chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Admitted to hospital on 6/18/2022 for treatment of acute hypoxemic respiratory failure likely in the setting of right lower lobe PE and possible contributory effects of COVID-19 pneumonia (during hospital stay was treated with dexamethasone from 6/18-6/28 and remdemsivir from 6/19-6/23)  Hospital course was complicated with aspiration pneumonia that led to septic shock eventually required transition to ICU and use of pressors. Pneumonia was treated with IV vancomycin and Zosyn. Patient already on admission with severe protein calorie malnutrition and cachexia in setting of chronic hematologic malignancy and frequent hospitalizations. This condition got worse during hospital stay and it was in part contributing to his worsening clinical status and failed video swallow study. After family meeting and palliative care team assessment patient was transitioned to comfort plan of care on 7/1/2022.  During 7/3/2022 alternative plan made for hospice in hospital but while waiting for transfer patient passed away around 1:50 PM on 7/3/2022." If further medical records are needed, please contact Hospital
Fatigue, headache, muscle pain, joint pain, chills, nausea, fever (101 highest) fever maintained for 48 hours.  Lymph node swelling left armpit onset 24 hours after injection, still swollen and sensitive at 72 hour mark. Other than lymph nodes, all other symptoms came on at the same time just as I felt when I had COVID 19 March 11, 2020, date of onset of symptoms. Sleep, Tylenol, Zinc, Vitamins C and D. Symptoms began to improve at 36 hour mark. 72 hours after injections only symptom that remains is lymph node inflammation.
Pt had nausea, vomit x2, diarrhea x2 and headache (HA) but went away after vomit.
JUMPING HEART; HIGH BLOOD PRESSURE; PROBLEM WITH WHITE BLOOD CELLS; DIARRHEA; NAUSEA; HEADACHE; SLEEPY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalization, and covid-19 infection, and concurrent conditions included immune variable disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced jumping heart. On MAR-2021, the subject experienced high blood pressure. On MAR-2021, the subject experienced problem with white blood cells. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced nausea.  On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sleepy. Laboratory data included: Blood pressure (NR: not provided) high, COVID-19 virus test (NR: not provided) Negative, and White blood cells (NR: not provided) problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jumping heart, high blood pressure, problem with white blood cells, nausea, diarrhea, headache and sleepy was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
HYPERGLYCEMIA LASTING APPROXIMATELY 48 HOURS. POLYURIA, POLYDIPSIA, HEADACHE, FATIGUE.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none drug reactions or allergies. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (in the left arm, intramuscular, 0.5 ml, lot # K006681, expiration date: 21-OCT-2015). Concomitant medications included ADACEL and unspecified influenza virus vaccine (reported as flu vaccine). In September 2014 (exact date unspecified, reported as after receiving PNEUMOVAX 23) the patient's left arm became swollen and red at the injection site and that also she felt sick and had no energy. None lab diagnostics studies were performed. The patient sought medical attention via calling the pharmacy. The pharmacist requested a lot check for PNEUMOVAX 23 (lot # K006681, expiration date: 21-OCT-2015) and requested a call back regarding the results of the lot check. The outcome of events was reported as recovering. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient showed red rash on the injected arm. The rash was warm and a little raised. Patient said he feels fine but his arm just feels really warm. We administered 10 mL of children's Benadryl and applied a cold pack to the site of the rash.
Within 5 hours of injection I was rendered unconscious in a state of shock falling to the floor in the hallway of my house.  For the next 12-14 hours I was incoherent and had no knowledge of repeated phone calls from people trying to reach me or the doorbell that was repeadtly pressed. I was locked in my house and live alone. After 18 hours passed a girlfriend who had a key was contacted and arrived to find me on the floor.  With the help a neighbor I was carried to a bed where I remained comatose for close to 30 hours. Upon waking up I was completely disoriented and confused for about 4 more hours.  It was hard for me to accept that I lost 24-36 hours of time. The only thing relate this incident to was when I was a child and learned I had a fatal allergy to Penicillin Tablets which were gibe to me by a family member.  I was in a state of shock and incoherent for 3-4 days.  I doubt there is an connection as I was only 8 years old at the time it occurred. AS a result of this allergic reaction I canceled a second dose of Modera secluded for today at 1 pm until more information becomes available
Approximately 10 minutes after injection in right deltoid, patient came back from waiting room saying head feels fuzzy, also feels like the right side of throat, pt given O2 at 14:00.  Rescue called, no transport needed.
