chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from a registered pharmacist and a licensed practical nurse (nurse manager) concerning a 78 year old retired female in a long term care facility with diabetes mellitus nos, coronary artery disease nos, hypertension nos, meperidine allergy (unspecified) and dementia nos, who on 03/05/2002 at 14:00 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L), intramuscularly, in the right deltoid. There was no concomitant therapy. On 03/06/2002 at 06:00 the pt awoke with complaints of pain/sore arm, redness/red arm and swelling at the injection site. No laboratory tests were performed. On 03/08/2002, the pt recovered from her pain, swelling and redness at the injection site. The physician pharmacy were "updated" with no orders. The licensed practical nurse reported that there were no long-term effects. The registered pharmacist and the licensed practical nurse reported that another pt was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L) from the same multidose vial and developed a sore, very red arm at the site of the injection (WAES #0203USA00901). No additional info is expected.
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in August 2016 (reported as on or about 20-AUG-2016), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in August 2016 (reported as on or about 26-AUG-2016), the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
no adverse effects; patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 23-MAR-2020 the patient was vaccinated with impoperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S023219, 0.5 milliliter, intramuscular in the right thigh for prophylaxis.  Other suspect therapies included pneumococcal conj vaccine (unspecified)(PNEUMOCOCCAL CONJ VACCINE (UNSPECIFIED)), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ).    On 23-MAR-2020 the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB).     {Additional information has been requested. / Additional information is not expected.} .; Sender's Comments:  US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2003USA002275:
Red, hard and swollen -> on 9-8-12 was tender on 9-7-12. Still swollen and red, blisters at injection site on 9-11-12, but is resolving.
Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # M018810 (expiration date 28-MAY-2018), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No date logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.
Sick; left side hurt extremely; mind was messed up; confused; vision go bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN (left side hurt extremely), FEELING ABNORMAL (mind was messed up), CONFUSIONAL STATE (confused) and VISUAL IMPAIRMENT (vision go bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), PAIN (left side hurt extremely), FEELING ABNORMAL (mind was messed up), CONFUSIONAL STATE (confused) and VISUAL IMPAIRMENT (vision go bad). At the time of the report, ILLNESS (Sick), PAIN (left side hurt extremely), FEELING ABNORMAL (mind was messed up), CONFUSIONAL STATE (confused) and VISUAL IMPAIRMENT (vision go bad) had resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pain, redness and swelling remote from the injection site. Fever marked induration and fatigue. Facial redness.
Fully vaccinated patient admitted for hypoxia found to be COVID positive.  Providers discharge note below:  "64 YO female with h/o Wernike-korsakoff dementia, chronic immobility living at Nursing home, COPD, HTN, HLD, presenting to the ED for evaluation of hypoxia, found to have COVID-19 pneumonia. She was treated with typical care including decadron and remdesivir. She required a maximum of 6L oxygen NC but was weaned to RA x24h prior to discharge. No complications of COVID while admitted. Discharged home to SNF in good condition.  "
Child started with sudden onset of fevers up to 102.6 degrees F on 5/18. In the morning, next day he was noticed with erythematous fine papular rash on trunk/lower face. Spread to upper limbs not to lower limbs yet on 5/20. Child had T about 102.6 F, retroauricular bilat soft adenopathies/rash papular erythematous on lower face, trunk, arms. Not on palms, soles/lower limbs. No toxic appearance eating well.
lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry; temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F); This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)) and SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)). On 23-Jan-2021, the patient experienced SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry). At the time of the report, BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)) and SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
On 02/24/2023, it started as a really severe sore throat. I had some minor nasal congestion, fatigue, and body aches. That waxed and waned over two days. By the third day, I was almost immobile with body aches, fatigue, and could hardly swallow anything. On 02/27/2023, I took and at home COVID-19 test, which was positive. I called my doctor who prescribed Paxlovid. I began taking that the same day. After taking the Paxlovid, things began to improve the next day and continued until I was able to return to work on 03/06/2023.
Large local reaction left upper arm at injection site 7 cm W x 5.5 cm H.
Hot from the elbow to the shoulder of the vaccinated arm; Itching from the elbow to the shoulder of the vaccinated arm; Redness from the elbow to the shoulder of the vaccinated arm; Swelling from the elbow to the shoulder of the vaccinated arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm). At the time of the report, SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Heart rate increased, pale and very weak with 2 hours of vaccine, bruising, swollen, hot, hard and very sore even under my arm very red for over 1 week.
fully vaccinated and two booster shots and month later with UH COVID-19; fully vaccinated and two booster shots, month later with UH COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), 1 month after the suspect product(s) administration, outcome "unknown", described as "fully vaccinated and two booster shots and month later with UH COVID-19"; SUSPECTED COVID-19 (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "fully vaccinated and two booster shots, month later with UH COVID-19".  Clinical course: Patient wanted to file a complaint.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large red area in his left upper arm that is about five inches long and two inches wid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red area in his left upper arm that is about five inches long and two inches wid) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PRAVASTATIN, FOLIC ACID, VITAMIN D [VITAMIN D NOS], B & FOLIC and PROBIOTIC 10 for an unknown indication.    On 22-Mar-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 VACCINATION SITE ERYTHEMA (Large red area in his left upper arm that is about five inches long and two inches wid). At the time of the report, VACCINATION SITE ERYTHEMA (Large red area in his left upper arm that is about five inches long and two inches wid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Med: Multivitamins and Inhaler
large red circle appeared around the injection site. Its warm and a tiny bit itchy. It looks exactly like 'Covid arm' so I'm not worried but I wanted to report it incase the data would be of any use
Mom reports on way home after receiving Tdap patient became "gray" looking, had a loss of hearing and vision with decrease heart rate. Took patient to ER was diagnosed with syncopal episode and vagal response. Mom reports patient was given 2 Liters of IVF and sent home.
