chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe lower back pain radiating to RIGHT leg unable to stand or walk without extreme difficulty. Had relatively mild symptoms   21/2- 3 weeks after first dose, not so unusual as similar to ongoing back problems that I've had last many years.Starting 6 days ago and continuing to present much worse affecting RIGHT  leg severely, never before have had R leg so affected.Hard to get comfortable in any position can only walk with cane very short distance.
The patient did not want to wait the 15 minutes and went out to his truck. A customer brought the patient back in as he was complaining of chest pain and SOB. After resting 15 minutes pt stated that he was having a panic attack.
Information has been received from an 82 year old female with thrombocytopenia, cold induced asthma, peripheral neuropathy and penicillin allergy who on approximately 05-OCT-2010 (reported as "about 2 weeks") was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included ATENOL, LEVOXIN and vitamins (unspecified). On approximately 05-OCT-2010 (reported as "about 2 weeks") the patient had a "horrible reaction". Patient stated that her arm swelled to "about the size of a lemon" and her arm became "burning hot". This condition lasted for 4 days. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from her adverse events. The patient did not seek medical attention. Additional information has been requested.
After my first dose Pfizer vaccine, I developed enlarged lymph nodes found in a calcium scan. I underwent CT scan, mammogram and ultrasound of the axilla. They thought it could be breast cancer or lymphoma. Today my lymph noes are still present.
pt experienced nausea, vomiting and dizziness with in 15 min of vaccination
PATIENT HAD PFIZER VACCINE  12/23/02020 and  01/13/2021, AND TESTED POSITIVE TO COVID.
Soreness in arm shortly after injection Next morning, tired, periods of dizziness and nausea Later in day next day, muscle soreness (primarily back muscles) No fever
Patient was previously in a rehab facility who was in communications with the patients long term care facility. However, the patient received her first dose of the COVID vaccine (Moderna) through the rehab facility on 1/27/2021, which they did not communicate with the long term care facility. Therefore, when the COVID vaccine clinic team went to the long term care facility for our second trip (first trip was 1/20/21), the patient was listed as getting dose 1. Therefore, the patient got the vaccine on day 21. No adverse events have been reported.
pt recv vax & exp vaso-vagal response, loss of consciousness x 3sec, color pale, P56 improved to 76;BP 95/60 improved to 110/70 stable;VS monitored;when alert apple juice given;
auto immune hepatitis; drug induced liver injury; Primary Delivery Conjunctivitis; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program.  A 40-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on an unspecified date (at the age of 40-years-old), as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was taking an unspecified medication for 2-months which she stopped before. It was reported that on an unspecified date, the patient had an increased INR, ALT and liver enzymes elevated along with jaundice, and Hepatitis. Patient was admitted to hospital for Hepatitis. The elevation of the liver enzymes reached to a point that she needed the liver biopsy which was more challenging to interpret. Then sent out at 7 PM to her medical surgery and they had reported neuropathologist, so they were saying that her Jaundice elevated function test and overwhelmed drug reaction. As per the expert pathologist report, the patient had only the drug (unspecified medication) that she had been on that for 2 months which she stopped before and she did have "elevated intestinal muscle antibody" (not clarified) but she was not consisting auto immune hepatitis, however, the serology suggested an auto immune hepatitis but the biopsy could not and then the liver biopsy shows patient has "Primary Delivery Conjunctivitis" (further not clarified) but the serology is not consisting with that, so the reporter stated that her concern was that mimicking this disease process. Pathologist said that it was a drug induced liver injury. The reporter stated that their doctor reporting that several patients after taking of Covid vaccine has had elevated liver function test and even had one that needed the liver biopsy, and he was asking if this was something that happening with the Covid vaccine or what are the study showing. The patient underwent lab tests and procedures which included: Liver Biopsy: Primary Delivery Conjunctivitis; INR (International normalised ratio): elevated; Liver function test: elevated; aminotransferase: elevated; antibody test: elevated intestinal muscle (not clarified); all tests on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Redness, itching and swelling of face and neck, starting about 9 hours after the vaccine and persisting for at least 2 days
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed/tested positive for COVID-19, had acute illness at the time of vaccination and up to one month before, or had chronic or long-lasting illness.  It was unknown if patient had taken any prescriptions, over the counter medication, dietary supplements or herbal remedies at the time of vaccination.     On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The age of the patient was reported as 28 years 11 months.  No concomitant medications were reported.  The patient had no adverse reaction after the vaccine administration.  No treatment medications were reported.
