chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My throat felt like it was swelling up; The next day I had a temperature; body aches; nauseaus; fatigue; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Dec2020, single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced my throat felt like it was swelling up, the next day had a temperature, body aches, nauseaus and fatigue. She said that she had the first covid vaccine in December and had a reaction. She said that her throat felt like it was swelling up. No other reaction initially. The next day she had a temperature, body aches, nauseau, and fatigue. She was told because of her reaction. She asked that whether she should not get the second dose. She knew it was little late now but this virus was not going away. She was looking for input into how she should move forward. She asked that she could get another dose in the future. She was worried about the fall and the ever changing virus. Outcome of the events were unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Significant tenderness around the administering of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine). At the time of the report, INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.   Reporter did not allow further contact
Shot rec'd 10/18/17 - 10/21/17 R-arm started itching, turned red and was swollen in 6 inch circle around site. This continued for 10 days. Days 5, 6, 7, I took 2 ibuprofen and 1 ALEVE each day to reduce inflammation and irritation. I saw Dr. on Day 12 and I felt fine then.
pt recv vax;had red welt at inject site,approx 3"x2",raised area,blotchy & itchy;low grade fever;use apap for Y;may take dph;
Mild flu; Runny nose; Cough; Fever; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for her 70 years mother-in-law.   A 70 years old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 23Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccination, the patient experienced symptoms of a mild flu with runny nose, cough, fever and headache. Patient was tested for COVID-19 because of her symptoms but the result was negative. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Warmth, swelling, rash of face within minutes of receiving HPV vaccine. Reported there signs and symptoms about 2 hours later. Appearance at time of RX facial redness, swelling, urticaria. Treated with Benadryl PO, Prednisone PO, ranitidine PO.
Information has been received from a physician concerning an approximately 13-year-old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Shortly after receiving the vaccine, the patient developed a rash of 20 pox on her body. It was noted that the patient had titers drawn before vaccination that showed immunity to varicella. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Nurse inadvertently gave tetanus instead of PPD. Develop 6 1/2 x 4 1/2 redness with 1cm hard area. Has redness, swelling, itches. Was painful on day of administration.
patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our local health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
p/vax pt returned to clinic c/lumps all over body; referred to ER & private provider;seen in ER & given benadryl
Red, hive type rash to face, itching no resp. distress no S.O.B.
Patient reported swelling and redness at injection site. She said it was hot to the touch  and was very itchy.
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: F58742) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "melanoma" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: THERAFLU COLD AND FLU, start date: 16Apr2022, stop date: 25Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (03May2022) positive, notes: Viral rebound detected on Day 18 starting Paxlovid on Day1; (27Apr2022) Negative, notes: negative via RAT on Day 8. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had other medication in 2 weeks. Patient had no known allergies. Patient not receive any treatment.  No follow-up attempts are possible. No further information is expected.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with hypothyroidism. The patient was vaccinated with dose 3 GARDASIL on 14-JUN-2012. No other co-suspects were reported. Concomitant medications included: SYNTHROID. On 22-JUN-2012 the patient experienced pain in extremity, 9 days after onset of therapy, rash and injection site swelling. No treatment information was reported. The outcome of pain in extremity, rash and injection site swelling is unknown. The relatedness for pain in extremity, rash and injection site swelling is unknown for GARDASIL. Additional information is not expected.
C/O sore throat with a few days of red bumps to forehead side of abdomen that are slightly itchy. Also c/o mild headache. Pt. also stated he had a fever, but none noted at visit. Also had faint redness and tenderness to L deltoid area.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow up information received includes non-significant information updated.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-APR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # J006681, expiration date 05-DEC-2015; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 72, 32 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Pt developed s/s of COVID and tested positive 3/29/2021.  A planned surgical procedure was rescheduled.
"COVID arm" - 6 days post-vaccine patient developed large, red, swollen, itchy/slightly painful area at injection site.
had a stroke; Right facial paralysis; mouth swelling; mouth numbness and swelling; mouth numbness and swelling, scramble, imbalance; fatigue; left eye pain due unable to close; arm pain; This is a spontaneous report from a contactable consumer.  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 13Mar2021 12:45 (Batch/Lot number was not reported) (at the age of 51-years-old) as single dose for covid-19 immunisation.  Medical history included known allergies not to food, to some medications. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant drugs included prescribed medication since a long time. On 13Mar2021 the patient experienced right facial paralysis, mouth swelling, mouth numbness and swelling, scramble, imbalance, arm pain, fatigue, after been at the hospital it moved to the left side of face, left eye pain due unable to close. She had a stroke. The patient was hospitalized for 2 days and treatment for the events was received. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Rash. Red pinpoint rash on shoulder upper chest and back. Rash occurred within 10-15 minutes of below immunizations. Chest pain - 10-15 minutes after immunizations never any shortness of breath. Pt was very upset crying after administration of vaccines.
