chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling and rash on her arm (opposite to injection); swelling and rash on her arm (opposite to injection); Headache; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NASAL CONGESTION (stuffy nose), PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache) and NASAL CONGESTION (stuffy nose). On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Rash, at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (Headache) and NASAL CONGESTION (stuffy nose) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling and rash on her arm (opposite to injection)) and RASH (swelling and rash on her arm (opposite to injection)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Daily pulse reading on the days following the injection have been between 149 and 160, whereas long established baseline pulse readings for years have been in the 80 to 90 range.
IRON PUTS IN HOSPITAL WITH BLEEDING IN GI; UNABLE TO MAINTAIN A NORMAL HEMOGLOBIN LEVEL; BEDRIDDEN; RUINED LIFE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 1, 01 total was administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: iron (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for hemoglobin abnormal. No concomitant medications were reported. It was reported that, on an unspecified date, the patient was bedridden since the vaccine in APR-2021, the patient was unable to maintain a normal hemoglobin level and was taking iron puts the patient in hospital with bleeding in gastro intestine (GI), It ruined the patient's life  (dose number in series was 1), and was hospitalized on an unspecified date. Number of days hospitalized and discharge information was not reported   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with iron was not reported. The outcome of the bedridden, unable to maintain a normal hemoglobin level, iron puts in hospital with bleeding in gi and ruined life was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220112751-COVID-19 VACCINE AD26.COV2.S-iron puts in hospital with bleeding in GI, bedridden, unable to maintain a normal hemoglobin level. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I cannot walk; This case was reported by a consumer via media and described the occurrence of unable to walk in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unable to walk (serious criteria hospitalization). On an unknown date, the outcome of the unable to walk was unknown.   It was unknown if the reporter considered the unable to walk to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient put the shingles shot and could not walk and went to the hospital. The follow-up would not possible as no contact details were available.
Patient is 5 months pregnant.  About 15 minutes after injection patient felt numbness in arm and in legs.  Blood pressure was 101 /62.  No trouble breathing.  Patient was evaluated by physician and RN.  Patient contacted her OBGYN  who told her to present at ED.  Medical transport was called.  Patient was transported to hospital.
DOWN FOR NEARLY 3 DAYS IN BED; MISERABLE TIME AFTER FIRST DOSE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced down for nearly 3 days in bed, and miserable time after first dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from down for nearly 3 days in bed, and the outcome of miserable time after first dose was not reported. This report was non-serious.
This spontaneous report was received from a physician and refers to his wife 62 year old female patient. The patient's concurrent conditions included postherpetic neuralgia (for many years). The patient's medical history included shingles (3 or 4 times). The patient suffered from postherpetic neuralgia for many years and she has experienced shingles 3 or 4 times. As a result of her postherpetic neuralgia symptoms, the patient received many unspecified injections for treatment of back pain along her spine for years and years. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU subcutaneously as routine vaccination (lot number and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), ADVIL, desloratadine, atorvastatin, pantoprazole, Vitamin D3, PROVERA and PREMARIN. The physician and his wife reported that his wife experienced positive result after receiving ZOSTAVAX. After she received ZOSTAVAX at her physician's practice, the patient became aware that she was no longer experiencing the pain from her postherpetic neuralgia. She was not able to identify exactly when her pain began to alleviate, but she became conscious of her increased mobility and comfort on 29-OCT-2016. She stated that it is like a headache, you don't notice it until it is gone. The patient also reported that after she received ZOSTAVAX, she also received on 19-SEP-2016, an unspecified influenza vaccine (also reported as the one that doesn't have mercury in it). The physician and his wife were agreeable to follow up to discuss this unexpected improvement in postherpetic neuralgia symptoms after ZOSTAVAX. No additional information was provided. No treatment was given for the event and no lab tests were drawn. The outcome of the event was unknown. No product quality complaint was involved in this case. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
bad rash; her eyes felt swollen; felt like her throat was closing up; there was pressure in her neck and face; there was pressure in her neck and face; itchy skin; limp-nodes were swollen; some swelling; This spontaneous report was received from a consumer referring to a 40 years old female patient. The patient's drug reactions/ allergies included sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA), sulfamethoxazole (+) trimethoprim (BACKTRUM), acetaminophen (+) oxycodone hydrochloride (PERCOCET). The patient's medical history and concomitant therapy were not reported.   On an unknown date in 2010 (reported as 10 years ago), the patient received the regular quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine, all 3 shots (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 24-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). on an unknown date in 2020, the patient experienced some swelling.   On 27-AUG-2020, the patient was vaccinated with the second of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). At the same time, the patient got influenza virus vaccine (unspecified) (strength, dose, route, lot number, expiration date and indication were not reported).  On 03-SEP-2020 (reported as a week after getting the second shot), the patient experienced limp-nodes were swollen and bad rash, her eyes felt swollen, she also felt like her throat was closing up and there was pressure in her neck and face and she stated she had itchy skin. The patient spoke with her primary care and went to an ear and throat doctor. The patient was given diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) for the events. The outcome of the events was not recovered. The causality between the events and all the suspect therapies was not provided.
