chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic shock; bleeding disorder (blood clots); atrial fibrillation; little sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient calling-in because she received her 1st shot of vaccine earlier today. She claims that it is too late when she reads the fact sheet. she called-in because she has bleeding disorder (blood clots) or atrial fibrillation and taking xarelto. She also reported that she had anaphylactic shock. Reporter stated she never experienced an anaphylactic reaction just a little sore arm, she just called to obtain information as she currently takes an anti-coagulant. Therapeutic measures were taken as a result of bleeding disorder (blood clots), atrial fibrillation. The outcome of the events was unknown.
This case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), Influenza vaccine. A physician or other health care professional has not verified this report. There were no concurrent medications. Approximately 10 to 15 years ago, on an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced "slight reaction to a flu shot about 10 to 15 years ago, described as 'flu like symptoms' ". On 29 September 2010 the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 23 January 2011, 116 days after vaccination with FLUARIX, the subject experienced vaccination failure, influenza, sore throat, fatigue and aches (pain). The subject, a GSK employee, received FLUARIX on 29 September 2010 at the employee health office and reported he had a confirmed case of the flu. The first symptoms occurred on 23 January 2011 in the afternoon with a sore throat, later that night he had fatigue and aches, no fever. He saw his physician on 28 January 2011. At the time of reporting the outcome of the flu-like symptoms, vaccination failure, influenza, sore throat, fatigue and aches (pain) was unspecified. This case was assessed as medically serious by GSK.
GI bleed - The patient underwent esophagogastroduodenoscopy which revealed the presence of a large deep ulcer at the gastrojejunal anastomosis with visible sutures.  Hemostatic clip was placed to aid in visualization if needed during the time of possible angiography.  Patient was subsequently started on IV Protonix for 48 hours.  The patient then eventually switched to oral PPI twice daily. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient reported on 7/5/2019 that the Zoster vaccine he received on 3/15/19 had caused him to "feel terrible" six hours after the injection and for 2 days thereafter. The patient refused the second shot in the series.
she passed out for 2-3 min; A spontaneous report was received from a consumer, concerning that his wife who is of age 48 years, was received Moderna's COVID-19 vaccine and experienced passed out for 2-3minutes/ loss of consciousness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 10 MAR 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (002A21A) via unknown route for COVID-19 infection prophylaxis.  On 11 MAR 2021, the patient experienced the events of passed out for 2-3min/loss of consciousness. No treatment information was provided.   The outcome of the event, passed out for 2-3minutes/ loss of consciousness, is considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
pt recv vax & devel a fever, upper resp infect, & felt achy all over;sx of a low grade fever & joint pain have persisted for several months;
Deep ache in whole arm down to wrist. Movement restricted due to severe pain especially on left shoulder and injection site.  Striking pain upon lifting the hand or elbow, could not lift any weight or left hand above elbow.
Large, localized reaction at injection site on right upper arm. Area red, very swollen, tender, warm to touch, firm. Symptoms started a few hours after injection. Patient given MENACTRA and TDaP vaccines on 11/6/18 in right upper arm. Patient's mom called office to report reaction on 11/7/18 around 5pm. Patient seen in the office on 11/8/18 and evaluated by MD.
rapid heart beat; shortness of breath; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ENALAPRIL MALEATE (VASOPRIL [ENALAPRIL MALEATE]), AMLODIPINE BESILATE (NORVASC), ISOSORBIDE MONONITRATE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LEVOTHYROXINE and LORAZEPAM for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FOSINOPRIL SODIUM (VASOPRIL [FOSINOPRIL SODIUM]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat), DYSPNOEA (shortness of breath), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication reported was eye drops.  Company Comment: 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.; Sender'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.
tenderness; swelling; chills; pain in left arm; fever; fatigue; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
intense soreness in arm , I could not get dressed, nausea and very intense diahrrea. After going to the bathroom at 2:15 AM I had to lie on bathroom floor for 20 minutes.  The rest of the day I experienced arm soreness, nausea and diahrrea. I could not go to work.  The symptoms ended after 48 hours
pt devel enlarge tonsillar glands approx 3-4cm non tender;afeb-few bilat enlarged inguinal nodes;to clinic;
PATIENT HAD A VAGAL RESPONSE WHICH SHE REPORTS IS A TYPICAL REPSONE FOR HER
Booster/  Came in next Monday reported high blood pressure,  night after vaccine high temp of 103 and body aches with terrible headache and ringing in the ears.  This was the same as the 2nd dose but he checked his blood pressure and it was 165/120.   When he came into pharmacy I checked it and it was 165/105 11/22 12:10pm.  Asked patient to go to PCP or urgent care so they could look at his heart and make sure there was no pericarditis.  He had no SOB or wheezing
Staff reported patient entered facility on 08/11/2021 at approximately 0700, dragging right leg. At approximately 7:15am patient passed out for approximately 1 minute,  She became alert within 1 minute but could not remember what happened.  EMS was call, patient transferred to ER for further evaluation.
