chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had reddened area on left thigh with mild induration. Was given Ciproffloxacir HCl 500 mg, advised to use warm compress. Motrin 2 tsp q 60 prn.
Pt experienced lymph node swelling in arm that injection was given. This issue resolved on it's own. The patient received the 2nd dose of the vaccine with no issue.
Narrative: Pt is a 76y.o. male w/ h/o COPD, NAFLD, pre-diabetes, HLD, GERD, hypothyroidism, colonic polyps. Pt received Moderna Covid-19 Vaccination 1/2 on 02/02/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
She got covid two weeks after receiving this vaccine; Quite ill with it; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (She got covid two weeks after receiving this vaccine) and ILLNESS (Quite ill with it) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She got covid two weeks after receiving this vaccine) and ILLNESS (Quite ill with it). At the time of the report, COVID-19 (She got covid two weeks after receiving this vaccine) and ILLNESS (Quite ill with it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Tested for Covid before and was negative.     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. No treatment information was provided.
Patient reported swollen, itchy arm. She had at least 1 prior dose of FLUAD with no issues.
Following vaccine, went to store, noticed vision went "while" looked down, lights seemed bright. Next he knew, paramedics were there. Wife received call from "nurse" at store stating he had grand mal seizure lasting 2-3 min. Pt with no previous history of seizure. This occurred within 20-30 min of vaccine.
Within a day or two after the first shot on 03/25/08 she developed severe back pain. On 04/27/08 she had a seizure and went to the ER. She had the second shot on 05/06/08 and had another seizure. She had two more seizures between then and 06/20/08 when she had three seizures at work and was admitted to the hospital. She had daily seizures throughout the summer, was diagnosed with epilepsy and put on anti-seizure meds. After a cluster of 4 seizures when she turned blue and stopped breathing she was admitted to the hospital and a Video EEG done. Epilepsy was ruled out and psuedoseizures diagnosed and meds stopped. She continued to have seizures and saw a psychiatrist as suggested. The psychiatrist said the seizures were not psychological and were medical. Put back on anti-seizure meds until she became toxic from the meds and was admitted to the hospital through the ER where she was given charcoal. After discharge she began to start feeling better and has been seizure free now for 30 days. Also from March until now she suffered from severe stomach aches, eye problems, headaches, one kidney infection and one urinary infection (never had any in her life before this), severe fatigue (this is a very hyper kid)and body aches. She is not currently on seizure meds and is slowly gaining her strength and getting back to her independent life as before the shot. She lost the ability to drive, to be left alone, was injured repeatedly from the drop seizures, lost her job and her confidence with the way the medical community threw her back and forth between treatments and diagnosis and labeled her as emotionally disturbed. This was a very happy, Dean's list, independent college kid before this shot.  Thankfully, she appears to be coming back to us but still has fatigue and stomach issues which we are treating with diet and vitamins. 10/27/08-records received for DOS 6/20-6/21/08-DC DX: Generalized tonic clonic seizures. First seizure 4/26/08 a partial seizure and two additional ones. Did not begin her anti-seizure medication until last week. Grand mal seizure 3 weeks ago after an upsetting episode. Tired feeling prior to seizures. Admitted for titration of anti-seizure medications.
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area.  She felt a sudden weakness from head to toe and felt an impending sense of doom.  She began to feel dizzy and panicked.    EE moved to evaluation area at 1333.  HR78 BP 174/96 O@ 97%RA.  Pt was anxious and noted BP was high for her.  FNP continued chatting to EE.  EE declined the ED at this time.  A&O x4.  1350 HR 75 BP 151/94 O@97%.  EE reports feeling much beter.  EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation.  EE will call if her condition changes.
10/22/14- AM- lightheaded, T= 100.2, weakness, (R) shoulder-> neck pain. PM- "hot" like burned palms and soles of feet, with lower leg joint sharp pain. 10/23/14- lightheaded, unsteady gait.
Vaccine received on 12/23.  Sore arm on Day 0.  Day 1 = severe fatigue in morning.  No additional symptoms until 12/30 ~5pm when injection site arm became red, hard to touch, raised, and itchy.  Size about a quarter.  Patient called physician and was instructed to call vaccine clinic for instructions.  Pharmacist in vaccine clinic advised physician to recommend options (i.e. antihistamine, steroids) and/or visit ED.
This spontaneous report as received from a medical assistance refers to a 12 month old female patient. Medical history was not reported. On 29-APR-2014 the patient was vaccinated with M-M-R II, (lot # and expiration date not reported) 0.5 ml, subcutaneous in the left thigh. Other suspect therapies included PROQUAD (Merck) (lot #, expiration date, dose and route not reported). Concomitant therapy was not reported. The reporter stated that on 29-APR-2014, the patient was mistakenly vaccinated with M-M-R II and PROQUAD (Merck) at the same day. No adverse effects were reported. Additional information is not expected.
