chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 71 year old male consumer with no known allergies and hypertension who on 12-DEC-2006 was vaccinated SC with a single dose of Zostavax. Concomitant therapy included Lipitor and atenolol. On 13-DEC-2006 the patient experienced conjunctivitis. Unspecified medical attention was sought. There were no lab tests performed. On 14-DEC-2006 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Follow up information received from the registered nurse indicated that on the night of the injection (also reported as 16-DEC-2006) the patient developed pus in one eye and was seen by an ophthalmologist. At the time of the report the patient had recovered. It was unknown if the patient had any adverse events following prior vaccination. No further information was provided. Additional information has been requested.
Patient started to experience nausea/vomiting soon after getting the vaccine, then started convulsing and having seizure-like symptoms.
Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - This case concerns an adult male with a serious unexpected event of COVID-19. Latency a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-034551, US-MODERNATX, INC.-MOD-2021-022629, US-MODERNATX, INC.-MOD-2021-022705, US-MODERNATX, INC.-MOD-2021-022914 (E2B Linked Report).; Sender's Comments: This case concerns an adult male with a serious unexpected event of COVID-19. Latency a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-034551: US-MODERNATX, INC.-MOD-2021-022629: US-MODERNATX, INC.-MOD-2021-022705: US-MODERNATX, INC.-MOD-2021-022914:
Fever 103 for 3 days, spots appears approximately 230 PM on 8/3/06. Fussy - face, trunk, arms (spots).
febrile seizure 1/20/07, fever developed 1/19/07, full seizure with fever spike lasted 3-4 min, 911-> ER
Deathly ill; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 06-Dec-2020.    This case involves a patient with unknown demographics who experienced deathly ill (Illness) when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, (unknown latency) the patient experienced deathly ill (Illness), following the administration of INFLUENZA VACCINE (flu shot).  Relevant laboratory test not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Patient received the Moderna booster without omicron instead of the bivalent Moderna booster with omicron.  No reported adverse reaction.
Received 3 vaccines on 11/6/06 that evening around 6pm. Client complained of pain and redness in area of varicella injection. By AM on 11/7/06 area was 41/2 in long x 2 1/2 wide, very red, hot, swollen and painful. Was taken to ER. Diagnosed with cellullitis placed on antibiotic.
Golf ball size knot at the injection site; Pain and swelling at the injection site; Pain and swelling at the injection site; This spontaneous case was received on 14-Sep-2020 from other health professional via agency (reference number: SEQW20-01616) and concerned a female patient, of unreported age.   The patient's medical history and concomitant medications were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax QIV vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 283847, expiration date reported was 20-Jun-2021.  On the same day, about an hour after receiving Flucelvax QIV, the patient developed pain and swelling at the injection site. Later, in the evening, she developed a golf ball size knot at the injection site. The patient was treated with ice packs to site and it helped to reduce the size of the knot to size of small boil which was still painful.   At the time of initial reporting, on 14-Sep-2020, the patient had not recovered from the event 'vaccination site pain', and was resolving from the event 'vaccination site lump' .  The outcome of event 'vaccination site swelling' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.   The case is linked to 202004443 (same reporter).  Company comment: The patient developed vaccination site mass, vaccination site pain and vaccination site swelling on the same day after vaccination with the suspect product, Flucelvax QIV vaccine. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass, vaccination site pain and vaccination site swelling on the same day after vaccination with the suspect product, Flucelvax QIV vaccine. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received paxlovid from 23Sep2023 to 27Sep2023 as Treatment of COVID-19. Patient did not had known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322072 same patient, different drug/event;
red warm area approx 2cm achy entire body, low grade temp;went to ER red area inc to 4cm,temp 100.8, chills, vertigo;IV rocephin given & started keflex;PM back to ER, red area inc to 11x14cm, T103;
tetralogy of fallot; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 18Oct2021 16:40 (Lot number: 30145BA) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prosthetic valve functioning normally", start date: 24Nov2015 (ongoing), notes: placed 24Nov2015 18Oct2021. There were no concomitant medications. The following information was reported: FALLOT'S TETRALOGY (medically significant) with onset 18Oct2021, outcome "not recovered", described as "tetralogy of fallot". Clinical courses: No prior vaccination within 4 weeks. No family medical history relevant to AE(s).; Sender's Comments: There is no sufficient evidence that the reported tetralogy of fallot, although temporally related, may be related to administration of BNT162B2. Event is likely an intercurrent medical condition. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a pharmacist concerning a 34 year old female with asthma and no known drug reaction who on 21-MAR-2011 was subcutaneously vaccinated with PNEUMOVAX 23 (dose and lot# not reported) into her left arm. Concomitant therapy included Tdap(dose, route and lot# not reported) into the same arm different site. On approximately 21-MAR-2011 the patient developed an injection site reaction following vaccination with PNEUMOVAX 23. The patient contacted the office and was seen in the office on 23-MAR-2011and the patient's arm had a 3 by 5cm round, swollen, red, warm and painful to the touch reaction at the injection site of PNEUMOVAX 23. The patient was also complaining of fatigue and had a mild fever during the office visit on 23-MAR-2011. The patient called the office next day (24-MAR-2011) reporting a doubling of the injection site reaction and continued redness and warmth. The patient was sent to another physician (unspecified) where the patient was treated with a 7 day course of the antibiotic KEFLEX and pain medication (unspecified). No lab diagnostics study was performed. The reporter was unsure if the patient experienced significant disability; patient had significant pain and might have missed work. At the time of reporting, the patient recovered. Additional information has been requested.
