chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30+/- hours later I broke out in a rash on my upper body (chest, neck, shoulders, back).  Rash lasted 4 days, but itching on upper body continued.
10/15 Stomach cramp, vomiting, diarrhea. 10/16 Fever, pain at injection site. left shoulder redness, swelling edema. 10/17 hospitalized and treated with APAP. rehydration and ABX.
Dizziness lasting hours at a time on multiple days since injection. Nausea at times as well.
BP went up 170/90; increased heart rate and pulse; This is a spontaneous report from a contactable nurse (patient). This 55-year-old (non-pregnant) female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0140, expiration date: not reported) via an unspecified route of administration into the left arm on 19Feb2021 13:30 (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient medical history included hyperthyroid, PSA, rapid pulse, Vit D and magnesium deficiency, headaches. Concomitant medications included atenolol; apremilast (OTEZLA); levothyroxine; vitamin d nos (VITAMIN D); magnesium. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0140) via an unspecified route of administration into the left arm on 25Jan2021 10:30 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation at Hospital. No other vaccine in four weeks. No COVID prior vaccination nor tested post vaccination. No known allergies. A day after shot, on 20Feb2021, at around 17:30 PM, the patient experienced BP went up 170/90 and increased heart rate (112) and pulse. This continued the day after injection on 21Feb2021 (Saturday) and on 21Feb2021 (Sunday) off and on. This also continued after medications were taken for increased heart rate and pulse. Her BP and heart rate always responded to medication. Currently, it was 22Feb2021 (Monday) and so far, vital signs (V/S) were normal. Unspecified treatment was taken for BP went up 170/90. No other treatments received. Outcome was resolving for both the events. Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal relationship, the association between the event BP refractory to medication after vaccination can not be fully excluded. History of hyperthyroid may also be contributory.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Hot red and hot area of vaccine site on right arm. Noticed symptom on 4/26/21. No fever.
PATIENT RECEIVED PFIZER COVID VACCINE ON  Dose 1 date: Institute - 4/9/2021, Dose 2 date: Institute - 4/30/2021, AND  TESTED POSITIVE TO COVID ON 8/16/21.
Vaccine was given in the left arm.  Lymph nodes under left arm and under left collar bone are swollen.
Patient received 1st dose of Gardasil vaccine and the next day her arm got red and swollen and she experienced nausea and dizziness. 4 days later she reports arm continued to swell and be painful, but denies fever or chills. Patient was advised to take dihenhydramine and use ice on the area.
Stabbing pain, upper left side of chest; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 12:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma, chronic obstructive pulmonary disease (COPD), attention deficit hyperactivity disorder (ADHD) and COVID-19 infection. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluticasone furoate/ umeclidinium bromide/vilanterol trifenatate (TRELEGY), dexamfetamine sulfate/amfetamine sulfate/ dexamfetamine saccharate/amfetamine aspartate monohydrate (MYDAYIS), salbutamol sulfate (PROAIR), paracetamol (TYLENOL) and guanfacine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On an unknown date in Sep2021 at 17:00, the patient experienced stabbing pain in the upper left side of chest for two weeks before improving gradually over next two weeks. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'stabbing pain, upper left side of chest' was resolved on an unknown date in 2021.
This spontaneous report as received from a pharmacist via company representative refers to a 54 year old patient of unknown gender. The patient's pertinent medical history was not reported. Approximately in September 2015 (reported as last week), the patient was vaccinated with PNEUMOVAX 23 (lot # L007720 and expiry date: unknown, dose and frequency were unknown) and influenza virus vaccine inactivated (unspecified) (reported as flu shot) in the same arm. Approximately in September 2015 (reported as within five days of administration), the patient came back to the pharmacy and stated that he/she experienced arm soreness in the arm where the vaccines were administered. The outcome of the event was unknown. The relatedness of the events with suspect therapies was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Began to have difficulty breathing, tingling in left arm (injection site) traveling up left side into neck and head. Dizziness.  Tongue felt numb on left side, heaviness in chest. Contacted PCP-advised ER treatment immediately.  Symptoms remained for 24 hours - re-occured when an item containing bakers yeast was consumed.  Have not eaten bread or baked items since.
Dermatitis developed on L upper arm around site of injection-saw MD in office after 6 days.
Severe lower back pain.  Severe gout-like pain in right foot, not restricted to right toe joint.  Fever. Long term: Fever subsided, back pain subsided.  Pain in both feet that continues since the date of onset.  Disability.
Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Left arm tingling , pain as soon as shot was adminitered. Pelvic nerve pain , burning sensation on left pelvis within few hours of shot.
aches; fever; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (aches), PYREXIA (fever) and CHILLS (chills) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (aches), PYREXIA (fever) and CHILLS (chills) had resolved.      No concomitant medications were reported. It was reported that after receiving the vaccine patient had experienced fever, chills, and aches that lasted for about 10-12 hours. No treatment medications were reported.   This case was linked to MOD-2022-642391 (Patient Link).
