chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 3pm the day of receiving the 2nd dose, I started experiencing chills.  Within a couple more hours the chills subsided and replaced by elevated temperature by about 7pm (around 102 degrees).  Along with the elevated temperature my heart rate increased significantly to about 160 bpm.  With the current state of my hyperthyroidism I experience somewhere between 100-120 bpm normally.  At around 9pm my temperature reached 102.8 degrees, the heart rate was not decreasing, and a headache started coming in.  I took NyQuil to subside the pain and eventually was able to fall asleep despite the elevated heart rate. The following morning the temperature went down to 101 degrees; my whole body was experiencing soreness.  My heart rate decreased to around 140 bpm.  As the day went on the adverse effects starting wearing off; by the evening everything was back to normal levels.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 88 years, in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 which included treatment with Paxlovid (treatment start date: 26May2022, treatment stop date: 01Jun2022).
Corona Virus Concern     took a home rapid test and came back positive ? Hypertension     Patient presents with complaints of congestion and ended up taking two home Covid test that came back positive. She felt lightheaded when she sat up and ended up checking her blood pressure and found herself to have elevated blood pressure. She has a history of hypertension but has not been on any blood pressure medications for the past few months due to weight loss. She has been doing well off of the blood pressure medications. She does have a history of tachycardia. She was going to get an actual PCR test at a clinic but because of the blood pressure elevation and lightheadedness she decided to get checked out. No fever. No chest pain. No calf pain or swelling. No shortness of breath. No other acute issues, symptoms, complaints.
Started with a fever of 101 and tiredness on Friday night, had 2 TYLENOL, then at 3am Saturday started with great tremors, 102 fever after controlling the tremors. Had TYLENOL and after 30 minutes vomiting. All Sunday had a better time, then Tuesday sore throat that lasted 5 days.
Patient was administered the dose while the temperature excursion assessment was ongoing; Patient was administered the dose while the 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 (Patient was administered the dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the dose while the temperature excursion assessment was ongoing) in a 44-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered the dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the dose while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered the dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered the dose while the 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 medications were reported. No treatment information was provided.
On 9/28/2022, I was exposed to COVID-19. On 10/1/2022, I went to a party at noon. While I was there, I noticed my nose was running a little, and I had a slight tickle in the back of the throat. After about an hour, I left and went home. I took a nap and ended up sleeping until the morning of 10/2/2022. When I woke up, I had a painful, burning sensation in the back of the throat, plus phlegm. This continued for about five days and then began to subside. I was not able to function for another week. On 10/2/2022, I took a home antigen test and got a positive result. I had a telehealth visit with a local urgent care clinic on 10/3/2022, and I was prescribed Paxlovid, which I began taking 10/6/2022. I had no perceived improvement after beginning the medicine, but my symptoms also did not worsen. I took OTC Mucinex and Ricola lozenges to help treat the symptoms, but they weren't very effective. After about a week, I began to feel a little better. I felt much better after two weeks, but it took a month before I felt like I was back to normal. On 11/30/2022, I was again exposed to COVID-19. On 12/3/2022, I began to develop a sore throat, but it was less intense than it had been in October. I thought I had strep throat. I had sore throat and runny nose that continued for several days, but I powered through them and continued with my normal activities. Since I had recently had COVID-19, I didn't think I could possibly get it again so soon. On 12/9/2022, I went to a local urgent care clinic to undergo a strep test. A throat swab was performed, and I was given a brief physical exam before I was sent home. I learned within minutes after being tested that I was negative for streptococcus, but on 12/10/2022, I found out that I had tested positive for COVID-19 and RSV. I was offered Paxlovid, but I decided not to take it, because my symptoms this time around were less severe than they had been the first time around. I just treated my symptoms with OTC Mucinex and Ricola lozenges, but they didn't seem to help much. Because the symptoms were less severe this time, I was able to function well enough to work from home. I just took lots of naps and slept a lot. The symptoms lasted for about two weeks. It took a full month before I returned to my pre-COVID-19 functioning level.
It started with heavy vaginal discharge. I decided to go to the clinic to see what that was about; they did an endometriosis ultrasound, swabbing scan and a CT scan. They completed a hysterectomy procedure and additional swabbing for testing when they determined I had endometrial cancer (ferrous carcinoma), or practically uterine cancer. I'm currently undergoing chemotherapy for treatment in hopes of recovery.
