chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large reddened and sore area on shoulder and upper arm/shoulder redness; sore area on shoulder and upper arm; sore area on shoulder and upper arm; This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 19th July 2021) for prophylaxis.   On 17th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 17th April 2019, less than a day after receiving Shingrix, the patient experienced localized erythema, pain in arm and shoulder pain. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the localized erythema was recovered/resolved and the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the localized erythema, pain in arm and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had large reddened and sore area on shoulder and upper arm, later in the afternoon and came into clinic the next day of reporting and was put on antibiotics.  The redness was resolved.
Pt and mom reported to RN that he had a previous episode of fainting on 6/22/10 after receiving GARDASIL and MENACTRA. Had pt sitting for GARDASIL #2. Fainted within 1 minute and came to within 1 minute. Kept at chair for 30 min & able to walk out & OK.
2nd dose administered about 3 weeks after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th May 2022, the patient received the 2nd dose of Shingrix. On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Pharmacist stated that the first dose of Shingrix was administered about 3 weeks ago (13th April 2022) and the patient came back on the day of reporting, requesting the 2nd dose, which was administered. The reporter consented to follow up via postal. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Woke up to severe itching at injection site almost exactly a week after the injection for the moderna covid 19 vaccine. THe itching kept me awake for an hour and has cause pain and itching throughout today with need for benadryl Lot H02SJ20-2A. Dose was administered on 1/5/2021. I put in random expiration date because I did not have access to that information
Day of administration: sore arm and pain when lifting arm. Continued pain and worsening day after administration. Days later no pain improvement, trouble with basic mobility, wincing from basic movements. Shoulder injury related to vaccine administration.
Pt came on Oct 11th, 2010, 6 PM received Pneumonia shot in (R) arm and Flu shot in (L) arm. Started with bruise on (R) arm and the swelling in the (L) arm started and arm painful. Came to clinic Oct 12th at 5 pm with swelling from (R) upper arm to (R) elbow and below elbow with inflammation redness swelling and rash.
Sore arm, fatigue, dizziness, heart palpitations, tachycardia, chest pain
Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with PROQUAD, lot # M049123 with expiry date on 13-JUN-2018, lot # M038228 with expiry date on 06-MAR-2018 and lot # M033209 with expiry date on 09-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced an excursion of unknown temperature for 48 hours. The previous temperature excursion of 10 degrees Fahrenheit for 19 hours was also reported (it was unknown if the vaccines which experienced previous excursion were administered to the patients). Data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003359: US-009507513-1707USA000400.
stroke; This is a spontaneous report from a contactable nurse (patient's sister). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 15Jan2021 at 18:30 (Lot Number: EL1283) at 1st dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included rabeprazole sodium (ACIPHEX) taken for acid digestion. On 31Jan2021 at 08:00, patient had a stroke (very mild stroke with just some care needed but, not much). She was not able to receive the second dose because she was in the hospital. Caller would like to consult on some guidelines for receiving the vaccine after 6 weeks. The reported wanted to know if the patient need to start all over again. The patient was hospitalized for stroke (cerebrovascular accident) from 31Jan2021 to 03Feb2021 and then went to Rehabilitation right after and was there for 2 weeks. She was currently doing speech therapy because that is what she qualifies for. Things were improving, she has been released from physical rehab but still qualifies for the speech therapy. Outcome of the event was recovering.; Sender's Comments: Based on the limited information and the advanced age, the event stroke is considered more likely an intercurrent medical condition that was unrelated to BNT162B2. Additional information including detailed event information, relevant present and past medical conditions would be needed to better assess the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
She got her vaccines, she felt fine.  She went to sleep Friday night, her husband tried to wake her up saturday morning.  She was sweating, she was too weak to wake up.  She went back to sleep, he woke her up once or twice to drink or eat, and could not get one bite of toast down.  At 2:45 Sunday morning she woke up and felt drained.  She was still extremely tired and she went back to sleep.  She woke up again around 8:00 AM and she could tell that she was feeling better, and around 11:00 AM she got out of bed, I wrapped up some meat she had bought on Friday.  She told him that she had to go back to bed, didn't have the normal sweating or nausea.  The next thing she knows she woke up on the floor, she had slipped on the floor, busted her lip open and her husband said it was enough and that your going to the hospital.  He called 911, they took her to the ER, Hospital and took x-rays but noticed her troponins were very very high.  They did not have a cardiac unit at that hospital and was transferred to different Hospital.  They put her on Heparin because they were not sure if she had a heart attack or not.  They did an echocardiogram, a chemical stress test and showed something blocking behind her heart, and did a heart catheter and it was normal, said it was an anomoly.  Her heart was in good shape but diagnosed her with myocarditis as her BP was very low and felt that the inside of her heart was inflamed.   She was supposed to have an MRI of her heart, but her insurance did not cover it, and feels that nobody should take these two shots together as it was too much for her heart.  They did not put her on any new medications.  She is supposed to see a cardiologist on 10/20/23.    She had her high dose flu shot 2-3 weeks prior to these two vaccines.
Vaccinated for Covid-19 on 1/29/2021 and 2/18/2021.  Symptom onset 6/10/2021 of fatigue, dizziness, vomiting, abdominal pain, shortness of breath and eventually fever.  Tested positive on 6/13/2021.  Sample sent for genomic sequencing
fainting incident after receiving a MENQUADFI vaccine; Initial information received on 19-Aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves 2 patients of unknown demographics who experienced fainting incident after receiving a menquadfi vaccine, after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.   On an unknown date, the patient experienced fainting incident after receiving a menquadfi vaccine (syncope) (unknown latency).  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (fainting incident after receiving a MENQUADFI vaccine).  Outcome: unknown   Seriousness criteria: medically significant for the event; Sender's Comments: Sanofi company comment date 25-Aug-2022:This case concerns 2 patients of unknown demographics who experienced fainting , after vaccination with Menquadfi. The time to onset is compatible with the role of the vaccine. Patient's the lack of information regarding past drugs, relevant medical history, concurrent conditions, psychiatric history, personal history, therapy details, latency and concomitant medications preclude a comprehensive assessment of this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
One day after injection patient developed red warm induration area on left thigh that rapidly grew to involve entire anterior and lateral left upper thigh. No fever. Parent took patient to ER: started on a Rx for presumed cellulitis. Improved.