One week later arm at injection site swelled became itchy and had a red ring around it, 1-2 inches around.  Itching continued to my face, down arm.  The two days prior I had strong under arm pain, which I'm guessing was swollen lymph nodes, this continued for 5 days.  Itching continued for a few days and had tingling sensation that ran up and down left arm, chest and sometimes legs.  Also felt a burn/tingle in back of my throat.  All symptoms lasted for 1-2 weeks.  Seem to be much less now, only occasional tingling.
Redness at injection sites and erythematous rash to torso.  Some itching.  Given 12.5mg of diphenhydramine and observed for 30 minutes.  Rash mostly resolved and pt continued on diphenhydramine at home for 24 hrs.
Patient falsified DOB when registering for vaccination, stating the minor was born one year earlier. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB made the vaccine a contraindication.  No known adverse reactions noted.
Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice.  Patient passed away on 2/13/2021.
Patient was vaccinated at a senior residence. She was a new patient that had just transferred facilities and it was not noted in the chart that she had previously received a COVID-19 Vaccine  so her first dose of Moderna was on 3/11/21 and she received another dose on 3/24/21.  This was reported to the facility so that the patient would not receive anymore per the Moderna dosing protocol.
pt recv vax & 3 wk following the vax & devel arthralgia & edema of the knees, ankles & lower extremities; an inc sedimentation rate, & malaise which resolved p/3-4 days; No further details were provided;
Hospital gave wife dose 1 of physer monday and on wednesday she started having blood in stool, which is not normal for her.
sting; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of stinging in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced stinging (Verbatim: sting). The outcome of the stinging was unknown.   It was unknown if the reporter considered the stinging to be related to Arexvy.     It was unknown if the company considered the stinging to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 A GSK Field Representative reported that a pharmacist stated that of 169 patients that received the vaccine Arexvy at a local pharmacy, the most common comment from the patients was that the vaccine stings. The pharmacist stated that the ratio was 50/50 for male and female patients. No additional information was provided. The reporter consented to follow up. This case is linked to US2023AMR152513, same reporter.; Sender's Comments:  US-GSK-US2023AMR152513:Female Patients case
"She comes in reporting gradually increasing swelling as well as pain to the right lateral triceps region following recent Shingrix vaccination administration 3 days ago. Beginning the next day she developed nausea with resultant vomiting as well as soften stools and slight bloated sensation. Reports 3-5 emesis episodes of 1st day with 2-4 today. denies any suspicious food exposure with no recent travel and other household/ family members with similar symptoms. No previous history of sensitivities to vaccines or other medications beyond anaphylactic like reaction to Dulcolax. She denies any other chest pains, abdominal pain, hematemesis, coffee-ground emesis, chest pain, difficulty breathing, lightheadedness or dizziness, diarrhea, hematochezia or melena"  Given prescriptions for cephalexin, promethazine, and ondansetron.
Varicella vaccine breakthrough. Diagnosed 10-17-07 with Varicella. Had about 60 papular and papulo-vesicular lesions. Itchy. No fever.
Pt has body aches, severe nausea, vomited. Sx 3 days post administration of vaccine. Local swelling and pain, inflammatory at site of vaccine. Pt still has knot today.
Within 1 hour of receiving vaccination she developed diffuse urticaria.  responded to injected benadryl and depomedrol. 03/09/07-records received. for DOS 3/7/07-developed whole body hives and itching, chest felt heavy. Current medication Ketek. PE: WNL except for confluent hives on arms
anaphylaxis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and ANAPHYLACTIC REACTION cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus."  Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.
