chrisvoncsefalvay/vaers-outcomes huggingface dataset:
normal post shot malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal post shot malaise) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (normal post shot malaise). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (normal post shot malaise) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient reported that they already got the first 2 doses of the Moderna vaccine, and after the second dose he had a normal post shot malaise. He took an aspirin to feel better.   This case was linked to MOD-2021-371905 (Patient Link).
received his Pediarix vaccine and was prescribed a HIB vaccine / was instead administered a Pentacel vaccine; This case was reported by a other health professional via other manufacturer and described the occurrence of accidental overdose in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (batch number S006471, expiry date unknown) for prophylaxis.   On 9th April 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL (intramuscular) .5 ml. On 9th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Pediarix vaccine and was prescribed the HIB vaccine as well, but was instead administered with Pentacel vaccine, with no reported adverse event, which led to accidental overdose of diphtheria and tetanus toxoid component.
dizziness; nausea; vomiting; fever; chills; fatigue; headache; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications reported were blood measure medication, thyroid medication, Symbicort 2 inhalers if needed and allergy medication Treatment information was not provided.
About 15  minutes (1:28pm)  after injection, patient stated that they felt itching and goose bumps on left arm and left side of back.  I asked patient to wait another 15 minutes and gave 10ml of diphenhydramine 12.5mg/5ml oral solution at 1:35pm. At 2:05pm patient said itching had somewhat diminished.  Patient is  Store employee, I counselled store manager on situation and employee went to work.  At 3pm, I asked tech to go find Pt and see how she was doing.  Tech returned to pharmacy with Pt,  Pt said she couldn't take deep breaths. I called the (manager on  duty and asked her to take Pt to er for evaluation.  Which she did.
Injection given 9/23/03. 9/24/03: increased temp, erythema, swelling upper arm. Antibiotic dicloxicillin.  9/27/03 resolved.
one month post second injection she was noted to have pancytopenia:  she was urgently referred to hematology where work up over the last month has been un revealing of etiology of pancytopenia.  most recent counts are wbc 2.7, hbg 9.9, hct 28.5, PLT 14. she has required IVIG and platelets.  she is needing a referral to a tertiary center.
4.0cm x 6.5 cm erythema around injection site. Warm non tender.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    The concomitant and treatment medication was not reported.  This case contains information for the 15th of 15 adult patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 15
temp 102;uncontrollable tremors;body weakness;h/a, chills;lasted approx 12-14hr;
21JUL92 12PM pt woke w/sx feeling hot, sweaty & chills; felt heaviness in chest, tightness in throat & heavy breathing, throat felt esp tight on rt side; sx lasted till 8AM; c/o diarrhea, tired, tightness in throat;
lt leg recv vax on 18MAR96 -swelling (x2 other leg) & reddened reported by mom 48hr then improved;ice packs applies & APAP given;onset of swelling 2-3hr p/vax;
Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; This is a spontaneous report from a contactable consumer (patient, reported for himself). The report was not related to a study or programme. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry dates were not provided), via an unspecified route of administration, on an unspecified date in 2021 (reported as two days ago), as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the vaccination, the patient reported that whenever he tries to grab something his center middle finger hurts, and it was swollen. He also reported that his third finger was purple right now. It was reported that he had flight first aid health experience. The patient was asking whether he should go to the hospital to have this checked out. The patient was really concerned about this being a blood clot. The investigation assessment was not provided. The events were reported as non-serious. The outcome of the events was unknown.  No further information provided. Unable to clarify details provided or gather additional information.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after administration of vaccine. nurse practioner on site helped her to feet and monitored vitals. low blood pressure. patient was fine after 15 min
pt exp tiredness, fatigue, arched all over, delirious, acted oddly @ times & hallucinations few days p/vax;pt was belligerent to melancholy;pt failed to be aware of surroundings;poss vascular problem assoc w/senile dementia &/or psychoses
I got a flu on 12/4/2018 and have experienced throbbing pain radiating from the injection site since that time.
