chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in to let us know that the injection site was sore and warm to the touch, the day after the vaccine. Recommended OTC analgesic and will contact tomorrow to see how they are doing. Called office (PCP) they will note in Chart & let provider know followed up with pt on 8/17/19, everything is much better now, healing just fine. no further follow-up needed
48 year old male with no significant medical history who underwent his first COVID-19 vaccine (moderna) due to his status as a corrections officer.  Within 4 hour of receiving his vaccine (IM, left deltoid), he experienced "numbness" in his left arm which he further described as altered sensation rather than lack of sensation.  Describes numbness as extending from left shoulder to his wrist involving his entire shoulder and arm.  Further, described a band of numbness that extends from his posterior shoulder, down his back, and extended to his knee.  No motor weakness.  No difficulty walking or difficulties with hand dexterity.   This resolved suddenly after 3 hours.  He did not take any medications nor was he evaluated by a clinician. No previous history of strokes, TIA, or similar symptoms.  No pertinent medical history.    His only medication is OTC ibuprofen.
Screaming Pain upper chest left arm. Stomach pain. Insomnia. Fatigue. Migraines. Pounding chest. Feeling hot with no irregular temperatures. Depression. Dizziness. Couldn't get out of bed for two months. Inability to participate in school.
Beginning 1/12/21, site of injection was itching. Upon touch, there is a lump that is raised and bigger than a quarter. Additionally, there is redness on the site of the lump.  A sore arm began to return again and the site is warm to the touch.
Felt a painful lump on my thyroid, went to my endocrinologist who ordered ultrasound and labs, diagnosed with subacute thyroditis post covid booster.
Hard of hearing with left ear. It felt like covered by something.  And Pain on the left side of under arm,  shoulder and neck.
At 12:35, pt began to feel faint, post vax. At 12:36, pt complained of hot flashes with numbness in left arm and shortness of breath. At 12:37, pt put on O2 at 10LPM via non-rebreather and put on monitor X 1 hour. Pt's vital signs at onset were BP-110/71, P-66, R-16 and temperature was 96.5F. Pt had a vasovagal reaction to injection.
Red bumps all over (starting on her thigh and spreading to her feet); some areas itchy; rash on her stomach and inner thighs/The rash is spreading/The rash has gotten worse in the last hour and a half; fever; I had trouble breathing; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red bumps all over (starting on her thigh and spreading to her feet)), PRURITUS (some areas itchy), DYSPNOEA (I had trouble breathing), RASH (rash on her stomach and inner thighs/The rash is spreading/The rash has gotten worse in the last hour and a half) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Diabetes and Ulcer. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE+TRIMETHOPRIM) for Ulcer.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced DYSPNOEA (I had trouble breathing) and PYREXIA (fever). On 09-May-2021, the patient experienced ERYTHEMA (Red bumps all over (starting on her thigh and spreading to her feet)), PRURITUS (some areas itchy) and RASH (rash on her stomach and inner thighs/The rash is spreading/The rash has gotten worse in the last hour and a half). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 07-May-2021, DYSPNOEA (I had trouble breathing) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (Red bumps all over (starting on her thigh and spreading to her feet)), PRURITUS (some areas itchy) and RASH (rash on her stomach and inner thighs/The rash is spreading/The rash has gotten worse in the last hour and a half) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received and Reporter information updated, concomitant medications added, medical history added, dose 1 details added, new events added
Patient called pharmacy at 5:40pm on Tuesday, 03/16/21 stating that since Monday evening she has had an increased heart rate (approximately 100bpm). She stated that she bought a pulse oximeter and it was showing 135bpm at times but then it would lower to only 100-110bpm.  She called her primary care physician and they had her schedule an appointment (scheduled for 03/18/21) and told her that if it got any worse, if she felt faint, or noticed any palpitations to go to the ER. On 03/17/21 she reported to the pharmacy that she was feeling better but was still going to follow up with her primary doctor on 03/18.
After 2nd shot, I began having a noise in my left ear, for 3 day's it would come and go, on the 4th day it just stayed on and has been making the noise in my ear at all times. Once or twice a day when I stand up I get dizzy or wobbly feeling, sometimes it is bad enough I have to sit back down. I no longer sleep well. I used to just lay in one spot all night, barely making a dent in the covers. My dog slept in bed every night for over 7 years. But after vax, she stopped sleeping on bed and I wake up to a trashed bed and the covers all balled up on my head. How or what I eat has changed, I no longer like most of the stuff I always liked. I no longer feel right, just always feel off, tired and by the end of most days the noise in my ear is driving me insane. I have never experienced the ear noise or the getting dizzy ever in my entire life until the Govt stuck poison in my arm.
