chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out if upright for too long; Nausea; Severe abdominal pains; Racing heart; Feeling like I was going to pass out; This is a spontaneous report from a contactable Other HCP (patient). A 39-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left, on 07May2021 16:00 (at the age of 39-year-old, not pregnant at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine, hypothyroidism. Concomitant medications included escitalopram oxalate (LEXAPRO); imipramine; levothyroxine; meloxicam.  The patient received them within 2 weeks of vaccination. The patient previously took topiramate (TOPAMAX), rizatriptan benzoate (MAXALT), flu vaccine, nitrofluorontin, neomycin, and had known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07May2021 16:15 (as reported), the patient experienced nausea, severe abdominal pains, racing heart and feeling like she was going to pass out when upright in the first 24hours post shot. Passed out if upright for too long. Racing heart would calm down after laying back down. No treatment received for all events. Events outcome was recovered in May2021.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of loss of consciousness and other. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate
Pt hospitalized 2/25/18 requiring supplemental O2 and TYLENOL for fever 103.4 degrees F, alb. neb treatments. Discharged 2/27/18 at 10:17. Follow up call 2/28/18 mother states "patient is back to her old self ".
Fever; chills; body aches; migraine; migraine; This is a spontaneous report from a contactable consumer (patient) received via a sales representative. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0153) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. No other health issues. The patient's concomitant medications were not reported.  The patient experienced fever, chills and body aches. Woke up today (15Apr2021) with a migraine as well. Events took place after use of product. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Itchy rash all over my body; Right hand was sore; the injection site was sore; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), via an unspecified route of administration, administered in right arm on 22Feb2021 10:30 (at the age of 78 years old) as dose number unknown, single for covid-19 immunisation. Medical history included Blood pressure (abnormal) from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure measurement (blood pressure abnormal) from 2000 and ongoing at an unknown dose (reported as 10/12.5 mg), once a day; rosuvastatin at 5 mg, once a day taken for an unspecified indication, start and stop date were not reported; and omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. The patient was also concomitantly taking, unspecified vitamins. Patient got the shot on 22Feb2021 and that was about 10:30 in the morning and then when patient woke up the next morning, 23Feb2021, patient had a rash, itchy rash all over my body. It lasted most of the day, but it was gone by the next evening. So, patient only had it for one day, the itchy rash. Patient's right hand was sore, and the injection site was sore (23Feb2021). This only lasted for one day and by that time the pain was gone. The soreness started "the next day on the arm". The sore arm was with patient for a few days. Weight on an unspecified date "was about 165." Patient did not receive treatment for events and stated, that she did not do anything. It was itchy, but she could live with it. At the time of the report, patient didn't have a sore arm now, and patient didn't have a rash now. The rash, maybe 24 hours and the rash was gone. The event itchy rash recovered on 24Feb2021, while the events right hand was sore and the injection site was sore were recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Right arm pain, numbness, tingling, down the arm, numbness of fingers and hand, limited range of motion
Child presented on 07/01/2016 at 12:00 pm with right deltoid swelling, rash, and skin warm to the touch.
Information has been received from a registered nurse concerning an elementary school aged child patient with medical history and allergy unspecified who on unspecified date was vaccinated with VARIVAX (Oka/Merck) (Lot # was not provided).  After receiving 2 doses of VARIVAX (Oka/Merck) (Lot # was not provided), the patient experienced chicken pox.  The patient sought medical attention, but lab and diagnostic tests was unspecified.  No further information was provided.  Additional information has been requested.
This report described possible infection at the injection site in a 20-month-old male who received DTaP. On 05/16/01, the vaccinee a 0.5 IM left deltoid dose of DTaP; it was not known many doses of DTaP the vaccinee had previously received. Subsequently, the vaccinee experienced a "large" swollen area at the injection site (left shjoulder) with pain. He was found to have allergic vs. infection". The vaccinee was treated with amoxicilliin  trihydrarte/clavulanic acid (Zyrtec) 25 mg daily. The reporter stated that the adverse events could possibly be associated with erroneous administration. As of 10/04/01, the outcome of the events was unknown.
Breakthrough case admission after 3 vaccines  Pfizer 1/27/21 lot# EL9261;  Pfizer 2/27/21 lot# EN6201;  Pfizer 11/12/21 no lot#
Right arm immune brachial plexitis/ parsonage turner syndrome Alopecia areata involving scalp Absent menstrual cycles
Staff member drew up 1.3 ml of normal saline dilutant into a syringe and then drew up 0.2ml of pure vaccine into the same syringe and then administered this 1.5ml dose into the child's LA.  Based on calculation it appears that the child received 3 times the normal amount of pure COVID 19 Pfizer Bivalent 5-11y vaccine.  Child is not experiencing any symptoms or side effects of this event.
