chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering; Hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration date: unknown) intramuscular, administered in Arm Left on 25May2021 11:00 (at the age of 46-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included SARS-COV-2 antibody test negative; prior to vaccination, did not get COVID when 3 persons in immediate family were positive and no extra precautions taken within household from an unknown date and unknown if ongoing. Concomitant medication included magnesium l-threonate (MAGNESIUM L-THREONATE) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any medications prior to the event being reported. She did not receive any vaccines for any other conditions prior to the event reported and not had any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. She did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0175; Expiration date: unknown) intramuscular, administered in Arm Left on 29Apr2021 10:00 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 25May2021 15:00 the patient experienced hives (neck) and rash (arms, neck, ears, legs) occurring due to exercise, heat outdoors and showering. AEs resulted in physician office visit but patient was not seen in the emergency department, not hospitalized nor admitted to an intensive care unit. Therapeutic measures were taken as a result of AEs as patient had received topical antihistamine only and patient took a dose prednisone after second dose (two weeks after as rash was still present); Details: Prednisone 20mg was taken X1day. The outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
felt like she couldn't breath; Congestion nasal; a crackling cough; was very sick after receiving the first dose; described as having pain in the arm which had been injected.; sometimes gets lightheaded or dizzy; being very tired a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (felt like she couldn't breath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Hypertension since an unknown date.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (felt like she couldn't breath) (seriousness criterion medically significant), NASAL CONGESTION (Congestion nasal), COUGH (a crackling cough), ILLNESS (was very sick after receiving the first dose), VACCINATION SITE PAIN (described as having pain in the arm which had been injected.), DIZZINESS (sometimes gets lightheaded or dizzy) and FATIGUE (being very tired a lot). At the time of the report, DYSPNOEA (felt like she couldn't breath), ILLNESS (was very sick after receiving the first dose) and DIZZINESS (sometimes gets lightheaded or dizzy) outcome was unknown, NASAL CONGESTION (Congestion nasal) had not resolved, COUGH (a crackling cough) was resolving and VACCINATION SITE PAIN (described as having pain in the arm which had been injected.) and FATIGUE (being very tired a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs included blood pressure medication.  Treatment Her local pharmacist suggested her to take Mucinex DM for the symptom. She started taking the suggested Mucinex DM therapy three nights ago.  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
Dermatomal vesicular rash began 4 days after varicella #2 vaccine and with acyclovir with improvement resolved lypopigmented area mandibalardermatone. History eczema.
I felt an sore arm and lethargic after the vaccine for a two days. On my 05/22/2022  tested positive for COVID-19 with the home test. My symptoms where I had a  sore throat, stuffy head, difficulty breathing, didn't run a fever, my arms and legs where freezing but my head felt very hot. I also felt very fatigued and slept a lot. My breathing got worse so I went to an urgent care center. They gave me a steroid  which helped for a few days. After that tampered off I got worse again. I went back to the doctor and they prescribed another steroid which helped again. The biggest complaint now is fatigue. I am sleeping  10-12 hours a night.
Severe sinus congestion, headache similar to a migraine, extreme fatigue. This started within 24 hours of vaccine.  It was like an instant sinus infection. Developed a fever on 4-18-21 and 4-19-21.
This case was reported by a nurse and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41FB446A, expiry date 30th January 2016). On 3rd November 2014 15:00, the patient received the 2nd dose of ROTARIX (oral). On 3rd November 2014, 10 min after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional information received: 4 months old girl administered 2nd dose of ROTARIX, after drinking a lot of milk, and then spit out/vomited. No further information provided.
Received booster dose from expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Patient was admitted to the hospital with COVID symptoms and was treated with typical COVID medications. Patient remains in the hospital.
Large amount of swelling and redness at injection site. Right arm. BENADRYL.
