chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 40 year old male patient with a history of autoimmune disorder who "2 years ago", in 2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported). On an unspecified date the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot number not reported). Concomitant therapy included methotrexate. Shortly after the vaccination the patient had a local adverse reaction that spread to a systemic adverse reaction. The patient was hospitalised for 3 days. The patient was diagnosed with a systemic inflammatory disorder. At the time of the report, the patient was recovering. Systemic inflammatory disorder was considered life threatening by the physician. Additional information has been requested.
Severe arm soreness, severe fatigue, weakness, lightheadedness, violent shivering during the night, feverish feeling without elevated temp, slightly irritated sinuses.
Pt complained 4 days after vaccination of headaches, abdominal pain, and diarrhea. No reaction at time of vaccination.  Dr  was notified on 04/12/2021 when pt  complained.
Case number PHHY2017US046059, is an initial literature report received on 23 Mar 2017. The author discussed about a report of new onset lupus nephritis (LN) presenting as nephrotic syndrome in a formerly stable systemic lupus erythematosus (SLE) following influenza vaccination. This report refers to a 38-year-old female patient. Medical history included SLE. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in Nov 2015. On an unknown date, the patient was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in Nov 2015, at which time she had no protein on urinalysis (UA). In Feb 2016, UA showed new 300 mg/dL protein and 2 red blood cell count (RBC) (units not specified). Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. In Mar 2016, the renal biopsy showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) at a dose of 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) at an unknown dose in early Jul 2016. Her proteinuria improved to 3.9 g/day in late Jul 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in Sep 2016. Proteinuria remained at 2 g/day in Nov 2016, when she was started on azathioprine. Outcome of the event proteinuria was reported as condition improving. Outcome of the other events was not reported. Seriousness of all the events was not reported. Seriousness assessment of the event lupus nephritis (medically significant), glomerulonephritis membranous (medically significant) and nephrotic syndrome (medically significant) was upgraded based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza vaccination and new onset of lupus nephritis in a formerly stable SLE patient. There is a need for increased awareness that vaccinations might be potential triggers for lupus nephritis onset, and further research in this area is warranted.
pt recvd vax approx 10AM 21OCT92; p/arriving home sitter called mom; pt broken out in strawberry-like hives over entire body; called clinic instructed to get pt to MD for exam;  pt seen by MD, rash lasted 20-30 mins;
day p/vax pt devel diarrhea, dec urination, dec appetite, changed formula also to inc iron same day;child slept a lot that day;became more fussy, cries easily;
Seen ER Dr on 12/12/21, developed low grade fever, weak, couple epidoses of bradycardia with oximeter reading down to 37, came in and and monitored for 3 hours without reoccurance, unremarkable workup, push fluids, tylenol PRN, return if further episodes.
Received vacine at work. Awoke day after day of vaccine with swelling of lips and face, No swelling of tongue, no obstruction of airway, , no urticaria, no respiratory symptoms. No treatement indicated . Returned to work.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history information is reported.  Concomitant products included LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included prenatal vitamins No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
FEVER OF 103.2 FOUR AND ONE HALF HOURS AFTER INJECTION.  FEVER UP TO 106 BY NEXT AM.
Fever 101. Erythema LUE approx. 3cm, warm to touch. Started several hours after injection. Seen in office 9/29/11, treated with antibiotic for cellulitis.
the day after I had a few bumps and itching on my left arm but not near the site so I didn?t think anything of it but as days went by I noticed the itching got worse and more bumps developed in my skin on the left arm. 5 days later bumps started appearing on my right arm as well, also itchy. a day later I started having a rash all over both arms and on the tops of my thighs. Then it spread to my calves. Starting on day 5 I also started a vacation in a warm, sunny climate, not sure if that effected the spread. The rash continues, I treated it with some topical creams, aloe. it may be subsiding. I don?t know that this is a reaction to the vaccine but I can?t identify any other unique factor that may have caused this.
pt recv vax 12JAN98 & 21JAN98 9 days p/vax devel a typical erythema mult rash;fever 100.5 & oral candidiasis;
I found out 07May2021 that I am positive for COVID; I found out 07May2021 that I am positive for COVID; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I lost my taste and smell for 2 days which is how I found out; I lost my taste and smell for 2 days which is how I found out; This is a spontaneous report from a contactable other HCP (nurse) for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as sing dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She found out 07May2021 that she was positive for COVID. She was having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. She was currently day 4. she lost her taste and smell for 2 days in May2021 which is how she found out. Outcome for event lost my taste and smell was recovered in May2021, for the rest was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded.