Right thigh cellulitis at injection site. Treated with 10 day course of antibiotic - Keflex and resolved.
1/5/22 pt initially taken to ED; found to be positive for COVID; increasing sx of cough, fever, SOB; treated with Remdesivir and ABX; 1/9/22 taken to different Hospital for further treatment and care; AHRF due to COVID pneumonia; BiPAP; transferred to ICU and required intubation; pt became  DNR; pt's condition worsened and transitioned to comfort care; pt expired in the hospital
Headache, Myalgia, NauseaVomiting, Fatigue, chills Narrative:
Started period week early; Have been bleeding very heavily like never before; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0151) via an unspecified route of administration in the right arm on 16Apr2021 (both at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), tizanidine (MANUFACTURER UNKNOWN) and hydrocodone bitartrate/ paracetamol (NORCO); all on an unknown date for unknown indication and unknown if ongoing. On 13Apr2021, the patient period started week early, had been bleeding very heavily like never before. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period started week early and had been bleeding very heavily like never before were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
My arm was sore at first but within 1 day it got worse; My arm was sore at first but within 1 day it got worse and spread to my armpit; My arm was sore at first but within 1 day it got worse and spread to my armpit, my breast muscle; My arm was sore at first but within 1 day it got worse and spread to my armpit, my breast muscle, and towards my back.; It was a odd pain sore to the touch even my clothes hurt to wear.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history included endometriosis and migraines. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 08:00, the patient experienced arm was sore at first but within 1 day it got worse and spread to arm pit, breast muscle, and towards back. It was a odd pain sore to the touch even the clothes hurt to wear. It finally wore off after about 3 days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm was sore at first but within 1 day it got worse and spread to arm pit, breast muscle, and towards back, it was a odd pain sore to the touch even the clothes hurt to wear were resolved on 06Apr2021.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Developed symptoms of Vertigo 2 days post vaccine, diagnosed with cerebellar stroke secondary to vertebral artery occlusion on 5/12/21. She had extensive work up which was normal following diagnosis.
this was why it's Dr. ordered it to take a test for COVID.; feeling unwell; quite a bit of a cough; some mucus on the nose; feeling tired; head ache just a little; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, head ache just a little, and was ordered to take a test for Covid by the doctor.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol for Blood pressure, half tablet once a day, cyanocobalamin for unknown indication, tamsulosin for the prostate gland, has prostate enlargement and Nasal Spray from time to time.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2021 post receiving the vaccine, the patient felt unwell, and tired, had quite a bit of a cough, some mucus on the nose and headache just a little. The patient was ordered to take a test for COVID by their doctor. The patient went to ER, took a test tested positive for Covid 19 on 27 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, headache just a little were considered not resolved at the time of this report and the outcome of the event, was ordered to take a test for Covid by the doctor was resolved at the time of this report.; Reporter's Comments: This case concerns a male of unknown age with a serious unexpected event of COVID-19, and nonserious unexpected cough, secretion discharge, malaise and expected fatigue and headache.  Event onset with unknown latency after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Enroll in registry for being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 29A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use from 22-Sep-2014 to 01-Dec-2020. Concurrent medical conditions included Trauma (Trauma due to racism, patient went to therapy and is still working through it.) since March 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2021 to an unknown date for Pregnancy, DIPHENHYDRAMINE for Sleep disorder, MULTIVITAMINS [VITAMINS NOS], ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Dec-2020 and the estimated date of delivery was 17-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Pregnancy test: positive (Positive) Pregnancy test positive.         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Patient demographics updated, Medical history information updated,  pregnancy  test updated, Concomitant medications added, second dose added,
Excessive crying (unconsolable) for greater than 3 hours.  Within 12 hours of the vaccine.
Received his first Moderna dose in January, did not have second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose) 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.    In January 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 PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information received and contains No new information.
Sudden swelling, pain, itching and marked skin redness ( 8 cm in length and 7 cm transverse dimension) left arm/deltoid region at injection site 7 days post injection. Prior to this I only had left deltoid/arm pain for the first 3 days post injection which then resolved. Had to apply topical Benadryl and take oral Benadryl 25mg po tid for one day.
Arteriolar thrombosis in left arm, 2 blockages of the Ulnar and anterior crural interosseous arteries
COVID-19; COVID-19; Exposure to COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4216771-00 (Agency).  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single and intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 28Dec2021, outcome "not recovered" and all described as "COVID-19"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Dec2021, outcome "not recovered", described as "Exposure to COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. The action taken for adalimumab was unknown.The reporter considered "covid-19" and "exposure to covid-19" related to bnt162b2.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of exposed to Covid 19 was not provided. The reporter's causality for the event(s) of COVID 19 with Humira(adalimumab) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 vaccine (TOZINAMERAN): The reporter's causality for the event(s) of exposed to Covid 19 was possible. The reporter's causality for the event(s) of COVID 19 with TOZINAMERAN was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events COVID-19, Vaccination Failure, Exposure to SARS-CoV-2, cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of COVID-19, Vaccination Failure, Exposure to SARS-CoV-2 is : expected. The case will be reassessed further upon receipt of additional information.