His throat briefly tightened.; vision was blurry (in and out); broke out in sweats in his: hands, neck, and underarms; His fingertips were tingling; breathing heavily; May not get second dose (unsure); his stomach cramped up; symptoms sounded like he was going into cardiac arrest; still has the hacking he had before but it is almost gone; felt very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (His throat briefly tightened.), VISION BLURRED (vision was blurry (in and out)), HYPERHIDROSIS (broke out in sweats in his: hands, neck, and underarms), PARAESTHESIA (His fingertips were tingling) and DYSPNOEA (breathing heavily) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  The patient's past medical history included Common cold (Had severe hacking a week prior to the shot.) and Nose bleed (a week prior to the shot.). Concurrent medical conditions included Rhinorrhea (Had a week prior to the shot.) and Atrial fibrillation (Baseline of Atrial Fibrillation). Concomitant products included METOPROLOL, LISINOPRIL, PANTOPRAZOLE, TAMSULOSIN, PARACETAMOL (TYLENOL) and DIAZEPAM (VALIUM) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced THROAT TIGHTNESS (His throat briefly tightened.), VISION BLURRED (vision was blurry (in and out)), HYPERHIDROSIS (broke out in sweats in his: hands, neck, and underarms), PARAESTHESIA (His fingertips were tingling), DYSPNOEA (breathing heavily), PRODUCT DOSE OMISSION ISSUE (May not get second dose (unsure)), ABDOMINAL PAIN UPPER (his stomach cramped up), CARDIAC DISCOMFORT (symptoms sounded like he was going into cardiac arrest), COUGH (still has the hacking he had before but it is almost gone) and FATIGUE (felt very fatigue). On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (May not get second dose (unsure)) had resolved. On 02-Apr-2021, THROAT TIGHTNESS (His throat briefly tightened.), VISION BLURRED (vision was blurry (in and out)), HYPERHIDROSIS (broke out in sweats in his: hands, neck, and underarms), PARAESTHESIA (His fingertips were tingling), DYSPNOEA (breathing heavily), ABDOMINAL PAIN UPPER (his stomach cramped up), CARDIAC DISCOMFORT (symptoms sounded like he was going into cardiac arrest) and FATIGUE (felt very fatigue) had resolved. At the time of the report, COUGH (still has the hacking he had before but it is almost gone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-075244 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075244:cluster case for several patients
COVID19; Felt bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Felt bad). On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID19) and FEELING ABNORMAL (Felt bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Following vaccination patient started to feel bad, 3 days after vaccination he tested positive for COVID19 and was hospitalized. He was told not to get the vaccine after 90 days and after that patient lost his vaccination card.  No treatment information was provided.  Company comment: This is a spontaneous case concerning a 53-year-old male patient with no reported medical history, who experienced the serious event of special interest COVID-19, that lead to hospitalization. Patient get covid-19 3 days after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 53-year-old male patient with no reported medical history, who experienced the serious event of special interest COVID-19, that lead to hospitalization. Patient get covid-19 3 days after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
About 5 minutes following vaccination patient reported redness and itchiness around injection site. A few (~5 minutes) minutes later patient reported itching spreading down same arm, cold and clammy hands, and itchiness of chest. A few minutes after that she reported mild tightness in throat (slight inability to breath normally).
No additional adverse effects; adult patient received pediatric dose of VAQTA.; adult patient received pediatric dose of VAQTA.; This spontaneous report was received from a medical assistant and refers to a 59-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 20-JUN-2022, the adult patient received one pediatric dose of Hepatitis A Vaccine, inactivated (VAQTA) lot # U016222 was confirmed to be valid with expiration date 06-FEB-2023, for prophylaxis (exact dose, route and site of administration were not reported). No additional adverse effects were reported.
Reports she noticed a raised knot at injection site with redness about 4" diameter.  Warm to touch and mild tenderness.  Not relieved with OTC Ibuprofen,
Patients mother observed her being dazed, lethargic, tensing her body and staring into space.
LEFT THIGH WHERE MENACTRA WAS GIVEN SHE WAS RED, WARM, HAD A KNOT-PT WAS TOLD TO USE BENADRYL CREAM AND ICE. IBU IF NEEDED. A PA went in and saw pt.
COVID-19; Coughing; Muscle weakness; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (Coughing), MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 25-Apr-2021. Concomitant products included FLUVOXAMINE and RISPERIDONE (RISPERDAL) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced COVID-19 (COVID-19), COUGH (Coughing), MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 08-May-2021, COVID-19 (COVID-19), COUGH (Coughing), MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) COVID Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash under left breast; forgetful; Fever; feeling tired; received the bivalent formulation as dose 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 11:45 as dose 1, single (Lot number: GJ3277) at the age of 65 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "Hypo Thyroid" (unspecified if ongoing), notes: Hypo Thyroid. The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 31Oct2022 at 11:45, outcome "unknown", described as "received the bivalent formulation as dose 1"; PYREXIA (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "Fever"; RASH (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "Rash under left breast"; FATIGUE (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "feeling tired"; MEMORY IMPAIRMENT (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "forgetful". Therapeutic measures were not taken as a result of rash, memory impairment, pyrexia, fatigue.  Additional Information: The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not receive any treatment for adverse event. The patient did not have covid prior to the vaccination. The patient was not tested for covid post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea; Fever; Myalgia; This spontaneous case was reported by a physician assistant and describes the occurrence of PYREXIA (Fever), MYALGIA (Myalgia) and NAUSEA (Nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINOCYCLINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Myalgia). On an unknown date, the patient experienced NAUSEA (Nausea). On 11-May-2021, PYREXIA (Fever), MYALGIA (Myalgia) and NAUSEA (Nausea) had resolved. Not Provided      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.
