chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in accident (unrelated to vaccination) and incurred 2nd and 3rd degree burns over 45% of surface area. Superficial burns over vaccination site. Potential for vaccinial spread or immune suppression. Given VIG-IV from CDC NPS. Treated at Medical Center, then transferred to burn center. After VIG treatment, umbilicated lesions developed around original vaccination site.
Pt came into clinic and stated her left arm had started swelling where she received the flu vaccine on 03 Jan.19 .She stated she has gotten flu vaccine in past with no previous reaction.
Pt called call center on 5/10/21. Complained of sxs starting 4/30/21 headache,blurred vision felling tired,slight occasional dizziness,right eyelid twitching on/off,diarrhea and feeling anxious.  Pt was advised to go to ED for evaluation
Pt had flu-like symptoms post immun/vaccination that lasted 4 days and ended in a macular rash over trunk and bilat lower extremities.
High Fevers (5 illness events leading Up to Hospitalization Starting in 5/2021 Hospitalization 4/8/2022 8 days Cardiac ICU  Severely Swollen Glands Night Sweats  Diarrhea Weight Loss Thyroiditis  Severe Pericarditis (Requiring operative pericardial window) local Medical Center Pneumonia (Requiring Operative Thoracotomy) Left Lung local Medical Center  Anemia  High Platelets  High Monocytes High Neutrophils Negative Blood Culture x 2  Low Creatinine  Multiple Cat Scans Chest and Lungs with Contrast and without  Multiple Chest X-rays
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 27-Sep-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) outcome was unknown. At the time of the report, 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 assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medications were reported.  The pharmacist states they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11 years.  No treatment medications were reported.
Drug ineffective; COVID -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: FD0810) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005." (unspecified if ongoing), notes: I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005.; "I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005.", start date: 2005 (unspecified if ongoing), notes: I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", described as "COVID -19"; DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Negative; (18Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral (Ibuprofen) treatment was given from 08Apr2022 and treatment stop date was 13Apr2022. She tested negative for COVID on Saturday, April 16 after feeling great for a couple days. She began to get congestion in her head and throat in the evening on April 17. The next day she felt like she had a head cold. That evening, April 18, I took an over-the-counter COVID test and tested positive. The afternoon of April 19, she began to get fatigue and body aches and a cough. she took my temperature and it was in the high 99s Farenheit. On April 20 my temperature normalized, but my cough worsened. Her head cold symptoms were much improved by April 25, but her cough continued and still lingers today, May 9.  No follow up attempts are possible. No further information is expected.
Vaccine appt was at 10:00 am. Lightheadedness for about 10 seconds immediately after left  arm was injected. Later in the evening hands were swollen as if they were retaining water.
Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) outcome 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.   ?patient's lab test data not reported. No treatment information was provided.
Hallucinations, dry mouth, psychosis, sleep issues, sleep paralysis, possible auto immune disease, hospitalized.
caregiver reported noticing raised red areas to her right arm and trunk/back the following day post vaccination on the same side the vaccine was given
In a few minutes following administration of both vaccines, the patient's face turned red and she stated her heart was racing  and her throat felt tight but she was able to continue talking to us. The pharmacist  administered an epi-pen and stayed with the patient until she reported feeling better and her heart rate was normal and was still able to talk and have a conversation.
This spontaneous prospective pregnancy report as received from a healthcare worker via a company representative refers to a female patient of unknown age. The patient was vaccinated with first and second dose of VARIVAX (Merck) (dates, dose, route and Lot # were not reported). On an unknown date the patient became pregnant (LMP and EDD unknown). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date "greater than 2 weeks" age, 56 patients had Chicken Pox due to vaccine failure. 23 patients had two doses of VARIVAX (MARRS case #1211USA001359 and MARRS case #1211USA001898 respectively, Same reporter link). One of the 23 patients was reported to be pregnant (current case). There was no correlation between lot number, age or provider. No treatment information was reported. The outcome of vaccine failure, chicken pox and Vaccine exposure during pregnancy is unknown. The relatedness for vaccine failure and chicken pox was not reported for VARIVAX (Merck). Additional information has been requested.