The patient was administered a properly stored but expired vaccine; This spontaneous report was received from an office manager concerning a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-JUL-2020, the patient was vaccinated with the first dose of a properly stored but expired pneumococcal vaccine, polyvalent (23-valent) (PNEUM OVAX23), lot number R012550 with expiration date 25-JAN-2020 for prophylaxis (route of administration was not provided). No additional information was provided and no product quality complaint (PQC) was reported.  At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R012550; expirationdate: 25-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Hematuria. Severely thickened urinary bladder with blood clots in organ and urine .    Please note 1st Doze of Covid-19 vaccine was on 03/25/2021 and 2nd doze was on 04/15/2021.
Patient called the pharmacy 2 days after receiving her shot complaining of pain and swelling at the site of injection.
Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent).  A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation.  Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 24Jan2021 16:00 (lot number=EL9261; vaccine location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.
Red rash at injection site, itchy, sore, no blisters, no fever - Pt visited local Dr who prescribed SEPTRA DS one tab every day for 7 days and BACTROBAN ointment - for a possible bacterial infection at injection site - rash resolved in 48 hours or less.
gout flare; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout flare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 UNK. On an unknown date, the patient experienced GOUT (gout flare). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain, at an unspecified dose and frequency. At the time of the report, GOUT (gout flare) had not resolved.            no concomitant medications information were provided   This case was linked to MOD-2021-044348 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-OCT-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On 18-JAN-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not  limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Hives and Nausea began 24 hrs after the first injection with hives (swelling, itch, redness) last for a week after.
within about 12 hours of the vaccine, I had a fever of 103, a very bad headache, and achy muscles for about 12 hours.  Within 2 weeks I started breaking out in pretty severe hives.  I did not make any connection to the vaccine and thought it might have been a change in my laundry detergent or some other unknown allergy.  The hives were occurring at least 4 nights a week if not every night.  This went on for several weeks, I switched back my laundry detergent, re-washed any laundry I thought I might have washed in the new stuff and started logging my foods to see if there was a connection.  There was none.  Around the middle of June my Primary Care Doctor (Dr.) wanted me to have an ultrasound on my gallbladder because my alkaline phosate number was high.  The ultrasound said I do have small gallstones but none were blocking anything and we should just watch it.  At the same time he was running new bloodwork and one of my thyroid numbers came back low.  I was called back to his office and had more bloodwork.  He said when the one number is low it is because the other T#'s are too high.  The additional bloodwork did come back with elevated thyroid numbers.  He also wanted me to see an asthma and allergy specialist and an endocrinologist.  I was put on a 7 day round of steriod that stopped the hives during that period.  They came back within 3 days of the end of the steriods.  The asthma and allergy specialist had my bloodwork and said he didn't want to test me for allergies.  He suggested that I follow up with him after I saw the endocrinologist. It was his opinion that I have some auto immune disorder such as Graves.   I saw him on June 25th.  His name is and the number is.  He put me on Methimazole for hyperthyroid and ran additional test. He said he suspects I have Graves but wonders if there is a secondary contributor to my issue since it came out of now where.   I go back to his office on August 2nd to give blood and then back to see him on August 9th.  At that time he will give me the results of the test he performed on 6/25 and will know from my 8/2 bloodwork if the thyroid medication needs to be adjusted.  I am still breaking out in hives 3-4 times a week.  I'm taking 2 Claritin in the AM and 2 Xyterc around 6:00 PM.
Guillane Barre including lower extremity numbness and inability to walk. Elevated spinal protein at 410.  6 plasma exchanges with improvement.  Transfer to Rehab hospital 12/14. Lyrica for new neuropathy symptoms. 12/31/07-records received for DOS 12/3-12/18/07-DC DX: Guillain-Barre syndrome. Status post total plasma exchange times six.   Neruopathic pain. Serratia marcescens urinary tract infection. Benign prostatic hypertrophy. Prior to admission seen in ED 11/23/07 for C/O difficulty breathing with DX of primary acute and chronic dyspnea, D.M. leg edema. ED 11/24/07-C/O weakness-low potassium, chronic shortness of breath. edema improved. ED 11/27/07-C/O back pain. Developed progressive weakness and numbness in hands and feet and unable to stand.  At time of discharge able to move arms and legs but unable to walk. Weaker proximally than distally. Developed significant neurpathic pain related to nerve regeneration. Discharged to transitional care.
I had extreme pain all over my body. I was in agonizing pain for a week and for 2 weeks before it was reduced. I had fever and chills. I had intense burning pain all over. It felt like my body was on fire. I was on Percocet for 2 weeks straight. I have severe fatigue, fever, aches, and short of breath. My muscles burn and cramp up. I get tired so easily and can hardly sleep. I have tried potassium, calcium, and ibuprofen but nothing has helped.