chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Arm is killing; very weak; Couldn't hardly eat; injected thru the band aid in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) and CHILLS (Chills). On 26-Feb-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) had resolved. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.
Medical Information Potential AE; Ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching.  Rash and itching continues./Followed by a rash; Ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching. Rash and itching continues.; She experienced pain that lasted for about 3-4 days; she was diagnosed with covid arm about 10-12 days after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration in right arm on 25Mar2021 at 11:15 AM as single dose for COVID-19 immunization. Medical history included sinusitis, Allergy to antibiotic. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously took ibuprofen (ADVIL) and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Apr2021 at 08:00 AM, ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching. Rash and itching continue. Patient was diagnosed with covid arm about 10-12 days after the vaccine. She experienced pain that lasted for about 3-4 days. Followed by a rash. New or worsened muscle pain on 06Apr2021 was reported. She had the COVID arm like is mentioned on the CDC website after the first injection. She needs advice to proceed with second one. It was a delayed response happening 10-12 days after the initial vaccine. The rash appeared on inside of elbow and creases of underarm on right side where shot was administered. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events rash/itching occurred inner elbow right arm followed by same under the arm was not recovered; for other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Although test read normal, there was thickening under skin for over a week.  Site remained red, dime size area for two weeks and still hasn't completely faded after four weeks.
FIRST DOSE:  Little to no adverse reaction  SECOND DOSE:  12 hours after administration I began shivering quite severely. -After sleeping for 3 hours I awoke covered in sweat, with an extremely intense piercing headache. Fever was 104. Only relief was ibuprofen after several hours.  -12 more hours and the headache and fever went down. Expected but extremely intense.  (inflammatory cytokine response?)   -Following days began having IBS like symptoms. Diarrhea, then colon spasms that made me feel like I had to "finish" but there was nothing left.  This lasted two weeks.   THIRD DOSE: Same reaction as second dose. Though more pronounced shaking from the cold.  -Two months later Gut health upside-down. Celiac like symptoms. IBS like symptoms.  Anything ate turned to soft stool. This was helped by various supplements / probiotcs but is still an everyday occurrence after 11 months.  -11 months; extreme brain fog setting in. Work completely disturbed. Extreme depression. Anxiety spiking out of control, worsened by all the above.
Myocarditis; Started having symptoms and typical symptoms; A spontaneous report was reported from a nurse (patient), concerning herself, a 62 years-old female patient, unknown race and ethnicity, was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced myocarditis, and started having symptoms and typical symptoms (vaccination complication).     The patient's current condition included blood donor. Concomitant medications reported included acetylsalicylic acid, atorvastatin, and escitalopram.   On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient had nothing after the first dose and typical symptoms after the second dose. She started having symptoms on 07 Mar 2021. The patient was healthy and doesn't have any coronary disease. This was a red herring and stated that she was a blood donor and gave blood on Sunday, 07 Mar 2021. That's, the same day, the symptoms started. Also, the patient was a blood donor all last year. All the antibody tests were negative for last year and including the recent 07 Mar 2021 donation. This was outside the window of expected reactions, but she's been diagnosed with myocarditis, effective last week on 11 Mar 2021. The patient reported that the doctor started her on metoprolol tartrate 25 mg twice daily, which was started on 14 Mar 2021.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the events, myocarditis, and started having symptoms and typical symptoms were considered as 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. However, Further information is requested.
Metallic / acidic taste and burning in mouth and throat which began roughly a week after vaccination and has persisted since that time.
at 1pm EST on 3/19/21 patient reports onset of fatigue. then around 3pm 3/19/21 she developed nasal congestion, sore throat, increased fatigue, muscle aching generalized, backache generalized mid and lower back, chills, headaches, loss of appetite, swollen neck glands. She visited the Health Clinic on 3/20/21 at 3:40pm at which time she was noted to have temp of 100.6 and heart rate of 108. General exam indicated some tender anterior nodes, nasal mucous, and fatigued appearance.
The patient began to experience severe dizziness. While laying flat the patient complained of pain in the arm that received the vaccination and complained of feeling hot. The patient decided to be transported to the hospital.
intensive lower abdominal pain, electrical nerve pain in right knee, Late night Charlie horse that wrapped around upper abdomen (liver area), Massive headaches, severe leg pain (rt  only)Working up from back of knee to top of thigh (VERY intense and most concerning because it felt very much like a blood clot, severe loss of short term memory for 3 days, Dizziness, loss of appetite, nausea   All this starting on day following vaccine and for 5 days.
