chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20(O)A OR 041LZ0(O)A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow). On 03-Feb-2021, VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Antibody test: 20 (Inconclusive) Patient had a COVID -19 Antibody Test and was resulted having protein spike of 20.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-048204 (Patient Link).
lethargy; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 05Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lethargy and fatigue on an unspecified date in Jan2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 at 10:00 as dose 1, single (Lot number: ER8732) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 11Apr2021, outcome "unknown", described as "mild chest pain".  Additional information: The patient received first dose on 26Mar2021. Went on a vacation to Withheld 05Apr2021 to 11Apr2021. Began feeling mild chest pain on 11Apr2021 on drive to airport. Pain progressively worsened.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200708649 same patient and drug, different dose and event;US-PFIZER INC-202300013382 same patient and drug, different dose and event;
After tetanus shot at 9:30 began experiencing severe cramping of the abdomen, shoulders, and chest. Pain reduced after 2 hours of lying down. Returned to work. Cramping and spasming gradually got worse. At 4:30PM of the same day I experienced a severe cramp and spasm attack accompanied by immense pain. The most painful thing I've ever experienced. First attack lasted 25 seconds, then subsided for 5 seconds when I dropped to my hands and knees. Another attack immediately began and this one did not stop. Lying on my back My entire upper body was cramping and pulsing. Had difficulty breathing. Could not speak. Ambulance was called, arrived 10 minutes later. Administered benadryl injection. Taken to hospital. Given saline drip, took blood, and chest x-ray. Symptoms got better by over the next few hours but when discharged at 10PM I was still in immense pain. Cramps continued. Took tylenol 3 and Donnatal when I got home. Cramping continued through the night mostly on right torso and shoulder. Cramps pulsed on for 4 to 5 seconds then suspended for several seconds. By morning cramping had reduced, still painful, by less spasms. Now experiencing general muscle soreness. 10/1/08 Reviewed ER medical records of 9/18/2008. FINAL DX: non-cardiac chest pain; abdominal pain of unknown etiology Records reveal patient experienced chest pain, crampy abdominal pain day of vaccination.
Healthcare Professionals are unsure of adverse events.  Family called into office to say that patient had passed away on 12/30/2021.  Patient was evaluated on 12/28/2021 by Dr. at 2 month check up and then received 2 month vaccines at same time.  Please contact family for more information regarding adverse event.
SKIN  RASH OCCURRED 2 DAYS AFTER VACCINE WHICH PRESENTED ON TORSO, ARMS , UPPER LEGS AND GROIN AREA.  RASH DISSAPATED TWO DAYS LATER WITH SLIGHT ITCHINESS OF PRESENTED AREAS.
Pt vaccinated with DTP/OPV/HIB died approx 24 hrs later. preliminary dx SIDS.
PATIENT REFERS IN A ROUTINE VISIT THAT DEVELOPED AN "SINKING" OF THE INJECTION SITE.
pt recv 3 doses of vax FEB93, MAR93, & AUG93 & was dx w/ulcerative colitis p/ c/o vague sx in 1993;MD did not associate the condition w/the vaccine;mom came to the conclusion that the vax caused condition p/MD report;
Woke up on morning after shot with uncontrollable shaking. I ended up needing to lay under several blankets in order to feel warm and stop shaking. My temperature was normal and shaking was not due to a fever. The shaking stopped about 15 hours after I received the shot but then I continued to have a headache and extreme fatigue.  The following day (about 48 hours after injection)  I had an extremely high pulse.  I took both my blood pressure and was able to take an EKG using a EKG recorder.  Both devices came back that I was having an irregular heartbeat. I repeated both tests about a half dozen times and they kept coming up the same indicating an irregular heartbeat. I have never had an irregular heartbeat before in the past. Finally after a couple of hours my heart rate slowed and the irregular heartbeat went away. As of right now (6 days post injection) it has not come back.
Information has been received from a 66 year old male consumer with no known allergies who on 29-MAY-2007 was vaccinated with a .65 ml dose of Zostavax (Oka/Merck) subcutaneously.  Concomitant therapy included NORVASC, HYTRIN, NAPROSYN and finasteride.  The consumer stated that "every week or so, a pox pops up".  He described them as "angry red circles with a white blister head in the center".  He had them on his ankle, upper arm and his legs.  He reported that they "don't hurt or itch" and they "go away eventually" but new ones appear.  Onset date was reported as "maybe 2 weeks after the shot" and outcome was reported as recovering.  The patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.
Sickness; Skin cysts/Two cysts on right arm; Tooth loss/Teeth felling out; Mass/Lump in right side of nose; Difficulty breathing/Hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out), MASS (Mass/Lump in right side of nose) and DYSPNOEA (Difficulty breathing/Hard to breath) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sickness), DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out), MASS (Mass/Lump in right side of nose) and DYSPNOEA (Difficulty breathing/Hard to breath). At the time of the report, ILLNESS (Sickness) had resolved, DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out) and MASS (Mass/Lump in right side of nose) had not resolved and DYSPNOEA (Difficulty breathing/Hard to breath) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of sick, two cysts on right arm, teeth felling out and lump in right side of nose with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of hard to breath was not provided.