Patient died on 9/13/2021 - Cause of Death Pulmonary Thromboemboli
No appetite; does not taste food very well; either really hot or really cold; headache; Nauseous; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was very sore), NAUSEA (Nauseous), HEADACHE (headache), DECREASED APPETITE (No appetite) and TASTE DISORDER (does not taste food very well) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 09-Jan-2021, the patient experienced NAUSEA (Nauseous). On 12-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold). On 12-Jan-2021, NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was very sore), HEADACHE (headache), DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
24 hours after rec' the vaccine she had started her cycle with blood clots. Her cycle did not come on that day. She had to use the bathroom no matter what time for it to come on. Doctor office, Doctor perfomed a series of lab test. Doctor states that she is getting blood clots and think it may be from the vaccine. SHe had her cycle for 16 days straight and now has become anemic.
Dizziness, Headache, Fever, Tachypnea, CoughWheeze, Diarrhea, NauseaVomting, MD visit- covid test, cough meds, antibiotics--injection site pain Narrative: antibiotics, cough meds - started feeling better 1/27 - RELATED TO FIRST DOSE
Mom states rxn began several hours after vaccine given. Sx's included redness, swelling & warmth at site. Sx's persisted x 10d, and became weepy, skin cracked & with d/c & odor.
Nose bleeding about 12 hours after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 22Mar2021, the patient experienced nose bleeding about 12 hours after the injection. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in a visit to the emergency room/department or urgent care. Therapeutic measures were not taken as the result of the event. The clinical outcome of the event nose bleeding was 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.
Developed T approx 3hrs post vax;Pt did not sleep-cried all nite;MD recommended ASAP;MD felt pt reacted to Pertussis&advised only DT;pt had rt ear infection
Painful and extremely swollen lymph nodes in neck by left collar bone and in left armpit. Larger than a quarter since 02/23/2022. Still large and painful on 02/28/2022 (today).
Fever 100.1 vomiting, chills, arm hurt, for 2 days
itchy rash; severe bruising; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itchy rash) and CONTUSION (severe bruising) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Disorder gastrointestinal (unusual gastrointestinal problems). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, URSODIOL, RIFAXIMIN, LIOTHYRONINE SODIUM (CYTOMEL), LORAZEPAM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B12) and PARACETAMOL (TYLENOL) for an unknown indication.    On 01-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced RASH PRURITIC (itchy rash) and CONTUSION (severe bruising). At the time of the report, RASH PRURITIC (itchy rash) and CONTUSION (severe bruising) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   After she got the 1st dose of the bivalent vaccine, she had very itchy rash and severe bruising. She consulted a colleague and was told that it was concerning and that if she was getting another bivalent dose, she should take premedication like antihistamines or steroid. She did not have a problem with her 1st 2 doses.   This case was linked to US-MODERNATX, INC.-MOD-2023-739852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739852:same reporter ( Different Dose 2)
After the first vaccination, I had headaches that lasted for one week, extreme throbbing behind my right eye. Migraines, lethargy and exhaustion.   After my second vaccine on Saturday, I woke up in the middle of the night vomiting violently with the chills, then a fever, headache and muscle aches.
Initial report was received on 01 October 2010 and 26 October 2010 from a health care professional. A 54 year-old male patient with a history of an upper respiratory infection (URI) after receiving a "flu" vaccine at age 49 and also in the "1980s", had received a left deltoid (LD) injection of FLUZONE, lot number UT3569BA (route not reported) on 30 September 2010 and the next day, experienced a productive cough, increased chest mucous (mucus) and weakness in the chest. Concomitant medications include niacin, FLOMAX, metoprolol, PREVACID, ASA and multi vitamins. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002939, expiration date: 29-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
MICRO BLOOD CLOT; HIGH BLOOD PRESSURE; This spontaneous report received from a company representative concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient was healthy and fit. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, the patient's blood pressure was increased and he was taken to the emergency room (ER). Later, he was diagnosed with micro blood clots and he was hospitalized . As per his doctor, micro blood clots might be linked with vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the micro blood clot and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210846293-COVID-19 VACCINE AD26.COV2.S-micro blood clot, high blood pressure. 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).
Pt recvd 1st dose of Recomb on 19FEB91 & 2 & 1/2 hrs p/vax pt devel a diffuse pruritic rash on chest; w/in 24 hrs sx subsided & pt recovered;
Rash over entire body. Went to ER given IV, prednisone, Benadryl, Zyrtec. Today is 10-5-09 still has rash - will see PCP.