Had vaccines but got shingles last week / suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had vaccines but got shingles last week / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by the patient via interactive digital media. The patient had vaccines but got shingles last week  The shingles lasted for a week only with medication and no pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
SOB, coughing , BNP and BUN elevated. Covid REGN-Cov2 antibodies
No adverse reaction, patient got symptoms 3 weeks later after second vaccine, tested positive for Covid 19 on 3/29, patient was fully vaccinated.
Nurse documented that she gave a Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
stuffy nose; cold; little bit of headache; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HEADACHE (little bit of headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On an unknown date, the patient experienced SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold) and HEADACHE (little bit of headache). At the time of the report, SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HEADACHE (little bit of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
EXTREME pain in the arm, body aches, fever sweats, internal organs hurt, hip and lower back pain that began within 24hrs of injection. Flu-like symptoms continued for two weeks
the patient presented her sisters id . Due to communication issues and pt looking slimiar to id we assumed the id was hers. After patient immunized they brought back the imz card stating we had the wrong date of birth. I paged patient and she stated that infact she presented an id with the dob that we thought was hers. So it was a 14 yo getting the imz.
Pediatric Customer received incorrect dose of Pediatric Pfizer (0.3ml) IM; nurse of drawing vaccine (LPN) diluted 0.3ml of normal saline into the Peds Pfizer Vail drawing just 6 vaccines. when she noted the error this customer already received the dose of (0.3ml) and customer already left the observation area. Customer didn't have any adverse reactions or symptoms.
Shock symptom; drowsy; felt like she had the flu; odd reaction; shaking like cold extreme; hands hurt; legs hurt; stomach ache; chills; mild fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction) and TREMOR (shaking like cold extreme) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache). At the time of the report, SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information were not provided by the reporter.  Concomitant medications were not reported by the reporter.  Company comment: 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.; 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.
No problem 1st set immun. fever 1 day elevated 102, decreased appetite, fluids and solids. Consolable when held, otherwise cranky and cries. Vomited x 2
extra dose administered; Inappropriate schedule of vaccine administered (3rd dose administered on 01-JUL-2010); This spontaneous report has been received from a physician, via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included nspecified polio vaccine inactive, rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and hepatitis B vaccine (manufacturer unknown). His historical vaccines included unspecified Hepatitis B Immune Globulin. The patient's medical history and concurrent conditions were not provided.    On 02-FEB-2010, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 09-APR-2010, he was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 01-JUL-2010, he was administered the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided (inappropriate schedule of product administered). On 27-JUN-2011, the patient was vaccinated with the fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (extra dose administered).   This is one of 4 reports referring to the same patient (linked # 2309USA005464, 2309USA008646 and 2309USA008645).; Sender's Comments:  US-009507513-2309USA008645: US-009507513-2309USA008646: US-009507513-2309USA005464:
ASTHMA EXACERBATION: Acute onset of cough and wheezing HTN: BP 167/100
rash on face; tongue started to swell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0153), via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have a history of allergies to any food or medications or others products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12.00, the patient immediately experienced rash on face and tongue started to swell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events rash on face and tongue started to swell was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Sore throat, congestion, increased pain and congestion so I took Mucinex D, and an allergy pill thinking I was coming down with severe cold.  Sx continued and I took 2 ibuprofen before bed at 9:30pm.  Within minutes I was nauseated, then began to vomit harshly.  On my 3rd trip to bathroom, I fainted in the bathroom, hitting my head, obviously having passed out and woke up in a sweat and a significant goose egg on my head.  I laid for quite a while til I knew I was ok.  I do not know how long I laid on the floor passed out.  After that episode I was able to fall asleep, had no more sx other than fatigue.  I took it really easy for 1 week but had severe bruising from hitting my head that lasted 16 days.
head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided          Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1
After vaccination had increased muscular pain and weakness for several months. Progressed to daily facial tingling. Over course of time there was a progression of tingling, weakness, and pain to entire body. This includes joint pain, chest pain, numbness of the tongue.  These symptoms progressed over time since Spring 2021.
Reciepient reported fever,chills, body aches, swollen lymph nodes, pain/swelling at injection site. Symptoms started the night of 3/9/21 and have resolved almost resolved as of 3/12/21.
Child stated he felt like his eyes were blurry, hearing was off, sweaty, racing heart. States he felt nauseous for a few seconds. Low blood pressure 80/62. Stayed with child. Gave Orange juice. After 10 min. child felt much better. After mom and child left, mom states that she and spouse remember child feeling faint after sight of blood. She was questioning if this is what happened.