Sore arm; feeling run down; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 13:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR), all taken for unspecified indications from unknown dates. The patient previously 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 03Apr2021 at 13:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 24Apr2021 at 18:00, the patient experienced sore arm, feeling run down and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, feeling run down and body aches were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21.  Aside from some drowsiness I felt fine the entire day.  Then that night I woke up at 2:30 AM with severe pain in my right knee.  I was unable to bend the knee or walk for the next 36 hours.  After that the pain transitioned to the back of my calf muscle for the next few days.  The pain then went back to my knee for a day and then returned to the back of my calf muscle.  On 3/30/21 I saw my primary care physician who then sent me to get an ultrasound which determined that the pain in my knee and calf were caused by blood clots (DVT).  I was then prescribed Eliquis 5 mg blood thinners.
p/vax pt exp varicella like rash w/approx 36 lesions on face, head, back & stomach;pt sought unspecified medical attention;36 mildly pruritic lesions on face, head, back & abd;a few appeared infected;
Pt came down w/Influenza A 48 hours after his twins got their H1N1 Flumist.
pt devel fever the next day p/vax;saw MD 10FEB96 because fever that wouldn't go away;fever started 48hr;t104, stiff neck;stopped eating Wednesday noc;lethargic; hearing loss
Wrong dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided by the reporter.   It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.   No treatment information was provided.   This case contains information for the 82nd of 104 adult patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Pt. woke up night after booster with chills and severe headache.  After about 30 minutes still had not been able to fall back asleep due to headache and chills.  At this time experieced nausea followed by a  large volume of projectile vomiting.  Took ibuprofen for headache and presumed fever and was able to return to sleep.
6-8 weeks after vaccination, patient started experiencing exercise intolerance. Experienced chest pain lasting several hours on 10/20/2021 and diagnosed with right bundle branch block. Followed-up with cardiologist and found to have mildly enlarged left ventricle, right bundle branch block and reduced ejection fraction of 45%. He also takes Clozaril so either the Clozaril or vaccine could have had cardiac effects, but reporting because he has been taking Clozaril for one year with no symptoms.
This spontaneous report was received from a pharmacist referring to a 63 year old female patient, with no drug reaction or allergies. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (dose, route and anatomical location were not reported), reported lot # M026876, expiration date 26-JUL-2017. The patient called the pharmacy, on 04-JAN-2017, with complaints of "hive type rash" (urticaria) and "burning at injection site" (injection site pain) which started on 03-JAN-2017. The outcome of "hive type rash" and "burning at injection site" (injection site pain) was unknown. It was reported that the patient sought medical attention; no lab diagnostic studies were performed; no interventions to prevent serious criteria were performed; no significant disability or incapacity; no life threatening; no hospitalization was required. The relationship between ZOSTAVAX and "hive type rash" (urticarial) and "burning at injection site" was not reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Pt was given flucelvax which is indicated for patients 4yo + older. Patient is 3yo
He got COVID positive and hospitalized at the end of JAN2021or  beginning of FEB2021; The patient has not received the second dose yet; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication MONOCLONAL ANTIBODY 17-1A (He had Monoclonal antibody treatment > 90 days ago and after having COVID disease).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE. On an unknown date, the patient experienced COVID-19 (seriousness criterion hospitalization). On 04-Oct-2021, PRODUCT DOSE OMISSION ISSUE had resolved. At the time of the report, COVID-19 outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  Per reporter, the patient became COVID positive and hospitalized at the end of Jan-2021 or beginning of Feb-2021.   Treatment included monoclonal antibody received more than 90 days ago, after developing COVID disease.  A 30-year-old male hospitalized with a serious unexpected event of COVID-19, and product dose omission issue. Latency 1-2 months after first dose mRNA-1273. Events resolved with monoclonal antibody treatment. Rechallenge not applicable due to product dose omission. Reporter causality not provided. No confounders were reported. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Lethargy and excessive sleepiness for at least 72 hours; high pitched inconsolable screaming on day three for at least three hours, followed by loss of speech, loss of eye contact, development of sensory processing dysfunction, plateau in development, eczema and new food sensitivities.
102.2 fever considered severe reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Fever.
