chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; BLEEDING THROUGH NOSE; This spontaneous report received from a consumer concerned multiple patients of unspecified age, gender, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced bleeding through nose and then later died. On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of bleeding through nose was not reported. This report was serious (Death).; Sender's Comments: V0- 20220830199-covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Pt began having arthralgias the evening after receiving vaccines. Pt came into clinic on 11/3/2018 with small, red, blisters on Right arm at injection site. Very itchy. Center of blisters purple in color. Infected area opened and wound culture sent. Negative culture. Pt started on antibiotics on 11/3/2018 for diagnosis of cellulitis. Area has improved. Physician questions vaccine reaction vs. spider bite.
Lower back pain for 10 days starting about one week after second dose. Excruciating pain 9/10., could not stand or sit, only laying down relieved the pain. Could not drive to work. Same  lower back pain (9/10) lasting 3 weeks two months after second dose.
Itching, stinging at site of shot.  Next day continued itching, warm, small dots.  Benadryl cream stopped itching.  Sore like after getting shot.
Chicken pox and/or random shingles rash spots all over hands, left upper arm, a few on chin and one on eye lid. Major right arm pain after shot. No fever, no other aches after first dose. The pox were red dot, filled with fluid, and popped after a week or so.  Second dose given on September 2, 2021, right arm. Woke up to a burning type rash 2 days after second dose. Face was red and swollen, rash on both arms and hands felt hot. Rash went a little down my neck, but stopped. I took Benedryl [3 pills] and within 90 minutes, the rash went away. I had no fever, no aches or anything other than the extreme sore arm again after the rash went away.
Brain fog; Confused which bathroom was men's at a restaurant; A spontaneous report was received from a nurse concerning her husband, who was the patient. This case concerns a 66 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced brain fog and confused which bathroom was men's at a restaurant with the use of mRNA-1273.   The patient's medical history included left lower lumbar back surgery, left and right hip replacement, right arm elbow surgery, steel rod in left leg, arthritis, and drinks but not as much. He has had atleast five surgeries in the left hip and one in the right..   Concomitant medications included allopurinol sodium, losartan, metformin, hydrocodone, and gabapentin for unknown indications.   The patient received his first of two planned doses of mRNA-1273 (Lot # 025L20A) on 29 Dec 2020 intramuscularly, in his left arm, for prophylaxis of COVID-19 infection.   A couple hours after the after the administration, the patient experienced "brain fog" and "confused which bathroom was men's at a restaurant".   Additionally, the patient experience decreased stiffness including exceptional increased ability to move within 24 hours of administration. It was noted that it was not hard for him to get up from the sitting position. He could get up without the use of armchair and just with his two arms. The second day, he was able to bend his knees and get his shoes from the closet, which he had not been able to do for a year. Additionally, he got up and helped unload the dishwasher, which he had not been able to do before. The patient was feeling much younger and much better and was excited for the second dose. The arthritis changes were dramatic and happened within the first 48 hours. There was no treatment information provided for the reported events.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events brain fog and confused which bathroom was men's at a restaurant were considered resolved as reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Light headed and mild heart arrhythmia (fast beat).  After 10 days, chills, joint pain and sore throat
Pt got shot around 12:15p. Around 5pm he began sweating profusely, hands started tingling, felt dizzy. Pt said he was going to call 911
Skin rash. Treatment was fluocinonide .05% cream to apply to area twice daily for 14 days.
Feverish and woozy/dizzy starting 3/6/21 following 3/2/21 vaccine. Continues (today is 3/24/21). Pretty much bed-ridden. App't with naturopath will be 3/31/21.
Had heart fluttering; Drowsy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 021B21A and 017A21A/ 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache). At the time of the report, CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: The case was downgrade to non-serious since there is no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.   This case was linked to MOD-2021-381126, MOD-2021-381125 (Patient Link).; Sender's Comments: The case was downgrade to non-serious since there is no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.
That night I experienced some chest discomfort but just thought it was GERD. I woke up in the middle of the night with extreme chest pains that I?ve never had before. I stood up and walked to the kitchen to get some water because I felt very ill and I ended up passing out on my way there. We ended up going to the ER and all my tests came back normal, they just gave me a five day course of steroids and I was fine. No chest pain since  two days after going on the steroids
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe.
A report was received from a health care professional on 11/03/03 concerning a female vaccinee of unknown age who experienced swelling, pain, warmth and tenderness at the injection site 1 day after receiving Fluvirin on 10/30/03. The reporter recommended symptomatic treatment with an ice pack at the affected area. On 11/03/03 the vaccinee had not yet recovered and indicated using a heat pack instead of an ice pack. The vaccinee is to attend her physician for further follow up. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/23/04: Further information was received from a health care professional indicating that the vaccinee was 48 years old and experienced extreme pain in her arm which had spread from the injection site 6 hours following vaccination and resolved on 11/30/03. The vaccinee also experienced pain and swelling in her shoulder. The vaccinee visited her physician twice and her symptoms were treated with antibiotic and anti-inflammatory agents. No follow up pending, all information received.
