chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an unidentified patient who was vaccinated with Hepatitis B vaccine recombinant. Subsequently two weeks after the patient was vaccinated, the patient experienced a "delayed reaction" described as "generalized hives". The patient sought unidentified medical attention. Additional information has been requested.
pt recv vax;was pregnant, devel "sl spotting"; in f/u MD stated pt had moved back to China & was therefore lost to f/u;
First , started out with normal side effects : headache, mild chills and fever of 100.4.  Symptoms resolved after 12 hours. Then I had fatigue  on the third day.  On the fifth day after vaccine, I began having pain and tingling sensation in extremities, back and joints, along with a feeling of numbness. This lasted for about 3 days.  It was like the feeling of being thawed out...my bones ached.   My heart rate also would rise when resting. I also had a rash under my left breast and stomach area. In addition I had swelling in my knee and slight swelling in my toes, hands.  Now, that has subsided but I had severe exhaustion to the point I could not do daily activities without having to lie down in between. I also am very forgetful and have fogginess that still resides.  I went to my PCP on Monday who is doing bloodwork....waiting on results.
I have always had relatively heavy periods due to my diagnosis of VonWillebrand's disease.  Four days after receiving the vaccine, my cycle came on early and I had heavier bleeding than I have ever experienced with large clots.  The bleeding slowed down, but lasted for an entire month.   My cycle then returned to normal.  It seemed very coincidental that this happened immediately following the vaccine, and was not normal for me at all.  I recently read similar stories of other women reporting this, so while at the time it was concerning, I did not report it.  I am a firm believer in science and thought this was possibly just a fluke, but felt that after reading many stories of women having a similar experience, that the responsible action is to report this, to ensure that all of the data is being studied, since the vaccine is so new.  That being said, I only had mild side effects from the vaccine, and I am very grateful that I was able to receive the vaccine, as I have known quite a few people that have died from COVID.  This bleeding for me was not dangerous at any time, and while I was a bit faint, the bleeding during the course of the month did slow down and this all resolved.  Therefore, I would still get the vaccine again.  I should note that after my second vaccine, I had a few days of spotting outside of my cycle, which resolved as well.  I have had no issues since.
grand maul seizure; vision changes; Feelings of pressure at the back of his neck radiating to right side of his head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On 14-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) had resolved and VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head) 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.   The patient had a seizure three days after his first Moderna Covid vaccine and was hospitalized.  CT scan was negative.  The reporter's causality for co-suspect drug, adalimumab, was not provided.  Concomitant product use was not provided. No treatment information was provided.  This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2022, the patient received Shingles vaccine. On 17th August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On 17th August 2022, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: This case was reported by the patient's wife via interactive digital media. The patient had the shot day before reporting.  The patient's wife reported that the needle was bad and of course his arm was sore the next day of vaccination but the patient was fine. It was well worth it.  A couple of years ago the patient saw some one who developed shingles and she remembered he was in agony for a couple of weeks.  That was why the patient took the shot and it would be worth it. Additional supportive information: The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR121375 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121375:Same reporter
Large red rash around injection site.  Fever 101.8, chills, fatigue., elevated heart rate.
Patient feels "light headed", paint in back. Sent home with ice bags to arm and Motrin. Returned to work on 2/11/03. Denies any discomfort.
Fever for 3 days, runny nose, cough, vomiting from cough.
The initial side effect was that I felt really sick the next day, it lasted about 12 hours. I was nauseous and felt icky, I was bedridden for a day, and I just laid in bed and felt bad. The injection site was sore and had a knot and it lasted 4 days. Resolved within 12 hours, the injection site soreness was to be expected afterwards. I had similar experience with previous doses (one and two) it was more extreme than first two doses but not by much.
Woke up with itchy hands.  Hives started to appear all over body quickly within 12 hours.  Hives were not resolved with basic antihistamines.  Next day hives had progressed and swollen throat presented.  Was seen by doctor and was given a epinephrine shot and a steroid shot.  Neither helped.  Three days later was seen in ER for worsening symptoms.  An IV of steroids, benadryl, and pepcid AC did not help.  A visit to the allergist followed the next day where I was diagnosed with spontaneous urticaria and dermagraphia.   I was put on a regimen of Zyrtec 2x a day along with Pepcid 2x a day, Benadryl as needed.  This has helped the presentation and itchiness of the hives but dermagraphia remains.  Any lapse in taking of meds results in another outbreak.