Initial unsolicited report received from a healthcare professional (medical assistant) on 17-Aug-2017. This case is linked with: 2017SA152905 (same reporter). This case involves a male patient (age not reported), who was vaccinated with first dose of QUADRACEL via intramuscular route (batch number: C5222AA; expiry date: 20-Jun-2019, dose and site of administration were not reported) on an unknown date of Aug-2017 (one patient got it on 11-Aug-2017 and other on 14-Aug-2017) and VARICELLA VACCINE (LIVE) via intramuscular route (manufacturer: Merck) (batch number, expiry date, dose and site of administration were not reported) MEASLES, MUMPS AND RUBELLA VACCINE (MMR) via intramuscular route (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Illness at time of vaccination was none. Concomitant medication was not reported. Any other vaccinations within 4 weeks of vaccinations was unknown. On an unspecified date, following the vaccination patient experienced redness and swelling at the injection site and was seen (emergence room/doctor visit) in the office and disgnosed with superficial cellulitis. No laboratory investigation was there. Corrective treatment included BENADRYL and warm soaks. Outcome of the events were unknown. Upon internal review the case was considered as serious because of important medical event: superficial cellulitis. List of the documents held by sender: none. Sender's Comments: The patient experienced cellulitis and vaccination site redness and swelling post vaccination with QUADRACEL. Time to onset was not available and the event cellulitis is not listed with the vaccine. The patient received vaccination with VARICELLA (UNK MFR) and MMR (OTHER MFR). Site of vaccination and reactions was not provided and it could be possible that the vaccination site reaction occurred at the site of other vaccine. Cellulitis indicates infectious etiology which needs to be investigated and patients pre-existing conditions need to be looked into. Based upon reported information the role of the vaccine cannot be assessed.
Patient's arm started a rash, itching and fever to the arm on the same day of injection. The next day, the injection site formed a blister and then popped. On the seventh day after day of injection, patient states now he is having shoulder pain and arm tightness. Mom have been giving patient BENADRYL and ibuprofen.
Charted as left deltoid but patient reports was her right. Pain reduced left deltoid ROM, stiffness. Currently only 75% better after 7 weeks.
After I got the vaccine I being observed because of my existing allergies. I had a reaction after the shot after I left and took some Benadryl. I was itchy all over and when I woke up that night I got a fever and chills. I was so cold and I was super tired for 3-4 days. I was takin Nyquil and Dayquil and I had headaches. I felt like I was drunk. I developed a tickling uncontrollable cough which got worse. I missed work due to the cough for the first time 05/08/2021. The cough gets worse sometimes and I have had to miss work multiple times since then over the last. Sometimes it becomes hard to breath because the cough is constant. It is mostly a dry cough and sometimes I throw up because I can't get it to stop. It had been six months and I am having trouble talking. I may have had COVID-19 during the winter of 2019-2020. I am a flight attendant and I was coughing for months then. I recovered but the cough came back after I got my shot. It is difficult for me to work. I went to Urgent care again and they prescribed Albuterol, Prednisone, Fluticasone and Benzonatate. I have had Advair added since then. I have been using all of those prescriptions for a month and it has improved slightly but it is still a constant cough.