Fatigue; Punk; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ILLNESS (Punk) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included METHYLPREDNISOLONE for Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (Fatigue) and ILLNESS (Punk). At the time of the report, FATIGUE (Fatigue) and ILLNESS (Punk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.    Reporter did not allow further contact
Patient began having tightness in his chest while sitting in the lot for observation.  Wife stated she was transporting the patient to local hospital by private vehicle.    ON 2/11/2021 @ 4:20 p.m. patient was called.  He stated that he and his wife decided not to go to the hospital.  States that his chest is still tight.  Nurse asked his if he was following up with his private cardiologist to which he replied he will visit   sometime.  Said that he went recently and next visit "will be in a while"   Nurse asked him to call  911 and/or visit his private provider regarding  continued illness.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M007960, expiration date 05-AUG-2017) for prophylaxis (dose and route of administration were not reported). The vaccine was stored at >5°Fahrenheit, but <14°Fahrenheit for 10 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008690: US-009507513-1702USA008691.
Pain, swelling, and redness at injection site x 4 days, General fatigue x 48 hours, nausea without vomiting x 48 hours, diarrhea x 24 hours, body aches x 48 hours, joint pain x 48 hours, lightheadedness/dizziness x 48 hours, fever >101.8F x 24 hours. Conservative treatment at home, returned to baseline at 2 days post vaccine.
I've had mild heart palpitations since my late 20s that have never gone on for extended periods of time. I've managed them just fine with diet (figuring out my sensitivities, cutting out soda and other caffeine). After my 2nd vaccine, I had significant heart palpitations that delayed my getting to sleep. Over the next 3.5-4 months, I had occasional heart palpitations that kept  me up at night. They often came on if I were up late at night. I was no stranger to late nights BEFORE the vaccine and have had more late nights in the last month and a half and yet my palpitations are back to the low level from before.   I can't prove it's from the vaccine but I'd never had heart palpitations that bad in my life and I haven't had an event in the past couple of months.   In an appointment, I discussed the events with my naturopathic doctor who is also my primary care, Dr. (in answer to Item 21). I almost went to the ER one bad night but had a friend come over to watch me instead ( to see if he could get me to sleep and not go to an ER).
Patient received the shingles vaccine on Monday, and she came back today on 6/11/09 due to allergic reaction. She was told if she had any problem with shingles vaccine to return within three days, and unfortunately she did. After examination, Dr. decided to have patient placed on medrol dose pack and hydroxyzine. On physical exam, patient had red macular papular rash on neck area, and hands bilaterally. She was given decadron shot, Explained to patient side effects of decadron shot. lot#8797 expires nov,2010. decadron shot given in right gluteal area. patient tolerated well temp 97.8.
I had just come from running an errand when I was on my way home in my car. I suddenly realized I was coughing more than usual. I also had a sense of malaise. I just didn't feel good. I also believe I had a headache. When I got home, I drank a lot of water, because whenever I get a headache, it's usually because I'm dehydrated. It didn't occur to me that I could possibly have COVID-19; I thought my symptoms were caused by other things. The next morning, though, I woke up with headache, fever, deep cough, and head congestion. I felt ill and realized then that I probably had COVID-19. I believe that I had a home test, which I took and which yielded a positive result. This was on 12/23/2022. My holiday plans were ruined, so I was very distressed. Either that day or 12/24/2022, I called the urgent care at the clinic where I normally see my doctor and spoke to one of the nurses. The nurse basically advised me to stay home, get lots of rest, and drink lots of water. She also recommended that I take OTC remedies for cough and congestion like MUCINEX and cough syrup, which I did. I asked if I could get an antiviral, and she told me that I didn't need it. I wasn't happy about it, but I trusted her judgment. After that, I treated my head congestion with MUCINEX, which caused an extremely runny nose. Afterwards, the congestion and runny nose were, but the cough, exhaustion, and fever remained. By the fourth day, I no longer felt ill. The congestion and runny nose were gone, but I continued to have a fever for about two weeks. The cough continued for probably a month. I also had brain fog at one point, but maybe after about a week, my brain function returned to normal.
little bit of a chill; soreness in shoulder area; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area) in a 76-year-old male 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) 1 dosage form. On an unknown date, the patient experienced CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area). At the time of the report, CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was not provided. Lab details were not provided.  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.
