chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient feels weak; He lost appetite; He can't sleep; He feels hot in the face; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient feels weak), DECREASED APPETITE (He lost appetite), INSOMNIA (He can't sleep) and FEELING HOT (He feels hot in the face) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced ASTHENIA (Patient feels weak), DECREASED APPETITE (He lost appetite), INSOMNIA (He can't sleep) and FEELING HOT (He feels hot in the face). At the time of the report, ASTHENIA (Patient feels weak), DECREASED APPETITE (He lost appetite), INSOMNIA (He can't sleep) and FEELING HOT (He feels hot in the face) had resolved. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient was feeling fine now.    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Event outcomes were updated
R57.0 CARDIOGENIC SHOCK 6/13/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.0 CARDIOGENIC SHOCK 6/13/2021 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/13/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/13/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.0 CARDIOGENIC SHOCK 6/13/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/13/2021 ADJUSTMENT AND MGMT OF PICC LINE R57.0 CARDIOGENIC SHOCK 6/13/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/13/2021 PALLIATIVE CARE
Started as a blood clot in my left eye in which in which I lost some vision.  Then needing blood work for job, the phlebotomist could not draw blood as it was dark colored and thick and clotted as it was being drawn.
Patient has hsitory of anaphylaxis to foods and medications, carries Epi-Pens.  20 minutes post delivery, patient "feels throat swelling" and slight shortness of breath.  Patient checked by on staff physician.  Patient took 25mg (self) of Benadryl (oral).
Information has been received from a male consumer who reported that he had a "mumps and measles vaccine" when he was a child.  It is unknown if he received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and whether he received rubella.  He now has a negative titer for rubella.  No medical attention was sought. No product quality complaint was involved. Additional information is not expected.
COVID-19; COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 as dose 4 (booster), single (Lot number: 088D21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: Jul2022; LOSARTAN, start date: Jul2022; ATORVASTATIN, start date: Jul2022, stop date: 11Aug2022; ALOPURINOL, start date: Jul2022; LEVOTHYROXINE, start date: Jul2022; ASPIRIN (E.C.), start date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Rebound covid"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Vaccine brand other: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21Aug2022) Positive, notes: Rebound case of COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Additional information: Patient had received other vaccine. Yes, for Other medications in two weeks. Patient had Paxlovid for covid 19 as an treatment on 12Aug2022 and stopped on 17Aug2022.  No follow-up attempts are possible. No further information is expected.
reaction a week after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (reaction a week after receiving the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (reaction a week after receiving the vaccine). At the time of the report, HYPERSENSITIVITY (reaction a week after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment information was provided.
pt recvd vax 5NOV92 & returned w/red circular reaction approx 4" in diameter on 11NOV92; t99; rx Dicloxacillin
100.6 degree F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100.6 degree F fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (100.6 degree F fever). At the time of the report, PYREXIA (100.6 degree F fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 100.6 (Inconclusive) 100.6 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Four weeks after receiving the first shot and one day before 2nd shot appt, I developed a ringing in the ears (3 on a scale of 1-10).  It has been going on now for 5 days.
Patient received 2 month old vaccines at 11 AM 12/17/15. Patient then developed temperature 101.5 that evening, as well as being fussy/decreased appetite. CBC done in clinic 12/18/15 - WBC 18.3.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 06-JAN-2015, the patients were vaccinated with M-M-R II INJ (strength, dose and route were not reported) (lot # K001231 and expiration date 27-JAN-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 16-year-old female patient who received BEXSERO. The patient's past medical history included acne. Concomitant products included tetracycline. On 21st August 2017, the patient received the 2nd dose of BEXSERO. On 23rd August 2017, 2 days after receiving BEXSERO, the patient experienced rash. On 24th August 2017, the patient experienced hives. On 25th August 2017, the patient experienced lip swelling. The patient was treated with prednisone. On an unknown date, the outcome of the rash, hives and lip swelling were not recovered/not resolved. The reporter considered the rash and lip swelling to be possibly related to BEXSERO. It was unknown if the reporter considered the hives to be related to BEXSERO. Additional details were provided as follows: The case was reported by the patient's mother. The patient received MVI (multivitamins) concomitantly. The reporter denied any allergies for the patient. The patient received BEXSERO in left shoulder. On 23rd August 2017, within 72 hours of receiving the vaccine the patient had a rash that started on her back, then moved to her front and then down her legs. The reporter stated, the patient was seen at the physician office. On 24th August 2017, 3 days after vaccination the patient experienced rash-hives and the physician did not believe the issues were related to the vaccine and prescribed a prednisone dose pack for the patient that she began yesterday from the date of reporting. On 25th August 2017, 4 days after vaccination, the patient had swollen lips the morning and the reporter reported that her daughter was worse. The patient received no other vaccines on the day of reporting or 4 weeks prior to this vaccine. The reporter also noted it comes and goes.
Patient complained of burning rash, lump, prickly sensation at site of injection - has had this for approximately 2 months.
Tender lump on left upper anterior chest. Sore left arm. Also, red, itchy, warm area at site of injection, resolving.
This case was reported by a other health professional via sales rep and described the occurrence of spot pigmented in a patient who received HIBERIX. On an unknown date, the patient received HIBERIX (intramuscular 0.5 ml. On an unknown date, less than a year after receiving HIBERIX, the patient experienced spot pigmented. On an unknown date, the outcome of the spot pigmented was unknown. The reporter considered the spot pigmented to be probably related to HIBERIX. Additional details were provided as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The patient received HIBERIX in unknown thigh. When the patient was returning 2 months after receiving HIBERIX, the patient had a black mark on thigh that they attribute to HIBERIX. The spot was looking like a black tattoo, not like a blood blister or a bruise. It was unknown whether this office purchased this vaccine with private or public funds. The lot and expiration date of the vaccine was not known. The gender or age or date of birth was not provided. It was not known what other vaccines may have been administered at the same time for these two patients. This case was one of the two cases reported by same reporter for potentially siblings.