Three weeks after receiving the first Moderna Co-Vid vaccine, pt developed a stomach virus (?) vomiting and not being able to hold down anything but water.  This lasted four days.  She then started getting pain in his hips and legs.  Over the next two weeks her condition worsened to where she couldn't even use a walker to stand.  We went to the ER where they diagnosed her with Bell's Palsy (which went away in a few days) and did an MRI and took X-rays to ascertain the source of the pain and weakness in her legs.  Another week at home and her condition deteriorated to where we went to the ER.  A neurologist was called in who diagnosed her with Guillain-Barre Syndrome.  She was admitted to the hospital and was given two  IVIG treatments.  She was released after three days to the rehab facility where she spent two weeks before being discharged to our home.
Shingles per MD. Rashes, pain left side of the the body Valacyclovir 1 gm TABlet 3x a day for 7 DAYS
caught COVID; caught COVID; DVT; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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), COVID-19 (medically significant), outcome "recovering" and all described as "caught COVID"; DEEP VEIN THROMBOSIS (medically significant), outcome "recovering", described as "DVT". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: caught COVID. Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: Mother was vaccinated with the Pfizer COVID 19 vaccine, caught COVID traveled and developed a DVT after the flight. She is currently being treated with ELIQUIS for the DVT. The patient is doing well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
30JUL93 mom reported during routine well child clinic exam that pt had diarrhea 9 times first day & vomiting; diarrhea lasted about a week; also, rash present on trunk, legs, arms; pt called MD who dx mild ear infect on 10JAN93;
Narrative: Admission: 8/30/2021 Discharge 9/10/2021 in stable condition 74yo M w/ hx bradycardia, sick sinus syndrome s/p pacemaker (2016), HTN, asthma, DM (last A1c 5.2, not on meds, obstructive sleep apnea on CPAP, hx DVT not on anticoagulation, presented to Emergency Room with worsening SOB and cough. First symptomatic on 8/22, had progressively worsening SOB w/ productive cough (yellow sputum). Reported increasing dyspnea on exertion, inability to climb small flight of stairs without feeling SOB, subjective fever/chills, coughing/SOB at night making it difficult to sleep. When walking complained of chest heaviness, difficulty catching breath. Received 2 doses Moderna Covid vaccine vaccine in Dec 2020/Jan 2021. Tested positive for COVID 8/27/2021. Tested positive for COVID 8/30/2021. No other complaints. Admitted for COVID pneumonia with sepsis: Tested positive for COVID 8/27 with symptom onset 8/22. Required up to 4L O2 in Emergency Department. Treated with remdesivir, oral dexamethasone and enoxaparin. Discharged 9/10/2021 in stable condition.
"Patient who had recently been vaccinated approached me and stated that he did not feel well." "Complaining of weakness and dizziness after COVID Vaccine." "Pale and notably diaphoretic" "Vital signs assessed and found to be bradycardia and hypotensive in seated position. EKG completed and transport to medical facility via medic ambulance."  11:43 BP 90/31, HR48 (weak, regular), RR 16 normal and SpO2 98% room air. 11:46 BP 86/39, HR52, SpO2 98% 11:55 BP 125/68, HR73, SpO2 100%  12lead performed to show brady-sinus with no indications of heartblock. IV fluids, 100mL LR via 20g in LAC.