Severe eye and facial swelling, nasal passages became completely clogged, throat became sore and difficult to swallow  . Accompanied by headache and extreme fatigue
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concomitant therapies were reported. On an unknown date, the patient was vaccinated with PROQUAD lot # M007961, expiration date: 15-AUG-2017, therapy type # rHA, subcutaneously in the back of the arm (dose and frequency were not reported) which underwent a temperature excursion. The patient did not experience any adverse event. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of injection site soreness in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included high blood pressure.  Concurrent medications included PINDOLOL.  On 11 February 2009 and 11 March 2009 at 09:30 the subject received 1st dose and 2nd dose of ENGERIX B (10 mcg, unknown, right arm).  On 11 February 2009, less than one day after vaccination with ENGERIX B, the subject experienced injection site soreness in her right arm which started late that day and lasted a couple of days.  On 14 March 2009, at 6:30 am, the subject experienced vertigo and dizziness.  She developed headache in the afternoon.  The subject was seen in the emergency room, but was not admitted to the hospital.  For the first three days (dates unspecified) the subject could not get up and walk as a result of these events.  The subject reported that the events had improved, but they were  still ongoing.  The pharmacist considered the events were disabling.  On an unspecified date, the injection site soreness resolved.  At the time of reporting the events of vertigo, dizziness, headaches and inability to get up and walk were improved.
Erythema Multiform on both arms, started with left arm and radiated to right arm
Pt refers treat since vaccine adm (MENVEO & HPV) has had back pain 11/19/11.
Cellulitis to area, treated with KEFLEX 500mg ine by mouth twice a day for 7 days, lidocaine patches 5% one patch as needed for pain #12 given.
polymyalgia rheumatica a 71 year old female who presents for an ACUTE VISIT to review rheum consult. Had onset of both upper arms and legs. Has rotator cuff tear on L and getting MRI soon. The prednisone + tylenol bid relieves her symptoms. Pain now 1.5/10. In the am 3/10 prior to prednisone. Prior to prednisone 8/10. Pain is in muscles, gets stiff on muscles behind knees and front and back thighs and tops of calves. NOT in the joints. +stiff in the am for 2 hours. Has been holding Lipitor since 5/5/2021= 3 weeks and no change in symptoms. She is taking metamucil and walking instead to help cholesterol. No unintentional weight loss, night sweats, or unexplained fevers.
Information has been received from a physician concerning a female patient who's 6 year old brother was vaccinated on 29-Oct-2006 with a 0.5 ml ProQuad (upgrade process). Subsequently the patient was exposed to her brother and developed full blown chickenpox with over 300 lesions. It was not reported if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES#0610USA10769) developed chickenpox after vaccination with ProQuad (upgrade process). Additional information has been requested.
Despondent, depressed, sad, crying a lot without cause, irritable, panicky, tight chest, upset stomach, loss of appetite.
On 8/15/21 developed SOB and chest pain with inspiration worsening over 12 hours.  On 8/16/21, developed rapid atrial fib, cardiac cath also done later that day.  Had frequent episode of atrial fib with chest pain requiring several hospitalizations.  On   09/03/21  RAF, ablation not tone due large pericaridal effusion requiring pericardial window,  Other complications included, pulmonary embolus and pneumonia.  I am still having pericarditis symptoms.   Symptoms began approximately 5 months post 2nd vaccine.
sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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.   Treatment and concomitant information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Followup was received on 24-Jun-2021. No new information is present in source document.
The injection site is swollen like a mosquito bite, but it feels hard under the skin. The immediate muscle  surrounding that injection site is now sore after being gone on the night of June 20th (3 days after injection).
On the evening of 12/16/2022, I had a slight sore throat that continued through the night. On the morning of 12/17/2022, I still had a slight sore throat. I took a home antigen test and got a positive result. I also went to a clinic, where I also tested positive. Later that evening, I ran a temperature of about 101. For the next 48 hours, I ran a fever of about 100. Then the fever broke, and I got better. During my illness, I had a headache and sinus congestion. I had very little chest congestion and seldom coughed. It felt more like a cold than anything. On about 12/30/2022, I took another test and got a negative result.
Cancer; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: The patient was scheduled to receive the bivalent vaccine next Tuesday. He stated that he and his wife were taking Keytruda for cancer. His doctor said because they had received booster doses of the Pfizer COVID-19 Vaccine before and done well, this one should not cause a problem as it is similar and a combination of mRNA from the original vaccine. The patient was also asking if there are any interactions between Keytruda and the new formulation of the COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170301 same reporter, drug, and event; different patient;