chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it inflamed my lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONITIS (medically significant), outcome "unknown", described as "it inflamed my lungs". The action taken for methotrexate sodium was dosage permanently withdrawn. Therapeutic measures were taken as a result of pneumonitis. Clinical course: the event was reported as non-serious. It was reported that patient has gotten the vaccine twice. The first one she was on Methotrexate and it didn't mix with that, it inflamed her lungs and was on oxygen for a year. The second one was on hydroxychloroquine, and it broke all the capillaries in her body. So she had to go off both.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states she has pain and swelling at injection site. Knuckle size lump. Redness around site. She has called MD for advice but may go in to see MD in 2 days if not feeling better.
loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported.  The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown.  Follow-up attempts are needed. Information on lot/batch number is available.
3 days after H1N1 vx, pt developed a fever with temp. over 39 degrees C. He also had a diffuse rash of red dots, flat over entire body
patient was administered Menquadfi after temperature excursion deemed vaccines non-viable for usage with no reported adverse event; lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12 years old male patient who was administered Menquadfi (meningococcal a-c-y-w135 (t conj) vaccine ) after temperature excursion deemed vaccines non-viable for usage with no reported adverse event and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Feb-2023, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Suspension for injection (strength were not reported) (lot U7450AA and expiry date- 10-Oct-2024) via intramuscular route in the left deltoid for Immunization after temperature excursion deemed vaccines non-viable for usage with no reported adverse event (poor quality product administered) (latency: same day)  On 13-Feb-2023 , vaccine has lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (product storage error) (latency: same day)  Action taken was not applicable.  At time of reporting, the outcome was Unknown for 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 guidelines. 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.
1st dose 08Oct2022, 2nd dose 05May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 08th October 2022 with lot no 2KE55 and expiry date as 22nd September 2023).   On 05-MAY-2023, the patient received the 2nd dose of Twinrix. On 05-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 08Oct2022, 2nd dose 05May2023). The outcome of the drug dose administration interval too long 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: 05-MAY-2023 The pharmacist reported that a patient did not receive the second dose until the day of reporting. The reporter consented for follow up via email. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
pt recv vax 26SEP95 & the same day pt exp recurrent rash @ inj site;persisted for 2 wk, resolved, 4 wks later recurred, resolved within a few days;
Pneumonia; Bronchitis; Quite ill; This spontaneous case was received on 31-Dec-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-06748) and concerned a 70-year-old, male patient.   The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported.  On 11-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (2022-2023) (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) to prevent flu. The batch number was not reported.  On an unspecified date in 2022, reported as 'a couple of weeks' and 'two weeks after' receiving Fluad Quadrivalent, the patient was ill as she had bronchitis and pneumonia. The patient was not hospitalized but she got unspecified antibiotics and steroid prednisone.  On an unspecified date in 2022, the patient had an X-ray done, and it showed some residual changes from pneumonia that were improving.  On an unspecified date in 2022, after several weeks, the patient recovered from all events.  The reporter did not provide causality assessment. The patient wanted to know if bronchitis and pneumonia were associated with the flu vaccine as he did not believe it was related to the vaccine.  The event of pneumonia was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 70-year-old patient developed pneumonia, bronchitis, and illness reportedly a couple of weeks or two weeks after receiving the suspect product Fluad Quadrivalent. Underlying medical history of chronic obstructive pulmonary disease contributed to the development of the events. Based on unsuggestive temporal relationship, biological implausibility, and confounding factor (medical history) causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A 70-year-old patient developed pneumonia, bronchitis, and illness reportedly a couple of weeks or two weeks after receiving the suspect product Fluad Quadrivalent. Underlying medical history of chronic obstructive pulmonary disease contributed to the development of the events. Based on unsuggestive temporal relationship, biological implausibility, and confounding factor (medical history) causal role of the suspect vaccine is assessed as not related.
3 days after administration patient develops fever and lethargy - ER visit after 4 days hospital admission 7 days after.