Pt recvd Pneumococcal vax & devel a local reaction which consisted fo cellulitis & swelling of the entire arm; pt recvd inject of cortisone & w/in 3 to 4 days sx subsided; no further details were provided;
Feels like bursitis; Left elbow pain that radiates to forearm; Problems lifting his left arm; This spontaneous case was received on 20-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03957) and concerned a male patient of unspecified age.  The patient's medical history and concomitant medications were not reported.   On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was P100244639 and expiry date 23-Jun-2021.   On an unspecified date in Oct-2020, an unknown amount of time after vaccination with Afluria Quadrivalent, the patient experienced problems lifting his arm, left elbow pain that radiated to forearm and felt like bursitis. The patient was referred to healthcare professional.  At the time of initial reporting on 20-Oct-2020, the patient had not recovered from events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to cases 202005338 and 202005339 (the same reporter).  Company comment: A male patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving vaccine, the patient experienced bursitis, radiating pain and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A male patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving vaccine, the patient experienced bursitis, radiating pain and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with Gardasil.  Subsequently the patient experienced dizziness.  Subsequently, the patient recovered from the dizziness prior to leaving the office.  This is one of several reports for the same source.  Additional information has been requested.
NO ADVERSE EFFECTS; The patient was inadvertently administered an expired Pneumovax 23; This spontaneous report was received from a medical assistant regarding a 48-year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions or allergies were not reported. On 16-MAY-2019, the patient inadvertently administered expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency were not reported) (lot number: N027624 and expiration date: 11-MAY-2019) intramuscularly for prophylaxis (Expired product administered). No adverse effects reported.
Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid.  States she would like to reschedule because she was not feeling well.  Reports she has not felt well since the first dose.  States initially she felt dizzy and had a headache - the symptoms progressed to dizziness, headache unable to be relieved by medication, stomach pain and nausea.  States she has consulted with PCP and lab tests will be ordered, she anticipates she will receive an order for a MRI of the brain.  She also stated because of her symptoms she was considered by her work as a presumptive positive for Covid and was required to complete three Covid tests - all were negative.  Encouraged patient to continue consulting with PCP and possibly an allergist.  She will reschedule when she is feeling better.
ringing in the ear and it's been ongoing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear and it's been ongoing) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and LABETALOL HYDROCHLORIDE (NORMODYNE) for Hypertension, LEVOTHYROXINE SODIUM for Thyroiditis NOS, VITAMIN D NOS and CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM & ZINC [CALCIUM;MAGNESIUM;ZINC]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 8:00 AM, the patient experienced TINNITUS (ringing in the ear and it's been ongoing). At the time of the report, TINNITUS (ringing in the ear and it's been ongoing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was  reported   This case was linked to US-MODERNATX, INC.-MOD-2021-119527 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient contact details: Email address updated. On 13-May-2021: Additional information was received on 13-may-2021, patient demographic details , concomitant medications and their indications are updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-119527:2nd dose case
vaccine administered post excursion with no reported adverse event; temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409520(CLUSTER) and 2022SA409694(CLUSTER).  This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022 the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error).  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20220927002156:
Pt presented to office complaining of shoulder and neck pain and headache. Exam revealed 4cm erythema surrounding area of immunization, tender to palpation. Treatment: hot packs and NSAIDS.
HPI: PT 28 y/o F feeling light headed after J&J vaccination.  PT with her mother, became light-headed and dizzy while walking from vaccination site back to vehicle for 15 minute wait. PT became unresponsive with mother and fainted.  Parking staff alerted rapid response team, PT regained responsiveness and was given chair to sit on, water to drink.  Rapid response team arrived to a responsive, A&Ox4, pale female who was still feeling weak and light-headed.  PT was transferred to a cot (in the shade) where she was placed in supine position with legs elevated on a chair.  Pt was given water and hard candy to suck on while vitals were taken,,  Airway, breathing and circulation were all WNL.     PT states she presently has a strep infection (throat area)  and has been afebrile, and is to begin oral antibiotics once she picks RX up from pharmacy.     PT began feeling significantly better over 10-15 minutes of laying down in the shade.    EMS LAFD was called and transfer of care to EMS Station 93 for further work-up was instituted.  PT felt much better and was able to stand and ambulate from cot to EMS vehicle without issue.    PT chose to go home with her mother instead of being transported by EMS to medical facility.      Exam (update as needed): GEN: Alert and oriented x 4, relaxed in appearance. HEAD: WNL EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema, no cyanosis  NECK: Supple, without LAD.  CV: RRR, no m/r/g
Soreness in arm 1 hour after shot. Limited mobility of arm next few days with constant lingering soreness. Strained pressure on lower left back when breathing deeply post shot.  Roughly one month after shot arm and shoulder had excruciating pain that put me in the ER. Nothing irregular  found in blood work or X-rays. Pain prescription and anti inflammatory patches prescribed.