Case number PHEH2012US010165 is an initial spontaneous report received from a healthcare professional on 11 May 2012. This case refers to a 28-year-old male patient. He was vaccinated with expired MENVEO vaccine (batch number and expiration date: Apr 2012) intramuscularly on an unspecified date. No other information was available.
Soreness in upper arm beginning about 2 hours after injection. Fatigue and chills beginning about 15 hours after injection, low grade fever (37.8  measured 20 hours post-injection).
This is a spontaneous report obtained from a contactable consumer (patient). A 84 year old female patient of an unspecified race and ethnicity received, on 22Aug2015, PREVNAR 13 in the arm, at single dose, for immunization. The vaccine was administered at the physician's office. Relevant medical history included hypertension. Concomitant medication included metoprolol succinate from an unspecified date, 50 mg, once daily, for hypertension. On an unspecified date, in the second week of Sep2015, the patient had itching like crazy on her legs and rash. She saw two different dermatologist. She went to the first dermatologist in 12Nov2015 and said she had too much sun. She went back on 25Nov2015 and was put on prednisone. She took all of it but the rash never left and it got worse on her arms, back, and neck. It was very itchy. She also used Gold Bond itch cream. The patient reported that she stopped her blood pressure medication (metoprolol succinate) to see if that had anything to do with the reactions but no difference was noted. The patient did not recover from the events at time of this report.
Reported at 1852 on 6/23/2022 a rash of new onset after PM shower.  The rash is located on her back and abdomen and in skin folds of torso.  No signs of itching or discomfort.  Reports no changes in soaps, lotions, detergent, bedding or foods.  No new meds. except a covid booster on 6/21/2022 at 0744. Skin: rash was scattered pink, flat in appearance to her upper and lower back, various sites to the abdomen and skin folds. Per RN that rash is pick unraised to her abdomnen and under the breast area, the shape is irregular and sporadic with no regular board.  Patient was seen on 6/24/22 describes a maculopapular rash noted to lower back and abdomen.  Onset of symptoms occured the evening of 6/23/2022.  Treatment:Bendaryl 25mg once Benadryl 25mg q6hrs while awake for 2 days. Rash resolution on 6/26/2022
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown gender and of about 40 year old (reported as "about age 40 years"). On unspecified date in 1994 (also reported as "20 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # were not reported). There were no concomitant medications. No adverse effect were reported. Additional information has been requested.
BILATERAL PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose and start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had bilateral pulmonary embolism after Covid injection. Treatment medications (dates unspecified) included: rivaroxaban (Xarelto). The reporter stated that, "What say you to the bilateral pulmonary embolism I had after your Covid injection BS paying for your blood thinner dollor400/mo of Xeralto. Coincidence I think not." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220525470-COVID-19 VACCINE AD26.COV2.S-Bilateral pulmonary embolism. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
On the 3rd day notice a lump the size of a hard boiled egg. Itched and was red .
SARS-CoV-2 breakthrough infections; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (SARS-CoV-2 breakthrough infections) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  Concurrent medical conditions included Hypertension, Renal disease and Vasculitis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (SARS-CoV-2 breakthrough infections) (seriousness criterion hospitalization). The patient was treated with Immunotherapy (B cell depleting therapy) for COVID-19. At the time of the report, COVID-19 (SARS-CoV-2 breakthrough infections) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 breakthrough infections) to be related.    Treatment medications were not reported.  it was reported that COVID-19 diagnosis was made, antigen or antibody test. Patient outcome for hospitalization was he required Non-invasive ventilation or high flow oxygen devices due to COVID-19. Company comment This literature-non-study case concerns a male patient of unknown age, with medical history of hypertension, kidney disease and vasculitis, who experienced serious, unexpected event of COVID-19, which occurred on an unknown date after administration of the 2nd dose of mRNA-1273 vaccine and led to hospitalization. He required Non-invasive ventilation or high flow oxygen devices due to COVID-19. The mentioned medical history could contribute to severity in COVID-19 and lead to hospitalization. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The vaccination dates of both doses are unknown, so lack of efficacy situation cannot be evaluated.   This case was linked to MOD-2022-496442, MOD-2022-496508, MOD-2022-496509, MOD-2022-496510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Live Follow up received by safety on 21-Apr-2022 has Email received from team and contains significant information: Reporter information (author details and additional authors), literature information  and medical history were updated. Sender's Comments: This literature-non-study case concerns a male patient of unknown age, with medical history of hypertension, kidney disease and vasculitis, who experienced serious, unexpected event of COVID-19, which occurred on an unknown date after administration of the 2nd dose of mRNA-1273 vaccine and led to hospitalization. He required Non-invasive ventilation or high flow oxygen devices due to COVID-19. The mentioned medical history could contribute to severity in COVID-19 and lead to hospitalization. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The vaccination dates of both doses are unknown, so lack of efficacy situation cannot be evaluated.