On 01/31/2001 the patient was seen in the physician's office and had a varicella like rash with 15-20 lesions on his trunk, arms, hands and feet. The physician's assistant reported that she did not know if the patient had been exposed to 'wild type varicella'. Unspecified medical attention was sought. The physician assistant also reported on the patient's sibling who had an experience following vaccination with varicella virus vaccine live. In follow-up, the physician's assistant reported that this turned out not to be a reaction to the varicella vaccination. The child was seen 03/13/2001 and diagnosed with flea bites. This was much more consistent with the history that we eventually got from the parent and the distribution and timing and longevity of the rash. No further information is available.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information about concurrent conditions, medical history, concomitant medications and drug reactions or allergies was not provided. On 23-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010476, expiration date 09-JAN-2017, dose and route of administration were not reported), for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 6 hours, 40 minutes; 15 to 46 degrees Fahrenheit for 8 hours, 30 minutes; and 47 to 77 degrees Fahrenheit for 1 hour, 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
hives surrounding the injection site; redness /  surrounding the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 5-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date 30th June 2021) for prophylaxis.   On 8th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 8th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site hives and injection site erythema. On an unknown date, the outcome of the injection site hives and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site hives and injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2020-2021 season and presented with redness and hives surrounding the injection site which had resolved. The reporter consented to follow up. The Doctor Address to be used for contact.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202330:same reporter
Initial report received from a health care professional on 02 Mar 2010: This patient was inadvertently vaccinated with FLUVIRIN (Batch No. 105461P1), 0.5 ml, intramuscularly, on 01 Mar 2010 and secondly on 02 Mar 2010.
No adverse effect reported; a four month old baby was administered with GARDASIL 9; This spontaneous report was received from a pharmacist, referring to a 4 months old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medications was not provided. On 03-OCT-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, anatomical location, route of administration, lot# and expiry date was unknown) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. There was no associated product quality complaint.
Horrible headache on Sunday, tears from pain, took rizatriptan and amitriptyline and did not help, Monday could not lift head off pillow due to headache still there. Started day with 2 naproxen
Left arm went limp/ walks with a limp; Has a hard time putting words together; Left leg was heavy; Mind was foggy; Suffered a stroke on his left side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT DISTURBANCE (Left arm went limp/ walks with a limp) (seriousness criterion hospitalization), APHASIA (Has a hard time putting words together) (seriousness criterion hospitalization), LIMB DISCOMFORT (Left leg was heavy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Mind was foggy) (seriousness criterion hospitalization). The patient was hospitalized from 17-Aug-2021 to 20-Aug-2021 due to APHASIA, CEREBROVASCULAR ACCIDENT, FEELING ABNORMAL, GAIT DISTURBANCE and LIMB DISCOMFORT. The patient was treated with TPA for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) 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 concomitant medications were reported. On 17-Aug-2021, the patient went to emergency room, was transported to the hospital and was admitted through 20-Aug-2021. The received TPA treatment immediately.  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. Further information has been requested.; 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. Further information has been requested.
headaches on and off; blood pressure was elevated; soreness; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches on and off), BLOOD PRESSURE INCREASED (blood pressure was elevated), ARTHRALGIA (soreness) and PAIN (pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches on and off), BLOOD PRESSURE INCREASED (blood pressure was elevated), ARTHRALGIA (soreness) and PAIN (pain). At the time of the report, HEADACHE (headaches on and off), BLOOD PRESSURE INCREASED (blood pressure was elevated), ARTHRALGIA (soreness) and PAIN (pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-068619 (E2B Linked Report).; Sender's Comments:  MOD-2021-068619:Second dose of vaccine case.
Two days after getting the first vaccine dose, I started to experience fever, chills, body aches, extreme fatigue, headache, dizziness. It stopped after 36 hours, but started again the next day. I'm currently still experiencing extreme fatigue and weakness.
HEADACHE; ACHINESS OF MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced achiness of muscles. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and achiness of muscles. This report was non-serious.
cut finger; Accidental Exposure; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a male who was preparing Rabies NVS (RabAvert) (batch number unknown, expiry date 31st July 2022) for administration in other patient for prophylaxis.  On 10th October 2019, the patient received RabAvert. On 10th October 2019, immediately after receiving RabAvert, the patient experienced laceration of finger, occupational exposure while administering product and exposure via skin contact. On an unknown date, the outcome of the laceration of finger, occupational exposure while administering product and exposure via skin contact were unknown.   It was unknown if the reporter considered the laceration of finger to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The batch number was not reported. The nurse was giving a pre-exposure dose of Rabavert to a patient and accidentally broke the vial and cut himself, 1 to 2 drops of the vaccine went into the cut, which led to laceration of finger, occupational exposure while administering product and exposure via skin contact. No symptoms were reported.  The reporter consented to follow up. This case linked with US2019186971, reported by same reporter for same patient.
Moderna COVID-19 Vaccine EUA.  Welts and itching on left arm started Jan 7 in the evening. This started either at or very close to the injection site. By the morning of the 8th the area was no longer itching but there was a red rash still visible.
injection site is "pink"; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is "pink") and VACCINATION SITE SWELLING (swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is "pink") and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is "pink") and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient had not taken any treatment medications for the events.
Pt recvd 3 doses of Engerix-B on 5APR91; 17MAY91 & 21OCT91 & 21NOV91 serology indicated non-responder no tx was given;
11 days after receiving the booster shot, I woke up with extreme itchiness on my head and behind ears. They were very red. Later throughout the day, it spread to my entire body and I was covered in huge hives that became worse upon scratching or touching my skin. It was unbearable and benadryl did not help. I went to urgent care and they said my throat was clear--I was advised to take benadryl and see an allergist. The hives at this point were on my elbows, stomach, breasts, everywhere. My feet and hands were swollen and physically hurt. I could not walk properly. This continues every single day. I have seen 2 allergists who confirmed I am not allergic to anything and this was not caused by food or any product I used. They both believed this could have been caused by the vaccine and recommended over the counter antihistamines. I have been taking 4x the normal daily dose and still experience extreme itchiness. Nothing gives me relief--every day I take two oatmeal baths, apply topical cortisone, and take the antihistamines. This is very unbearable and difficult to experience. Please, please look into this and do what you can to inform the public and find a solution for those suffering. It has now been almost 2 weeks and I am still experiencing these symptoms.