Hard, painful, red, hot to the touch lump at injection site. Also cery itchy
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 05-DEC-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
vision is severely impaired; asthma; heart trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "Kidney cancer" (unspecified if ongoing), notes: Patient has had kidney cancer; "breast cancer" (unspecified if ongoing), notes: just getting over breast cancer; "auto immune deficiency disorders" (unspecified if ongoing), notes: her auto immune system doesn't even work right. The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision is severely impaired"; ASTHMA (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart trouble". Additional information: Her vision is severely impaired. Patient later stated that she had serious health issues, she was just getting over breast cancer, she has had kidney cancer, she have auto immune deficiency disorders that her auto immune system doesn't even work right. She has asthma, she has heart trouble.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
negative for the measles disease, but positve for the mumps and rubella disease/ the serology test was "under 25" for measles immunity; Information has been received from a nurse referring to a non-pregnant 33-year-old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  The patient received two doses measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R001658 (expiration date: 17-JAN-2020) (additional dosage regimen information was not reported) for prophylaxis on 12-NOV-2018 and 22-MAR-2019 respectively.  On 20-JUN-2019, the patient was tested for serology, which resulted negative for measles disease, but positive for the mumps and rubella disease. The serology test was under 25 (units were not specified) for measles immunity. There was no treatment given for the event. At the time of the report, the outcome of measles antibody negative was reported as not recovered. The causality between the event and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011300:
Bivalent doses of vaccine are administered, when the second dose of COVID-19 vaccine should have been administered.
Seizure, loss of bladder control on 10/2 10 at 10:30 AM. Mother reports child having seizure. She did not seek medical attention for her child. Did not speak to a doctor until 6 1/2 hours after the seizure. Unclear whether seizure was MD diagnosed. No others adverse effects per mother.
This spontaneous report as received from a medical assistant refers to a 20-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # M023892, expiration date: 15-SEP-2017, intramuscularly in the right deltoid for prophylaxis. At the same day, the patient was also vaccinated with tuberculin purified protein derivative reported as "PPD". Other concomitant therapies included sertraline hydrochloride (ZOLOFT), sulfamethoxazole (+) trimethoprim (BACTRIM DS), sulfamethoxazole (+) trimethoprim (SEPTRA DS). The patient tolerated vaccination with RECOMBIVAX HB well at date it was given. On 06-OCT-2017, the patient came back to the office for tuberculosis test (reported as ""TB") read. No reactions from RECOMBIVAX HB was noted.  No adverse event was reported.
PATIENT COMPLAINS OF PAIN IN RIGHT ARM THE MORNING FOLLOWING ADMINISTRATION OF VACCINE. PAIN EXTENDS FROM UPPER ARM TO MID CHEST. SHE REPORTS WARMTH AT INJECTION SITE AND HAS DIFFICULTY RAISING ARM. PATIENT TOOK TWO IBUPROFEN 200MG TABLETS AROUND 11AM ON 7/1/17 WHICH TEMPORARILY RELIEVED THE PAIN. ADVISED PATIENT TO ICE THE AREA FOR 15 MINUTES AND TO REPORT TO PCP IF SYMPTOMS CONTINUE AND TO ER IF SHE EXPERIENCES AN ANAPHYLACTIC REACTION.
There was an excursion from their freezer/ Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
pt devel hepatitis & was dx 13MAR98;pt was jaundiced w/elevation of liver enzymes;pt had h/a, high fever & muscles aches;
Suggestive of Myocardial Damage per ED Provider note,  intubated,  Hospitalization.
I had pain on armpit and a little bit swelling , uncomfortable around the heart area and rush on my throat
MUSCLE ACHES, JOINT STIFFNESS, EXTREME FATIGUE, SEVERE  HEADACHE
devel hives, itching, red "all over" 45 mins p/vax was given DPH by mom; taken to MD but was not seen since sxs relieved p/taking DPH
feeling unwell and got tested for Covid positive; feeling unwell and got tested for Covid positive; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a sponsored program (172086). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "oncology patient" (unspecified if ongoing), notes: She was an oncology patient; "had one lung" (unspecified if ongoing), notes: only had one lung. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 26Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "feeling unwell and got tested for Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: got tested for Covid on 10Jan2022 afternoon and got her results back on 11Jan2022. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation, Vaccination failure, covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
No further AEs reported; patient was administered an expired dose ofMMR II on 19-APR-2021, (expiry date 09-DEC-2020).; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 1 injection, lot # R035700, expiration date: 09-DEC-2020 for prophylaxis. No further adverse event was provided.
Fever of 100 1hr after immunization was given. She was moaning and fussy all night. Mom rushed her to the clinic the next morning because of purplish discoloration of face, arms 2 hour mottling from fever 101.1.