chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old, non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (age at vaccination 55-years-old) as a single dose for COVID-19 immunisation. The patient had medical history (unspecified). The patient had history of allergy to milk, macadamia nuts and pine nuts. The patient received other medications (unspecified) within 2 weeks of vaccination for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 18:00, the patient experienced soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Nausea; Fever of 104 Degrees; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache). At the time of the report, NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Injection site soreness (x4 days), loss of left shoulder abduction (x1 day),  felt feverish, moderate headache, fatigue
received 2 doses of the Fluarix 2023-2024 season vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number C2PH4, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX TETRA).   On 18-OCT-2023, the patient received Fluarix Tetra 2023-2024 season (left deltoid). On 18-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced overdose (Verbatim: received 2 doses of the Fluarix 2023-2024 season vaccine). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-OCT-2023 The registered nurse called to report that a minor child (patient) received 2 doses of the Fluarix 2023-2024 season (injection) vaccine. The vaccine was given in the same location, left deltoid, on the same day, which led to overdose. Guardian had been notified. No harm had been reported as of present time. The reporter consented to follow up.
This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008053, expiry date 30-NOV-2016, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Localized rash warm and itchy on (R) arm began 2 days after Tdap injection.
episode of episode of lung fungal infection after the administration of the first dose of shingrix; was administered first dose of Shingrix on August 2018 / second dose was not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of pulmonary mycosis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pulmonary mycosis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pulmonary mycosis (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the pulmonary mycosis and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pulmonary mycosis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose of vaccine. The age at vaccination was not applicable for 2nd dose of vaccine. This patient had a history of lung fungal infections. The patient had an episode of lung fungal infection after the administration of the first dose of Shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter gave consent to follow-up.
Chills; Aches; Drowsiness; Dizziness; Nausea; Extreme pain starting from left arm up the left side of neck; Extreme pain starting from left arm up the left side of neck; Pain shooting down spine; Pain jabs in right side sinus cavities; Pain jabs in right side of frontal lobe; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: JDAMH) via an unspecified route of administration in the left arm on 15Sep2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medicines (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448,) via an unspecified route of administration in the left arm on 25Aug2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 03:30, the patient experienced chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and the patient also developed itchy, red, hot spot where vaccine was injected. The events did not result 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and itchy, red, hot spot where vaccine was injected was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
rash was all over his back, chest, arms and legs/widespread rash; This is a spontaneous report from a contactable pharmacist reported for her brother. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported and Expiry Date of Covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Ibuprofen and Diazepam, both taken for an unspecified indication, start and stop date were not reported. On 26Aug2021, the patient experienced rash was all over his back, chest, arms and legs/widespread rash. The clinical details of the events as follows: She stated her brother is in (City Name) and she is in (State name) and her brother wanted to come visit her in (State name) but she told her brother he could not come unless he was vaccinated. Her brother and his wife received their first Covid 19 vaccine last Tuesday and now her brother has this rash. He was the only one she knew of who had this type of reaction. She reported she had a couple of patients faint after getting the Covid 19 vaccine. She was calling on behalf of her brother who received his first dose of the Covid 19 vaccine last Tuesday, 24Aug2021 and probably around Thursday night, 26Aug2021, her brother got a rash but not on the arm where the injection was. The rash was all over his back, chest, arms and legs. She was asking if it was safe for him to get the second dose of the Covid 19 vaccine. She stated that the reaction did not happen within the first 4 hours after the injection. Her brother sent her a picture of the rash and it was not the Covid arm at the injection site and it did not look like measles but it was widespread. She clarified from the beginning of the call when she stated the rash was not on the arm where he received the injection, she meant it was not the Covid arm associated with the injection site. Her brother asked her if he should go to the urgent care but the caller told her brother the urgent care would just suggest Benadryl and he was already taking that and Zyrtec during the day. Her brother wife did say the rash was looking better. When probing medical history and concomitant medications she stated he might just take an Ibuprofen every now and then and a Diazepam every now and then for his muscles. He was a mechanic and has been for 20 years so his body is pretty beat up. There was no investigation assessment provided. The patient outcome of the event was Resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number not available for [vaccine/BNT162B2. No further information is expected.