Injection site redness, itching, swelling, and pain began 6 days after injection. Redness has expanded over last 2 days. Have been treating myself with over the counter Advil, Benadryl, & Pepcid
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010803: US-009507513-1705USA001584: US-009507513-1705USA001585:
This case was reported by a consumer via call center representative and described the occurrence of lightheadedness in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included leukemia and low blood pressure. Previously administered products included SHINGRIX (did not mention any adverse event). On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced lightheadedness, blood pressure systolic increased and feeling hot and cold. On an unknown date, the outcome of the lightheadedness, blood pressure systolic increased and feeling hot and cold were recovering/resolving. It was unknown if the reporter considered the lightheadedness, blood pressure systolic increased and feeling hot and cold to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm at a pharmacy. Immediately after the injection, the patient felt faint and lightheaded. The patient also felt hot and then cold intermittently. The patient could not drive for home and an ambulance was called. The patient was taken to the hospital emergency department. She stayed for 3 hours, was monitored and went for home. The patient also experienced a high systolic reading of 148 and at discharge, it dropped to 110. At the time of reporting, the events were improved. The reporter did not consent to follow up.
She received the shot on  Jan. 25,2008. Immediately after she started having an upset stomach. She then developed flu- like symptoms on April 18,2008. She was then hospitalized with pancreatitis on April 27, 2008 and was in the hospital with that till May 1, 2008 she had residual pain for 5-6 days and returned to school. Then on May 19, 2008 she started having abdominal. She has seen a pediatric gastroenteralogist every since with no explanation of her pain. She has had several blood test, CT scans, endoscopy, colonoscopy, and stool test. She has had little to no effect from the antispasm medication. She has been hospitalized on and off since several trips to the ED for pain management. She has also now for the last week had unexplained joint pain in her shoulders. I have given her Tylenol and Motrin for pain with little effect.10/20/08-records received for DOS 4/21-4/24/08-DC DX: Acute viral pancreatitis.Presented with C/O abdominal pain localized around epigastric and right upper quadrant began several days prior. GI type flu one week ago and suspected pancreatitis was probably due to enteroviral Coxsackie infection. Follow-up: Within a couple of days of receiving the shot she had minor abdominal pain. This continued for 5-6 weeks. She then experienced flu like symptoms. One week after the end of the flu like symptoms she was hospitalized (March 20, 2008) with pancreatitis. She has continued to have severe abdominal pain everyday since. She has had multiple Ct scans, Endoscopy, colonoscopy, fecal tests, blood work, and more hospitalizations with no diagnosis. She has had a birthmark removed from her leg, but other hospitalization, illnesses, or major injuries.
pt recv vax & w/in 2-4hr p/vax started having severe h/a & a feeling of less energy;medication relieved h/a but a knot came on lt forehead;purple h/a's & tiredness;lasted x 2wk knot still apparent w/diarrhea;red dot in middle;
(very high) fever per touch and sweat 3-5 hrs after Iz's, partial improvement with acetaminophen L, tab PO every 8 hrs. Currently mild headache, joint and back ache, decreased appetite. Pt's mom states that pt has early in the ill process frequent shivers, present mild dehydration per drs notes.
Immediately after injection, I developed a headache and slight dizzyness.  I returned home in 45-60 minutes and found that I had a significant increase in my blood pressure.  Normally, 115 -120 mm Hg systolic and 75 - 80 mm Hg diastolic; when I returned home, my blood pressure was 150 mm Hg systolic and 90 mm Hg diastolic.   The blood pressure has gradually returned to normal over 3 days.  Tachycardia has also been present (110 bpm), but has returned to normal of 70 - 75 bpm.
had fever x 4 days & lt arm was painful x 8 days w/swollen arm; hot, red, up to elbows; seen in clinic 16FEB95 to 10MAR95; pt again w/onset of swelling & arm pain;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media concerned a unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-JUN-2022, the patient started feeling sick (dose number in series 2). On 28-JUN-2022, major symptoms started (suspected covid-19 and suspected clinical vaccination failure) (dose number in series 2). On 01-JUL-2022, Laboratory data included: SARS-CoV-2 test Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number: 90000240790.; Sender's Comments: V0-20220705993-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient received unauthorized Pfizer COVID-19 bivalent vaccine on 9/12/2023.
Onset of severe chills and headache approximately 8 hours after the injection of the second vaccine. Extreme fatigue, nausea and chills lasted 24 hours plus after injection. Still feel weak, nauseated and have headached 48 hours after injection.
New loss of taste or smell  Sore throat  Congestion or running nose  Diarrhea
Myocarditis, chest pain, shortness of breath. Chest pain starting 15 hours after vaccination. Diagnosis 2 days later in hospital.