chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Lot number: EN6201), in right arm, on 03Mar2021 at 09:00 as dose 2, single (Lot number: EN6205), in right arm and on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 00155BA) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 at 14:00 as dose 4 (booster), single (Lot number: 004M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: almonds" (unspecified if ongoing), notes: almonds. penicillin, sulphamexathole; "Known allergy: penicillin" (unspecified if ongoing), notes: almonds. penicillin, sulphamexathole; "COPD (gold standard stage 1)" (unspecified if ongoing), notes: COPD (gold standard stage 1), prostatitis; "prostatitis" (unspecified if ongoing), notes: COPD (gold standard stage 1), prostatitis. Concomitant medication(s) included: FINASTERIDE, start date: Jan2010, stop date: 25Sep2022; TAMSULOSIN, start date: Jan2010, stop date: 25Sep2022. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies: sulphamexathole", notes: almonds. penicillin, sulphamexathole.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that the patient had Covid initial symptoms on 11Sep2022. The patient received full course of Paxlovid from 12sept2022 to 17Sep2022 for COVID-19.
Fever over 101f, nausea, dry fetching, headache, hallucinations, dizziness, muscle aches. Nausea persisted for 1 week.
developed a redness at the injection site; a reddened hard bump at the injection site; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old female patient who had developed a redness at the injection site(Vaccination site erythema ) and a reddened hard bump at the injection site(Vaccination site mass), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Oct-2019, the patient received a dose of 0.5ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ281AB and expiration date 16-MAY-2020 via intramuscular route in the left arm.  On 25-NOV-2019 (latency 1 month 24 days) after the initiation of suspect the patient had developed a redness at the injection site (Vaccination site erythema) and a reddened hard bump at the injection site(Vaccination site mass). It is approximately 1/4 inch in diameter.  The patient has been to her doctor, who referred her back to the pharmacy.  No laboratory result was reported.  Final diagnosis was a redness at the injection site (Vaccination site erythema) and a reddened hard bump at the injection site (Vaccination site mass).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.
Three hours after Pfizer vaccine given patient began having dermatologic reaction.  The symptoms have worsened over the last 2 days (May 24 & 25) so patient came to be seen in urgent care clinic.  She reports the puritus and rash is  persistent and substantial disruption of the ability to conduct normal life functions.
Got tetanus shot 3-19-12 on 3-21-12 called doc because arm was sore from the shot. They said it is common. On 3-29-12 said it still hurt no anger and other doc's would not say anything it's been over a yr it still hurts.
This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported for coworkers who was sick after receiving SHINGRIX. The age at vaccination was not reported. The reporter reported that the patient's got sick. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This case is 1 of the 3 linked cases.
(L) arm is swollen from armpit to just above elbow on underside (medial). Area is slightly red & firm. No streaking noted. Pt reports his lymph node was swollen yesterday & that arm was more red & swollen. Advised him to see his doctor. Client had same reaction to either flu shot at age 45 or Td vaccine at age 45. Client was not sure which vaccine caused the reaction.
Symptoms started 10/2/21: cough, congestion, body aches, HA,  denies SOB.
Swollen supraclavicular lymph nodes on left side. Biopsied and two removed after a few months. New lymph node appeared after biopsy next to surgical incision.
sore arm; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
severe Rt knee pain & weakness/severe Lt knee pain & weakness; severe Rt knee pain & weakness/severe Lt knee pain & weakness; loss of appetite; unintentional weight loss; fatigue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 11:00 (Batch/Lot Number: EL9266) at the age of 75 years old, as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included heart disease, diabetes and hypertension. Concomitant medications received by the patient within 2 weeks included lisinopril; metformin; rivaroxaban (XARELTO); carvedilol; furosemide (LASIX); all taken for an unspecified indication, start and stop date were not reported and "amio" (unspecified drug). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021, the patient experienced severe rt (right) knee pain and weakness/severe lt (left) knee pain and weakness, loss of appetite, unintentional weight loss, and fatigue. The events were reported as serious (hospitalization). The patient underwent sars-cov-2 test with result of negative on unspecified date post vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was given for the adverse events. The patient has not recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19.
papular scattered rash on arms, legs, face, ear lobes and diaper area.  Onset of rash day 16 post vaccine.  Rx - Orapred 15mg/5ml give 1.6ml once a day x5days.
Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps; Hands and wrist looked like little red raised bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps). At the time of the report, RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient reported that the AEs did not occur because of the vaccine.
Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021). In May 2021, EXPIRED PRODUCT ADMINISTERED (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. It was reported that four patients were given vaccine dose number one outside the 12 hour first puncture expiration. Two patients received the vaccine on 18-May-2021 and two patients received the vaccine on 20-May-2021. The patient's races were reported. The patients had no adverse reaction. There was no treatment information reported.
she became dizzy and nauseous withing few minutes of vaccines and had few episodes of emesis. She felt better by lying down, cold compress on head and water and pedailyte popsicle She was able to walk after 15 minute without any recurrence of symptom
Swollen uvula; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:45 (Lot number was not reported) as single dose (at age of 59-year-old) for covid-19 immunisation. Medical history was not reported. The patient had no known allergies. First dose of bnt162b2 (BNT162B2) was administered on 28Jan2021 04:15 PM in right arm (at age of 59-year-old) for covid-19 immunisation. Concomitant medication in two weeks included quetiapine fumarate (SEROQUEL). Patient did not receive any other vaccine in four weeks. On 20Feb2021 07:00 patient experienced swollen uvula. Patient was treated with paracetamol (TYLENOL). Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sudden onset of excruciating  sharp, stabbing pain in left chest, radiating pain to upper left shoulder and base of head, pain when taking deep breath. These symptoms started 3.5 hours after getting booster shot. I took 800 mg Advil shortly after pain started. Within 1.5 hours the pain was gone so I did not go to the Emergency Room.