Discolored, raised lump on left breast with tenderness; Discolored, raised lump on left breast with tenderness; Discolored, raised lump on left breast with tenderness; Fever; chills; whole body muscle aches; headache; nausea; fatigue; sore injection site; This is a spontaneous report from a non-contactable consumer or other non health care professional (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot Number: EL3247, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in arm right on 24Feb2021 14:45 (29-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a known allergy to eggs, peanuts and tree nut. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19), dose 1 via an unspecified route of administration, administered in right arm on 04Feb2021 14:45 PM (Lot Number: EL3247, Expiry date was not reported) (29-year-old at the time of vaccination) as dose 1, single for covid-19 immunization. On 25Feb2021,12:45 the patient experienced Fever, chills, whole body muscle aches, headache, nausea, fatigue, sore injection site. On 27Feb2021, the patient experienced discolored, raised lump on left breast with tenderness and she visited doctor office and emergency room for this event. The clinical outcome of the event discolored, raised lump on left breast with tenderness was not recovered and other events were unknown.  No follow-up attempts are possible. No further information is expected.
2x2 itching size/the itching size is; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (2x2 itching size/the itching size is) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046bz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (2x2 itching size/the itching size is). At the time of the report, VACCINATION SITE PRURITUS (2x2 itching size/the itching size is) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
KINRIX= 5.5x3.0 cm area on left thigh after injection. Varicella and MMR= 2 cm Erythema at injection site.
Became weak, chilled and after 12 hours.  After 24 hours - symptoms increased and felt fatigued, weak and with body aches.  Could  not function during the day hardly at all.  After 36 hours felt almost no symptoms.  Shot given on Tuesday and Thursday night awoke with very high heart rate.  114 BPM - upon arriving at work was given a blood pressure reading of 170/160.  I called my doctor and due to not having any other symptoms of stroke prescribed a low dose high blood pressure medication.  I took only 2 doses but due to very adverse effects to the medication stopped after 2 doses.  My BP was going down as I was checking it.  The medication made me feel very dizzy with fatigue and increased heart rate.  On Monday morning at 1:00 A.M. - 2/8 I awoke AGAIN with chest discomfort and extremely high BPM - 140.  I called 911 and was admitted to the ER.  After 3 hours both BP and BPM decreased to a normal range and i was released.  Chest x-ray and blood draw  were all normal.  Continued to experience some dizziness during the day but could function.
Approximately 6 or 7 days ago patient's mom noticed increased bruising. On 8/19/2010 patient fell and mom noted significant bruising within 45 minutes of the fall.  Patient was seen by her PCP who did a CBC which was significant for a platelet count of 2000.  Following this finding patient's mom was instructed to bring her to Hospital for treatment.  Following admission a CBC was obtained which was significant for a platelet count of 6000.  Treatment was initiated with IVIG 1 gram per kilogram (10 gram dose given).  A few hours after finishing the IVIG her platelet count was 16,000.  A repeat check of platelets will be performed later this afternoon.  Patient has been otherwise healthy with the exception of some clear rhinorrhea which was noted to have begun within the last 4 or 5 days.
received second vaccine 5 pm on 11th of June.   Had a 100 temp by noon the next day.   Temp went to 103.4 by 6 pm  Sat. June 12th.  Migraine, extreme back pain and nausea.    Fever broke on Monday the 14th.   Migraines, confusion, dry eyes, and extreme runny nose and exhaustion continued.  Upset tummy lasted from 14th until 19th....migraines and confusion continued until 20th.   Exhaustion is still ongoing as of Friday June 25th.  And this afternoon I have temp of 100.3 .    Any exercise I do is followed by terrible muscle tightness and extreme fatigue.    Confusion and head pressure comes and goes.   Not able to return to work.   Driving a vehicle is not advised either.
This case was reported by a health professional to a distributor and described the occurrence of an injection site reaction in a male child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 14Apr04, the pt received the fifth dose of Infanrix (lot DTPA622A2). At an unspecified time following the administration of Infanrix, on 14Apr04, the pt experienced an injection site reaction characterized by swelling, warmth, redness, and induration. The pt was seen at a physician's office. The event was unresolved. The health professional considered the injection site reaction to probably be related to vaccination with Infanrix.
I felt light headed and I felt like I was going to pass out. I experienced headache, body ache, joint aches, swollen injection like the size of a gulf ball that lasted for a week, chills, fatigue lasted for a couple of weeks. My face began to swell and it also threw off my period cycle.
Chills, body ache, headache, fever, tired, sore arm with this shot and the first Temperature of 100.4 treated by self with Tylenol  Resting heart rate usually 55-57 but increased to 77-84 End of side effects March 12, 2021 at 7:00
Edema to extreme in hands, feet, ankles, wrists, thighs, arms, lower legs, redness, from 4/01?04/04