Dizziness, pallor, sweating. BPs 74/52 (pulse 128), 118/77 (pulse 87). Given water, orange juice, and crackers.
Pt states 2 days after vaccine administered had redness, swelling, itching, cellulitis in area Pneumococcal vaccine administered.
Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
A pharmacist reported that a subject of unspecified age and gender had a decreased response to hepatitis B vaccine recombinant (Engerix-B).  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  In the year 2001, the subject received an unspecified number of injections of Engerix-B (Lot # ENG3375A4).  Subsequently, on an unspecified date, an unspecified titer was "below normal".  Comment: The reporter indicated that a total of six subjects out of seven vaccinees had "below normal titers" after immunization with Engerix-B Lot # ENG3375A4. However, they are not presently identifiable.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 10-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction. At the time of reporting the outcome of the event was unspecified. The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 subjects developing adverse events after receiving the FLUARIX vaccination. No details of the report are available and the sales representative heard the report third hand. Linked cases include: A0753365A, A0753367A, A0753368A, A0753369A and 0753370A.
Nose was bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (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: EPISTAXIS (non-serious) with onset 09Oct2021, outcome "unknown", described as "Nose was bleeding".  Additional information: After two days of first dose of vaccine in the morning her nose was bleeding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nauseous/felt like throwing up; Overall felt like she had the flu; flu symptoms; weak/can't get up; couldn't sleep; sneezing a lot; tired; feeling so sick; breathing was affected not as easily as normal; very itchy on face; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up) and INFLUENZA LIKE ILLNESS (Overall felt like she had the flu) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity and Asthma. Concomitant products included CEFPODOXIME PROXETIL, CLAVULANATE POTASSIUM (FORENZA) for Allergy, MONTELUKAST for Asthma, IRBESARTAN for Blood pressure management, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Chronic sinusitis and Nasal polyps, BUDESONIDE for Nasal polyp and Chronic sinusitis, PRAVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and DENOSUMAB (PROLIA) for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal) and PRURITUS (very itchy on face). On 22-Sep-2021, the patient experienced NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Stomach ache, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach ache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired) outcome was unknown.            This case was linked to MOD-2021-328121 (Patient Link).
COVID-19 pneumonia  93-year-old female who was admitted to Hospital for acute hypoxic respiratory failure.  Patient found to be Covid positive and had a positive urine antigen for strep pneumonia.  She also had ischemic appearing limbs and was found to have arterial occlusions in bilateral lower extremities on CT angio.  On arrival, patient was on BiPAP and stated that she wanted to be DNR/DNI.  She was started on broad-spectrum antibiotics and remdesivir.  In the morning on 11/5, it was explained to the patient that she would require antibiotics, anticoagulation, and continued respiratory support.  She decided that she would prefer to go on comfort care measures of these were initiated.  Patient died at 1313 on 11/5.
Cough, low  grade fever , 24 hours  after shot. Positive  Covid test on 3rd day after shot.
9-10 hrs after receiving vaccine I had bad HA,  fatigue & severe joint aches.   Severe enough I cnx'd my appt's the next day.   These sxm's were very similar to my sxm's when I had Covid 19.  Sxm's subsided  24 hrs after they started.
Swelling of a round shape, quite large, in the area of the clavicle on the right side. Has decreased in size over time.
exposed to COVID on Sunday and had a positive at home test today.  He has had increased weakness and was unable to transfer from the couch to the chair.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jul 20, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 20, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vaccine: May 7, 2021.
93-year-old male with history of persistent Afib, complete heart block with symptomatic bradycardia and as result had a Medtronic micra leadless permanent pacemaker placed in the past, CAD s/p CABG x4v, L carotid artery stent, AAA s/p repair 2002, hyperthyroidism, and worsening dementia. The patient came to ER with C/O low grade temps, body aches, generalized weakness, mild cough, and decreased oral intake
Having dizzy spells and headache and pain in the injection area; Having dizzy spells and headache and pain in the injection area; Having dizzy spells and headache and pain in the injection area; This is a spontaneous report from a contactable consumer. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, schizoaffective disorder and narcolepsy. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included metformin (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN), oxybate sodium (XYREM), armodafinil (MANUFACTURER UNKNOWN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), simvastatin (MANUFACTURER UNKNOWN), risperidone (MANUFACTURER UNKNOWN), agrimonia eupatoria (AGRIMONY), guaifenesin (MUCINEX), cetirizine (MANUFACTURER UNKNOWN), chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX), boron, chromium, copper, germanium, iodine, manganese, molybdenum, selenium, silicon, sitosterol, vanadium, vitamin d nos, zinc (SUPER BETA PROSTATE), probiotics and curcuma longa rhizome (TURMERIC); all for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 at 14:00, the patient was having dizzy spells and headache and pain in the injection area. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event having dizzy spells and headache and pain in the injection area was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 16MAY96 & 19DEC97 pt devel a mild case of chickenpox w/itching;pt had less than 20 lesions, some pustules on face & hands;pt was afeb;
Arm swelling from elbow up on right arm, large visible knot on right arm, complete body pain, fever
Pt was given the J&J shot and within 24 hours experienced weakness to the point that he was unable to move his legs. He had decreased circulation in the lower extremities and was hospitalized. Since that time he has been confined to a wheelchair.
exposed to chickenpox 2 days prior to vax;began 8MAY98 w/ 5-6 red marks on body;today reports 10-12 pox noted total;afeb; dec appetite;;change in disposition 2 on chin;2 on shoulder;1 on back; 1 on dorsal aspect of foot;2 on thigh;1 ankle