HPV vaccine on 12-4-12. On 12-5-12 evening, injection site very itchy. Used hydrocortisone cream. 12-6-12 complained of itchy, large area of redness, hard spot. Brought to MD office - left upper arm red, warm to touch, 10x16 cm area of induration. Rx for prednisone given.
expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number BB74J, expiry date 30th June 2021) for prophylaxis.   On 8th September 2021, the patient received FluLaval Quadrivalent. On 8th September 2021, unknown after receiving FluLaval Quadrivalent, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The nurse reported that patient received an expired dose of Flulaval Quadrivalent, the vaccine expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow-up. This case had been linked with US2021191998, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191998:same reporter
A mother reported via company representative that her 2 month old female infant received a dose of Prevnar and "other 2 month injections" (manuf unknown). The mother reported the infant experienced "extreme irritability" and "cried continuously for two hours." The infant developed an injection site reaction characterized by erythema, swelling, and warmth. The infant was treated with Benadryl; she subsequently recovered. Follow-up info was received from the mother, a pediatric nurse practitioner, on 05/21/2002. The mother described the injection site reaction as "moderate." Early in May 2002, the infant received her second dose of Prevnar. She was treated with Benadryl prior to vaccination and subsequently experienced no adverse event.
Full body rash, small hive like, with small blisters. Spread to extremities the next morning, still spreading (getting denser) 4 days later.
Generalized aches and pain (muscles and joints) Severe fatigue Chills Fever of 100.8 Nausea Ear Pain
injection site redness; injection site pain; lump at the site; more redness today and it is still there but was worse on Sunday; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 50 years old female patient who experienced injection site redness, injection site pain and lump at the site while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2022, the patient received a dose of 0.5 ml injection of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot: U7187AA)(expiry date :28-Sep-2023) via intramuscular route in the left arm for immunization.  On 19-MAR-2022 (latency :1 day) the patient developed non-serious events of injection site redness (vaccination site erythema) injection site pain (vaccination site pain),lump at the site (vaccination site mass) more redness today and it is still there but was worse on Sunday (condition aggravated) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  The patient was treated with Ibuprofen.  At time of reporting, the outcome was Unknown for all the events.
This study case was received from the investigator in a trial on 27 September 2012. A 27 year-old male subject was found to have a subendocardial infarction and chest pain, unspecified 11 and 12 days respectively after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (manufacturer, lot number, route and site of administration not reported) on 11 April 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.57 on 21 April 2012 and an abnormal ECG on 21 April 2012. Echocardiogram result was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data-mining, non-interventional) study. Documents held by sender: none.
WITHIN 8 HOURS PATIENT BEGAN FEELING ILL, DEVELOPED A FEVER OF 100.5, LEFT ARM BECAME RED/ WARM TO TOUCH AND "FIRM" 2 DAYS LATER SEEN AT URGENT CARE GIVEN LIDOCAINE AND CEFTRIAXONE INJECTION. CONTINUED WITH KEFLEX 500MG SITE IMPROVED AND RESOLVED WITHIN 5 DAYS.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/18/2021 and 4/9/2021. On 12/8/2021 presented to ED for altered mental status. Also short of breath requiring HFNC. Admitted for acute respiratory failure due to COVID-19. Tx'd with dexamethasone, diuretics, heparin, hydrocortisone, broad spectrum antimicrobials, pressors, remdesivir, and dialysis. Developed pneumonia, pneumothorax, and para pneumonic effusion -> grew pseudomonas tx'd w/meropenem. Resp. status cont. to decompensate requiring intubation and proning, status c/b AKI, hyperammonemia and encephalopathy. Expired 12/27/21. Patient transitioned to comfort care and expired 12/27/2021 at 1526.