The patient reports having soreness in the arm/injection site as well as redness. Recommended the patient use cold compresses as well as tylenol for the pain.
eyes very red, itchy & watery;dry mouth, felt like object in throat 1hr p/vax;persistent cough;BP fine, P=fine;called MD who sent to ER;tx w/DPH;throat better;6PM devel temp 100.6 & was achy;nothing unusual to eat or drink;
MMR site very erythematous w/in minutes p/inject; DPH given in lt thigh @ 255; erythema much reduced 345PM when released w/mom;
patinet presented with nausea,vomitting and diarrhea, was treated with fluids.Patient was discharged home
Had regular physical for sports at my college.  During physical doctor stated that testicals were swollen (blood vessel) on left side. Said need to watch and report if needed.  Moved to college ended up in UPMC ER Aug 27,2021.  Left leg was swollen as well as scrotem. Was painful.  Had ultrasound.  Have blockage in blood vessels  more on right than left.  Will/can effect fertility.  Watch for changes, contact dr.  Get underwear with the sack pouch.
Thrombophlebitis in the left dorsal foot on 8/22, resolved same day. Development of similar tender, warm, red areas on the left medial calf 8/23, lasted for about 6 days. Those two sites resolved on 8/30, and new area developed on the right anterior-medial ankle. 8/31 ultrasound was performed to evaluate for DVT, which was negative. D-dimer drawn that day was notably elevated. 81 mg Aspirin started. Intermittent chest pressure and mild SOB increased to constant on 9/5, resulting in UC visit. CTA chest negative for PE. Follow up office visit on 9/7 with ankle still symptomatic, repeat ultrasound confirmed 7.4 cm fully occluding thrombus of the distal portion of the left greater saphenous. 45 days xarelto started on 9/11.
Patient is fully vaccinated.  Vaccinated recently in August.  COVID + on 12/8/2021.  Hospitalized from 12/7-12/14. Admitted with SOB and hypoxia.Hyperkalemia (5.5).+ for Thrombocytopenia.    Patient is a knoVitals: Blood pressure 95/57, pulse 60, temperature 97 °F (36.1 °C), resp. rate 16, height 172.7 cm (5' 8"), weight 61.7 kg (136 lb), SpO2 93 %.wn case of congestive heart failure coronary artery disease and diabetes who presented to the hospital acute.   Respiratory failure related to COVID pneumonia.   Patient is status post been treated with IV steroid and also IV antibiotic for the pneumonia. Lovenox SubQ daily Patient will continue on Breo inhaler daily and albuterol nebuizer.    Patient condition continued to be improving and patient weaned off from high-flow oxygen to nasal cannula. Discussed the case with the brother who opted for the patient to be transitioned to go to subacute rehab.  Discharged to rehab.
Varicella administered in right thigh, MMRV administered in left thigh, pt has slight redness at right thigh injection site
Patient received wrong Covid-19 vaccine. Received Moderna when Pfizer was indicated. No swelling of tongue, throat, or face. No difficulty swallowing, speaking or breathing. No abdominal pain or distress. No swelling in any extremity.
feeling pain around the injection site; pain in whole part of her shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (feeling pain around the injection site) and ARTHRALGIA (pain in whole part of her shoulder.) 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 No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PAIN (feeling pain around the injection site) and ARTHRALGIA (pain in whole part of her shoulder.). At the time of the report, INJECTION SITE PAIN (feeling pain around the injection site) and ARTHRALGIA (pain in whole part of her shoulder.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Patient has a history of dizziness, headaches and Tourette's syndrome.  Immediate complaints of headache, nausea, arm tenderness and being dizzy. Patient was laid down, given water and a snack. She was discharged with her parents after 30 min of observation.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 12-JUL-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, lot # L035506 with expiry: 16-DEC-2016, for prophylaxis and sterile diluent (MRK INJ) (lot# and expiry unknown by the reporter). No adverse effects were reported. Additional information has been requested.
Diagnosed with Bell's Palsy.  Symptoms began 4/9 and still occurring. Treatment has included steroids,  antibiotics, antivirals, eye drops, and physical therapy.
This spontaneous report was received from a quality coordinator who reported that an unspecified number of patients were administered an unspecified number of doses of GARDASIL, from 24-SEP-2013 to 31-OCT-2013, that were exposed to temperatures as high as 55F for 126 hours and 55 minutes and as low as 29F for 188 hours which was not supported. No adverse events were reported. This is one of several reports from the same reporting source. Additional information has been requested.
Severe headache for 3 days, itching and rash only on upper body, saw Dr. at Health Center and received Steroid Dose Pack along with a Prednisone Injection, rash in healing stages, not completely gone
pt recv vax; inc T 103; v x 24 hr; CBC - WNL;
Diagnosed with COVID on 4/14. Admitted . Released on 4/18. Readmitted to hospital with pneumonia and low O2 levels,high blood sugars.
Myalgia inj site swelling and pain; chills, body aches Narrative:
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2017, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.