Patient received Flucelvax Quadrivalent after temperature excursion; Patient received Flucelvax Quadrivalent after temperature excursion; This is a spontaneous case, initially received from other health professional via Med Communications (reference number: SEQ20-00509) on 14-Feb-2020, concerning a 10-year old patient of unspecified gender.   The patient's medical history and concomitant medications were not reported.   On an unknown date in 2019, the sticker on the box that contained Flucelvax Quadrivalent vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261228 and expiry date: not reported] turned red and showed that storage temperature was out of range, but it did not indicate when temperature excursion happened and how long it lasted. The first temperature excursion was confirmed (explicitly coded as Product storage error').  On 10-Nov-2019, there was another excursion at 10.9 degrees Celsius for undetermined time, potentially five hours.  On 11-Nov-2019, the patient was administered Flucelvax Quadrivalent [anatomical location: left deltoid, dose and route of administration,expiration date: not reported] for an unknown indication after temperature excursion (explicitly coded as Product administration error').  It was not reported whether the patient experienced an adverse event due to Flucelvax Quadrivalent administration.   This case is linked to cases 201907258, 202001725, 202001745, 202001746, 202001747, 202001748, 202001749, 202001750, 202001752, 202001753, 202001754, 202001755, 202001756, 202001757, 202001758, 202001759, 202001760, 202001761, 202001762, 202001763, 202001764, 202001765, 202001766, 202001767, 202001768, 202001769, 202001770, 202001771 and 202001772 (the same reporter).   Company comment: Reportedly, the patient was administered the suspect product Flucelvax Quadrivalent after two temperature excursions. It was not reported whether the patient experienced an adverse event. Product storage error and product administration error are assessed as not related per company's conventions.; Sender's Comments: Reportedly, the patient was administered the suspect product Flucelvax Quadrivalent after two temperature excursions. It was not reported whether the patient experienced an adverse event. Product storage error and product administration error are assessed as not related per company's conventions.
Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 2nd of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202101466426 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101468109 Same Reporter/Drug/AE, Different Patient
Saliva lab test positive for COVID-19; Saliva lab test positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "short colon" (unspecified if ongoing), notes: short colon; "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine: Pfizer BioNTech, Dose number: 4 and 3/Vaccine: Moderna, Dose number: 2 and 1. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Saliva lab test positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient also received that Paxlovid from 11May2022 to 16May2022 of unknown lot number for the indication of treatment of COVID-19 and patient received several per & otc of various brand on 01Jan2015 of unknown lot number.  Clinical course: Adverse event Saliva lab test positive for COVID-19 09May2022, 1 day after symptoms started. Started Paxlovid 11May2022, 2 days later. Patient felt much better by 16May2022, on 8th day. On 21May2022 again had COVID symptoms, home-test positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine was given approx. 1 month after recovery from Shingles.  Shingles pain in the back returned after the vaccine was administered.
Began vomiting several hrs p/recvd vax; vomited twice; began diarrhea about the same time, which persisted until 8MAR92 when pt was hospitalized by MD; no fever reported;
This spontaneous report was received from a licensed nurse practitioner and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of ROTATEQ (orally, dose, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was given Pfizer vaccine for 6 mos - <5 years. Should have received Pfizer 5 yrs - < 11 years
Sore arm at injection site, fatigue, headache, chills, muscle and join pain, nausea,
I have had the same reaction after each vaccine with a fever, hurt all over my body but this one was the worst. I was in bed for three days after each one. After all, three boosters within four weeks, I get a rash on my face itches, burns and hurts. I still have the rash from my last booster. I use a cortisone cream to help with the rash. My allergist believes that I have eczema. If I stop using cortisone, the rash returns.
I had my vaccination on 01/21/2022. I started to experience atrial fibrillation 02/2022. I was administered the Holter monitor and diagnosed with Premature atrial contractions (PACs). I was prescribed medication for the Premature atrial contractions (PACs) and currently followed by cardiology. I had the last Atrial Fibrillation 11/2022 and scheduled for ablation surgery 2023.
Pt received Hep A injection on 5/31/12 and on 6/2/12 he woke up with hives. He developed swelling to mouth and tongue.