chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches and temperature after first dose; Body aches and temperature after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiry date was not reported) via an unspecified route of administration, administered in the left arm on 12Mar2021 (age at the time of vaccination was 49-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included coronavirus infection from May2020 to an unknown date, hives from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 13Mar2021, the patient experienced normal body aches and temperature, states it only lasted 10 hours and went away. The patient underwent lab tests and procedures which included body temperature was she experienced normal body aches and temperature on 13Mar2021. The outcome for the events was resolved.  No follow-up attempts are needed. No further information is expected.
Illness including mild fever and dizziness requiring bedrest. Very sore left arm. Missed one day of work.
This spontaneous report was received from a physician referring to a male patient (currently 59-year-old). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced shortness of breath, nausea and diarrhea. The outcome of dyspnoea, nausea and diarrhoea was unknown. The reporter considered dyspnea, nausea and diarrhea to be related to PNEUMOVAX 23. This case was linked to the case#1902USA004040 (same patient and reporter). Sender's Comments: US-009507513-1902USA004040.
2 days after vaccine administration, pt developed swelling, redness and tenderness at injection site. Pt also developed pruritic rash on abdomen and back, along w/fever (101 degree F) and irritability. Treated w/MOTRIN, BENADRYL and warm compresses.
On my right upper inside arm I have some itchy red bumps that formed. They are shiny, tiny, red, and three dimensional and are itchy. 5 of them total.
Pt reported to post observation RN "I am feeling week, can you take my blood pressure?" Skin pwd. Pt denied pain, dizziness, nausea, SOB. Pt denied any reaction with her 1st dose of Pfizer. No significant medical hx. RN called for aid and walked Pt through breathing exercises and gave her juice to drink. EMS arrived and VSS. Pt reported "different feeling in my chest, but now its better". After VS by EMS, Pt reported feeling " well and I know to contact a medical professional is I need more help later, yes". Pt ambulated independently with steady gait and family to check out.
27 yo male with macular appearing rash that appears on arms, legs, chest, back and face. Rash pruritic and moves throughout the day. Thought related to bandaid use.
sly chest pain  like in his breast bone on the top of his chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest). At the time of the report, CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest) had not resolved.            No concomitant medications reported. No treatment medications reported.
Diarrhea on 7/29/16, 15 days after tetanus vaccine was given.
My symptoms started on a Friday. I was having ear pain and a discharge from the ear. I had just returned from trip, and I started having sinus drainage from my nose and in my ear. I went the doctor after 1 day of severe drainage. A chest x-ray was completed to confirm I did not have pneumonia on February. The provider looked in my ear and determined that I had an ear infection in my left ear. I was given an antibiotic and some ear drops. My symptoms improved a little and then I returned to see my doctor and was still taking the antibiotic. It took a week and a half to get rid of the major congestion. The ear infection cleared up in less than a week. The coughing caused me to lose my voice. I took over the counter medication to treat the remaining symptoms.
I have been vaccinated (unspecified vaccine) and I am on Xeljanz; I got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), (Lot number: FH6267, Expiration Date: May2025) at 5 mg 2x/day (one tablet in the morning and one tablet in the evening) for rheumatoid arthritis, osteoarthritis. The patient's relevant medical history included: "Depression" (ongoing); "Blood pressure high" (unspecified if ongoing); "Sleep and Depression" (ongoing), notes: Sleep and Depression; "Sleep and Depression" (ongoing), notes: Sleep and Depression; "to maintain cellular integrity" (ongoing), notes: to maintain cellular integrity; "I take it for my bones" (ongoing), notes: I take it for my bones. Concomitant medication(s) included: VITAMIN D3 taken for bone disorder; FOLIC ACID taken for plasma cell disorder; PAMELOR taken for sleep disorder, depression. The following information was reported: HERPES ZOSTER (non-serious) with onset 10Jun2022, outcome "unknown", described as "I have been vaccinated (unspecified vaccine) and I am on Xeljanz; I got shingles". The action taken for tofacitinib citrate was unknown. Therapeutic measures were not taken as a result of herpes zoster.  Additional information: It was reported that a patient on the back line, needs to report about reporting earlier a case of shingles after receiving the vaccine, so she said it was the Pfizer vaccine, she got shingles. And consumer stated, "No, that's not what I am calling about, I am on Xeljanz 5mg B.I.D and I have been vaccinated all the vaccine that are available, and I have taken the vaccination had disasters shingles, vaccine (unspecified vaccine) which would be two (doses) and of the Jun I started developing up Shingles. I am calling to report having the shingles and after I have been vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient experienced an anaphylactic reaction characterized by throat closing, shortness of breath, cough, and inability to speak due to airway narrowing. The symptoms started at 0800 and were severe enough that he was having difficulty speaking, so he had a friend talk to dispatch. He was given 2 doses of IM epinephrine, 50 mg Benadryl, and 125 mg Solumedrol by EMS and transferred to the ER department at the Community Hospital.
