. Caller stated that he called the pharmacy, and they were also puzzled with the lot number so caller wanted to verify if that Lot number if for the Pfizer BioNTech COVID-19 vaccine. Called Customer Service, spoke with Agent withheld and verified that the "actual lot number is 30145BA" and that a lot are getting "confused with that Lot number". Response: Provided information from Agent withheld of Customer Service, "actual lot number is 30145BA" and that a lot are getting "confused with that Lot number".  No follow-up attempts are possible. No further information is expected.
my left eye gets very blood shot and a little irritated; my left eye gets very blood shot and a little irritated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 02:00 (Lot number: EW0170) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP7533, Administration time: 2 PM, Vaccine location: Left arm), administration date: 05Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious) all with onset 01Dec2021, outcome "recovering" and all described as "my left eye gets very blood shot and a little irritated". Therapeutic measures were not taken as a result of ocular hyperaemia, eye irritation.  Follow-up attempts are completed. No further information is expected.
10 weeks since I had the first dose, longer than 28 days since I had my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose) 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 PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
sinus pressure in one ear; running nose; UTI infection; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure in one ear), RHINORRHOEA (running nose) and URINARY TRACT INFECTION (UTI infection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI infection). On 22-Feb-2021, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure in one ear) and RHINORRHOEA (running nose). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure in one ear), RHINORRHOEA (running nose) and URINARY TRACT INFECTION (UTI infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 17 year old female pt who was vaccinated with a 1st and 2nd dose of Hep-B. Twenty-Three days, post vax, the pt developed herpes zoster in the distribution of the right C3 nerve. The 1st vaccination was administered in her right C2 dermatone. The herpes zoster resolved on it's own. Forty-two days, post vax of the 2nd dose, the pt developed herpes zoster in the C1 dermatone which was similar to the previous episode. The pt received no other medication and has no medical problem. No further information is available.
On day 8 post injection felt soreness to arm and warm to touch, also slightly swollen and red rash over upper arm where shot was given. Today is day 9 post injection with pain on touch and rash still visible as well as the swelling. Rash is flat red flushing type
Patient had some issues with her heart after receiving her first booster dose one year ago; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Feb-2021 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) (seriousness criterion hospitalization prolonged). At the time of the report, CARDIAC DISCOMFORT (Patient had some issues with her heart after receiving her first booster dose one year ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took 2nd dose of Moderna booster 1 month later of 1st dose. No concomitant medication information was provided. Patient went to ER and after 5 hours patient went home feeling better. No treatment medication was provided.  Company comment: This is a spontaneous case 73 years old female patient, with no relevant medical history, who experienced unexpected serious (Hospitalization) event of cardiac discomfort (reported as Patient had some issues with her heart after receiving her first booster dose one year ago), which occurred unspecified days after first booster dose of mRNA-1273 vaccine. It is reported that patient went to Emergency and after 5 hours patient went to home and feeling better. At time of reporting outcome of the event is unknown. No further information on risk factors, concurrent illness, clinical course, treatment given was available in the report. Elderly age could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case 73 years old female patient, with no relevant medical history, who experienced unexpected serious (Hospitalization) event of cardiac discomfort (reported as Patient had some issues with her heart after receiving her first booster dose one year ago), which occurred unspecified days after first booster dose of mRNA-1273 vaccine. It is reported that patient went to Emergency and after 5 hours patient went to home and feeling better. At time of reporting outcome of the event is unknown. No further information on risk factors, concurrent illness, clinical course, treatment given was available in the report. Elderly age could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Extreme fatigue, gut wrenching abdominal pain, chills, fever, body aches
A few days after receiving the second dose of the vaccine, patient developed sudden  about 1/8 inch, pink/flesh-colored bumps on all for joints of extremities (left and right elbow, left and right knee) that do not itch or cause pain. These bumps cover entirety of each joint. Patient has not yet attempted treatment for this reaction.  We advised the patient to seek medical attention with his primary care doctor as soon as possible.
Stroke - globus pallidus area  Lost ability to speak and recognize objects.  Immediately taken to ER and evaluated and TPA given.  Results good following drug administration sent home after two days.  Some mental affects still.
