chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain or myalgia or achiness lasted for approximately 48 hours. I continued normal activity, but it was uncomfortable and more pronounced than I had expected.
Pt developed a fever X 48 hours, post vax, along with being irritable.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 26-FEB-2016, the patient was vaccinated with a dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 26-APR-2016, the patient received a second dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 31-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 lot # M009378 and expiration date of 23-APR-2018, for prophylaxis (dose and route of administration were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003341: US-009507513-1801USA006860.
Reports swelling of arm to elbow, unable move-redness-took ALEVE and BENADRYL and applied ice which helped.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eczema. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. Additional details were provided as follows:  The age at vaccination was not reported. The patient received SHINGRIX and experienced a big rash on her arm and all the way down to her leg. The pharmacist said that this reaction was really abnormal. She did not know if it was an exacerbation of her eczema. Event was resolved and the patient came in for her second dose.
Patient received vaccine on Wednesday.  Then Thursday at 11 am she stated she started to feel achy, nauseated and feverish.  At about noon patient vomited.  She took 2 Motrin at about 1 pm, slept the afternoon, took more Motrin at 7 pm, went back to bed later that night and by Friday morning felt fine.  Her injection site is red, warm to touch, tender, and a firm area felt.
Abnormal skin, macular rash, confluent w/trunk. Most like measles VS Varicella.
stroke; Caller would like to know if can get the second shot now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Caller would like to know if can get the second shot now). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Caller would like to know if can get the second shot now) had resolved.        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 information provided. No treatment information provided.  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.
Pt recv vax on 10/22/98; on 10/26/98 pt exp stomach cramps, diarrhea, chest tight, congestion, sore throat, headache, fever
Patient approached the RN, and stated that he thought he was going to pass out. The patient's knees buckled and he sank to the floor. (witnessed fall) The patient did not hit his head on the floor. At 105 the Patient was moved to the recovery area where he was laid on the floor and his feet were raised onto a chair. Patient was diaphoretic BP 116/74 pulse 70 oxygen 99% on room air.  Around 1210 the patient sat up on the floor and complained of dizziness and nausea. Patient was placed back into a lying position and BP recorded at 140/90. At 1230 the patient was sitting on the floor and nausea and dizziness had subsided. At 1245 the patient was placed in a wheelchair and assisted to the car and the girlfriend drove him back home. BP recorded at 116/70 upon leaving the vaccination clinic.
Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00771, 2012-00772, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "achy-ness, nausea, left sided weakness of mouth, nose and chin, lethargy, tiredness, chills, low grade fever, cough and congestion." Illness at the time of vaccination was reported as none. It was unknown if the patient had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
mom reported lt arm site of inj in lt upper arm site of base ball & warm;no fever referred to MD to care for problems;letter sent to mom
Patient stated that she did not like needles/shots, was apprehensive, but wanted to receive the vaccine. Administered the vaccine, gave the patient and her timer, she sat down to be observed. Before her 15 min. was up, she said she was clammy, hot and felt faint. We offered to call an ambulance. She did not want one.  We layed her down in the floor, with legs elevated, took her bp 117/73 (normal), but she was hot. Got her a cold pack and she placed it on her forehead. She layed in the floor for several minutes, but said the cold pack made her feel much better. Waited, we asked her to sit up, took bp again, it was 117/75, she felt better and wanted to go home. Her husband was with her, he drove her home.
-flu like symptoms - body aches, fatigue, malise 1st day or so -Lymphocytopenia (absolute) 3/28/22 0.8 (normal) 12+/ 12/5/2022 1.1 15 (increased) -Monocytosis
Initial report was received 04 June 2009 from a health care professional as part of a cluster.  A 51-year-old female patient with no concurrent illness, had received a right deltoid injection (route not reported) of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) between 7 and 8 AM on 13 January 2009, and at midnight on 13 January 2009, she developed fever, chills, general malaise, achiness all over and restless sleep.  She had a past medical history of reflux and seasonal allergies and had been taking NEXIUM and CLARITIN concomitantly.  The events did not require a doctor's visit.  According to the reporter, the symptoms resolved on 15 January 2009 and the patient recovered.  This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients.  The other four identified patients have been captured in case numbers 2009-00586, 2009-02398, 2009-02399, and 2009-02401.  This case also has the same reporter as case number 2009-00128. Documents held by sender: None.
bowel cramping/ pains; 3 loose bowel movements/ would not call the movements diarrhea since they are not watery; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 10Mar2021 10:00 (Lot number: EN5318) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart attack", stop date: 2020, notes: about a year ago; "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "stent placed in one of the coronary arteries", start date: 2020 (unspecified if ongoing), notes: about a year ago. Concomitant medications included: SHORT ACTING INSULIN taken for diabetes mellitus; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; LANTUS taken for diabetes mellitus. The following information was reported: GASTROINTESTINAL PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "bowel cramping/ pains"; DIARRHOEA (non-serious) with onset 17Mar2021, outcome "recovering", described as "3 loose bowel movements/ would not call the movements diarrhea since they are not watery". Therapeutic measures were not taken as a result of gastrointestinal pain, diarrhoea.  Additional information: The reporter stated that he takes a lot of medication. He takes high blood pressure pills and other stuff. He felt the most important medication he takes is insulin for diabetes. The patient did not receive any other vaccines within four weeks prior to vaccination. The events did not require a visit to emergency room or physician office.   No follow-up attempts are possible. No further information is expected.