Burning at time of injection at site in left shoulder. Sore shoulder muscle for 48 hours. Pain on lifting arm for 48 hrs. After 48 hrs post injection, the back of my head and upper neck area felt a slight burning sensation and mild neck pain at base of skull down to middle of back. Has not gone away after 11 days the burning mild pain sensation remains and has spread to my jaw on both sides and to the skin on both sides of my neck. I have been taking 400 ibuprofen 2x per day with little relief. Reported online to physician. Will call Dr tomorrow AM.
pt stated she developed a painful red area around injection site.  Pt has an appt w/ a new PCP on 2/23/2021 and will discuss getting the 2nd dose at this time.
COVID+ on 11/3/2021.  Indication for admission was SOB.  83-year-old gentleman with significant past medical history known for abdominal aortic aneurysm/COPD not on O2/hypertension, who presented initially to his primary care physician yesterday for generalized weakness and was asked to present to the ER. Admission dx: dehydration, nausea/vomiting, loose stools, acute kidney injury and COVID-19 virus infection.  D-dimer 3303--2280-- 3211. NSTEMI. Thrombocytopenia Platelet 89--111--125--improving. Hx of Right renal hematoma Early 6/2021, s/p coiling 6/1/21.  Completed 3 days of decadron and remdesivir.  Lovenox and eliquis.  Pt discharged
First dose 08JAN2021 and second 29JAN2021.  Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
pt recv vax 3SEP96 & 11SEp96 pt devel a bad case of chickenpox w/over 100 lesions located on the back, trunk, extremities & face & a mild fever;
I tested positive for covid on 03/31/2023 on a home test. Went to urgent care the following day and tested positive on a pcr test. I was unable to be prescribed any medications because they conflict with medications I am already taking daily. The symptoms I experienced with covid were relatively mild. I experienced a very bad migraine that lasted 3 days. A sore throat accompanied by a sore cough and congestion. I experienced fatigue throughout the first 5 days. I am still experiencing a slight cough currently and I am still testing positive as of 04/10/2023.
Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: patient wasgiven shot,a little bump seemedtooccur,  she sat afterwards for10 15minutes thenleft she make it outside then came back in , laater said ddisnt feel right,  fainted but did not passout   hadall the symptoms of low bllod sugar, clammy weakness hands a bit ttingling, after candy seemedto get better  mom was called  mom mentioed she didnt eat  recently ,left walking but a bit weak
PATIENT WAS ADMINISTERED 0.3ML OF UNDILUTED PFIZER VACCINE. PT WAS OFFERED AN MD EVALUATING TO INCLUDE AN EKG AND TROPONIN LEVEL. PT REPORTS PAIN AT SITE WITH NO OTHER SIDE EFFECTS AND DECLINED MEDICAL EXAM WITH MD.
Cold chills for more than 12 hours, with a headache. 2 Tylenol were take at 2PM and 9PM.
I had a twinge in my neck as I sat down to wait my 30 minutes and it felt stiff.  I noticed my index and middle fingers tingling while I grocery shopped (the pharmacy is in a grocery) about 40 minutes later.  When I got to my car I saw that the tips of my index, middle and thumbs on both of my hands were turning yellowish.  I drove 5 minutes to my next destination and they were turning almost white and were very tingly/numb.  By 3:07 all of these fingers were pinking back up except the right index which was starting to turn pink again (I took a photo so that's how I have the time stamp). I also realized that my next was no longer stiff.
Headache, Nausea, Coughing, Achy, Bowel Problems, Shaking Hands, Weakness.  Still continuing.