Patient was advised to come in for a Moderna Booster after a 2 dose series of Pfizer.  The patient received the Moderna 0.25 mL as a booster dose but the approved booster at the time was Pfizer.  Patient tolerate the Moderna vaccine well with no reported symptoms.
Patient experienced generalized weakness and was unable to support himself. Patient was taken to hospital ER. Patient has a history of episodes of weakness. ER diagnosed patient as having an allergic reaction to COVID-19 Vaccine. He was discharged to this group home.
Information has been received from the published literature article referring to a 15 year old female patient with allergy to shellfish and methylprednisolone. Medical history included allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) and a dose of Tdap (dose, route and lot# were unknown). 30 to 60 minutes after vaccination, the patient experienced angioedema (lips) and swelling (tongue). The initial evaluation was performed in a clinic and the family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level 2. The patient was treated with epinephrine, oral antihistamine and oral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692). Additional information has been requested.
Febrile seizure that lasted about 5 min., no jerking, just had eye rolling and limpness - went to ER.
Urticarial rash on arms, chest, back occurred about 12 hours after influenza vaccine administered. Patient took antihistamine and by morning symptoms resolved.
Immediately after receiving Pediarix, PCV and PedVaxHib, the baby stopped breathing, became pale and limp, this lasted about 2-3 minutes. I was called in to see the patient, she was breathing, alert but still pale, HR=97, O2  sat 100%. 1 minute after that she regained her color and was alert and active.
LEFT FOOT DROP, SLAPPING GAIT. STARTED FLU LIKE SYYMPTOMS  ON 12/17/14. TREATED WITH TAMIFLU.
METALLIC TASTE; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a 3 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced metallic taste, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metallic taste and slight headache was not reported. This report was non-serious.
Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Case previously recorded as MA2009-4452.  Initial case report received from a consumer source via MedCom on 19 NOV 2009.  A 90 year old male was vaccinated i.m. for the first time with SOIV FLUVIRIN (H1N1 influenza virus vaccine, batch no. Not provided) on 14-NOV-2009.  On 18 NOV 2009, he saw a physician who prescribed Benadryl to treat a rash all over his body.  On the morning of 19 NOV 2009, the patient experienced difficulty walking and weakness.  At the time of this report, the patient was being transported by ambulance to his local hospital.  The outcome was reported as ongoing.  On a case level, the case is considered expected.  No change in risk benefit ratio.  MedCom reference no : NA09-008534.
blood sugar went up the next day to around 200-300 range, blood sure is still around 200; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200) and PAIN IN EXTREMITY (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood test: 200-300 (High) Blood sugar around 200-300 range.. On 20-Feb-2021, Blood test: 200 (High) blood sugar is still around 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
pt recvd vax & was found to be a non-responder p/3rd dose; additionally, exp elevated liver function tests p/3rd dose;
Patient given dtap #4, mmr #1, and prevnar #4. Two minutes after administration of vaccines patient began seizing.  Seizure lasted for approximatley 2-3 minutes. He was  posturing and pupils were dialated, arms and legs shaking, lips and face were blue.  We did treat with 5L of oxygen.   Vitals were within normal limits and stable afterwards 128hr and 32 resp/minute, o2 sat 98%. Valium prepared but not needed.  911 called and pateint transported to Hospital.
Initial case received on 18 December 2009 from a pharmacist. A 32 year old female patient received a left arm injection of FLUZONE (lot number U3224BB) on 17 December 2009. "Later that day" the patient experienced burning at the injection site and a slight red area. The next day the adverse events continued and the patient developed more burning sensation at the site and redness the size of a "nickle" at the site and swollen area. The patient experienced soreness of back area at trapezius area. The patient was advised to take anti-inflammatory and BENADRYL and to return call if adverse events worsened or continue or to seek health care from a health care professional. It was unknown at the time of the report if the patient recovered. Follow-up information was received on 01 February 2010 from a pharmacist. The pharmacist had suggested the use of Ibuprofen to the patient as an anti-inflammatory. He stated he presumed the adverse events resolved, but has had no further contact with the patient, who lives in another part of the state. The patient's physician is unknown. It is unknown if the events resolved. Documents held by sender: none.