Started with sore muscles in the arm of injection several hours after the injection. The following day developed a fever, chills, headache, muscle aches, joint aches, and could not move the injected arm without significant discomfort. The injected arm had to be positioned in a specific way to reduce discomfort. Spells of throbbing pain in the injected arm.  On the third day the fever and headache subsided. The throbbing in the injected arm was more intermittent and I was able to use the arm a bit more freely, but still had significant discomfort when using the arm. I could not raise my arm straight up. I also developed swelling and tenderness in some of the lymph nodes in the arm pit opposite the injection arm. The discomfort and throbbing in the arm returned that evening. Again I was only able to sleep for about an hour at a time before waking in pain and needing more advil. became irritated and inflamed in addition to the. Could not sleep due to discomfort in the injected arm. The fourth day and night was pretty much the same as the previous day. I am on the fifth day now and my injected arm is feeling less discomfort. I have developed a rash on the wrist opposite the injected arm.
his shoulder is bothering him; inflammation on the arm; his arm is sore; This is a spontaneous report from Pfizer Sponsored Program with Regulatory Authority Support via contactable male nurse (patient reported for self).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took Advil [ibuprofen] (he also mentioned that he's been taking Advil even before when he's getting a flu shot for years). On an unspecified date, the patient experienced his shoulder was bothering him, inflammation on the arm and his arm is sore. Nobody in their hospital could answer his question. He read on the CDC guidelines that a person shouldn't take an Advil prior to getting the first dose. To his knowledge, he was confident that he did not take Advil a night before his scheduled first dose. But after he got the first dose on 08Mar, he took Advil because his shoulder was bothering him and inflammation on the arm because his arm was sore. He wanted to make sure that he did not render the effectiveness of the vaccine and asked how long he needed to wait before taking Advil after getting the vaccine. Therapeutic measures were taken as a result of his shoulder is bothering him, inflammation on the arm and his arm is sore which included Advil. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 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 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 4:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 4:35 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 06 Feb 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 went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 4 April 2022.   No treatment medication was reported by reporter.
had the shot and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had the Shingles vaccine and got shingles.  The patient stated he/she had shingles 5 times and had them shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report was received from a healthcare worker concerning 2 adult patients of unknown genders. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, both patients were vaccinated with PNEUMOVAX 23 lot # N022650 and expiration date of 01-MAR-2019 for prophylaxis (dose and route of administration were not reported). On unknown dates, patients experienced reactions (adverse reaction) to PNEUMOVAX 23. The outcome of the event adverse reaction and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. The reporter wanted to inquire that there were no issues with the lot that was reported.
Dizziness body aches chills temperature to 104.0 nausea. 3/26/202- and 3/27/2021
administered a dose that was not reconstituted; administered a dose that was not reconstituted; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number of the accompanying lyophilized portion that was not administered was FS52T, expiry date 11th June 2023) for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Shingrix. On 16th February 2022, unknown after receiving Shingrix, 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 details were provided as follows: The patient inadvertently administered a dose of Shingrix that was not reconstituted, so the patient only received the AS01B adjuvant portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   The vaccine was administered by a physician.   Reporter did not have the lot number of adjuvant portion.   At the time of reporting, the patient had not been re dosed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Initial unsolicited report received from a nurse on 21 May 2018. This is an invalid case as no patient identifiers were reported. This case involves vaccination with an expired dose of MENACTRA on an unspecified date. It is a case of actual medication error as expired vaccine was used. 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. Documents held by sender: none.