I received a Tetanus shot during a visit to my primary care doctor. Around 4 days later my muscles started to feel weak. I called the doctor to let them know I was not feeling well and I believed the Tetanus shot was the reason. The doctor said the adverse reaction should go away shortly. I waited hoping for relief but the weakness and pain persisted and got so bad I was debilitated and could not function. Any movement of my muscles caused pain and I was extremely weak. On September 27 I checked into the emergency room and was hospitalized for a week and 2 days. The doctors said my I have Myositis and my CK levels was beyond normal. At the current moment I am still experiencing the affects of the Tetanus shot.
High inflammation; Stiffness; Slight high temperature; Muscle pain; Rheumatoid arthritis flare up; Systemic lupus erythematosus syndrome aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Migraine, Acid reflux (esophageal), Hypertension, Nerve pain and Drug allergy (Codeine allergy manifested by skin crawling and itching). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for Hypertension, TOPIRAMATE for Migraine, GABAPENTIN for Nerve injury, TRAMADOL for Pain, FOLIC ACID for Supplementation therapy.   In August 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated), INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-213828 (E2B Linked 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 events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-213828:Patient 1st Dose
Information has been received from a nurse practitioner concerning a 16 year old female with no medical history of allergies, who on 09-DEC-2008 was vaccinated with a 0.5 mL first dose  of GARDASIL vaccine, intramuscularly. There was no concomitant medication. On 17-DEC-2008 the patient developed widespread achiness and joint pain. The patient consulted her unspecified pediatrician but no treatment was prescribed. There were no laboratory diagnostics studies performed. The patient had not recovered. The sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 1/15/2009.  Information has been received from a nurse practitioner concerning a 16 year old female with no medical history and allergies, who on 09-DEC-2008 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscularly.  There was no concomitant medication.  On 17-DEC-2008 the patient developed widespread achiness and joint pain.  The patient consulted her unspecified pediatrician but no treatment was prescribed.  There were no laboratory diagnostics studies performed.  The patient had not recovered.  The patient sought unspecified medical attention.  No further information is available.
Patient states shingles vaccine set off his arthritis in other arm, he didn't think it caused because he had arthritis before, but said it might have set this spot off.
74y.o. female with PMHx of kidney stones who presented with shortness of breath. She stated that she is being worked up for possible lung cancer and had a biopsy done of a mediastinal mass at the end of June that was concerning for lung cancer. She states that she has been experiencing some exertional dyspnea. She had imaging done on 7/20 which revealed a moderate pericardial effusion and pt was sent in for eval. In EC, ECG shows sinus tachycardia. Imaging revealed a large pericardial effusion with possible early signs of tamponade. Pt was admitted to ICU for further management. Pt is s/p pericardiocentesis with drain. Repeat Echo demonstrated minimal pericardial effusion. Drain was removed. Developed fever and Urine culture with GNB and was treated with IV ceftriaxone and transitioned to Augmentin until 8/7. Pt started on radiation therapy for her lung cancer. Pt on radiation therapy until August 11th. Pt originally to stay IP until radiation completed but transportation was able to be arranged and patient wishes to go home. Pt to follow up with hematology and pulmonology as OP. Cleared for discharge home on 8/5. She returned on 8/6/2022 for shortness of breath that started earlier that day.  In EC, Bedside echocardiogram showed small pericardial effusion w/ no signs of tamponade.  Labs indicated a positive COVID-19 swab and CXR concerning for L sided pleural effusion. She was admitted for further workup. CT of chest showing significant enlargement of patient's anterior mediastinal mass with severe compression narrowing of the main pulmonary artery. There is also relative compression of the left atrium due to the increased size of the mass. There is increased pericardial effusion and there is new moderate left pleural effusion. She had episodes of NSVT improving, continue lopressor BID. repeat ECHO with EF 50%, small pericardial effusion. She  compelted remdesevir and sats stable on RA. hematology following  And completed 10 radiation treatments. Pt is stable for d/c home with close Op follow up