chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my first dose back in April 2018, and waited until 60 days had passed to have the second dose on 06/09/2018, and all of the symptoms I'm about to report OCCURRED on the initial dose and the follow-up dose. First, I began to feel "yucky" is the only word for it about six hours after the administration of the vaccine. Then slowly increasing fatigue as the hours passed by, then when I awoke from my sleep maybe 17 hours after the initial administration, I awoke SHIVERING intensely, and felt hot, but was so weak I didn't take my temperature. Instead I was able to get up, and take an ALEVE, 220 mg, and returned to bed. By morning the shivering and hot temperature feeling were gone, but the best way to describe the day was feeling tired as if I had run a marathon or was getting over a severe flu. By the way, I bicycle and or walk 4-5 times per week for up to a hour. When I had my follow-up dose on 06/09/2018, the weather forecast was for rain that weekend, so that's why based on the same set of symptoms in April, 2018, I was prepared for the same reaction on 06/09/2018, and I would say both symptom constellations in April and June were exactly the same. Lastly, it was like having a bout of severe flu for THIRTY-SIX hours with a peak symptoms at 17-20 or so hours!
sz, spasms no treatment;fever no treatment;hyperactivity, sleep problems-no treatment;diarrhea no treatment;crying, nervousness-no treatment;elevated muscle tone-no treatment;  Doc # 195957 states that patient has severe mental retardation, feeding problem, sleep problem, allergic to most food items; still cannot mae or communicate. Permanent and severe brain damages have been done by the vaccinations. The reactions have put a lot of stress on family. Parents cannot work outside of their home and have to take care of their daughter constantly, 24 hours a day and 7 days a week.
Patient displayed a bruise-like appearance at the injection site that spreaded outward, it's warm to the touch and pt is experiencing pain throughout the left arm. Patient was advised to follow-up with MD and came back to the pharmacy with an Rx for an antibiotic on 5/29/12.
The patient may have experienced a seziure. Patient was unable to speak or answer questions. She was transported by ambulance to the ER at 11:35.
Patient received the Mederna Covid vaccine on 1/14/2021. On 1/19/2021 started with swelling to lymph nodes in the arm pit and collar bone. On 1/20/2021 started with redness and itching. 1/21/2021 Woke with redness swelling  and hot to touch to the right arm.
This case was reported by a pharmacist and described the occurrence of injection site tenderness in a 46-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUVIRIN (non-gsk) ; non-GSK manufacturer; unknown; unknown given on 18 November 2013. On 18 November 2013 the subject received a dose of BOOSTRIX (unknown). On 19 November 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site tenderness and swelling injection site. The pharmacist reported that FLUVIRN was administered in the opposite arm from where the injection site tenderness and swelling injection site occurred. At the time of reporting the injection site tenderness and swelling injection site were worse. Follow-up information received on 08 January 2014 via healthcare provider who reported the symptoms started subsiding on 23 November 2013 and resolved on an unspecified date. The healthcare provider did not consider the events to be serious. No action was taken with BOOSTRIX. At the time of the report no other information was provided.
Fever - began within 12 hours; highest temp recorded was 101; Massive headache/migraine; Rapid heart rate - resting in middle of night was approx. 100bpm and is normally approx. 50-55bpm. Heart rate was elevated above 85bpm for most of the day with low to no movement; Dizziness and hard to talk from heart rate; Hard to talk from heart rate; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 08Apr2021 at 17:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included heart condition- congenital pulmonary stenosis and subclinical hypothyroidism. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included etonogestrel (NEXPLANON) and levothyroxine (MANUFACTURER UNKNOWN), all taken from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 18Mar2021 at 17:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 02:00, within 12 hours the patient experienced fever; highest temperature recorded was 101-degree, massive headache/migraine and rapid heart rate. Resting in middle of night was approx. 100 bpm and was normally approx. 50-55 bpm. Heart rate was elevated above 85bpm for most of the day with low to no movement. The patient also had dizziness and hard to talk from heart rate. On 09Apr2021 patient checked body temperature and resulted in 101 degree Fahrenheit and checked heart rate which was 100 beats per minute, and 85 beats per minute for most of the day with low or no movement. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever; highest temperature recorded was 101-degree, massive headache/migraine and rapid heart rate. Resting in middle of night was approx. 100 bpm and was normally approx. 50-55 bpm. Heart rate was elevated above 85bpm for most of the day with low to no movement. The patient also had dizziness and hard to talk from heart rate were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
soreness at the injection site; body aches; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Hypertension, Glaucoma and Anxiety. Concomitant products included BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for Glaucoma, METHOTREXATE for Rheumatoid arthritis, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown and MYALGIA (body aches) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication included pills for anxiety and hypertension. The patient did not receive any treatment for the events.