Did not convert p/5 doses of Engerix-B; to receive a 6th dose;
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) 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 EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022).    No concomitant medications were provided by the reporter.  The patient received half dose.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
Patient was admitted to Hospital on 12/8/2021 for COVID related symptoms. This is considered a breakthrough case.
Within 5 minutes of the shot, my throat started to close a little bit. Not as bad as the first time. I told the nurse there of what was happening. It is the same reaction as when I eat a raw tomato. My oxygen was fine. I took two Benadryl before and then one right after the shot. That medicine helped, so then I went home. I was aware of this since last shot was much worse.  I had a plan a place and talked to my allergist. I had an Tele Health appointment with and advised me to take the shot, although my primary care doctor advised me not to take it since I had a severe reaction last time.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient received his second Moderna booster (0.25ml) around 12 noon on 3/31/22. Patient said he experienced "bad" chest pain that started later that night and into the next day (4/1/22) and resolved on 4/2/22. He said the chest pain on 4/2/22 was mild. Patient said he spoke to his primary prescriber via phone.
Atrial fibrillation with rapid ventricular response. Seen in consultation by cardiology with diltiazem drip started.  Continued on her usual meds, although metoprolol tartrate 25 mg BID rather than metoprolol succinate 25 mg daily.  LHC also recommended. Discharging home in stable and improving condition. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
R arm injection site with superior inferior and posterior non confluent patchy erythematous warm red rash non itchy no streaking no joint involvement.
A report was received from a health care professional on 11/17/03 concerning a female vaccinee less than 4 years of age who inadvertently received 0.25ml Fluvirin vaccine on an unspecified day in November 2003. On an unspecified day in November 2003, the vaccinee received Fluvirin. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a contactable Consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955) via an unspecified route of administration, administered in left arm on 06Mar2021 at 12.45 PM (at the age of 48-year-old) as single dose for COVID-19 immunization. The did not have allergies to medications, food, or other products. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 (next day of vaccination) It was in the middle of the night (probably after midnight), the patient experienced muscle pain, restlessness, severe chills, prolific cold sweats. Did not received treatment for the adverse event. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Received H1N1 vaccine on 11/30/2009 - late afternoon. Approx 24 hours later developed hive-like rash around injection site.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    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. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR 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 28th of 104 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:master case
Chest pain; Swollen tongue; Swollen epiglottis; Nausea & Vomiting
Pt recvd 5 doses of Engerix-B & exp jaundice 16MAY92, then hemolytic anemia requiring 5-day hospitalization 29MAY92; bone marrow done; tx steroids (pred), iron, potassium & prilosec;
Received call from client stating that the evening of her second immunization she began to feel severe 'razor blade like' pain in her L arm (muscles), joints and several fingers as well as a sensation of severe heat in L hand (reports R hand is cool to normal in temp.  No edema or errythema reported.  Complains of random and fleeting moments of feeling flushed and feverish s/s with temp reaching 99.5 degrees F.   L arm remained extremely painful for > two weeks which keeps her up at night.  Ice is the only relief for pain.  Saw private MD reportedly dx with myalgia and arthralgia. As of 3/30/21 she cannot lift her L arm above the height of her chest.  Reports MD is ordering labwork to help dx possible infection, viral response, etc... non specific report given of medical plan for intervention.
Body aches, chills, fever of 101.9, legs felt like lead, and mild head ache. I toke Tylenol two times. I drank a lot of liquids.
Lesions, blisters, and ulcers throughout mouth, lips, and tongue.   2 weeks duration and continuing.   Prescribed Valaciclovir on 1/23/22.
Initial unsolicited report received from a non-healthcare professional on 02 December 2016. This case involves a 2-months-old female patient who was vaccinated with a dose of DAPTACEL (batch number- C5148AA, expiratory date-02 September 2019) via intramuscular route in right site of administration; ACTHIB (batch number- UI549AA, expiration date was not reported) via intramuscular route in right site of administration; ROTAVIRUS other company product (Merck) (batch number- L008997, expiration date was not reported) via oral route of administration and site of administration was not reported (dose in series was not reported for all vaccines) on 26 October 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Concomitant medications were not reported. On 27 October 2016, one day following the vaccination, the patient had experienced moaning, crying and screaming even at rest for 4 days straight. It was reported as unknown if patient was febrile. Relevant laboratory data and corrective treatment was not reported. On an unspecified date the patent was recovered from events. List of documents held by sender: none.