Immediately after administration of Gardasil vaccine, patient had a syncopal event (lost consciousness, became weak). She was laid back on exam table with feet up and immediately regained consciousness. She remained supine with an ice pack for 20 minutes, drank a full juice and water and was then back to baseline.
she felt like her whole back was on fire; hands and palms were hot; having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she felt like her whole back was on fire), FEELING HOT (hands and palms were hot) and RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash). On 22-Apr-2021, the patient experienced BURNING SENSATION (she felt like her whole back was on fire) and FEELING HOT (hands and palms were hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (she felt like her whole back was on fire), FEELING HOT (hands and palms were hot) and RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
He has now body aches, headache, chills , sore throat, myalgias, a little bit of nausea. Unsure if he had a fever because he didn't check his temp. Currently temp is 99. He reports he has had a headache since he got the shot.
OFF LABEL USE; VACCINE ADMINISTERED TO 14 YEAR OLD; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced off label use. On 24-MAY-2021, the subject experienced vaccine administered to 14 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 14 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547868.
Developed some severe inflammation in her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (141010). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "Developed some severe inflammation in her eye".  Additional information: Patient reports that she held a dose of her Xeljanz 5mg for 3 days following the COVID vaccine   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Asthma was irrited starting about 45 minutes after vaccine.  Took inhaler but kept getting worse and felt light headed with chest pressure.  Went to urgent care and vitals were Normal and I was given a breathing treatment.  I felt a bit better but chest flushed that night and felt worse again.  Continued to struggle with asthma like inflammation and was prescribed prednisone 3/26.  After 5 days 0f prednisone still having asthma flare.  Prescribed more prednisone.
her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified since the vaccine; her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified since the vaccine; heart was slightly enlarged; blood pressure was up; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included covid-19 from 25Nov2020, blood pressure increased, cardiac flutter from 2020.   The patient's concomitant medications were not reported. The patient was wondering since she did have COVID and then probably a couple months later noticed her blood pressure going up and flutters in her chest and stuff, then had the vaccine as well and it was more intensified in 2021 since the vaccine. She said that they said her heart was slightly enlarged in 2021 and could be because her blood pressure was up in 2021. She said her blood pressure was back down to her normal level. She did not have her vaccine card with her, so she was not sure when she had her vaccine, she thought it was in April. She had COVID in the end of November, before 01Dec, so maybe 25Nov, it was right around Thanksgiving. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On 10/16/2021 around 6pm the child complained of left chest pain and dyspnea.  Vitals and pulse ox were all in normal range. Transported to hospital to rule out source of symptoms. The child was examined, EKG normal, labs normal and vitals all remained WNL during visit. Child was discharged without chest pain.  No further chest pain during the night or the day od 10/17/2021. In the morning of 10/18 child complained of left lateral rib area pain. All vitals were stable with a regular heart rate, no SOB. Warm compress was applied, decreasing the pain from 7 to 3. Ibuprofen was given. As of this time the child 1645 10/18/21, the child has not complained of any further pain. PRN Ibuprofen script was left for the child.
Awoke at 4am, 9/20/11, severe pain, heat and redness at injection site (left upper arm). Knot as big as a softball. Went to ER - Rx - ice & ibuprofen. By 8pm that evening, swelling increased to size of grapefruit with increased pain, swelling and redness. Went to Urgent Care - prescribed Keflex, prednisone, Benadryl and ibuprofen and additional cool compresses.
Very sore injection site. Large knot at injection site.  Vertigo first day after shot and still continues.
10-8-14 noted redness on (L) upper arm as well as warmth 2 days after having Flu shot. Also notes itching to area. Not sure if it is related to Flu vaccine or not.