used a 5/8 inch needle, patient had very little fat on his arms and she went in at 90 degrees, NO AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old male patient who experienced Wrong injection technique while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ301AA, exp date: 24 June 2020  via intramuscular route in the left deltoid.  It was a case of  Wrong injection technique as pharmacist used a 5/8 inch needle, when the recommendation was to use a 1 inch needle. It was also reported that patient had very little fat on his arms and pharmacist went in at 90 degrees.  At the time of the report, no adverse event was reported.  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 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
Got the vaccine, have shingles again/Suspected vaccination failure; Have shingles again; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine, have shingles again/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Have shingles again) and pain (Verbatim: Painful).  The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 04-Mar-2023. This case was reported by a consumer via interactive digital media. The patient stated that he/she 3 years ago got the vaccine and had them again now taking medications and it was so painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator in a trial on 09 June 2017 and follow up information received on 12 June 2017. A 24-year-old male subject with no significant medical history reported. The subject's concomitant medication were not reported. The subject received a dose of ACAM2000 (lot number and site of administration not reported) on 15 June 2010. On 14 July 2010, 29 days after vaccination the subject was diagnosed with 429.0 non-specific myocarditis, unspecified. The lab data included 14 July 2010, the Troponin I was 02.12 ng/mL (abnormal); on 25 July 2010 electrocardiogram (ECG) was abnormal; on 05 August 2015 Echocardiogram was normal. MRI (heart), MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Sender's Comments: This case involves a healthy 24-year-old male who developed myocarditis non specific with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
TOOK TWO UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2109) was received from a consumer on 14-Aug-2019. It described a male consumer who "took two unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer placed Vivotif doses at 78 to 80-degree Fahrenheit for 24 hours. Then, he placed it in the refrigerator for 1 hour before taking the first dose. The two doses were taken on Saturday and Monday. He also stated that he will go to another country on 24-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.
Second Covid-19 booster (Pfizer): Underarm(axillary) tenderness, soreness, pain on same side as injection persists more than 7 days. Although described in product literature with 16.7% incidence, this adverse reaction inadequately publicized. 69 y/o female is concerned about tenderness being adjacent to breast.
Pt. reports that on 10/24/11, 1 wk after receiving 2nd GARDASIL vaccine she broke out in red, blotchy rash that turned into hives torso, arms & legs. Pt. started BENADRYL 10/27/11 with relief.
On my way to work and I started coughing, I couldn't stop coughing and I felt wheezing, like my throat was closing. I ended up at the ER  where they ran some tests. I went home with albuterol and since then no fever or anything.
only the adjuvant portion of the vaccine was administered; only the adjuvant portion of the vaccine was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA674A, expiry date 31st March 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: Certified medical assistant stated that they had one vial of the lyophilized component for Menveo left, but not an adjuvant portion, and believe that only the adjuvant portion of the vaccine was administered to a patient.  They had not identified a patient at this time and also did not know when this occurred. The reporter consented to follow-up via postal. Additional supportive information: The patient only received the adjuvant portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Tooth Infection; Tooth Extraction; This case was reported by a pharmacist via call center representative and described the occurrence of tooth infection in a 66-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced tooth infection and tooth extraction. On an unknown date, the outcome of the tooth infection and tooth extraction were not recovered/not resolved.   It was unknown if the reporter considered the tooth infection and tooth extraction to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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: 28-Sept-2022 Reporter's comment: The patient was 67 years old. The pharmacist reported that the patient had received first dose of Twinrix series and was not going to be able to come in for the second dose until 30th September 2022 or 1st October 2022. The reporter stated that the dose was delayed because the patient had tooth infection and had to have tooth extraction. The reporter gave permission for follow-up.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates (reported as before today, 04-FEB-2016), the patient received an unspecified number of doses of ROTARIX (strength, dose, dose number, interval and route of administration were not reported). On 04-FEB-2016, the patient was vaccinated with a dose of ROTATEQ oral (exact dose, lot # and expiration date were not reported). There were no concomitant medications provided. There were no adverse effects reported. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2022 at 2:26 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 2:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Dose was given at 27-Jan-2022 14:26:40 No treatment medication was reported by reporter.