Local reaction - arm swollen at inj. site, vomiting, fever, achy, neck soreness.
Pt fully immunized against covid19, presented 7/27/21 in very critical condition with covid19 pneumonia and severe hypoxic respiratory failure.
Grapefruit size red swollen at injection site. Hot to touch. Very sore more than usual.
mild cold; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non- health care professional.  This case involves patient of unknown demographic who experienced mild cold (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient past vaccination(s) included INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical history, medical treatment(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious cold (nasopharyngitis) (severity: mild) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, I've been getting a flu shot every year and haven't been sick for almost 5 years now other than a mild cold .Now I've got both poison shots, so I don't think I'm going to mix the flu shot with it for a while".   There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the event (mild cold).  At time of reporting, the outcome was unknown for the event mild cold.  There will be no information available on the batch number for this case.
Blackout, sweating, hearing loss, cold/pale. Symptoms lasting for a few minutes. No treatment necessary.
arm  soreness from COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Previously administered products included for Product used for unknown indication: LEVAQUIN. Past adverse reactions to the above products included No adverse event with LEVAQUIN. Concurrent medical conditions included Sulfonamide allergy, Non-smoker and Abstains from alcohol. Concomitant products included ATORVASTATIN for High cholesterol, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Indigestion.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination). In February 2021, VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   The patient was hospitalized for unknown reason. Patient was not enrolled in a COVID-19 Vaccine Trial. In August 2021, the patient experienced possible inflammation/inflammation all over body and increased from 94 to 152 caused by the Humira.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622389 (Patient Link).
On the 14th I thought I was getting a sinus infection and had a low grade fever. I was really stuffy, I couldn't breath, I had pain and sinus pressure, and it couldn't breath. By Monday my symptoms were worse so I tested on a home test and was positive. I reached out to my PCP and they got me a cough med, an antibiotic, and prednisone. Today is the first day I am really feeling good but Wednesday this week the 18th was the first day I had started improving.
Seizure; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Seizure) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient stated that after first dose he had seizure. No treatment information was provided. It was reported that the doctor wants to see if that was a contraindication.  Company Comment: This case concerns a 23-year-old, male patient, with no known medical history, who experienced the serious, unexpected, AESI event of seizure. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is unknown as it is not confirmed if patient received the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 23-year-old, male patient, with no known medical history, who experienced the serious, unexpected, AESI event of seizure. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is unknown as it is not confirmed if patient received the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
103-104 temp x 2 days; soreness @ site taken to MD 15FEB94 reported by mom;
Arm pain and swelling lasting 10 + days, Dizziness and Fatigue for 5 days. Swelling extended into neck and hand.
Patient came to get vaccinations with her mother, brought prescriptions from her provider. She was due for Engerix B, Boostrix, Menveo, & Havrix. I started vaccinating with Engerix B & Boostrix in one arm. I then gave her menveo on the other arm, soon as I finished patient convulsed for about 15 seconds. No treatment called EMS, test good patient left home with parents
'Bad thoughts' (further not clarified); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09May2021 (Lot number: EW0176) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose on 18Apr2021.), administration date: 18Apr2021, for COVID-19 Immunization. The following information was reported: MORBID THOUGHTS (non-serious) with onset 09May2021, outcome "unknown", described as "'Bad thoughts' (further not clarified)". Therapeutic measures were not taken as a result of morbid thoughts.  No follow-up attempts are possible. No further information is expected.
low grade fever; coughing; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (body aches). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever) and COUGH (coughing). At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (body aches). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever) and COUGH (coughing). At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Information has been received from a physician concerning a female who on 09-NOV-2007 was vaccinated with Gardasil. On 09-NOV-2007 the patient's arm was red and her arm went numb. The physician sent the patient to the emergency room where she remained for 6 hours. While in the emergency room, the patient developed tachycardia. She was treated with diazepam (Valium) to calm her down. The patient recovered on 10-NOV-2007; however, it was also reported that the patient's arm was numb for 3 days before the feeling came back. The physician considered the patient's red arm, numb arm and tachycardia to be disabling. Additional information has been requested.
