chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to vaccination, was the patient diagnosed with COVID-19: Yes; Prior to vaccination, was the patient diagnosed with COVID-19: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19: Yes".  Clinical Course: It was reported that prior to the second dose of vaccination, the patient was diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Painful, red raised rash below site of injection and down the arm. Lasted approximately 2 days.  Showed signs of improvement by the third day.
Rash on left arm that started 4 days later (4/10/21) that has spread to abdomen, shoulders, and back of neck.  Very itchy and painful due to the scratching.    Has not responded to any treatment yet and has not resolved.
Severe chills alternating with severe sweating. Constant 102 F fever with alternating Motrin and Tylenol.  Complete loss of appetite. Extreme weakness, rapid heartbeat upon exertion.  Aches and pains general malaise. After 36 hours arm at inoculation site developed extremely painful 4" x 4" x 1/4" to 1/2" thick red inflammation.
Very tired for 2 days then vertigo  rash to hands and fingers and now skin is peeling
Starting that evening, patient began being delusional. "He was making up a bed for his grandson to stay over,". He lost orientation to person & place (wife did not ask about time when occuring). His eyes were "glazed over," his arm was shaking, and he had a temperature.
Information has been received from a physician concerning a 5 year old male patient who was vaccinated on unspecified date with a second dose of VARIVAX (Merck) SQ, 0.5ml. Physician reported that the patient developed chickenpox after receiving the dose of VARIVAX (Merck). Physician confirmed the rash as being chickenpox. The patient has sought medical attention at office visit. At the time of this report, the patient was recovering. Follow up information has been received from a nurse concerning a 5 year old male patient with decay, otorrhea, tympanic membranal perforation, esophageal reflux and chromosomal anomaly who on 03-OCT-2009 was vaccinated with a second dose of VARIVAX (Merck), IM, left thigh, (previously reported as SC). Concomitant therapy included MMR II (MSD) given IM on the same day. Other concomitant therapy included KINRIX. On 07-OCT-2009 the patient developed chicken pox, no complications, rash itches, no fever, multiple raised red papules, and papulovesicles on left side of face, new papules forming on legs, several facial lesions crossed. A clinical laboratory diagnosis was performed (results unknown). A week later the patient recovered (approximately 14-OCT-2009). Additional information is not expected.
Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 15:15, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 26Jan2021, at 04:00 AM, the patient experienced sore arm and body aches. The events were considered non-serious. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
Swollen lymph nodes in both elbows; Numbness in right arm; Pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 13:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included marajuana (MANAFACTURER UNKNOWN) daily, ibuprofen (MANUFACTURER UNKNOWN) occasionally for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on an unspecified date 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 08Apr2021 at 19:00 the patient experienced swollen lymph nodes in both elbows, the right lymph node was about the size of a quarter and was causing numbness and pain throughout the arm. The left was smaller, more like a small grape. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph node, pain in arm, numbness in arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient received HPV vaccine via IM injection to L Deltoid around 10:12AM, no redness/swelling/bleeding noted to injection site. Patient reported  pain with injection, but was awake, alert, and oriented. Patient stood from exam table and sat next to Guardian in a chair. Patient started to flex both shoulders and became rigid around 10:13AM. Patient was stimulated with shoulder rub,  and verbal commands. Patient then became less tense, but was slumped down in his chair for about 5-10 seconds. Physician was notified, and came into exam room. Patient awoke immediately after and stood up, stating he felt hot. Dr. examined the patient, vital signs were taken, and patient was given a Gatorade to hydrate. Patient was awake, alert, and oriented at this time. Guardian reported that patient had a history of passing out with blood, lab draws, and needles.
Patient felt fine until 10/16/17 - woke up with headache fever body aches off balance resolved 10/20. C/O on 10/20 blurred vision can't sleep better today, but still doesn't feel right. Able to work. Cold sweats continue. Referred to PCP for evaluation on 10/23/17.