Body aches Headache Low grade fever Pain, heat, swelling, throbbing at injection site Swollen and painful lymph node in left arm pit Skin and hair follicles painful to the touch
Local Rx, delayed. Redness, warmth and swelling around injection site, 4x4cm. Given antihistamine and hydrocortisone cream. Local Rx started same day as MMR vaccine given in opposite arm. Continued tongue local swelling.
/Patient was admitted to a Medical Center on 09/25/2021 for acute hypoxemic respiratory failure d/t Covid-19.  She was started on Decadorn but did not quality for remdesivir d/t her liver and kidney disease.  Patient was attempted to be diuresed but developed an acute kidney injury and Nephrology felt she may have hepatic renal syndrome.  She was noted to have a significant decline and functional status and increased weakness during hospitalization.  On 10/05/2021 patient was placed on V60 machine, and expired on 10/06/2021.
Emp. received Varicella vaccine and state had local reaction of redness, raised and itchy. Reports it 11-20-17 at 12:45 and there is no redness, swelling there of at upper arm.
Body aches began that evening, continued into the next day along with a fever of 100.5 and extreme fatigue. Fever subsided the second evening. Fatigue subsided gradually over 48 hours.
Severe unilateral headache. Necesated ER visit with CT Scan & Spinal Tap.
Customer left site after waiting for 15 minutes and came back to the site once she started having a reaction. Client complained of tingling and numbness on right side of face and radiating to the mouth
Small red blotch turned into huge hot red itchy rash like area the size of a softball. By the 3rd day after vaccine, it was the size of a melon, spreading up/down and side to side of upper arm. VERY PAINFUL.
CHILLS; TIRED; FEVER; HEADACHE; NAUSEA; DIZZINESS; SEVERE HEART RACING; PASSING OUT; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 110 pounds, and height was not reported. The patient's concurrent conditions included migraines, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and  expiry: 25-MAY-2021) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe heart racing. On 13-MAR-2021, the subject experienced passing out. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021 06:00, the subject experienced chills. On 13-MAR-2021 06:00, the subject experienced tired. On 13-MAR-2021 06:00, the subject experienced fever. On 13-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heart racing, passing out, and nausea on 13-MAR-2021, dizziness, chills, and fever on 14-MAR-2021, tired on 15-MAR-2021, and headache on 17-MAR-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (tiredness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM, FINASTERIDE, CLOPIDOGREL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (tiredness). On 27-Jan-2021, HEADACHE (Headache) and FATIGUE (tiredness) had resolved.        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.   Patient Feels back to Normal and is not worried about the Events No treatment information was reported.; 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.
Developed anaphylaxis with abdominal pain, nausea, vomiting, shortness of breath, chest pressure, hypotension and urticaria. Required IM epinephrine -> epinephrine drip as well as steroids and antihistamines.
Vaccine expired on 13-Oct-2021 and placed in refrigerator on 27-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 27-Nov-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 27-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 27-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 27-Nov-2021.  No treatment medications were reported.
rashes on the armpit; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had some reactions like rashes on the armpit after the 1st dose of the vaccine on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received on 23Mar05 from a health care professional regarding an adverse event occurring, it was reported that an eight month old male pt received his first dose of Ipol, lot number X1040 and a third dose of Hep B vaccine, lot number AHBZA0588AA, on 19Mar05. The routes and sites of administration were not reported. Two days later, on 21Mar05, the pt developed irritability, swelling of his hands and feet and generalized urticaria. He was seen in an ER and was treated with Benadryl. On 22Mar05, the pt was referred to an allergist and was treated with steroids. At the time of this report, the pt's symptoms were improving, but he had not yet recovered from these events.
RASH IN NECK AND BETWEEN MY HANDS, HEADACHE, BLOOD PRESURE, LIVER PROBLEM.
Vanish point needle retracted when I tried to administer vaccine. The vaccine spilled out onto arm. Administered new vaccine to ensure patient received adequate booster dose.
Minutes after receiving vaccine I felt a tingling in my head, got a mild headache, brain fog. The tingling continued down into my body. Shoulders, chest, abdomen at which time I was slightly nauseas, and then slowly on to my knees when I became weak. The effects went on for several hours. These episodes went on for approx. 7 weeks. Not daily. In fact I didn't have another episode for several weeks. But at one time I had 11 days in a row. They lasted up to 4 hours. And several times I felt as though I would collapse when the effects reached my knees. But on the last week of the episodes, I could tell they were getting milder.
was out for the count; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was out for the count on an unspecified date. The patient commented that she'd heard about the first dose will affect you severely. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.80  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 & 28-Apr-2021 with temperature 35,33 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021 & 28-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported. No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received SHINGRIX vaccine on 3/1, stopped into pharmacy to report low grade fever and muscle aches on 3/2, wife had called back stating fever and aches continued on 3/3 along with some diarrhea. Follow up on 3/5, wife states adverse reaction has resolved with acetaminophen, ibuprofen, and rest. Patient stopped by pharmacy to note all reactions have resolved.
Moderna COVID-19 Vaccine EUA. Patient/Self reports that on Thursday, September 30, 2021 from approx. 1900 hours local: resting heartrate recorded on Whoop as "Meditation" activity (80-90bpm) while surge-like bursts at heart/chest area similar to zapping/intense electrified feeling; debilitating pain; unable to leave bed; unable to slow heart rate with focused breathing/meditation alone; moments away from calling 911; thought I was going to die.
received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of a vial after 12 hours of initial puncture) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of a vial after 12 hours of initial puncture). On 21-Aug-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.   This case was linked to MOD-2021-418964 (Patient Link).