The patient phoned the pharmacy on Sunday May 12,2019  saying she started having tingling in lips and swelling. I told her to go to the ER. Patinet received shot the previous Friday 5/10/10  at 12:32pm.
Information has been received from an investigator concerning a female who entered a study, title as stated above. On 23-APR-2009 was vaccinated with the first dose of GARDASIL (LOT# not reported). The patient's last menstrual period was last week of April 2009. The pregnancy is normal to date. Patient will be followed by study, but not receive any other doses of GARDASIL. Follow-up information was received from a caller who wanted to report a pregnancy registry for a clinical trial for GARDASIL. Unable to confirm information. In the follow-up the investigator stated they were no longer giving the patient GARDASIL and asked if it would be okay to only report the information to their contact for the clinical trial and if they need to call again. In the follow-up the investigator stated that the patient who had been approximately 28 weeks pregnant had a stillbirth on 21-NOV-2009. The relationship between the stillbirth at 28 weeks and GARDASIL was not reported. Upon internal review stillbirth at 28 weeks was considered to be an other important medical event. No further information was reported.
Pt felt a "warm feeling" upon leaving the immunization department.  No other significant reactions were noted.  V/S taken, patient observed for 20 minutes.
Rash, urticaria BENADRYL and Prelone by mouth for 5 days.
Crohn's aggravated; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4278994-00 (Abbvie).  A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 [booster], single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Route of Admin: Intramuscular), administration date: 28Apr2021, for Covid-19 immunization; Bnt162b2 (Dose: 02, Route of Admin: Intramuscular), administration date: 19May2021, for Covid-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's aggravated". The action taken for adalimumab was unknown.  Clinical Course: Solicited report from a consumer of an adult male with an event of non-serious Crohn's Flare Ups with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced Crohn's Flare Ups. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Event abate after stopping drug was not applicable. Concomitant drugs and dates of administration (Exclude those used to treat event and other Relevant History was not reported.  Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN, UNKNOWN, UNKNOWN. Causality: Crohn's aggravated (Crohn's disease), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Crohn's Flare Ups was not provided. Causality: Crohn's aggravated (Crohn's disease), Action(s) taken with drug: unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A  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 CROHN'S DISEASE cannot be completely excluded. 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.
Pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 039A21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE MRNA (MRNA 1273) on 11-Mar-2021. Past adverse reactions to the above products included Pain in leg with COVID-19 VACCINE MRNA (MRNA 1273). Concomitant products included PRAVASTATIN and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in both legs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and MELOXICAM at a dose of 15 mg. At the time of the report, PAIN IN EXTREMITY (Pain in both legs) outcome was unknown.            This case was linked to MOD-2021-060835 (Patient Link).
36 hours .  Extreme Weakness . Muscle aches. Shortness of breath and tachypnea . Chills . Fever.
Information was received on 23-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 14-NOV-2007 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed prednisone (manufacturer unknown) and VALTREX, for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
12:30pm Light-headedness  12:40pm Difficulty breathing and shortness of breath 12:41pm Returned, Epi-pen was administered IM (thigh) & 911 was called 12:50pm EMT took over patient & patient refused to be taken to hospital  1/24/2020 5:45pm Patient was contacted and reported no re-occurrence of SOB or Difficulty breathing but did report headache and diarrhea
approx 15mo p/vax pt exp mild case of scattered lesions & low grade temp
Headache, stiff neck, achy body, unusually sore injection site (more than normal). Later in the day-fever, chills, weakness -general awful feeling. Next day, still not feeling 100% better. Sore/stiff neck, sore injection site, tired, sick feeling.
lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm). At the time of the report, LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.  The patient had lot of discomfort in left arm. The patient was wondered if the patient was having heart issues, so the patient took aspirin during the night.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received, contains significant information: reporter information added.
