chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT IN LEFT CALF; This spontaneous report received from a patient and concerned a female of unspecified age. The patient was called to obtain additional information on 21-APR-2021 and message was left on a voicemail. The patient's height, and weight were not reported. The patient has no family history of thrombosis. The patient does not have any underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-APR-2021, the subject experienced blood clot in left calf. The patient noted that she did not have any underlying conditions or family history that may have made her more predisposed to this diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report concerns a female patient of unspecified age who experienced a blood clot one day after Janssen COVID-19 vaccine was administered for prevention of symptomatic SARS-CoV-2 virus infection. The patient's height, and weight were not reported. The patient has no family history of thrombosis and has not reported any underlying conditions. No concomitant medications were reported. The patient did not provide details related to the blood clot, except it was not resolved at the time of the report. Given lack of alternative explanation and temporal plausibility the event is considered possibly related to Janssen COVID-19 vaccine.
Chest pain began around 10:00 Tuesday 17th. Started localized to sternum- spread across pectorals left and right equally as day progressed. Took Aspirin.   Next morning pain was still there- had spread to left arm with some numbness and tingling. Took more Aspirin. Went in to Dr's office first thing to get EKG- hard rhythm normal.  Had prior incidence of costochondritis (inflammation of cartilage) recorded 2 years prior- likely a flare up.
Patient was administered on 11/6/2019 Prevnar and was advised on possible side effects and recommended to use ice in the area. On 11/13/19 the patient complained of redness, itching and burning sensation in the injection site. Patient was advised to continue to use ice and hydrocortisone cream in the area. Today 11/15/19 the patient states there has been improvement and that he would be well by tomorrow. The patient was very grateful for the services provided.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional (practice manager). This case involves a 78 years old female patient who received vaccine FLUBLOK QIV. The patients past medical history, concomitant medications and family history were not provided. On 27-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1821, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that FLUBLOK QUADRIVALENT syringe malfunctioned and product ran out of both sides and bottom of needle. Leaking from out from the base of the needle where it meets the tip cap. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
scalp numbness/numb face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (scalp numbness/numb face) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0032b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HYPOAESTHESIA (scalp numbness/numb face). At the time of the report, HYPOAESTHESIA (scalp numbness/numb face) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not provided..   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021 contains no significant information.
chills, fatigue, congestion, postnasal drip, sore throat, cough, myalgias
Around 9pm the day I received the shot my heart rate was at 105 while I had been laying down and relaxing for at least an hour. This continued through the night. I also had a fever and chills, which I expected.  On Thursday, 11/16/23 I started my period and it was EXTREMELY heavier than normal and lasted 2 more days than normal. I called the pharmacy and Pfizer and confirmed this was not a listed side effect. However, I found other women reporting this and news articles noting studies and reports that this has happened to other women. This needs to be listed as a side effect because it's very scary when it's happening to you, and affects women's day to day life. I'm also scared that it's affected my body in a permanent way, and have no information about it. I was scared I was going to bleed too much and had very large blood clots for days which is not normal for me.
Given Varicella Virus Vaccine and she is pregnant. date given as 10/6/09 - vaccine prescribed and given on 10/7/09.
Blood sugar slightly elevated on Wednesday AM and continued to rise through day and following day - Thursday. On Thursday AM - felt warm, then had chills. I also had several dizzy spells on Thursday.
patient came in at end of clinic hours.  his appointment was for pfizer vaccine.  decision was made to switch last few patients to moderna in order to not waste any doses.  he ended up getting moderna though he is under 18 years old and not authorized for that age.
Narrative:  Patient was a resident of community living center, tested positive for COVID-19 8/23/21 and was admitted to hospital for isolation in airborne precaution room and for administration of Remdesivir.
Headache, Myalgia, C/O body aches and fatigue, and sore arm  Narrative:  Employee endorsed symptoms started 1/12/21 between hours of 2-5A.
This spontaneous report was received from a registered pharmacist concerning an 81 year old male patient with no pertinent medical history and no drug reactions/allergies. On 12-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as 1947AA and 20-OCT-2013 respectively), intramuscularly in the arm. Concomitant medications included PLAVIX and atenolol. On 12-DEC-2012 (same day), the patient experienced pain in the upper arm where the PNEUMOVAX 23 was administered and it was so bad it kept him up last night. The patient sought medical attention (went to the pharmacy). It was unspecified if the treatment was given. No laboratory diagnostic tests were performed. The pain was better at the time of report and the patient was recovering from the event. The outcome of the event 'it was so bad that it kept him up last night' was unknown. Additional information has been requested.
pain on my right side of my body; 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 MYALGIA (pain on my right side of my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 30-May-2021, the patient experienced MYALGIA (pain on my right side of my body). At the time of the report, MYALGIA (pain on my right side of my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment medications were provided
Had very bad headache, severe chills and arm pain which started night of vaccine. On Saturday I was extremely tired and slept most of the day. Started to feel much better on Sunday afternoon.  The arm pain lasted 10 days, the first 5 days the pain was bad and then it started to subside. I took 1000mg of Tylenol for the headache. I was able to endure the side effects.
pt recv vax 22MAY95 & ofc called on 24MAY95 by pts mom; pt arm @ site was extremely swollen, warm & painful;
swelling of 1/2 tennis ball size x 5 days/constipation;
HYPOTENSION 7/17/2022 COLITIS ACUTE RESPIRATORY FAILURE 7/17/2022 COLITIS HYPOTENSION 7/17/2022 COLITIS ACUTE RESPIRATORY FAILURE 7/17/2022 COLITIS
Cough; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team reported for herself that:  A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cough. The patient underwent lab tests and procedures which included Antigen test: negative on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Syncope post GARDASIL and MENACTRA administration. Patient fractured nose during syncope event (hit office counter during fall).
