chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 year old 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: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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).
Turned completely red.; Hot.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms; Started vomiting; Severe headache.; Rushed to ER for suspected anaphylactic reaction.; This is a spontaneous report from a contactable Nurse (patient).  A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 15:15 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Right arm on 18Aug2021 15:00 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Sep2021 (15:30), the patient turned completely red, hot, started swelling in the face, neck and arms, started vomiting and had severe headache; she rushed to ER for suspected anaphylactic reaction. The events resulted in emergency room/department or urgent care; medication and fluids were given as treatments of the events. Facility type vaccine: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.   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 reported information ,a causal relationship between the events and suspected drug cannot be excluded.
My husband first contracted COVID-19. He gave it to me. My symptoms at first were a headache, congestion, and a stiff neck. 12 hours later, I had chest heaviness, cough, and mild body aches and fatigue. We called our primary care physician, and because of my risk factors, she started me on PAXLOVID. My first dose of the prescription was on 06/16/2022. I tested negative on 06/25/2022, and on 06/27/2022, I started developing fatigue, heavy cough and congestion again. I tested positive for rebound COVID-19 on 06/28/2022. I went in and was seen by a nurse practitioner to ensure with my health history that I didn't contract bronchitis as well with the insisting cough. I treated everything symptomatically until feeling recovered. My rebound COVID-19 symptoms didn't fully subside until 07/06/2022. I tested again on 07/09/2022 which came back negative.
Patient reported on 10-4-2012 that "last weekend" she broke out in a rash on her lower back. Concerned it may be shingles, she made an appointment with a local clinic, was examined by two physicians, and told there was no conclusive cause for the rash. Patient continues to have the rash.
Itching; Handsswelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling). At the time of the report, PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling) outcome was unknown.            Patient stated that he is taking Benadryl.  Action taken with mRNA-1273 Moderna vaccine was Not Applicable
Fogginess, confusion, dizziness, higher than normal blood pressure, severe headache, trouble concentrating, short term memory loss
Shingles (Herpes Zoster) diagnosed on July 11, 2021.  Prescribed Valacyclovir 1000mg. Still taking today (it's second day of treatment. Rash started on July 9th, 2001.  NOTE:  I did donate blood on March 20th, 2021, about a month before my first dose (4/27/21) of the covid vaccine.  Some research shows that there is a temporary drop in certain immune cells after donating blood (serum protein & antibodies).  This should perhaps be looked into.
No symptoms for about 12 hours. But woke up with arm sore, quite inflamed, red and hot at injection site. I don't get a reaction with other vaccines.   My coworkers have had the same problem.
Redness, swelling, welt, and warm to touch about 1 inch radius from injection site, more swelling located medial to injection site. It went down after about 3 days, and then on 1/7/21, I woke up with pain at the injection area and redness again. Around 3:30/4pm that same day, my arm had even more redness and swelling than the day after the shot and was hot to touch.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, 26 doses of improperly stored LIQUID PEDVAXHIB injection (dose, route and lot number were not reported) had been administered to an unspecified number of patients. The temperature excursions were found to be supported excursion with in-house stability data. No adverse symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Starting about 15 hours afterwards, began feeling lightheaded and experienced chills. Fever of 101.5. About 20 hours after injection noticed rapid heartbeat (spiked at 150 bpm).  Resting heart rate is usually high (approx in the 80-90 range); treated at home with cold water splashed on face and resting, which decreased heart rate down to 120 range. All symptoms resolved by about 36 hours after injection.
1 wk after vaccine - fever 12 hours 100 degrees.  1 1/2 wk after intermittent swelling of digits.
Rash; inflammation; itching; hot; pain; tender to the touch beginning 9 hours post-vaccination and persisting greater than 96 hours.
Blurry vision; Difficulty reading; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 13:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 levothyroxine (MANUFACTURER UNKNOWN) and dexlansoprazole (DEXILANT); both for unknown indications from unknown dates and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and pregabalin (LYRICA); both for unknown indications on unknown dates and experienced drug allergy. On 06Mar2021 at 08:00, the patient experienced blurry vision and difficulty reading, which started the day after vaccination and continued (has persisted for 9 days). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blurry vision and difficulty reading was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shot 9/13 @ 11:30am Fever 10pm 101.5 lasting 24 hours Body aches 9/14 am, skin sensitive to touch Rash on arm below injection site, red, hot to touch and sore Rash on both sides of lower front neck 9/15am, swollen and sore supraclavicular lymph node on right side.  9/16 Rash wrapping around upper arm, splotches on both forearms 9/18 rash resolved, no longer sore to touch
Patient developed a fever about 2  hours after administration of vaccine of 104 on 4/16.  After fever 104 x 3 days patient was taken to urgent care, 4/19 found to be severely hyponatremic and acidotic was sent directly to ER.  Patient died in ER on 4/20/21.  Labs show normal wbc count, negative viral panel including covid, no other signs of infection on labwork.
my arm started to  hurt like someone was punching me in my arm/arm is very sore; had some itching/itching is in the upper and lower arm that she received the vaccine; lot of discomfort in her arm where she got the vaccine; injection site pain/she has had a lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts; lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts. She says for a while it was itching,; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 09:30 at single dose (right arm) for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient reported that she received her 1st vaccine shot last Thursday, 14Jan2021. She initially had no problem, then a day or 2 later, her arm started to hurt like someone was punching me in my arm. She also had some itching in the upper and lower arm where she received the vaccine; the itching was worse, but now it was better. She also had a lot of discomfort in her arm where she got the vaccine. She says it felt sore and hurts and for a while it was itching, but it stopped itching, she has no rash, just her arm was very sore. Patient reported that she never got her vaccine card after she left the room where she was observed for 15 minutes, and when she asked, they said she won't get the card until after her second shot. She says that she saw on all of the directions for the vaccine it says to keep your card, but when she left the room they told her she won't get it until after her second shot. She confirmed she has only had her first dose. Patient reported that she had no other recent vaccinations or started no other new medications. Outcome of events was unknown.  Information on the lot/batch number has been requested.