Patient had a lot of the side effects that were listed as possible but she had them all quite severely.  She had a fever of 104, extreme fatigue, headache, dizziness, required help to walk and perform activities of daily living.  She was not back to her regular actives for about a week including missing several days of school.  We call and talked with doctor because Tylenol was not helping her at all. They suggested giving her ibuprofen and we did but had to give her 400 mg every 4 hrs for days to alleviate side effects.
Pentacel (green top was taken out of fridge and mixed with sterile dilutent).  Pentacel was not banded together. It was administerd to the patient.
they had a reaction; She developed a case of bronchitis, so she was advised by her doctor not to get the second dose; she was advised by her doctor not to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (they had a reaction), BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) and OFF LABEL USE (she was advised by her doctor not to get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (they had a reaction), BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) and OFF LABEL USE (she was advised by her doctor not to get the second dose). At the time of the report, VACCINATION COMPLICATION (they had a reaction) and BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) outcome was unknown and OFF LABEL USE (she was advised by her doctor not to get the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       no concomitant and treatment medications are provided by the reporter.  First dose was given less then 25 days ago.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant follow-up received additional  lab data, suspect product administration date,action taken and event added .
Information has been received from a physician's secretary concerning a 20 year old female with no drug allergies, who on 20-JUL-2009 was vaccinated with her 1st dose of GARADSIL, IM, 0.5 ml. Subsequently, on the same day the patient's "blood pressure dropped to 62/40, she felt faint and became pale". Labs and diagnostic tests included blood pressure measurement. The patient had sought medical attention. At the time of the report the patient's status was unknown. Additional information has been requested.
products should not be used because they were delivered beyond the acceptable shipping time,3 patients received MenQuadfi from this shipment with no reported adverse event; products should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event; Initial information received on 20-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 3 patients of unknown age and demographics who were administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which were delivered beyond the acceptable shipping time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On 30-Mar-2023, it was reported that the products (Meningococcal A-C-Y-W135 (T CONJ) vaccine) should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient developed a non-serious event products should not be used because they were delivered beyond the acceptable shipping time,3 patients received menquadfi from this shipment with no reported adverse event (poor quality product administered) (same day latency) following the administration of Meningococcal A-C-Y-W135 (T CONJ) vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (products should not be used because they were delivered beyond the acceptable shipping time,3 patients received MenQuadfi from this shipment with no reported adverse event).  At time of reporting, the outcome was Unknown for the event products should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event and products should not be used because they were delivered beyond the acceptable shipping time,3 patients received menquadfi from this shipment with no reported adverse event.   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.
Information was received on 14-MAR-2017 from a health care worker concerning and unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccine involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lots of VARVAX involved in the temperature excursion were lot K002926, expired 26-FEB-2016; lot K003407, expired 06-FEB-2016 and lot K015972, expires 23-Sep-2016. Other vaccines involved in the temperature excursion were PNEUMOVAX 23 (MARRS# 1703USA014563), RECOMBIVAX HB (MARRS# 1703USA014564), GARDASIL 9 (MARRS #1703USA014565), PEDVAXHIB (MARRS#1703USA014567), GARDASIL (MARRS# 1703USA007376). Follow-up information was received on 20-MAR-2017 from the reporter. Doses of vaccine for VARVAX (Lot K015972, expired 23-SEP-2016) were administered on 15-OCT-2015, 20-JAN-2016, 02-FEB-2016, 12-FEB-2016, 03-MAR-2016 and 08-APR-2016. The temperature was out of range for 147 hours, 30 minutes. Lot K002926, expired 26-FEB-2016 was administered on 04-DEC-2015.  The temperature was out of range for 147 hours, 30 minutes. Lot K003407 was administered on 30-SEP-2015 and 29-OCT-2015. The temperature was out of range for 147 hours, 30 minutes. No dose or administrations sites were reported. No patient identifiers were provided. Additional information has been requested. This is one of several reports by the same reporter.