A 40 year old patient took the flu shot and died; Initial information was received on 10-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via Media.  This case involves a 40 years old male patient who died (death), after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was not reported.  At the time of reporting, the outcome was fatal.  Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a 40-year-old male patient who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown.  Additional information regarding patient's medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: A 40 year old patient took the flu shot and died
Developed area of redness, warm to touch, elevated area approximately 3 inch diameter. Referred to PCP for treatment.
heart disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart disease". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the patient was administered an improperly stored dose ofVAQTA; This spontaneous report was received from a liscenced practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-FEB-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # S010727, expiration date 26-JUL-2020 (dose, route and vaccination site were not reported),  for prophylaxis.         Temperature above 9°C 21.4C Time frame 41 hours 19 minutes Previous temperature excursion? No Was call because of a data logger Yes
MD reported pt recvd MMR vax ID instead SQ w/in 5 minutes devel red, raised area approx 2" in diameter @ inject site; pt recovered;
pt recv vax 6OCT97 & 10DEC97 pt devel an itchy, vesicular rash over the lt chest. Pt was afeb. Follow-up describes "varicella zoster lesions in a unilateral dermatome pattern on the torso."
Patient had received one dosage of the monovalent vaccine.  She presented to the clinic for her second vaccine.  This provider gave the patient a bivalent vaccine instead of a monovalent to complete the series.
Felt like I had a rapid heart beat. When I checked my heart beat it was 109 which is way higher then typical.  This lasted for about  3 days. .   Also felt like like a weird ache from the area of my heart.  I had covid back in December 2019 and I also got a similar feeling while I had covid.
Knot at injection site, pain in arm, red and itchy still 8 days after injection)
Received second vaccine on 3/31/2021 and on 4/22021 was designed with DVT.  On 4/9/2021 on way to work developed acute onset dizziness/vertigo.  Admitted to hospital for 3 days symptoms persisted to neuropathy type symptoms and left leg weakness and vision problems which is still present.  I do not know if these symptoms are from the vaccine, but my Dr wanted me to report them
Appendicitis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3183, Expiration date: Not reported), via an unspecified route of administration in left arm on 05Sep2021 at 15:30 as dose 1, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history was not reported. Concomitant medications/other medications received within 2 weeks of vaccination included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN). No past drug history was reported. The patient was not pregnant at the time of report and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced appendicitis on 15Sep2021 at 13:00. The patient was hospitalized for this events in Sep2021 for 3 days and there was no prolongation of hospital. This event resulted in emergency room/department or urgent care and received the treatment with surgery. Since the vaccination, the patient had been tested for COVID-19 with nasal swab and the result was negative on 15Sep2021. The outcome of the event was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced burning in the nose. The outcome of the event of burning in the nose is unknown. The report was considered to be non-serious.
11/28/18 approx. 7:45-8pm. I received a flu shot (L) Deltoid, approx. 1.5 later, I started feeling "swollen lips, swollen eyelids, hives on face, throat scratchy. "I took BENADRYL 25mg PO no effect, took another 25mg PO- relief. MGR aware.
No additional adverse event reported; Rotateq was administered after a temperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 18-JAN-2022, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742463, expiration date: 20-SEP-2022) (dose and vaccination site were not provided) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 27.3 Fahrenheit for 27 hours 25 minutes. Previous temperature excursion was not applicable. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
From 3/12-3/15, slept for about 9 hours/day instead of 15 hours, Daughter was spitting up a lot after every feeding.
No adverse effect. Tdap 0.5 mL was ordered but 0.5 mL of DtaP was administered.
Within 10min of the shot I experienced hot flashes all over my body. Then dizzy, nausea, diarrhea, body shakes, rapid heartbeats, tingling hands/feet.
Redness and swelling at site. Started on 8 th day after injection and continued to get redder and grow in size. Also began to itch. It was as large if not somewhat larger than the circumstance Of a Ping pong ball.. it was also raised.   Multiple pictures of site sent to dr over 3 days. He prescribed  AMOX/K CLAV 875-125 which is helping reduce size and color. Taking since 2/5/2021
Pt received 2 doses of tdap. 1 in 08/30/21 and a second on 03/08/22. No adverse reaction noted on the second dose.