23 y/o male is referred from the Smallpox Myopericarditis research group for 1-2 day history of substernal chest pain.  Symptoms: Flu-like symptoms <96 hours, Chest Pain, sub-sternal, Dyspnea (shortness of breath).
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday.  Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
pt recv vax 19MAR96 & 26MAR96 8 days post vax pt devel atypical rash w/wart-type lesions on hands;pt cont to breakout in over 100 vesicular lesions on arms, legs, feet, hands & stomach over the next 8 days;
I noticed a large red lump at the injection site (my daughter's right thigh) 30 min after she received her vaccination.
Increased temp 100.8, achy neck/back, (R) arm red, swollen at sore.
Burning feeling in chest; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Burning feeling in chest) 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.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Burning feeling in chest). At the time of the report, CHEST PAIN (Burning feeling in chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had  a burning feeling in chest after getting Moderna vaccine on 27 MAY 2021. Relevant concomitant medications were not reported.  Treatment medication was not provided.
Mom called on 3/19/01 to report reaction. On 3/16/01, entire right arm was swollen, red and warm. Did have fever any on 3/15/01. Was taken to ER and treated with Benadryl every 6 hours and steroid burst.
This spontaneous report as received from a healthcare worker refers to a 73 year old male patient with aortic dissection, aortic valvular stenosis, benign prostatic hypertrophy, hypertension, inguinal hernia and degenerative joint disorder. Patient had no drug reactions or allergies. The patient's medical history included old myocardial infarction and transient ischemic accident. On 18-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered once at dose 0.65 ml (lot # K009770 with expiry date: 09-OCT-2015). No concomitant medications were reported. On 19-NOV-2014 (reported as "the next day"), the patient experienced rash. The patient sought medical attention via an office visit on 19-NOV-2014 and was prescribed VALTREX. The outcome of rash was reported as recovering. No laboratory test were performed. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; This is a spontaneous report from a contactable physician.   A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on 01Apr2021 (at the age of 59-Years-old) as dose 2, single for COVID-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on Mar2021 (at the age of 59-Years-old) as dose 1, single for COVID-19 immunisation with no reaction were reported. Prior vaccination was reported as none. The patient was not tested for COVID after vaccination. There were no known allergies. The patient experienced patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli on 07Jun2021. The patient was hospitalized for patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli for 2 days. Patient received treatment for the reported event included Eliquis. The outcome of the events reported as recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Thrombosis  and Pulmonary embolism cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
no strength in left arm; she had a Big red spot at the site; brain was not functioning; tingling in the tongue; numbness in the both hands; BP it was 164; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 67, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she was fine for 10 minutes after the first dose then she noticed her brain was not functioning, tingling in the tongue, numbness in the both hands, the nurse checked her BP it was 164, they took her to emergency, put her on oxygen, on monitor, had EKG done, and observed her for 1 hour. She was released after that. For 3 days she was out of it, had no strength in left arm and then she had a big red spot at the site. The patient stated a lot of the strength has came back came now. The outcome of no strength in left arm was recovering while unknown for the rest of the events.   Information on the lot/batch number has been requested.
Pt. was given Gardasil @ 10:45 am. As I was throwing away items - (MA) Noticed that pt's pupils were dilated and she looked flushed. Pt was immediately laid back And was made to sit for 15 min. Pt was examined by Dr. I was instructed to take vitals & if stable pt could go.
Within 24 hours after the Pfizer vaccine pt experienced low grade fever of about 100 degrees. This was accompanied by mental status  changes . She was taken to hospital and admitted overnight to rule out stroke . All symptoms resolved within 24 hours . She is now fine