Sore arm at injection; back ache; body aches; chills; swollen tongue; burning eyelids(inner); nausea; headache; fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in left deltoid on 18Mar2021 09:55 (Batch/Lot Number: Er2613) as single dose for covid-19 immunisation. Medical history low back pain, ACP (advance care planning), chronic constipation, allergic rhinitis caused by unspecified, postmenopausal asymptomatic status sp hysterectomy with BSO, osteoarthritis hands, other and unspecified hyperlipidemia, overweight (BMI 25.0-29.9), osteopenia, ex-cigarette smoker, fatigue. Concomitant medication(s) included atorvastatin calcium (LIPITOR) taken for hyperlipidaemia; biotin; colecalciferol (VITAMIN D3 1000); loratadine (CLARITIN ONCE-A-DAY) taken for allergy symptoms; melatonin taken for sleep; plantago afra (PSYLLIUM SEEDS) taken for constipation; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (OCUVITE LUTEIN & ZEAXANTHIN); vitamin b complex (B-COMPLEX). Patient previously took BNT162B2 first dose on 25Feb2021 21:00 (lot number: EN60205) experienced back ache, tired and fatigue, treatment received and went to chiropractor for back ache. The patient experienced back ache, body aches, chills, swollen tongue, burning eyelids(inner), nausea, headache, fatigue, all on 18Mar2021; sore arm at injection on unspecified date. The event outcome for sore arm at injection was recovered on unspecified date, for other events was recovered on 21Mar2021.  No follow-up attempts are possible. No further information is expected.
mild hives at injection site; fatigue; headache; Pain; received her AREXVY and SHINGRIX vaccines on the same day and in the same arm; pain in the injected arm; pain in the injected shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix (intramuscular, unknown arm) and Arexvy (unknown arm). On 12-SEP-2023, less than a day after receiving Shingrix and Arexvy, the patient experienced headache (Verbatim: headache), pain (Verbatim: Pain) and wrong technique in drug usage process (Verbatim: received her AREXVY and SHINGRIX vaccines on the same day and in the same arm). On 13-SEP-2023, the patient experienced injection site hives (Verbatim: mild hives at injection site) and fatigue (Verbatim: fatigue). In SEP-2023, the patient experienced pain in arm (Verbatim: pain in the injected arm) and shoulder pain (Verbatim: pain in the injected shoulder).The outcome of the injection site hives was resolved and the outcome of the headache, pain in arm and pain were not resolved and the outcome of the fatigue was resolving and the outcome of the shoulder pain was not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.  It was unknown if the company considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date:15-SEP-2023 The patient called with questions about Arexvy and mentioned that she experienced some side effects. She received her Arexvy and Shingrix vaccines on the same day and in the same arm.  She mentioned that she experienced pain in the injected arm/shoulder, mild hives at the injection site, fatigue and headache.  The hives had resolved and the fatigue was lessening.  The headache and arm pain were still bothersome. The reporter did not consent to follow-up.
07/12/2021 I started with symptoms of not being able to use right hand really well. I could do things with it but when I did my hair that morning and rolled the brush it felt like it wasn't connecting to my brain, and also when I did my makeup. That was the first indicator. On the 14th it happened again where I noticed that I was really tired. By the 16th I was having trouble speaking and couldn't think of the words I wanted to use and because we are in a new location I hesitated to go to the doctor. We went to the hospital on the morning of the 18th and I felt like I had a stroke but I wasn't sure. I walked into the hospital and was admitted. It was that memory of speech and the right side not functioning at 100% and that was an indicator that something was wrong. When I was in the hospital they took blood work, urine work, an MRI, and a cat scan and found that I had a mild stroke in my lower brain near the base of the ganglia. They said that part of your brain controls speech, so it was on the left side and that's why my right side was affecting my motor skills. My writing has also been impacted. They did an electrocardiogram in the hospital and that checked out fine and they kept me overnight and put me on Plavix, Lipitor, baby aspirin, and lisinopril for blood pressure. Since then I've come off of the Plavix and they ordered a carotid artery heart monitor and it took forever to get it done because they are slow. In November 2021, I saw the neurologist and I was in speech therapy through Christmas. My doctor is going to have me come back in November 2022 to see how I've progressed not being in therapy. My memory has been affected by it and I don't remember things like I used to. I don't drive like I used to and where I live it's easy to get around but when it comes to driving I don't trust myself because there's times where I can get confused and I don't want to get confused on the road. I still get really tired and they say it takes a year plus for your brain to heal and I think I forget I had the stroke. I get fatigued during the day and I used to not be like that, and by 2/3 PM I'm just tired, but not physically tired, more like mental fatigue.
Sometime following the vax the pt experienced joint pain. An MD visit was required. As on 8/30/00, the outcome of the event is ongoing.
Bp 190/150. Sever nausea puking feeling faint. Exhausted
Hives and itching on injection arm(5) and side(1). Was advised to take Benadryl