I tested positive for COVID-19 on 07/29/21. I have similar symptoms to those I was exposed to: headache, fever, sore throat, cough.
Subsequent to receiving vax the pts developed nodules and indurations at the injection site. The pts sought unspecified medical treatment. The symptoms were noted to last anywhere form 2-6 weeks, most shots given in the thigh. No further information is expected.
8cm X 6cm red area on left deltoid at site of influenza injection with fever 1st and 2nd day.
expired product was administered to a consume/no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case concerns a patient of unknown demographi9cs who received an expired doe of vaccine IPV (VERO) [IPOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was of actual medication error case due to expired vaccine used..  It was unknown whether adverse event was noted or not.  Information on the batch number was requested.  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.
Patient contacted us at pharmacy to inform us of the following reactions she had after receiving the vaccine: face, eyes were itching and swollen, coughing, sneezing, severe headache, eyes were red. She was able to breathe however throat was closing. Patient took 2 ADVIL and BENADRYL. She stated she was feeling better today but wasn't able to go to work.
Information has been received from a medical assistant concerning an 11 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #657715/0609U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. Follow-up: Concomitant vaccines administered on 30-AUG-2007. Concomitant vaccines administered on 30-AUG-2007 included a first intrmuscular dose of hepatitis A virus vaccine inactivated (lot # 652293/0249U) adminsitered in the left arm and a first intramuscular dose ADACEL (lot # C2825AA) administered in the left arm. On 31-AUG-2007 the patient developed as injection site reaction described as injection site swelling and injection site itching. It was also noted on 31-AUG-2007 the patient experienced a 4 cm red, swollen area over VARIVAX site that was painful to touch. The patient sought unspecified medical attention.
bloody nose on Thursday morning upon waking; body aches; chills; fever throughout the day; chest pains; had left underarm lymph node swelling; swelling on the right side of her top lip; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Restylane kysse, start date: Sep2020, notes: Her lips were previously injected; Restylane dyfyne, start date: Mar2021, notes: Her lips were previously injected. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for Covid-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "bloody nose on Thursday morning upon waking"; PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "fever throughout the day"; CHEST PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "chest pains"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "had left underarm lymph node swelling"; LIP SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "swelling on the right side of her top lip".  Additional information: Patient received 2nd Pfizer Covid-19 Vaccine on Wednesday, 15Sep in the left arm. Patient experienced  a bloody nose on Thursday morning upon waking and body aches, chills, and fever throughout the day. She had chest pains that evening and a bloody nose upon waking Friday morning. Patient had left underarm lymph node swelling and swelling on the right side of her top lip.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of deltoid, firmness and heat as well as redness starting on day 7 post injection.  I have been taking 25mg diphenydramine q 4-6h since swelling and redness started
Patient was diagnosed with bilateral pulmonary embolism on 1/3/23, four days after receiving a covid-19 vaccine.  The patient submitted a concern to his healthcare provider that the two events may be related.   This is a 90 year old male with a history of CAD, HTN, and Afib.  The patient had been on apixaban from 11/24/2017 until 8/20/2021.  Through shared decision making, the decision was made to discontinue the apixaban given the high risk for patient falls, and the recent history of a hemothorax following fall while on apixaban.  The patient has been off of apixaban since 8/20/21.  The patient received prior Moderna monovalent doses on 2/19/2021 (Lot 012M20A), 3/19/2021 (Lot 031A21A), 11/5/2021 (Lot 051C21A), 4/26/2022 (033K21-2A) with no documented adverse effects.   On 1/3/23, the patient presented to the ED with a chief complaint of 'several days of dyspnea on exertion and fatigue.'  Vitals included temp=35.8, BP=128/95, HR=76, RR=18, SpO2=100%.  Troponins negative x 2.  A CT showed bilateral left and right pulmonary artery and downstream vessels.  The provider note stated that this appeared to be an unprovoked PE (aside from a recent 3-hour long car ride).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 13:00 as dose 1, single (Lot number: EP6955), in left arm, on 02Apr2021 at 04:00 as dose 2, single (Lot number: EW0150), in left arm and on 24Jan2022 at 20:00 as dose 3 (booster), single (Lot number: Fj1614) at the age of 50 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Sep2020, stop date: 05Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Negative; (02Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
After 3rd dose - rash on the the left arm below where I received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection). At the time of the report, VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection) outcome was unknown.            No historical medications were reported.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist refers to a currently 43-year-old male patient. The patient's concurrent conditions included asthma. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # M022086, expiration date: 09-OCT-2017) (dose, route of administration and injection site were not provided). On an unknown date, three to five days after the vaccination, the patient began to feel heaviness in his chest and experienced difficulty breathing. No treatment was given for the adverse events. There were no lab diagnostic studies performed. The outcome of the events was reported as recovered, on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Fatigue, headache, tinkling/numbness in hands. Went to urgent care, however, i got turned away and advised to come back after a few days if symptoms did not go away.
I'm patient have been getting numbness on my left arm; from shoulder all the way down to my fingers. It's been a month and still getting a feeling it every 10 to 15 minutes all day long. 24/7.
no adverse event; A patient received MMR II via intramuscular route.; This spontaneous report was received from a pharmacy intern concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 15-AUG-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) via intramuscular route (incorrect route of product administration), lot # R035701, expiration date 09-DEC-2020 for prophylaxis. The vaccine was reconstituted with sterile diluent (MRK), lot # S003613 and expiration date 22-JUL-2021. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA006764:
As per chart notes: had flu shot on upper left arm, last night, middle of the night, area became very red and swollen and tender. Rash developed on body and face. Area iced and looks better today.