Pt was given Pfizer Bivalent dose of 0.5 ml.  0.3 ml should have been given
Chills; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies, did not have COVID prior to vaccination, did not receive other vaccines four weeks prior, did not receive other medications in two weeks of vaccination, and was vaccinated at a hospital. On 16Jan2021 13:15, the patient experienced chills and slight headache. No treatment was received for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Reporter did not allow further contact
he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 21-FEB-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
TINGLING IN RIGHT ARM THAT LASTED 15 MINUTES AFTER INJECTION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported.  The patient's past medical history included hysterectomy, and concurrent conditions included congestive heart failure, diabetes, high blood pressure, allergies to tree, allergies to grass pollen, and left ventricular block. The patient was previously treated with , oral contraceptive nos for drug used for unknown indication; and experienced drug allergy and heart race when treated with hydrocodone bitartrate/paracetamol for drug used for unknown indication, drug allergy when treated with sulfamethoxazole/trimethoprim, povidone-iodine, codeine, erythromycin, and benzylpenicillin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced tingling in right arm that lasted 15 minutes after injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right arm that lasted 15 minutes after injection on 23-MAR-2021. This report was non-serious.
Patient called our onsite registered nurse on 18MAR21 to report injection site swelling and redness (left deltoid).  Patient was advised to take Benadryl at home after work.  Patient will follow-up with our onsite nurse as needed.
Inflammation in the gut; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 15:45 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot unknown: True, lot unknown reason: Not available/provided to reporter at the time of report completion, dose number: 1), for COVID-19 Immunization. The following information was reported: GASTROINTESTINAL INFLAMMATION (non-serious) with onset 23Jun2021, outcome "not recovered", described as "Inflammation in the gut". The event "inflammation in the gut" was evaluated at the physician office visit. Therapeutic measures were taken as a result of gastrointestinal inflammation.  Additional Information: Facility type vaccine of administered was pharmacy or drug Store. No other vaccine in four weeks. No covid prior vaccination and patient not tested covid post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case was vaccinated and boosted against Covid yet was infected in hospital with Covid 3 months later.  Hospitalized at Hospital.  Case was exposed to Covid while hospitalized, and tested positive on 1/23/22. Patient unfortunately was exposed during his hospitalization to healthcare worker with COVID-19. He subsequently tested positive and therefore due to concern of being able to take care of patient at home were having problems with the infection wife desired to have the patient stay in the hospital and therefore discharged on 1/23/2021 was held. Patient was evaluated by infectious disease for options and decided to undergo prophylactic treatment for 3 days. He tolerated the medication without problem. He had no oxygen requirement or other needs during his prophylactic treatment or following this (patient is vaccinated and boosted). All Covid precautions ended on date of discharge.
Rash at site (expected), large bright red rash macular in appearance 6 inches on abdomen (sunburn like in appearance) which started 24 hrs after immunization. Few papules elsewhere.
Information has been received from a physician via a company representative concerning an 89 year old male patient with a history of sepsis who "2 months ago" on approximately 21-APR-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included warfarin sodium (COUMADIN), digoxin, omeprazole (PRILOSEC) and "KESLEX." On approximately 21-APR-2006 the patient experienced "swollen arm where the injection site was." Subsequently the patient recovered. Additional information has been requested.
