chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; injection site pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection for Crohn's disease and Rheumatoid arthritis and METHOTREXATE for Psoriasis.    The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, Hepatic steatosis, General physical condition abnormal in 2012, Weight increased in 2012 and Elevated liver enzymes in 2017. Previously administered products included for an unreported indication: HUMIRA (40 mg/0.4 ml - for MODERATE TO SEVERE ADULT CROHN'S DISEASE and MODERATE TO SEVERE RHEUMATOID ARTHRITIS) in 2010 and LIDOCAINE from September 2020 to October 2020. Concurrent medical conditions included Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.), Diabetes mellitus since 2016, Psoriasis since 2016, Shingles in November 2020, Rheumatoid arthritis (Moderate to severe) and Crohn's disease (Moderate to severe). Concomitant products included DOXYCYCLINE and LIDOCAINE for an unknown indication.   In July 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started METHOTREXATE (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache). On an unknown date, the patient experienced FATIGUE (Fatigue). On 03-Jan-2021, VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.      This case was linked to MOD-2021-080937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 has no significant updates
Diarrhea; Numbness in the nose; Cold; his nose is kind of plugged/ clogged but there was nothing; This is a spontaneous report from a contactable consumer (patient himself). A 36-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine. Lot EL0140), via an unspecified route of administration in the right arm (reported as right shoulder) on 22Dec2020 at single dose for Covid-19 immunisation. Medical history was none.  There were no concomitant medications.  The patient experienced diarrhea on 22Dec2020. He informed that it appeared 2-3 minutes right after receiving the vaccine, however he though that it couldn't be from the vaccine, he does not think it would go through him that quickly. He seemed it was coincidental to him, he had the diarrhea even before leaving the observation. He also had numbness in the nose as well, it started on the same day. He clarified it was not really numbness but he can feel it almost. The cold also started after the vaccine, its like his nose is kind of plugged/ clogged but there was nothing. The outcome of event Diarrhea, cold was recovered on 22Dec2020; for Numbness in the nose was not recovered; for his nose is kind of plugged/ clogged but there was nothing was unknown.
Menquadfi was given instead of Menveo. No adverse side effects noted or reported.
headache, body/muscle aches, chills around 1130pm, about 12 hours after the shot. there was some arm pain about an hour after the injection.
Information has been received on 19-OCT-2019 from an office manager. The office manager reported that an unknown number of patients may have been vaccinated with ZOSTAVAX (lot # L037790, expiration date 30-DEC-2016), subcutaneous on unspecified dates over the last month that had been improperly stored. No adverse effects reported. No further information was reported. Additional information has been requested.
It happened a month later. I had the worst period pain I've ever had in my life that I considered going to the emergency room because the pain was so bad. It lasted for about a day.
Afib; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details provided. No treatment medication details provided. It was reported that two people that work for reporter had the vaxx had to quite shortly after they got the vax because they developed AFIB. Their lives have changed.  Company Comment: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2021-361453 (E2B Linked Report).; Sender's Comments: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report. MODERNATX, INC.-MOD-2021-361453:Crosslinked case (same reporter)
About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed to sit down. Never lost consciousness and was able to able to breath through the event and drink water after a couple of minutes. Patient also felt rapidly hot and dizzy. We had her sit down, take deep breaths, kept her talking, offered water, and got epinephrine ready. She recovered completely after a total of 30 minutes but did feel slightly dizzy throughout the day. Was able to continue with regular workday as we determined it was best she stayed with other people for the remainder of the day.
Soreness, myalgias for a few days then a red streak down his arm, then numbness in fingers and toes that progressed proximally. He lost coordination in his hands and decreased gag reflex. He received IVIG but couldn't tolerate this. His reflexes in lower extr are also absent.