Redness, swelling, hot to the touch, itching, and pain on the same night she received the immunization. She called the next day to ask for recommendation and recommended BENADRYL. She called later that day to say it was feeling better but called the next day to follow up and recommend cold compress.
This spontaneous case, received from pharmacist on 03-Oct-2017, concerning a 70-year-old elderly female patient. It was reported that, the patient was allergic to latex since an unspecified date. On 29-Sep-2017, the patient was vaccinated with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, lot no: 178323 (as reported) and expiry date: April 2018). On 30-Sep-2017, 1 day after vaccination, the patient felt hot and cold, her stomach was upset and swelling was seen below the shot. It looked like someone grabbed her under the shot (injection area). It was reported that, the patient experienced soreness at injection area. The subject was treated with BENADRYL (12.5mg), one single dose. At the time of this report, the patient had not yet recovered from events. The reporter assessed the reports as non-serious. Follow-up received on 16-Oct-2017: Event onset date were updated to 30-Sep-2017 from 29-Sep-2017 and narrative was amended accordingly. Non significant case correction done 03-Oct-2017: Reported events verbatims were corrected.
pt was adamant about receiving prevnar 13, rather than the pharmacist recommendation for prevnar 20.  Pharmacist counseled and advised the patient about the benefits of prevnar 20 over prevnar 13, but patient refused pharmacists professional advise
no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).     Concomitant medication was not reported.  Reportedly, in this report the patient was eligible for COVID-19 vaccine.   Treatment medication was not reported.   This case was linked to MOD-2022-691012 (Patient Link).
Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006K21A, 016M20A, 037A21B and 076C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 2:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 18-Apr-2022. The vial did not undergo any temperature excursions. No treatment  medications were reported.   This case was linked to MOD-2022-548558 (Patient Link).
Onset of Essential Tremor.  Has increased in frequency with 2nd injection on 03/10/2021 and with Booster injection on 12/22/2021. Most pronounced in left hand, noting injection was left arm. I believe it was intramuscular but cannot confirm. Injection 1 and 2 were given under auspices of local Health Department with assistance at a Church within our location.
got covid after receiving three shots; got covid after receiving three shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid after receiving three shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Thursday evening 10/06/206 complaints of feeling weakness in arm and shoulder followed by extreme pain in arm shoulder and neck. Upper left arm was extremely Red swollen and hot to the touch under injection site about 6 to 7 inch diameter. 10/07/2016 Unable to move his arm on his own. 2 1/2 wks before complete complaints ended and regular none pained movement returned.
Sore, achy, tight abdomen, mild headache, nighttime chills/shaking (12-14 hours post IM), sensitive skin, lazy, sleepy
Chest pain, shortness of breath 26 hours after dose. Treated with ibuprofen. Diagnosed with myocarditis
Complaint of pain upper arm for 3 days.  Day 7 complaint of bruising and swelling.  02/24/2006 complaint of numbness, left buttock to foot, still present.
1/6/2021- vaccine to right arm. slight dizziness 30 minutes after with increased HR but symptoms subsided within 20 minutes.  1/7/2021- fever (Tmax 102.3, headache, injection site pain, muscle pain, abd pain and diarrhea 1/8/2021- right sided swelling to adnexa area/ lymph nodes
Rash and continued to get worse as days went on with fever starting the day after rash started.