A FIB; GAS; ABDOMINAL PAIN; STOMACH PROBLEMS; CONSTIPATION; DIARRHEA; This spontaneous report received from patient via other manufacturer concerned a 70 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: idiopathic pulmonary fibrosis. The patient 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, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nintedanib esilate (capsule, oral, batch number was not reported) 150 mg, 1 time every 12 hours, from 24-MAY-2021 for idiopathic pulmonary fibrosis.  Concomitant medications included loperamide for drug used for unknown indication.  On an unspecified date (around Christmas, also reported as was diagnosed in JAN), the patient experienced A fib (atrial fibrillation).  The patient received company suspect Xarelto (rivaroxaban) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced gas, abdominal pain, stomach problems, constipation, and diarrhea. The patient had emergency room (ER) visit for pain 2 days ago and she was diagnosed of gas pocket. The patient stated that he had been experiencing stomach problems. He mentioned that he went to the emergency room Saturday Night and they told him that it was gas, but he don't think that was the problem. He stated that he thought he needed to try different foods with the medication. In MAR-2022, the patient had surgery for watchman device.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with rivaroxaban was not reported; and dose of nintedanib esilate was not changed. The patient had not recovered from diarrhea, constipation, and a fib, and the outcome of stomach problems, abdominal pain, and gas was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220910239.; Sender's Comments: V0: 20220864773-covid-19 vaccine ad26.cov2.s- Atrial fibrillation. 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.  20220864773-Xarelto -Atrial fibrillation. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Developed breathing problems , Dr. didn't treat condition until months later, heart failure stage 4, enlarged heart, and respiratory failure, June 18 to July 3 she was in the hospital. She now on oxygen 4 liters sitting down and 8 liters standing up such as eating, or standing up. Oxygen drops down to 70 once standing up. Cant do her daily basis any more.
shortness of breath; chest pain; low humming in the left ear; abdominal fulness; headache; horizontal pain across back below the shoulder blades; pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (horizontal pain across back below the shoulder blades) and PAIN IN EXTREMITY (pain in the left arm). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant), TINNITUS (low humming in the left ear) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (abdominal fulness) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 24-Feb-2021, BACK PAIN (horizontal pain across back below the shoulder blades) had resolved. At the time of the report, DYSPNOEA (shortness of breath) and PAIN IN EXTREMITY (pain in the left arm) had resolved and CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment is provided. No Concomitant list is provided.   This case was linked to MOD-2021-080428, MOD-2021-080027 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-080428:case for second dose MOD-2021-080027:case for wife
SARS-COVID19PCR, NP (+) signs of COVID bronchitis bilateral pulmonary embolism dx'd during recent hospitalization
Patient taken to the ER; Palpitation; Light headedness; Tingling sensation on hand and feet; Rash; Nausea; Fever (low grade); Chills; Server allergic reaction; A spontaneous report was received from a 43 years old female patient concerning her self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, palpitation, light headedness, rash, tingling sensation on hand and feet, fever (low grade), chills, was taken to the ER. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, at around 3:50 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly at unknown anatomical region for prophylaxis of COVID-19 infection.  On 19 Jan 2021, about 7-10min after receiving the first dose of mRNA-1273, the patient experienced had palpitation light headedness and nausea. The patient  was evaluated at vaccination post asked to go home. At home, the Palpitation continue (HR=150b/m in) and had rash and tingling on her hand and feet. The patient was taken to the ER at around 8:30-9:00 pm. At ER the patient was given IV fluids, Ibuprofen and acetaminophen. EKG was done and was normal, the patient was released to go home with a HR of 105 b/min. Since then she had repeated episodes of palpitation, fever (low grade) and chills.  On 26 Jan-2021, the patient experienced the  servere allergic reaction a week later after receiving the Moderna Covid-19.  The Patient consented to be followed up by the safety department. Patient had been advice by her physician not to take the 2nd dose of the vaccine on 28 Jan 21.  Treatment details included IV fluids, Acetaminophen, Ibuprofen Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include nausea, light headedness, rash, tingling sensation on hand and feet was unknown and  Palpitation, fever (low grade) and chill was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
3 hours after receiving H1N1 nasal mist at mass vaccination flu clinic held by the County Public Health District, mother took child to ER.  He had 105 F temp and complained of dizziness and eye pain.  ER doctor that saw him stated he didn't believe it was a vaccine reaction and diagnosed patient with laryngitis.  He was given antibiotics and sent home.  Child continued to have fever for 7 days.  Child was taken back to ER two days after first visit and diagnosed with tonsillitis.  Child felt ill for 2 weeks before illness resolved.
itchy rash the night of vaccine requiring daily antihistamines for almost 2 weeks, then rash came back 3-4 weeks later requiring antihistamines and again with more severe with hives/skin swelling during a cold 3 months later requiring stronger antihistamines and 2 weeks of prednisone