fatigue; fevers; runny nose; sinus congestion; bloody nose; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a patient that: An 81-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included Has mild elevated Blood pressure from an unknown date and unknown if ongoing but does not take meds for it. Patient takes no medications. Patient received second dose of Pfizer BioNTech Covid 19 Vaccine on 18Feb2021 and began experiencing fatigue, fevers, runny nose, sinus congestion and had a bloody nose morning of 19Feb2021. All symptoms except bloody nose remain today (20Feb2021), but patient stated it was a little better today. Event took place after use of product. The outcome of the event bloody nose was reported as recovered on an unspecified date in Feb2021 and rest all other events were recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Immediate numbing of lips, increased heart rate; within 10 minutes, numbness travelled to tongue; 15 minutes down throat; 25 minutes numbness in checks and jawline
patient developed a egg size lump in arm was red in color - developed 24 hours after injection and lasted 72 hours
Went into Atrial Fibrillation Nov. 10, 2021 at around 5:30 am-two weeks after Booster. Taken to Hospital by EMS and symptoms lasted 24 hours.  Out of A Fib at 6:05 am on 11/11/2021.  No recurrence as of 1/3/2022.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, 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 (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid, start date as 31Oct2023 and stop date as 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370153 Same reporter/patient, different product/event;
This case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a elderly female patient who received Influenza vaccine unspecified for prophylaxis. Co-suspect products included JUXTAPID capsule for homozygous familial hypercholesterolemia. The patient's past medical history included homozygous familial hypercholesterolemia. On an unknown date, the patient received Influenza vaccine unspecified 2014-2015 season at an unknown dose. In December 2014, the patient started JUXTAPID (oral) 10 mg at an unknown frequency. On an unknown date, unknown after receiving Influenza vaccine unspecified 2014-2015 season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine unspecified 2014-2015 season. Additional details were provided as follows: The case was received from a specialty pharmacy reported by a dietician. The age at vaccination was not reported. On an unspecified date in December 2014, the patient commenced treatment with lomitapide 5 mg daily orally. The dose was increased to 10 mg daily orally on an unspecified date. On an unspecified date, during the winter season, the patient experienced diarrhea after having the flu shot. The patient experienced an additional episode of diarrhea between April 2018 and May 2018. No additional information was provided. No change was made to the administration of lomitapide as a result of this event.
As a post-vaccination test of seroconversion, tested on 2 separate occasions, the first 21 days after first dose and the second 25 days...Both tests were negative for the presence of anti-sars-cov-2; As a post-vaccination test of seroconversion, tested on 2 separate occasions, the first 21 days after first dose and the second 25 days...Both tests were negative for the presence of anti-sars-cov-2; This is a spontaneous report from a contactable physician (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to make aware of a potential issue with the Pfizer Covid vaccine received. As a post-vaccination test of seroconversion, the patient was tested on two separate occasions, the first 21 days after first vaccine dose and the second 25 days after second vaccine dose. The first test was a proprietary assay through a research study conducted at School. The second test was commercial assay. Both tests were negative for the presence of anti-SARS-COV-2 IgG. The patient could provide the vaccine lot numbers and administration times/locations if needed. Outcome of the events was unknown.  Information of lot/batch number has been requested.
Invalid dose of 1ml of Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Invalid dose of 1ml of Moderna vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 06-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Invalid dose of 1ml of Moderna vaccine). On 06-Apr-2021, INCORRECT DOSE ADMINISTERED (Invalid dose of 1ml of Moderna vaccine) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant follow up received on 26-MAY-2021, Patient route of administration is updated; Sender's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 044A21A, with no associated AEs.