arm soreness; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Dust allergy, Seasonal allergy, Hypothyroidism and Acne. Concomitant products included SPIRONOLACTONE from 2019 to an unknown date for Acne, LEVOTHYROXINE SODIUM (SYNTHYROID) from 2012 to an unknown date for Hypothyroidism.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-445194 (Patient Link).
5 inch red circle at injection site; Exhaustion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (5 inch red circle at injection site), HEADACHE (Headache) and FATIGUE (Exhaustion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Headache). On 09-Mar-2021, the patient experienced FATIGUE (Exhaustion). On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (5 inch red circle at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (5 inch red circle at injection site), HEADACHE (Headache) and FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up contains No new information
patient reports positive COVID infection in feb 2021. Received 1stdose of COVID vaccine 04/06/21 with no concerning symptoms. Received 2nd dose on 5/6/21. since 5/9, stated her life completely changed. multiple complaints- headache, dry cough, pain in both legs and knee joints, tingling in the chest and LUE, malaise, hot and cold. h/.o elevated D dimer after COVID infection.        Reports symptoms started 2 days after her second dose. States could not feel her leg and arm.        Reports having leg burning, headaches, marks on tongue.        Reports she has been seen at hospital for these symptoms.        Reports has chest pain leg pain concerned about blood clots. Hotness in legs.        Reports has relief w Tylenol when taken.
I received A Pneumococcal Polysaccharide Vaccine (PPSV23) in my right upper arm on 2/28/22 at approximately 2:30 PM. I experienced a reaction to this vaccine. MY right upper arm became painful, swoolen, and reddened. This reaction gradually subsided over the next 4 days.
Arm soreness - began approximately 2 1/2 to 3 hours after the vaccination  Nausea, headache, and chills began approximately 15 hours after the vaccination
On day 8 after the vaccine, I woke up and it felt like a bee stinging my arm. I looked in the mirror and it looked red and inflamed. It was knotted and about the size of a regular band aid. As the day went on, it went bigger and redder. I took pictures too if needed. By Saturday it was about two inches tall and two inches wide. And so Sunday, it started going down but then on Monday morning, I was so busy I could not get up. It took me like three tries to try and get up out of bed. I could not even look upwards, I was so dizzy. I went to the DR that evening. He just said it was a reaction to the vaccine. He didn't really do anything, he gave me some Xanax for the anxiety part it was causing me.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. Concomitant medication(s) included: amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) 15 mg, start date: 16May2022, stop date: 21May2022; FLUOXETINE 20 mg, start date: 16May2022, stop date: 21May2022. Patient had no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: COVID-19 test: (unspecified date) negative, notes: I was diagnosed with covid and prescribed Paxlovid and took the entire course. On the last day of the course, I tested negative; (03Jun2022) positive, notes: Eighteen days later, on 03Jun, I tested positive. On the last day of the course, I tested negative. Eighteen days later, on June 3, I tested positive. I developed symptoms on June 5 and continue to test positive; (05Jun2022) Positive, notes: days later, on June 3, I tested positive. I developed symptoms on 05Jun and continue to test positive. Therapeutic measures were taken as a result of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient underwent reverse transcriptionpolymerase chain reaction (RT PCR) test and result found to be positive for delta variant (confirmed covid-19 infection) (confirmed clinical vaccination failure). On the same date she also had COVID-19 antigen test and result found to be positive for Covid-19 infection. It was also reported that on an unspecified date she had a high fever, cough, muscles and joint pain terrible pain that lasted for 6 or 7 days. She had no other respiratory symptoms and her oxygen level was ok. It was mild Covid but symptomatic. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211015754 -Covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Vaccine given 6-4-07. 6/14/07 itching left side of head, erythema left shoulder and upper back, fluid filled vesicle (varicella) Right upper arm.