This case was reported by a physician via call center representative and described the occurrence of fever in a 66-year-old female patient who received Shingrix for prophylaxis. On 16th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2018, 1 days after receiving Shingrix, the patient experienced fever. On 18th August 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: This case was reported by the retired physician for herself. On Tuesday, the patient had a dose of the Shingrix and woke up with a 99 degree F fever on Friday morning. The fever went up to 101 degree F by Friday afternoon. The fever went away on Saturday afternoon. The patient denied permission to contact their physician.
05/16/2018 08:08 AM patient presents to clinic with C/O pain, swelling, itching x 2 days post Tdap immunization. Patient reports she experienced "warm, red, hard, itching area" surrounding the injection site (R deltoid). Soreness and redness confined to bicep area. Patient reports she is feeling better now but wanted the nurse to check it prior to her leaving for vacation. Pain: 0/10. Meds: ZYRTEC. NKDA. T: 98.3. R deltoid area noted to have 4 in X 4 in ecchymosis, inflammation and slight firmness. Slight erythema noted to R deltoid. Area warm to touch. Patient advised to ice area to decrease inflammation. NP prescribed KEFLEX TID x 7 days. Patient instructed to take medication with food. Patient to return if symptoms persist or worsen. Pharmacovigilence notified. Signed by RN on 5/16/2018 at 8:35 AM.
Expired dose of Hiberix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received Hib (Hiberix) (batch number TH93R, expiry date 13th July 2022) for prophylaxis.   On 14th July 2022, the patient received Hiberix. On 14th July 2022, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022112341   Additional Information: GSK receipt date: 28-JUL-2022 Reporter comment: The pharmacy resident reported that expired dose of Hiberix was administered. Adverse event reported contains all reported information from healthcare professional. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Hiberix, which led to expired vaccine used. This case has been linked to the case US2022112341 reported by the same reporter
lt upper arm (just below shoulder to just above elbow) became sore & cont to be sore & mild to moderately painful on use; described to be on lateral outer aspect of arm; (moderately= 5 @ max on a scale of 1 to 10);
No adverse event; Patient administered an expired vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 001J21-2A, 029A21A, 039A21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  NDC number of dose received was reported as 80777-273-10.  The facility stated that the patient received the new omicron booster vaccine and that the dose was not expired. Patient provided the lot number and found out that the patient was administered an expired vaccine.   The patient did not experienced any side effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Follow up received inarrative supplement updated.
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to medical staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient verbalized understanding.
Pt recvd vax 11FEB92 & on 13FEB92 pt started w/fever which reached 103; pt began to have difficulty swallowing, swollen gums, & sores in mouth & throat; 18FEB92 pt dx of secondary infection from immun probably MMR:
Blood pressure over 200 /80 with increased hydrazaline. And clonodine  Sugar levels elevated from  average 130 to  150  went to over 200.  Sugars started to come down after 5 weeks Blood pressure seems to be going higher
4 days after Immunizations patient presented with fever and vomiting. 8 days after immunizations patient presented with hives and swelling in feet, hands, and face. Patient was admitted to Medical Center 4/23/08 in the evening for swelling. Patient is currently taking Benadryl, Adderax, Prelone, and Motrin. 4/25/08-records received for DOS 4/23/08-seen two times in ED for welts on axilla, groin and abdomen. Swelling hands and feet, pain when walking. Hands, feet and left knee hot and enematous. Hives over entire body.
STILL ACHY EVERYTHING HURTS  INSIDE AND OUT; DIZZINESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-MAR-2021, the subject experienced still achy everything hurts inside and out. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still achy everything hurts inside and out, and fever, and the outcome of headache and dizziness was not reported. This report was non-serious.
Sometime after the vax, the pt developed a slight fever. No rash was noted. Additionally it was noted that the pt's mother experienced a reaction after exposure to her son. Additional information has been requested.
Came in for second dose late   Narrative:  This is to report that the employee was late for her second dose. The efficacy was explained to her and she verbalizes understanding of any side effects.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8735), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Former breast cancer patient" (unspecified if ongoing), notes: Former breast cancer patient. Concomitant medication(s) included: METOPROLOL SUCCINATE, stop date: 03May2022; CELLTRION FAMOTIDINE, stop date: 03May2022; TARO ENALAPRIL, stop date: 03May2022; MYLAN ATORVASTATIN, stop date: 03May2022.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient began Paxlovid on 03May2022 for COVID-19.
I developed a large hard lump in my armpit of the arm; large hard lump; 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 PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump). At the time of the report, PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drug information provided. No concomitant drug information provided.   Reporter did not allow further contact
Muscle pain, joint pain, headache, extreme fatigue and chills. My doctor is off today. I will see him tomorrow 2/28/02
I received my first dose on 4/27/21 I felt some lumps around my right clavicle bone and a burning sensation on 4/28/21. On 4/29/21 I started having pain and burning sensation under my right armpit radiating to my breast area. I contacted my doctor she said it was probably my lymph nodes that were swollen. On 5/10/21 I started having pain on my right leg and some swelling. I went to the urgent care on 5/11/21 they told me to watch out for shingles. I wanted to make sure it wasn't a blood clot. On 5/12/21 I started having abdominal pain on my right side, I went to the Urgent care and they did a CT scan showing my small intestine and appendix inflamed. I was transferred to the Emergency room and admitted the same day. I had an appendectomy on 5/15/21. I went for my second dose on 5/21/21 I went to do blood work on 5/27/21 and I received a call from my doctors office that my Liver Enzymes were super high.
Patient and guardian came to clinic with complaint of redness, warmth and swelling at the site of injection. Guardian was informed that this appeared to be a normal reaction. Guardian was advised to follow up at primary care physician.