I got it. Mild case; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient stated that, bingo, he/she got shingles after the Shingles shot.  The patent said it was mild case but still got it. The patient thought he/she only did 1 of the 2 Shingles shots but still got shingles.
fever 101 degrees, shivering, chills, injection site pain,  fatigue, weakness, nausea .Resolved in 24 hours with fatigue lasting about 24 more hours. Injection site painful for approx. 1 week.
splenic abscess; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 68-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in Oct2018 and in 2019, both via an unspecified route of administration at single dose for immunization. There were no medical history and concomitant medications. Caller clarified that the patient actually had a splenic abscess in 2018. Caller stated the patient had her spleen removed very recently, Prevnar 13 is part of the recommended vaccinations for post splenectomy. Patient was now asplenic. Outcome of event was unknown.; Sender's Comments: The reported event splenic abscess required spleen removed was most likely an intercurrent diseases, and unlikely causally related to the vaccine of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On the 9th day after vaccination my arm began itching. The next morning (10th day) I noticed a red rash beneath the injection site, and the rash area was hot to the touch and swollen. I'm at day 14, the rash isn't as bright red but it's larger (larger than my palm), still swollen, and still hot to the touch. I'm reporting this because the CDC website says only 14 people have reported having this.
Arm pain and swelling; Arm pain and swelling; This is a spontaneous report from a contactable consumer(patient himself) or other non hcp. A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection),via an unspecified route of administration on 17Feb2021 01:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain and swelling. The outcome of event was unknown.
Received the shot on Saturday and was fine until I woke up at 6am Sunday with a fever. By 8am Sunday I had ringing in both ears. It has gotten worse over the next few days. It's consistent and loud. Will be scheduling a Dr. visit although I don't think anything can be done about this. As it stands right now, I regret getting the covid vaccine.
blood clot in arm, patient reported a bump in arm lower in same arm as vaccine received, ultrasound revealed blood clot, put on Eliquis 10/15/21
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Patient reports getting several immunizations on 1Jul08 to include smallpox. She was doing fine until 12Jul08, when she developed Hives, and blisters on her feet. States that an Infectious disease physician took pictures of her rash. Pt received a CDC form from MC requesting Lab work to include wound cultures. Pt was treated symptomatically with Atarax.  Pt reports that she did not keep the injection site covered until the scab fell off.  Pt also C/O 3 days of nasal congestion, runny nose and a burning sensation in her Chest.  Denies fever, chills, nausea, vomiting joint or muscle pain.
pt. experience itching on vaccine site left arm after 30 minutes of vaccine and redness 24 hours after of vaccine.
Malaise, nausea, bosy aches mild joint pain - started 12 hours post vaccination and resolved 48 hours later.  Upper axillary lymphadenopathy - started 5 days post-vaccination
Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-19 Pfizer Vaccine.  Post vaccination patient noted left arm pain to elbow and left supraclavicular swelling moving laterally. Noted tingling and pain then swelling in left neck/shoulder area. About size of a baseball.   Patient given option to take benadryl 25 mg once before leaving or take it later if she is not improving. She prefers to take it now. Benadryl 25 mg PO x1 given at 1715 self-administered. Patient monitored for a total 40 minutes before being released.   History of reaction to flu vaccination that resulted in arm swelling and high fever ~30 years ago. Vancomycin life threatening reaction.
Patient was waiting for 30 minutes post vaccination ( stated had previous had adverse effect ( fever) from infleunza vaccine. When patient was being approached to be discharge stated he was feeling lightheaded. At that time denied sob, dizziness, nausea, abdominal pain, trouble breathing, or wheezing. Patient immediatelt assessed by RN. Patient stated had eaten lunch and was feeling okay prior to visit. Patient was given 3 crackers and a juice box and after afew minutes stated was feeling better. Patient pulse was 89 and sats were 96% on room air.  APRN notified doctor who had the patient come into exam room (patient was sitting out in waitin room). Patient uses a cane but was easily able to get and walk to room with only the assistance of the cane.  In the room patient stated was feeling lightheaded when he was in the waiting room. Patient was asked if he felt short of breath and patient stated he would see and immediately took out albuterol inhaler he had in his pocket and performed 2 puffs. His b/p was 126/76, clear to auscultation, no wheeze, no dyspnea. Patient stated after taking albuterol inhaler felt dizzy and offered more crackers and juice which patient agreed to take. Patient was talking all throughout the incident easily with no signs of respiratory depression. Patient observed for 20 minutes and all symptoms resolved. Patient was walked out to the waiting room with no additional concerns.