This spontaneous report as received from a healthcare student refers to a female patient of unknown age. Five years ago, in approximately April 2008 the patient was vaccinated with first dose of GARDASIL. The reporter questioned if patient could test positive for HPV (Human Papillomavirus virus) after GARDASIL vaccination. A recent (Low Grade Squamous Intraepithelial Lesion) LGSIL test performed in April 2013, showed the patient was positive for HPV. The reporter confirmed that the patient only got one dose of GARDASIL 5 years ago, and never completed the GARDASIL series. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Causality was not reported. Additional information is not expected.
Mother, who is also a nurse, reported that her daughter received her first dose of Prevnar as well as Tripedia (Aventis Pasteur) on 10/27/2000 and 12 to 24 hours later, developed bronchiolitis with a "raspy" cough. She has a recent medical history (approximately 3 weeks ago) of RSV with a "raspy" cough, fever of 103 deg. F and "double" ear infections. The fever resolved 3 days later. She was treated with antibiotics and had been symptom-free for approximately 10 days prior to immunization. Follow up information received 12/28/2000 from the physician indicated the patient received Prevnar and Tripedia on 10/25/2000. On 10/30/2000 the patient experienced wheezing. Fifteen days later she was seen by the physician and a diagnosis of otitis media was made. The patient was prescribed an antibiotic. The patient was seen by the physician again on 11/28/2000 and had recovered. The physician indicated that these events were unrelated to the vaccine administration.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 18-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Second GARDASIL injection given 8/22/07. Had seizure 10/12/07-followed by Dr. We did not treat or evaluate patient after seizure. Was placed on TOPAMAX.
Patient developed ITP(acute thrombocytopenic purpura),as per hematologist's office,its an auto immune disease and cause is still unknown
RASH STARTED ABDOMEN, BACK, AND NECK. IT SPREAD OUT TO LEGS AND ARMS THE NEXT DAY. PATIENT DOING WELL. NO ANAPHYLAXIS.
Patient very anxious to receive vaccination as they are worried about side effects. After vaccine was given, patient sat in waiting room to be observed for 15 minutes. After around 5 minutes, patient noticed swelling of both hands at the thenar eminence. The swelling was more prominent on the left hand (vaccine arm). Patient did not have any shortness of breath and adverse effect was local at hands. Patient was given 50mg of diphenhydramine with resolution of signs within 10 minutes. The swelling had gone done and disappeared. Patient was observed for a total of 30 minutes.  After 30 minutes, the patient returned to work.
Whole body ached; pain in my hands; pain in my hands resulting in me not being able to hold a pen for any amount of time; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 17:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced whole body ache and pain in hands resulting in not being able to hold a pen for any amount of time. Pain in hands relapsed 2 weeks after the vaccine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with paracetamol (TYLENOL) and Naproxen (MANUFACTURER UNKNOWN) twice daily. Since the vaccination the patient had not been tested for COVID-19. On 03May2021, the patient underwent nasal swab, SARS CoV-2 test and the result was negative. The clinical outcome of the events whole body ache and pain in hands resulting in not being able to hold a pen for any amount of time, pain in hands relapsed 2 weeks after the vaccine were resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Suspected vaccination failure; I got my shot. I year later I had a mild case.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and 1 year later patient experienced shingles. The patient stated that it was mild case and patient had all the systems described above. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Patient was in waiting  area for 15 minutes post-vaccination, told me she was feeling dizzy. I gave her water and took her BP (117/84) and pulse (69). I asked her to wait an additional 10 minutes. Checked on her again, said she was doing better. Asked my associate to take her BP one more time before we sent her home about 5 minutes later. Associate went to go take her BP and patient fainted for a few seconds, woke up and vomited. At this point the paramedics were called and we were monitoring the patients.
waiting 2 weeks from 2nd vaccine and had a negative antibody test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (waiting 2 weeks from 2nd vaccine and had a negative antibody test) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 026A21A) for COVID-19 vaccination.  The patient's past medical history included Lymphoma. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Antibiotic therapy, OBINUTUZUMAB for Lymphoma.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (waiting 2 weeks from 2nd vaccine and had a negative antibody test). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (waiting 2 weeks from 2nd vaccine and had a negative antibody test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.