Fainted on second day after 2nd dose. Came to right away. Was weak the rest of the day. Arm still has a little fever in it  and itches.  Otherwise feel ok just a little tired.
administration of improperly stored GARDASIL 9; This spontaneous report has been received from a consumer of unknown age and unknown gender referring to himself/herself. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On 16-NOV-2020, the reporter inquired temperature stability evaluation and informed agent of administration of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687292, with expiration date 25-AUG-2022, dose, frequency, route of administration was not reported) for prophylaxis (product storage error). The vaccine was exposed to temperature "3" for 3 hours and 30 minutes. Previous temperature excursion was reported as not applicable. Data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date not reported) as recommended for routine adult health maintenance and for the prevention of shingles. After receiving zoster vaccine live (ZOSTAVAX) the patient suffered sustained severe and permanent personal injuries like multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious neurological problems. As a result of these symptoms, the patient was seen and treated by medical providers.The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Patient did not feel well after shot, said she felt off, had difficulty swallowing and felt nauseous at one point.  Gave patient epi pen and EMT came and took her to hospital.
This case was reported by a pharmacist and described the occurrence of an unspecified adverse reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  On an unspecified date, the subject received an unspecified dose of Flu vaccine. At an unspecified time after vaccination Flu vaccine, the subject experienced an unspecified adverse reaction.  At the time of reporting, the outcome of the event was unspecified.  This report was received.
Information has been received from a consumer concerning a 6 year old female with an allergy to sulfa based drugs and no known medical history who "at 12 months of age" was vaccinated SC with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 22-FEB-2006 the patient developed breakthrough chickenpox.  The pox were located on her trunk, and several on her face.  Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  There was no product quality complaint involved.  Additional information has been requested.
My Parkinson?s tremor increased on the left side where I had the Parkinson?s and a little bit on the right side where I don?t have it. My doctor indicated that this could be a temporary result of the vaccine which is what I?m hoping but she said to report it & To definitely get the second shot.
She began feeling dizzy with some nausea, apprehension, and numbness/tingling in her tongue. Her vital signs were monitored every 5 minutes for 20-25 minutes, and she was given 20 mL (50 mg) liquid Diphenhydramine. Her symptoms subsided, and she was ambulatory and stable without distress at dismissal from clinic.
After receiving vaccine, patient experienced minor swelling and flushing of face. Patient was then sent to emergency department. Patient was treated with prednisone, Pepcid, and Benadryl. Patient's symptoms resolved after treatment and was discharged home the same day.
Headache, Myalgia, NauseaVomiting, Fatigue Narrative:  Other Relevant History:
TOOK MACROBID AND VIVOTIF TOGETHER; This spontaneous case report (PVX2019-1867) was received from a consumer on 18-Jul-2019. It describes a 60-year-old female consumer who "took Macrobid and Vivotif together" (PT: Labelled drug-drug interaction medication error), while being on Vivotif for an unknown indication and Macrobid (nitrofurantoin) for urinary tract infection (UTI).  Case report: The consumer was on a four-day therapy of Macrobid for UTI. On 17-Jul-2019, she took the first dose of Vivotif.  Action taken with Vivotif and Macrobid was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
At about 03:30 AM October 31st, unable to take a deep breath, congestion, and had the sensation of choking, I became terrified, and utilized my rescue inhaler and then my Symbicort inhaler as well, then immediately after a 10 mg Pepcid. I then, began to vomit due to acid reflux, multiple times, and felt nauseous. I then, took my temperature abnormally at 99.7, and developed a vague pain on the right side, after a few hours I then went to the Emergency room, no longer vomiting, after receiving multiple tests, the doctors stated that I may have aspirated and just in case to take antibiotics. My other doctor also stated that the Emergency Room reported possibility of pneumonia.  The fever had stayed for a few days after hospital, I had a slight tightness in my chest and fatigue. Symptoms have almost completely cleared as of now.
Patient presented on April 1st, 2021 with COVID 19 pneumonia, B/L Pulmonary emboli and bilateral lower extremity DVT's. She was treated with heparin and warfarin for VTE. For COVID pneumonia, aptient was treated with steroids, remdecivir and actemra.
"44yoF c/o covid vaccine side effects - got 1st dose moderna vaccine yest. got vax in L arm. L arm soreness started immed after vax, last night started feeling other sx about 4 hrs after vax L arm very sore, having fatigue, chills, bodyaches, feels feverish, but no fever, c/o headache which turned into a migraine, has hx of migraine took tyl about 1 hour ago which is helping a little for ha ha 5-6/10, NOT WHOL."
Fever - temperature 103 for 48 hours. Woke up in the middle of night- shaking in pain and sreaming for 2 hours. Was hallucinating. Mom called triage nurse at night. MD had follow up call with Mom.
AFTER 2ND INJECTION ON 2/5/2021, DEVELOPED RASH/HIVES AT INJECTION SITE. IT HAS BEEN 5 DAYS SINCE 2ND INJECTION AND INJECTION SITE IS ITCHY, RED, AND WARM.