Pt experienced severe pain, weakness to left arm at injection site. Pt was seen in ER 5 days post vax and 7 days post vax. No fever or chills. Unable to move arm secondary to pain. Diagnosed with possible bursitis 7 days post vax in ER.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, administration route, lot number, expiration date and anatomical location were not reported) for prophylaxis. On an unknown date, the patient developed an unspecified injection site reaction (reported as "it was much worse than this one (reported on MARRS# 1703USA010172)). The outcome of the event was reported as fully recovered (on an unknown date) and the causality between the vaccination with ZOSTAVAX and the event was unknown. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010172:
1550 patient c/o being cold and clammy upon arrival to observation, patient states that she felt her legs were cold bilaterally. 1600 pts BP 138/96 HR 82 1610 patient out of chair and walked to bathroom;  patient  back in vehicle,  states she feels better BP 136/89 HR 79 1625 patient left with husbands driving, denies SOB/CP instructed patient to follow up with pcp if she continues to have problems, but pt states she feels better @ the time of leaving observation.
have ramsey hunt sydrome since 2015 and have taken two shingle shots in 2016. Have not had any syptoms of shingles  or sydrome since. Received covid-19 booster shot at 11:00 am and at 10:00 pm same evening starting having symptoms of sydrome. Have had symptoms every day beginning around 6:00pm and continuing as of today(9/27/21) ---Pain on left check, drawn muscles, sharp pain in left ear, dizziness, unstable balance, nausea, high fever.
Day of injection: sore arm, chills, headache, slight body ache Morning after: head cold, sinuses stopped, sneezing,  runny nose, fever of 100, body ache, stiffness. Took Tylenol to reduce fever. Cold symptoms lessened in 4-5 days. Joint, pain and stiffness in knees, hips, wrists, thumbs continued to get more severe.  - took Tylenol Arthritis 650mg to ease the pain.
Stated really sleepy at 3:30 pm 12/6-lethargic all evening until 9:00 pm, woke up was ok for 30 min-went to bed at 9;30 pm-whimped all night, am of 12/7 cried-screamed-would not console for 2 hrs. temp 99 deg. Did give tylenol various times "acted normal 2:00 pm 12/7/05 no problem since-went to med. doctor 12/7 pm-MD  said pass reaction or getting a cold.
left lymph nodes had multiple enlargements; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left lymph nodes had multiple enlargements) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear (Torn rotator cuff). Concurrent medical conditions included CLL (Diagnosed 3-4 years ago) and Arthritis (Left side of arthritis).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (left lymph nodes had multiple enlargements). At the time of the report, LYMPHADENOPATHY (left lymph nodes had multiple enlargements) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) Normal. On an unknown date, Ultrasound scan: abnormal (abnormal) Patient had a sonogram that showed her left lymph nodes had multiple enlargements..         No concomitant medication was reported. No treatment medication was reported.
On 5/31/2022, client presented to clinic for 2nd Moderna booster. Reported no issues or concerns. Had two-dose Moderna primary series and 1st Moderna booster previously. Administered Moderna booster 50mcg/0.25mL into left deltoid IM at 1330. No reaction within 15 minutes of administration. On 6/6/2022, client called in to report reaction to 2nd booster dose. Client admitted had a history of a feverish reaction of 100 degrees Fahrenheit after 2nd primary dose (reports average normal body temperature 97.5). Described no reactions after 1st primary dose or 1st booster dose. Received 2nd Moderna booster at 1330 5/31/2022 as per recommendation from Dr. due to history of double pneumonia that required surgical draining. At 0300 on 6/1/2022, client reported waking to 100 degree fever, severe nausea/dry heaves, and severe headache that "when I closed my eyes I saw white, not black." Unable to tolerate anything by mouth. Unable to take any medications due to unable to tolerate anything by mouth. Client stated was unable to get out of bed for two days due to headache; did not seek further medical attention. Fever broke after three days. Dry heaves subsided after four days. Discussed Covid-19 side effects and typical durations. Encouraged client to speak with Dr. about reaction and to seek advice in event a future Covid-19 booster would be recommended.
Hardness at injection site, 8 days post injection; Redness at injection site, 8 days post injection; Swelling at injection site, 8 days post injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection). At the time of the report, VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection) 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's concomitant medication was not reported.  The patient's treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: TCR added- No answer On 07-Apr-2021: TCR added- Spoke with HCP and she refused follow-up.
Moderna COVID?19 Vaccine EUA resulted in firm, raised large itchy spot at injection site. Only appeared as of this morning
Side effects started exactly 12 hours after vaccination. Started with moderate nausea and vomiting (which ended the night of the vaccination. Then severe muscle aches, severe headache, severe fatigue, and loss of appetite so far throughout the day after.
