chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020.  Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.  Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death.
I had fallen asleep in a chair. It was in the afternoon, I woke up and my nose felt like it was running. I wiped my nostril and saw blood. It bled profusely for almost 5 minutes. I never had a nosebleed in my life.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 06-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733), in left arm and on 20Apr2021 as dose 2, single (Lot number: EW0164) at the age of 34 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 05Mar2023 as dose 4 (booster), single (Lot number: O22H22A), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 031H21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: I decided to take a home COVID test and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in 2016 (reported as between May 2016 and December 2016), the patient was vaccinated with improperly stored VARIVAX lot # L021214 with expiration date of 10-JUN-2017, for prophylaxis (dose and route of administration were not reported), diluted in properly stored sterile diluent (dose, lot number and expiration date were not reported). Administered dose of vaccine experienced the temperature excursion of 15-46 degrees Fahrenheit (°F) for 12 hours. There were previous excursions of 15-46 degrees Fahrenheit (°F) for 29 hours.  There was not data logger involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001690: US-009507513-1705USA001692:
Patient received 0.2 Pfizer Pediatric dose undiluted. No reported or observed reactions in 15 minute observation.
On May 02, 2000 within 5 to 7 hours, pt developed an injection site reaction with redness and swelling which extended from his elbow to shoulder. He was treated with cool compresses and Tylenol. This is 1 of 2 reports from this facility of adverse events.
24 hours of severe flu symptoms, 10 minutes bilateral hip paralysis. Covid and a miscarriage a few months later.
G2P1 at 14w1d at time of vaccine, 14w 3D today.  Normal health singleton pregnancy. I had fever, chills, myalgias, headache 12 hours after second shot given, and lasted for 24 hours. Exhaustion was strong and moving took significant effort. Symptoms improved after 24 hours (36 hours after shot given), but the following day, I had strong heart palpitations increasing in frequency and severity throughout the day.
Fever; Chills; Body aches; abdominal pain; dizziness; sweating; This is a spontaneous report from a contactable other health professional (patient). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular, administered in Arm Right on 17Feb2021 14:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 intramuscular, administered in Arm left on 27Jan2021 15:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. On 17Feb2021 14:30, the patient experienced fever, chills, body aches, abdominal pain, dizziness, sweating. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Jul2023. Patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 AM.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300254007 same patient, different drug/event;
Within 5-6 minutes after receiving vaccine profuse sweating was noted, loss of hearing and impaired vision.  Also felt extremely nauseous
Patient received dose after its expiration date 13-Jul-2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Edema/inflammation at inj. site L arm from upper shoulder to mid shoulder; skin warm to touch. Child c/o pain at site. Return to clinic 8/11/03 for recheck.
I have aches in joints, bruising, tiredness, weakness, nausea, dizziness, headaches muscle pain, swelling and sleep problems.
dizzy; weak; same day- moderate arm pain radiating to chest and back/Next day- 5:30 am awakened by severe arm/back/chest pain; twitching; eye/headache; eye/headache; high fever; sweating; nausea/diarrhea; nausea/diarrhea; swollen glands; sore throat; whole body ache; same day- moderate arm pain radiating to chest and back/Next day- 5:30 am awakened by severe arm/back/chest pain; same day- moderate arm pain radiating to chest and back/Next day- 5:30 am awakened by severe arm/back/chest pain; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8731), dose 2 via an unspecified route of administration, administered in Arm Right on 25Apr2021 at 11:15 (at the age of 30-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergic to cherries. Concomitant medication included minocycline. The patient previously took bnt162b2 (Batch/Lot Number: Ew0150) as first dose on 04Apr2021 at 11:15 (at the age of 30-years-old) for covid-19 immunisation and experienced Arm pain and severe headache; ceclor and experienced allergy. On 25Apr2021, the patient experienced "same day- moderate arm pain radiating to chest and back/next day- 5:30 am awakened by severe arm/back/chest pain, on 26Apr2021 at 05:30 same day- moderate arm pain radiating to chest and back/next day- 5:30 am awakened by severe arm/back/chest pain (back pain), twitching, eye/headache, high fever, sweating, nausea/diarrhea, swollen glands, sore throat, whole body ache and dizzy on 28Apr2021, weak on 28Apr2021. other vaccine same date vaccine date was provided as 25Apr2021. Facility type vaccine was military base. The patient received no other vaccine in four weeks. Treatment was provided for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events were recovering.   No follow-up attempts are possible. No further information is expected.
Day 5 swelling, rash, itchy, and burning at site location and surrounding. Very swollen shoulder. Each day after it?s been getting worse. Reaction area approximately 6-7 inches. Have pictures   Currently day 9 it is still localized but getting worse and neck is itchy too. Taking anti histamines routinely.
PATIENT RECEIVED HER 1ST VACCINE ON 3/23 REPORTING SLIGHT FATIGUE AND SORE ARM AT THE INJECTION SITE. SECOND SHOT WAS COMPLETED AND PATIENT WAS ADVISED TO FOLLOW UP WITH PEDIATRICIAN. PATIENT WAS ACCOMPANIED BY MOTHER FROM THE  FACILITY.