pt w/accidental knife wound was given Td; pt devel an inject site react & swollen lymph nodes in the arm & neck;
This spontaneous report as received from a nurse refers to an unspecified adult patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-JUL-2015, the adult patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not reported) (dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Client states 1-2 hours after receiving immunizations she experienced headache, stomach ache, chills, dizziness, fatigue, felt "pins and needles" all over and her face was flushed.  These symptoms continued all night.  Client states she called her physician who instructed her to take 75 mg diphenhydramine.  On 11/2/07, client stated she continued to experience dizziness, nausea and fatigue.  On 11/5/07 client stated her symptoms had resolved, but on 11/4/07 she had one episode of unknown duration of dizziness, blurred vision and nausea.
pt recvd vax & c/o aching in calf of right leg; face flushed; fever,listless;
Chest pains; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains) and DYSPNOEA (Shortness of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pains) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST PAIN (Chest pains) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Shortness of breath, weakness, dizziness last night. Patient is a 28-year-old female with past medical history significant for psoriasis who presented as above. Patient is a health worker who received a mandatory influenza shot between 8 and 8:30 p.m. last night. About two hours later she began experiencing some shortness of breath. She felt like there was a knot in her throat. She reported feeling dizzy, tachycardic. She reports that her lips began to swell and her hands began to swell, and this prompted her visit to the emergency room. She received some epinephrine, SOLU-MEDROL, and some BENADRYL and her symptoms began to somewhat subside. Plans were being made for discharge but soon after symptoms recurred. She received further treatment and was thereafter admitted to intensive care unit for further evaluation and management. At this time she reports significant resolution of her symptoms. She said she is now back to her baseline respiratory status. She reports she has never had an influenza shot before, and she has no prior history of anaphylaxis. She did have an adverse reaction to DARVOCET, but the reaction at that time was itching. At this time she denies any headaches or dizziness. She denied any chest pains. Denies any other complaints at this time.
After my first Moderna shot, my left armpit's lymph nodes swelled up.  This continued past the second shot.  It deflated a little bit but is still notably more swollen than normal.  At my physical, I mentioned it to my physician (the doctor listed earlier in this form) and she suggested I go for an ultrasound since it was September at this point, past the time that lymph nodes would normally still be swollen from the vaccine.  I have received a booster since then and my armpit swelled up again, and deflated, but is still notably more swollen that it was pre-vaccine.  There are no other symptoms and I will be getting future boosters/vaccines as needed.
Tachycardia, marked edema, (L) deltoid. Presyncope x3 necessitating both an urgent care and ED evals. Episode has triggered "panic attacks".
A bad sore throat so bad that he could not drink water; He started feeling unwell; Had a fever of 103degF; Still feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Comirnaty (as primary series). Past adverse reactions to the above products included No adverse event with Pfizer Comirnaty.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired). At the time of the report, OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103degF. On an unknown date, SARS-CoV-2 test: negative (Negative) PCR twice for COVID 19 but returned negative..         No Concomitant informations were reported. No Treatment informations were reported.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's current conditions or medical history were not reported. On an unknown date, reported as in the past, the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, frequency, route, anatomical location, lot number and expiration date not reported). On an unknown date, the pharmacist reported that the patient will have his adenoids taken out (the reason was not reported). Outcome of the event was unknown at the time of the report. Additional information is not expected as the reporter did not have additional information to report.
Possible seizure, pt shaking, shortness of breath, bluish skin, kept saying "couldn't breathe." Epi-pen autoinjector administered afterwords patient was laid down and raised legs and blood pressure taken which was 118/68, pulse 68. Emergency 911 was called and arrived on scene in 2-3minutes. Paramedics took vitals and deemed it to be a syncopal episode, instructed patient to go to hospital for further monitoring. Husband to drive pt to hospital.
patient reports completing 2 shot series of Pfizer covid vaccine, 1st shot given 1/11 per wife, 2nd shot complete 1/25 per wife, but maybe actually given in February?  Both shots were taken, interval just unclear from family.  Patient admitted to Medical center on 4/9 with cough, fevers and coughing. Reported that his daughter was diagnosed at end of march and him and his wife had symptoms 4 days prior to admit and was positive for covid.