RED,SWOLLEN AND ITCHY INJECTION SITE; INJECTION SITE REACTION OF A RED, HOT, HARD CIRCLE LIKE A GIANT HIVE, BIG WELT, THAT CONTINUES TO GROW; FLU LIKE SYMPTOMS; ARM WAS SORE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: seasonal emu oil allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822309, and expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol for seasonal emu oil allergy, and loratadine for seasonal emu oil allergy.  On 18-NOV-2021, the patient experienced arm was sore. Treatment medications included: ibuprofen. On 19-NOV-2021, the patient experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 99 F, 101.3 F. On 20-NOV-2021, the patient experienced red, swollen and itchy injection site. On 20-NOV-2021, the patient experienced injection site reaction of a red, hot, hard circle like a giant hive, big welt, that continues to grow. Laboratory data included: Body temperature (NR: not provided) 99 F. On 21-NOV-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 20-NOV-2021, and had not recovered from injection site reaction of a red, hot, hard circle like a giant hive, big welt, that continues to grow, red, swollen and itchy injection site, and arm was sore. This report was non-serious.
Severe headache lasting 36 hours,  fatigue and malaise for at least a week.  No treatment except for rest.
On Oct. 18, 2023 I received the Covid vaccine in my left arm and the flu vaccine in my right arm.  That evening both of my arms became very sore and I developed a low fever - variable, but always below 101F.  I was unable to fall asleep when I went to bed.  I had to frequently get up urinate. One time when I went to the bathroom I lost consciousness and fell to the floor.  I almost immediately came to and stood up, but felt queasy and unwell.  I then passed out once again.  When I came to, I was wet with sweat and unable to get up, with my whole body now feeling sore.  My wife helped me up and into bed and I almost immediately fell asleep.  I remained with fluctuating low fever and body pains for about 3 to 4 days afterwards.  I then felt better, but now there was a swollen, discrete mass on the left side of my face.  Over the course of 2 to 3 days, the mass moved down and into the left side of my lower lip and then to the right side of my lip, and then disappeared by the next day.  (After one of my previous Moderna Covid booster shots, I developed a similar mass in the inside of my left cheek (the side of the body I received the injection), which disappeared in a day or two.))  None of these ?lumps? caused any pain or discomfort - just looked strange. I have recovered from these side effects, but still, a few weeks after, have pain in my lower back.  Perhaps I was injured in the the night time falls, but I was not aware of having these specific back pains right after the falls, being then just ?sore all over.?
Rash started at neck and developed to trunk. No fever or itch. Looked like chickenpox but have ordered test for confirmation.
This case was reported by a nurse and described the occurrence of expired vaccine used in a 25-year-old patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to HAVRIX. Additional information: An expired dose of HAVRIX was given to a patient. No adverse event was reported.
Chest pressure,  flushed. Evaluated by EMS - BP 165/112, HR 102, O2 99%.  2:18 EKG- NSR. Transported to facility.
Beginning evening of second dose. Reported tossing/turning in bed, restless legs, pain at injection site, chills, muscle pain, anxiety; no medication taken to relieve symptoms.  1-30-2021 reported nausea, vomiting, weakness, dizziness; no medication taken to relieve symptoms.  1-31-2021 reported waking up with bloody nose although not uncommon as she reported having hypertension and has had nosebleeds related to elevated BP in past, headache rate 8/10.
09/28/22 I had cold symptoms for a couple of days and they started to clear up. I took COVID home tests for 3 days that were negative. About four days later, I lost my sense of taste and smell. I went to the doctor and tested positive. I felt fine then. The cold symptoms were gone and I only had the loss of sense of taste and smell. I am still very tired and sleep more than normal. Blood work was done and everything was normal. My doctor feels I have long haul COVID.
Itchy pink splotches head to toe became noticeable irritation during the second night after the vaccination, confirmed in the morning. Went to urgent care the following Monday afternoon.  Consultation verified the symptoms.  Doctor concluded that the timing indicated a reaction to the vaccination rather than a reaction to the penicillin that I had been taking several days for a UTI.  I have never had any problems with any of the medications or supplements that I take regularly.  The doctor prescribed Prednisone, Cetirizine, and Tagamet, which I am currently taking.  There has not yet been any reduction in my extensive symptoms.
devel erythematous rash, 2 to 3 days p/the vax rash; erythema multiforme subsided in 1 wk; 10 days p/the vax devel fever & irritability needed septic w/u & hospitalization cult neg;
Patient was accidentally given a dose of HIB vaccine.  Patient does not appear to have any adverse effects to the vaccine.
Information has been received from a pharmacist concerning a patient who on 22-JUL-2009 was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (routes and lot numbers unspecified). No symptoms were reported. It was unknown if the patient sought medical attention. No further information is available.
Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included CABG and Stent placement. Concurrent medical conditions included Coronary artery disease, Hypertension, Hyperlipidemia, GERD, Drug allergy and Glucose abnormal (Abnormal glucose). Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CLONAZEPAM, CLOPIDOGREL, EPLERENONE, DOCUSATE, FINASTERIDE, FLUTICASONE, MONTELUKAST, HYDROCHLOROTHIAZIDE, PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]), LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], PANTOPRAZOLE, ROSUVASTATIN, SERTRALINE and ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported   This case was linked to MOD-2022-578981 (Patient Link).
unconsolable crying for 5 hrs & ran t102.6 R temp; also did w/1st vax but recovered sooner;
Pt was feeling short of breath, has aching left side pain, and fatigue.  Pt was positive for COVID.
52 yo WF presents for dressing change. She states that on 3/1/03 she woke up with an extremely sore throat and a red R eye and painful lymph nodes  under her jaw. She says she had cleaned her mother's garage  prior to this but was not near her mom. Her mother had had viral conjunctivitis last week. Pt also gave a hx of herpes simplex of her R eye that was work related in 1999. She has been on supression of 400mg tid but says she is  having trouble getting her meds through workman's comp and recently had to decrease the dose to BID. She was told to increase it for flair-ups to 5 times a day. She has had no fever. There have been no other lesions on her body. There has been no chills, nausea, itching elsewhere, or malaise.         She has kept her site covered. She washes her hands and uses gel and says she has been "meticulous" with these.  PMHX:No Hx chickenpox or Herpes Zoster Allergies: Erythromycin,zoloft, doxycycline, rifampin  Obj:WD,WN,WF no distress HEENT: PERRL,EOMI, R eye conjunctiva red irritated with small amount clear drainage. No lesions on lids. L eye WNL Tender in area of preauricular nodes and submandibular nodes Pharynx:no exudates masses or swelling, sl red Vaccination site:lesion scabbed over and dry. Dressing found in place and intact. Area redressed. Assmt:1)Probable conjunctivitis but need to R/O herpes as a source and much less likely vaccinia. Plan:Refer to Eye Clinic  Addendum:SEE EYE CLINIC NOTE Called the Clinician Information Line at CDC. Spoke with Dr. She took a report and suggested: 1)We should file a VAERS Report-As we do not have a digital certificate as yet this will have to be done on paper. Will down load the forms. 2)Slit lamp exam if not done today 3)Dacron swabs of eye ASAP to be sent to the state lab or to the CDC for PCR. I have obtained these from the lab and will obtain specimens tonight.  Dr. will call back tomorrow with info on where to send the samples.  4)Patient will be placed on leave for the required 5 days for viral conjunctivitis. At present, I doubt this is related to her vaccination, but the PCR may be of help if positive. At present, we are calling this a viral conjunctivitis and covering her work related herpetic eye infection with Trifluridine and acyclovir. 3/4/04 Phone contact - employee doing well. Eye no better but no worse. no more tender nodes under necck but right preauricular area still tender. Doxycycline allergy - it makes her irritable and agressive. Assmt: Viral Conjunctivitis vs. Herpetic Conjunctivitis vs. Vaccinia Conjunctivitis. Plan: 1) Continue therapy, 2) Swabs of the eye done last night sent to CDC, 3) Swab of eye sent to reference lab for viral culture, 4) Will email pictures of the eye to CDC, 5) Employee to return to Eye clinic in the AM for re-evaluation and slit lamp exam.
Provider summary "treated for E coli bacteremia and urosepsis   follow up blood cultures are negative  Sepsis, E coli bacteremia, 2 out of 1 Most likely source is urinary tract infection, urosepsis On IV ceftriaxone, IV fluids CT of the abdomen and pelvis is  -ve, was done to look for complicated urinary tract infection   Sensitivity of E coli in the urine and in the blood is showing pan sensitivity   CT of the head was done at the time of discharge patient complained of headache which is also negative Recent covid  positive, no shortness of breath, cough, 1st cord positivity on 1st of June, off isolation as per infection control    Thrombocytopenia mild, may be due to sepsis. Monitor.        Barrett's esophagus without dysplasia proton pump inhibitor    Insomnia QUETIAPINE."
chills; fatigue; injection arm soreness/right arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient took Advil to relieve the symptoms.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-086253 (Patient Link).