Code called at 3:00pm. Patient stated she felt flushed. Had BP 172/100. Pulse 68. Respirations 14.  Lungs were CTA B, No wheezing, stridor, or respiratory distress , No flushing seen, no rash or Hives. No murmurs noted and normal pulse rate on exam. Given 20mg pepcid and 25mg benadryl. Monitored for 30 minutes. Symptoms resolved. Repeat exam normal. Told to monitor symptoms for 24 hours and call 911 if any chest pain, SOB, or other signs of anaphylaxis discussed with patient.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had 1 dose of vaccine administered 1 day past the beyond use date.), PRODUCT STORAGE ERROR (We had 1 dose of vaccine administered 1 day past the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.      Vial size was reported as 2.5 milliliter. Reporter not sure about the date the vaccine was stored on refrigerator but reported likely, 30 days prior to 21-Nov-2022. The vial  did not undergo any temperature excursions. Only 1 dose was administered.   No treatment medications were reported.
Received (3) IM injections yesterday: Tdap left arm, Flu and PNEUMOVAX in right arm. Few hrs later, reported tenderness upper left arm and a "throbbing" pain right arm, radiating down to fingers and up into neck. Reports low grade temp "just under 101', along with some swelling just above collar bone. Denies redness. Reassured her: some pain, redness, swelling and low grade fever are all normal symptoms for few days, after receiving IM injections. Took ibuprofen last night and again this morning. Wondering if she could take naproxen instead, since she ran out of ibuprofen. Informer her naproxen is only an anti-inflammatory, and will not help with the fever. Informed her she could take for the pain/swelling, but recommended TYLENOL for fever if needed. Also recommended ice to area of swelling, plenty of fluids and to call back if symptoms worsen and/or redness develops. Patient in agreement with plan.
About 15 20 minutes the day after receiving the shot my left nostril started to run. Next day was really sore inside. Couple weeks later the right nostril has done same thing.  Now both nostri  feel raw inside. Just wanted to let you know of this. I was fine before hand and now nostrils are really sore .
This was my second dose, which was on my right arm. My first dose was injected on my left arm, and I experienced moderate to severe arm pain (it felt like I tore my shoulder). The  night after my second dose, I had cold/night sweats and completely drenched the bed. This occurred three nights in a row. The morning after the shot I also woke up with a 102.5 degree fever, but the fever went away shortly after I woke up. Additionally, I also experienced severe headaches and exhaustion for about two to three days after the injection. On the fourth day, all the adverse side effects dissipated and eventually went away completely.
PATIENT REPORTED "SHAKY BREATHING," "PAIN ALL OVER BODY," AND FEELING NAUSEATED.  SYMPTOMS WERE NOT RESOLVING UPON USING CONTROLLED BREATHING TECHNIQUES, AND RELAXATION.  PATIENT WAS BECOMING DISTRESSED ALTHOUGH WAS NOT EXPERIENCING RESTRICTED AIRWAY.
30 minutes after injection - hive 3x4cm, (-) itching (-) shortness of breath --> ice pack, ZYRTEC PO, recheck 24 hours.  3/17/09- still with redness / (-) hive/ (-) itch.
Patient experienced redness, itching, bruising, area was warmer than surrounding skin and fatigue.
Pain, which initiated within few days after vaccination and still present a few weeks out after vaccine was received/administered (pain/soreness on arm vaccine was given).
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-JUN-2019 , the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) at the age of 57-years-old as single dose for covid-19 immunisation. Medical history included hypertension and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; levothyroxine; amlodipine all taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism), 2 weeks after first vaccine on 08Apr2021. The patient was hospitalized due to the events for 1 day. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in Apr2021.  Information on lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events DVT (deep vein thrombosis) and PE (pulmonary embolism) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
increased insulin needs (basal); decreased appetite; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "T1D" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCREASED INSULIN REQUIREMENT (non-serious), outcome "not recovered", described as "increased insulin needs (basal)"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Additional information: Increased insulin needs lasted for approx 72 hours and has not subsided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
For the first week following second dose- extreme fatigue. The first few days also included body aches, nausea, and headaches.   Then on July 14 I woke up in the middle of the night with pain in my left ear cartilage- it was extremely swollen, red, and hot. In 24 hours the redness and heat decreased fully and the swelling decreased a lot, however, the cartilage is still swollen and painful. I also became congested in my sinuses and developed a cough, pain in my chest, and shortness of breath. These symptoms were so bad I could not talk or walk up stairs without losing my breath and several times a day blacked out from shortness of breath or coughing. I have seen the doctor twice, was put on two inhalers, oral steroids, and tessalon perles, however, still have extreme tightness in my chest, shortness of breath, and a cough. I have not had extreme asthma symptoms requiring medical intervention in 6 years, was not exposed to anyone sick, and have not been sick in years.