5/3/16 - received vaccine. Began getting weak starting with lower extremity weakness on 5/3/16 afternoon. 5/5/16 muscular weakness progressing upward to neck and worsening weakness overall. 5/4 brought to ER due to unable to bear weight and transferred to hospital.
Moderate sized reddened area on upper left arm. Site is red and slightly swollen. Pt states minimal discomfort noted with some pruritus. Localized to the upper left arm (site of injection)
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) in a 46-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 16-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 01-Mar-2022 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (positive for covid-19). On 09-May-2021, COVID-19 (positive for covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 09-May-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.  Patient tested positive for covid-19 on 21Apr2021 and turned negative on 9May2021 and went for the second dose and was denied and was advised to call us for guidance on how to proceed.
Post vax, the pt developed swelling of the leg, that was red and warm to the touch.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
big black blue bruise in her arms where the vaccine injected; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 26Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced big black blue bruise in her arms where the vaccine injected on an unspecified date. The clinical outcome of the event was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
pt felt flushed and had increase heart rate the evening following the shot, felt jittery and shaky, 1/14 morning was SOB and tachycardia noted went to the ED  subsequently needed cardiology evaluation and has had several ED visits.
she had bumps all over her body and below her eyes which appeared swollen.; itchiness; At 10:30 she started feeling sick; raised humps on her hands and arms/ throughout the evening the bumps went to different places on her body; This is a spontaneous report from a contactable consumer who reported for herself.  An 82-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 21Jan2021 for Covid-19 immunization. Medical history was not reported. Concomitant medications included gabapentin and paracetamol (TYLENOL). On 25Jan2021 around 5:30-6 p.m, the patient noticed raised bumps on her hands and arms, and throughout the evening the bumps went to different places on her body. At 10:30 she started feeling sick and noticed that she had bumps all over her body and below her eyes which appeared swollen. She went to the ER because the itchiness was unbearable. In the ER, they gave her Prednisone and a Benadryl, in which she broke out again after taking the medication. The ER sent her home with a prescription for Prednisone and Claritin. She slept all the following day and she normally only takes Gabapentin and Tylenol for her medication. Patient wanted to know that if these reactions have been reported, If she should take the second injection and have the reactions been reported days later. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
For approx 2 days 102 degree F fever, coughing, sore throat.
Terrible headache; Nausea; Fever of 101F; No appetite; Chills; Felt so bad I went to bed early; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache), NAUSEA (Nausea), PYREXIA (Fever of 101F), DECREASED APPETITE (No appetite) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O1112OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Colitis. Concomitant products included MESALAZINE (LIALDA) for For colitis, CLONAZEPAM, MULTIVITAMIN & MINERAL and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (Terrible headache), NAUSEA (Nausea), PYREXIA (Fever of 101F), DECREASED APPETITE (No appetite), CHILLS (Chills) and FATIGUE (Felt so bad I went to bed early). On 19-Jan-2021, HEADACHE (Terrible headache), NAUSEA (Nausea), PYREXIA (Fever of 101F), DECREASED APPETITE (No appetite), CHILLS (Chills) and FATIGUE (Felt so bad I went to bed early) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Body temperature: 101f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
FAINTING; DIZZINESS; BLURRED VISION; PAIN AT THE INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 51-year old White Hispanic or Latino female. 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: 1808986 expiries: UNKNOWN) frequency one total, dose was not reported, administered on left arm on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  After the vaccination Symptoms started on 18-MAY-2021 dizziness, pain at the injection site, and blurred vision.it was also reported she fainted while walking back home. All the symptoms resolved.The Patient was complaining of a headache at the moment of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, dizziness, blurred vision, and pain at the injection site on 18-MAY-2021, and had not recovered from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534713-COVID-19 VACCINE AD26.COV2.S-Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).