Improvement of Psoriasis on elbows; Fatigue; Total body soreness; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows), FATIGUE (Fatigue) and MYALGIA (Total body soreness) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows), FATIGUE (Fatigue) and MYALGIA (Total body soreness). On 11-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows) was resolving and FATIGUE (Fatigue) and MYALGIA (Total body soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided . No treatment medications were provided. He stated that he finished the antihistamines, but his face was still swollen.   This case was linked to MOD-2021-366514, MOD-2021-366526 (Patient Link).
viral exanthem rash 13 days p/vax (morbilliform);2 days later erythema multiforma appearance then hemorrhagic;pt achy/whiny,febrile;tx Pred
This case was reported by a healthcare professional via a sales representative and described the occurrence of inappropriate schedule of drug administration in a neonate subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. On an unspecified date, the subject received a birth dose of Engerix B (unknown). The subject received another dose of Engerix B two weeks later in the hospital. The sales representative did not known why the subject was hospitalized for so long. Per the Engerix-B prescribing information, the usual immunization regimen consists of three doses of vaccine given at 0, 1, and 6 months, respectively.
Client received MMR, Tdap, and hepatitis B at 11:50AM - During visit, client kept sleeping, 4 month old infant in carrier strapped to client's chest. Following vaccination, client reported feeling "dizzy and hot". This nurse applied a cool compress to client's neck and offered a cup of water. Client consumed a piece of candy during 20 minute monitoring window with this nurse. After monitoring, this nurse observed and assessed client as client began to stand - client stated she "felt better, more stable". This nurse informed client she would follow client downstairs in case client began to feel ill. Upon arriving to elevator, client stated, "I need to sit". This nurse helped client to a near-by chair, and had an administrative staff member sit with client while this nurse retrieved a wheelchair. Client was shivering as this nurse helped client into wheelchair. Client maintained consciousness, no issues with breathing, and client reported no issues with breathing, stating "I'm just very cold". A registered nurse brought this nurse a stethoscope and blood pressure cuff, but client began to lose consciousness. Client regained and lost consciousness and would shake/shiver. Admin staff member removed infant from carrier, and this nurse and second nurse removed child carrier from client. Second nurse stated that client's blood pressure was "very low" and client had a "weak pulse" in left wrist, alerting staff to contact EMS. This nurse was able to ask client, as she regained consciousness, the name of client's emergency contact. Upon EMS arrival, patient's emergency contact name was given to EMS, and infant child and client were transported from the health department.
Approximately 30 mins post vaccination, the pt returned with red eyes, generalized blotchy impetigo rash on legs and arms, and cough. The pt was given Tylenol and applied ice.
Started with 9 hours of straight screaming, fever of 104, rash, refusal to eat for 3 days (survived on breast milk) then 3 days later had "absence seizure.)
Feels sick; She cant even talk right; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 35-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration in left arm on 13Sep2021 at around 10:30 - 11:00 as dose 2, single (at the age of 35-years-old) for COVID-19 immunization. Patient medical history (including any illness at time of vaccination) was reported as none. Vaccine was not administered at military facility. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- FC3180) via an unspecified route of administration in left arm on 23Aug2021 15:00 as dose 1, single for COVID-19 immunization and experienced change in her menstrual cycle as it was longer and heavy than normal. On 13Sep2021 she took her second shot for Covid and was tell the person that helped when she got her second shot, that after the first shot she experienced a changed in her menstrual cycle. After the first vaccine it came early. She went to the bathroom and was like there it is. Then it was 1.5 days with no blood. After that, it came really strong and heavy, lasting for another 6 days. So it was longer and heavy than normal, from the first signs of blood it was 9 days total instead of the 4-5 days it normally lasts. Her normal period was 4-5 days and started low with a small amount in the first day, then on the second and third day was heavy, then the last days was just a small portion of blood. She was also very regular it comes every 27-28 days. She marked her calendar as it started on 30Aug2021 but it was the 28Aug2021 when she had the first sign and nothing until the 30Aug2021, she did not have accidents anymore, she was too regular. This time there was no sign and she was surprised. The patient experienced feels sick, she could not even talk right, she woke up today feeling that way on 14Sep2021. The adverse events did not result in emergency room or physician office visit. She felt fine yesterday. The outcome of the event was unknown.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
fever of 99.9 all night; Body ache; Pain in my arm from the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (herself and her husband). This is a first of two reports. A female patient of unspecified age received bnt162b2 (BNT162B2, lot number: EH9899, expiration date was not reported), via an unspecified route of administration on arm on 18Dec2020 (morning) at a single dose for immunization. Medical history and concomitant medications were not reported. The patient reported that she received the Pfizer vaccine (COVID Vaccine) yesterday morning (18Dec2020) and last night (18Dec2020) she had fever of 99.9 (unspecified unit) all night. And then at this morning (19Dec2020), she came to work at the hospital. And she has been with 99.2 all day. She also experienced body ache and pain in her arm from the vaccine on 18Dec2020. She added that her husband was experiencing the same way who also got the shot yesterday (18Dec2020). The outcome of the event fever was recovered on 19Dec2020, while outcome other events was unknown.   Information on batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020506517 Same reporter/ drug/ event for different patients.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.