Arm pain at shot site, swelling under arm and pain on shot side, pain in part of the chest and back on right side,, severe joint pain all joints, fever, extreme exhaustion
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. Patient's pertinent medical history and concomitant drugs were not provided. On 07-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9, lot # M004116, expiry date 12-OCT-2017 (dose, route of administration not reported). On 18-JUL-2016, the patient was vaccinated with the second dose of GARDASIL 9, lot # M004116, expiry date 12-OCT-2017 (dose, route of administration not reported). On 19-OCT-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M020103, expiry date 15-FEB-2018 (dose, route of administration not reported). No adverse effects were reported. There was no PQC involved. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The nurse reported that the patient received her first dose of GARDASIL in July 2012, her second dose in January 2013 and her third dose in March 2013 (lot numbers, expiration dates and doses were not reported). No adverse event was reported. The patient's outcome was not reported. Additional information has been requested.
Swollen armpit lymph nodes; A spontaneous report was received from a consumer, concerning a male patient of 32 age, who received ModernaCOVID-19 vaccine .  The patient's medical history was not provided. Concomitant product code was  provided as finasteride 1mg. On an 7-jan-2021 ,  the patient received their first of two planned doses of mRNA-1273 at Hospital.(lot number unknown) via unknow route of administration.   Said that 1/15/21 9 days after the vaccination the patient had swollen armpit lymph nodes patient never had any adverse reaction after being vaccinated not until 9 days after.  Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, shingles was considered to be not resolved at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from healthcare worker refers to unspecified number of patient of unknown demography. On an unknown date, the unspecified number of patients was vaccinated with improperly stored oral, ROTATEQ lot # L008578 (expiry: 14-DEC-2016). No adverse effects have been reported. The temperature for improperly stored oral, ROTATEQ was reported as 30 Fahrenheit. The time frame was reported as one hour. No product complaint (PQC) was reported. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
little bit of discomfort; Torn rotator Cuff muscle; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) 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 Shoulder discomfort.   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, 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 DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle). The patient was treated with Physical therapy (Exercises) for Rotator cuff syndrome. At the time of the report, DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle. On an unknown date, X-ray: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient said that after the shots , she developed a LOT of shoulder pain ( 8 to 9 out of 10 ) in a 10 scale range .   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received. Updated the Medical history, Lab data, Vaccine information (Dose 1 and 2), Action taken (from unknown to not applicable) and Events (Hypokinesia and Arthralgia).
patient was administered an expired dose of Act-Hib/no AE.; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a 19 month-old female patient who was vaccinated with 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] which was already expired (batch number uj076aa and expiry date 21-Aug-2020) via intramuscular route in unknown administration site on 31-Aug-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination  It was an actual medication error case due to expired vaccine used (latency: on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I am 26 weeks pregnant and had my 2nd shot at 26 weeks on 8/31/2021. I had a routine OB visit on  9/1/2021(the next day) and on the morning of  9/1 i noticed my left foot and lower leg were swollen and not the right. At my OB appointment my doctor thought it was important I get a venous doppler to rule out the possibility of a blood clot. It was done STAT and no clot was found.
Onset with redness, swelling and itching on right lateral deltoid where DTaP had been given. Measured 9.5cm in diameter. Advised, ice and Tylenol. Redness began resolving on Sat. much improved by 6/15/04.
Information has been received from a physician concerning a 6 months old male who on 04-AUG-2009 was vaccinated with the third dose of ROTATEQ (route and lot# not reported).  On 10-AUG-2009 the patient developed intussusceptions.  The patient required surgery.  At the time of the report, the patient's outcome was unknown.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.  9/22/09 Hospital records received DOS 8/13/09 to 8/22/09. Assessment: Ileo-Colic Intussusception.  Patient presented with history of bilious vomiting and abdominal pain. Lethargic, dry mucous membranes and skin. Dehydration. No bowel sounds. Abdominal mass. Respiratory distress. Barium Enema administration - unsuccessful reduction of intussusception. Surgical resection of intussusception, ileocolectomy with ilial transverse colostomy.  10/5/09 ICD-9 Codes: 751.5 Intestinal anomaly, 038.9 Septicemia NOS, 995.92 Severe Sepsis, 518.81 Acute Respiratory Fail, 785.52 Septic Shock, 285.9 Anemia NOS.
Localized moderately tender L sided anterior cervical lymphadenopathy that began same day as the COVID vaccine first dose. Possible association to concomitant acute pharyngitis however unlikely as the LAD preceded the pharyngitis by at least 3 days.