A report has been received from a health professional concerning a patient with unknown age and gender. The patient's medical history, concomitant medications and concurrent diseases were not reported. The patient received nasal FLUMIST on an unknown date. The patient tested positive for Influenza A. The outcome of the event of tested positive for Influenza A was unknown. The report was considered to be non-serious as per reporter. Corrected report 04-Mar-2013: event coding was corrected.
Very swollen lymph nodes under L arm, torso, and L breast; still present as of 1/11
Headache, Diarrhea, NauseaVomiting, body stiffiness, bump at injection site right arm Narrative:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash was unknown and the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in a last week of reporting date. The vaccine was not administered at the reporter's pharmacy, so she did not have many details about the vaccination. On 5th May 2018, the patient came to the pharmacy, so she did not have many details about the vaccination. On 5th May 2018, the patient came to the pharmacy with the rash from shoulder to wrist on arm where the patient received SHINGRIX. The rash was initially itching, but by the time the patient went to the pharmacy, the itching had resolved.
pfizer vaccine was given after being in freezer for 22 days - shehas not decided if she wants replacement dose
Weakness pain in all muscles and joints fever 100.4f dizziness inability to regulate temp (I'm freezing.). If this gets much worse I will go to the hospital.  This set of symptoms mirrors exactly what happened when I got Covid last December, but worse and progressing faster.
resp distress following inj of flu vax;adm to hosp for 24hr;
Occlusive deep vein thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE: 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 DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Author stated that there has been limited information regarding thrombosis development after receiving a messenger RNA (mRNA)-based vaccine. This case series highlights four different patients who received an mRNA-based COVID-19 vaccine and subsequently developed venous thromboembolism. Therefore, author hope that after reviewing this article, physicians will be more aware of thrombosis-related developments following mRNA vaccine administration for COVID-19. Fortunately, with early diagnosis and prompt treatment, patients can still expect full recovery from any vaccine thrombosis-associated complications, and the benefits of receiving an mRNA-based COVID-19 vaccine still outweigh the risks of post-vaccination complications.  Company comment: This is a literature non-study case concerning a 58-year-old male patient with No Medical History reported, who experienced the serious unexpected medically significant AESI deep vein thrombosis (reported as Occlusive deep vein thrombosis). The event occurred after receiving the booster dose of mRNA-1273 vaccine (event and vaccine date were not provided). No treatment or concomitant medication was provided. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732783:31-Y-F
diarrhea; a little weakness; muscle pain; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: NNI, FU call with patient's granddaughter, granddaughter states patient has no email and no one to speak on patient's behalf
20 minutes after shots: Cough, child looked tired, slightly lethargic, child passed out for about 45 seconds to 1 minute. When he came to, he had no clue what happened and kept passing out. I rushed him to the ER where they treated him for syncope.
Arm soreness at injection site worsened throughout the day - continuing for about 15 hours; about 17 hours (12:30am) after the injection took place, dizziness, unexplainable arm and chest pains (in the non-injected arm), headache, and fatigue occurred until I went to sleep; I woke up with a fever and fatigue about 7 hours later (8am), went back to sleep, and woke up feeling normal about 4 hours later (12pm)
Body ached so bad couldn''t move; Nausea still after 4 days; Headache; foggy; fluttering in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single, administered in arm left (Batch/Lot number: unknown) as dose 2, single and administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL HFA; SYMBICORT RAPIHALER. Past drug history included: Known allergies: tetracycline, reaction(s): "Drug allergy"; Known allergy: opioids, reaction(s): "Drug allergy".  The following information was reported: PAIN (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Body ached so bad couldn''t move"; NAUSEA (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Nausea still after 4 days"; HEADACHE (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "foggy"; TINNITUS (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "fluttering in ears". Therapeutic measures were not taken as a result of pain, nausea, headache, feeling abnormal, tinnitus.  No follow-up attempts are possible. No further information is expected.
Irregular mammogramS -- lymph nodes ALSO, irregular blood tests ...IgG.....IgM...MONO%...MONO#...Calcium spike
Patient non-responsive with cool, clammy hands, non responsive to noxious stimuli, eyes rolled back, tolerated oropharyngeal airway briefly while rescue breaths were given for inadequate breathing.  Transferred to community hospital for further eval.
2 min. after GARDASIL, pt. fainted for 5-10 sec. Did not hit head. No vomiting. OJ and sucker given prior to administration. Laid down. BP 113/67 HR 82. Monitored for 20 more min. in office. VS WNL 115/69 HR 77.
Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Gout, and Arthritis.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included high blood pressure medication, cholesterol medication, gout medication, arthritis medication.  No treatment information was provided.   This case was linked to MOD-2021-370207, MOD-2021-370208 (Patient Link).