After my second dose vaccine, I experienced fever and chills. No rash as in first vaccine.
Around 9:00 pm my upper arm began to itch and was warm to the touch. A hive formed at the injection site with a clear raised line approximately 1.5" around. By the time I called the nurse line at Hospital told me to take a pen and mark around it and go to the ER if it continued to get larger. It was about 2.5" diameter by the next morning. I called the pharmacy the next day to report and he thought it was a common reaction and call my doctor. I was told to take benadryl and to watch it. The benadryl has helped and redness has subsided greatly. I still have an itch and the swelling is subsiding.
had an unusual amount of swelling in the shoulder; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "had an unusual amount of swelling in the shoulder".  Additional information: Event took place after use of product. The patient received PCV20 and had an unusual amount of swelling in the shoulder.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Feel in my head as if snakes are walking on it; It gave me in my head, left side is just going to do a year; It's a terrible pain; Those painful blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of crawling sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced crawling sensation (Verbatim: Feel in my head as if snakes are walking on it), shingles (Verbatim: It gave me in my head, left side is just going to do a year), pain (Verbatim: It's a terrible pain) and blister (Verbatim: Those painful blisters). The outcome of the crawling sensation was not resolved and the outcome of the shingles, pain and blister were resolved.   It was unknown if the reporter considered the crawling sensation, shingles, pain and blister to be related to Shingles vaccine.     It was unknown if the company considered the crawling sensation, shingles, pain and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via  interactive digital media. The patient stated that it gave in his/her head, left side was just going to do a year and she/he still feel in her/his head as if snakes are walking on it.  That disease was horrible. The patient already got the first vaccine and he/she will get the second one.  The patient recommend, administered it on. it's a terrible pain and those painful blisters. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Pt says she first noticed a few days after receiving her MMR having increased mucus in her eyes. Then she noticed a few red spots on her legs. C/o body aches now. 7-10 days after receiving her MMR she had rash all over her body. Her physician told us to report it as we gave it.
I don't feel well; I am having loss of appetite; shortness of breath; I am not breathing through my nose correctly; but he was having the 'sweatery' part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: INHALERIN taken for chronic obstructive pulmonary disease; OXYGEN taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (First Shot, LOT: EL9261), administration date: 04Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Second Shot, LOT: EL9266), administration date: 25Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Third Shot, LOT: FE3592), administration date: 14Oct2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel well"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I am having loss of appetite"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NASAL OBSTRUCTION (non-serious), outcome "unknown", described as "I am not breathing through my nose correctly"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "but he was having the 'sweatery' part". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, decreased appetite, dyspnoea, nasal obstruction, hyperhidrosis.  Additional information: Patient have COPD and he was on inhaler and oxygen 20 percent on level 2. Regarding anatomical site consumer stated, Last one was on my right shoulder and before that it was in my left shoulder but my shoulder aren't sore or anything. No they are not, my shoulders are fine. Consumer stated, "he had the biotech covid 19 yesterday and he didn't get dizzy but he was having the 'sweatery' part. He don't feel well and having loss of appetite and breathing, shortness of breath. He was on oxygen 24/7 (later clarified as medical history). Put a mask on it when he try to sleep because he was not. He was not breathing through nose correctly (eventy captured conservatively). He don't think that like something. He don't know what's going on with me. But he was ok, he was existing, he was surviving and he was still eating and drinking water.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.
He got his vaccine, he woke up the next morning, felt warm and took some Tylenol.  He was very tried, and ate some breakfast but noticed soreness under his arm.  He woke up again and it was severe, and put heating pad on it.  He went back to sleep, woke up and put the sleeping pad back on it, and took some more Tylenol.  He was up half the night with the pain.  It's right underneath the armpit, on the side of his heart at the bottom part.  It feels swollen, like a muscle is tightening in it.  He is going to his doctor today.  He is getting raised marks on his foot again, and has an appointment with his dermatologist today as well.