Thinking is not straight forward; Dizziness in head; Nervous; Heart palpitations; Got a bad feeling after first shot; "inward heat" feeling; Sensation that she has "lead" and it affects her focus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Got a bad feeling after first shot), FEELING HOT ("inward heat" feeling), DISTURBANCE IN ATTENTION (Sensation that she has "lead" and it affects her focus), THINKING ABNORMAL (Thinking is not straight forward) and DIZZINESS (Dizziness in head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Got a bad feeling after first shot), FEELING HOT ("inward heat" feeling), DISTURBANCE IN ATTENTION (Sensation that she has "lead" and it affects her focus), THINKING ABNORMAL (Thinking is not straight forward), DIZZINESS (Dizziness in head), NERVOUSNESS (Nervous) and PALPITATIONS (Heart palpitations). At the time of the report, FEELING ABNORMAL (Got a bad feeling after first shot), FEELING HOT ("inward heat" feeling), DISTURBANCE IN ATTENTION (Sensation that she has "lead" and it affects her focus), THINKING ABNORMAL (Thinking is not straight forward), DIZZINESS (Dizziness in head), NERVOUSNESS (Nervous) and PALPITATIONS (Heart palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
VOMITING; NAUSEA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not on any medications. 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, administered on 08-APR-2021 around 12:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 08-APR-2021, treatment medications included: paracetamol. On 08-APR-2021 17:00, the subject experienced chills. On 08-APR-2021 17:00, the subject experienced headache. On 08-APR-2021 17:00, the subject experienced fever. On 08-APR-2021 22:00, the subject experienced nausea. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-APR-2021 03:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, was recovering from fever, and had not recovered from headache, nausea, and vomiting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
pt recv vax & 1/2 hr following vax rt eye & cheek devel a rash;mom gave APAP as ordered q 4 hr;pt was fussy & restless & did not sleep well-rash spread over entire body 28JUL95;pt sent to MD
5:30PM 3/4/11 Child was clammy and complaining that he felt sick like he was going to throw up. 6:30PM 3/4/11 Child was extremely weak and not able to walk real well so he sat down. Child burning up, parent not sure how high fever was they were away from home and did not have access to thermometer. Mother medicated child with ibuprofen.  10:30PM 3/4/11 Sibling alarmed parents that something was wrong with his brother in bed. Mother ran to him to find him convulsing and not responding to her. They were getting ready to go to ER and she picked up the child and he vomited. After that child spoke to the parents and he fell asleep. Child the next morning was otherwise sleepy, but more himself. To this date, child has been fine.
no rxn until 4hr p/inj when had abrupt onset of high pitched, non stop screaming;p/another 90min had poss apnea spells
patient presented with a (L) hand numbness + coldness (ipsilated to vaccine) right after her vaccination symptoms resolved after a warm shower
Pt recvd vax & devel elevated liver function tests; No further details were provided;
cough, chills, shortness of breath, chest pain and started on home oxygen prior to admission
Immunizations on 06/10/2003.  DTaP and IPV in left arm intramuscular.  Reaction started 06/11/2003.  About the size of a silver dollar.  today the area is baseball size.  3.5 in long x 3in wide.  1 small area in aspect of left arm.  size of quarter.  Area is warm and tender.  Mobility intact.  NO fever.
Day after my shot in the morning I felt very sore muscles hurt tempture of 100.9 sore throat cough Left side neck pain. day 2 ache all over body 100.7 temp. headache, sore throat arm red and swollen sore . Couldn't sleep arm throbed. Day 3 nauseous arm hurts left side neck hurts. Feel tired run down temp 100.2.. 4 day headache arm hurts red tired neck hurts temp 100, day 5 tired ache all over arm hurts temp 99 neck hurts I am taking tynoel
BAD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up was requested for this case. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced bad fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad fever. This report was non-serious.
Lightheadedness, rapid breathing, tingling sensation all over the body, sudden drop in blood pressure to 80/50. Lasted about 20 minutes and then gradually subsided without medical treatment .
Patient experienced chest tightness and difficulty breathing, jittery feeling, and nausea after receiving the Covid vaccine. Patient was administered PO liquid Benadryl 12.5 X 4, supplemental O2 was given, and patient was monitored for 62 minutes. Patient was discharged to coworkers and instructed to take 50mg Benadryl PO 30 minutes prior to second vaccine, and to take Benadryl PRN on their own.