chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 6 minutes after MMR - c/o itchy throat, SOB, dizziness, watery eyes, difficulty breathing, cough, nasal congestion and no hives. Treated in ED with Albuterol and Atrovent intralation, Benadryl 50mg PO, Prednisone 60mg PO and Pepcid 20mg PO. Discharged after 1 1/2 hours to home.
Patient experienced shivering, chills, fever, and muscle aches that started about 11 hours after the vaccine was given and they lasted into the next day.
4-5 days p/inject, site became swollen, red, tender; no fever; 3cm area of induration & erythema @ inject site lt upper arm; treated w/Duricef;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 16-NOV-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
Initial report was received from a health care professional on 24 September 2009. A 28-year-old pregnant female patient had received a 0.5 mL intramuscular left deltoid injection of ADACEL, lot number C3029BA and an intramuscular left deltoid injection of PNEUMOVAX (Manufacturer Merck, lot number 1577X) on 24 September 2009. The patient's date of last menstrual period was not reported; however her expected date of confinement was 30 April 2010. Past obstetric history included two previous pregnancies (dates not reported), one which resulted in a normal full term delivery, and one spontaneous abortion. The patient had no pre-existing medical conditions and she had been taking prenatal vitamins. The patient had not experienced any adverse events since receiving ADACEL and PNEUMOVAX. Follow-up information was received 17 June 2010 from a health care professional. Based upon new information received, it was determined this case meets seriousness criteria and this case has been upgraded from non-serious to serious. The patient's last menstrual period occurred 26 July 2009 and her estimated date of delivery was 18 May 2010. The patient's obstetric history included two prior pregnancies; one which resulted in a normal full term delivery with no congenital anomalies and one elective abortion (previously reported as a spontaneous abortion). The reporter noted the patient had not experienced any adverse events or pregnancy complications; however, the patient's pregnancy history included a positive chlamydia test on 23 April 2010 for which the patient received unspecified treatment. Results from additional prenatal lab tests and ultrasounds were normal. It was further noted the patient experienced gestational diabetes - pregnancy at term, and Cytotec induction of labor - nuchal cord incised on the perineum which the infant and mother tolerated well and had no problems. On 11 May 2010, the patient delivered a single live female infant vaginally at 38 and 6/7 weeks gestation weighting 6 pounds 15 ounces with no congenital anomalies. Apgar scores were 8 and 8 and one and five minutes respectively. According to the reporter, the patient had not experienced any complications during labor and delivery. An outcome for the events of gestational diabetes and chlamydia was not reported. Documents held by sender: None.
I did not have an adverse reaction to the vaccine but I tested positive on 05/25/2022.  I started to feel bad on 05/25 and  I went to the ER and they tested me for Covid 19 and it was positive.  I did not take anything to relieve my symptoms from Covid. I was re-test on 5/28 and it was still positive. I was admitted to the hospital on 5/28 because I felt really bad.  I was in the hospital for seven days. I had blood clots in my legs and chest and they  blood thinners.
developed a stye in my left eye starting 24 hours after2nd vaccination.  on the 4th day after 2nd vaccination, I woke up with blurred vision in my left eye.
6 days post injection, the area around began swelling, itchy and red.  Spread throughout the night.
Suspected vaccination failure; shingles rash; Itchy / Just itchy; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the vaccination failure, shingles and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 1st dose of Shingrix, the patient experienced broke out with shingles rash with itchy without pain. The patient got 2nd dose of vaccine 2 months after 1st dose and the same reactions were happened. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event were unknown at the time of reporting. The permission to follow was denied.
Pt developed encephalopathy/seizures 5 days after vaccination. No infectious etiology isolated.
Pain at site of shot, irritation, itching, swelling, redness, headache.
Injection site soreness bursitis and it started to spread up my shoulder, and to the left neck, and went to the doctor on 9aug2021. 10 day medication meloxicam. I had curvatures of the spine and shoulder replacement on the left.
9 am - vaccine administered .11 am - half dollar sized red bump formed ( mild discomfort). 5pm- shoulders neck and arm begin to stiffen and spasm . 10pm - full body aches and spasms.. excruciating headache behind my right eye. Lymph nodes were sore ( neck and arm pit) . 3-4 days after I kept experiencing 9/10 headaches ( behind my right eye), armpit( lymph node) pain and whole body spasms / tightness.
Several hours after vaccines given, developed hives on face and began to wheeze. No rash at vaccine site. Given PO BENADRYL & Albuterol -> did well and all symptoms relieved in several hrs.
got the virus before I receive the second dose; got the virus before I receive the second dose; This is a spontaneous report from a contactable consumer. A 68-years-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration on 19Mar2021 (at 68-years age) as 2ND DOSE, SINGLE DOSE for covid-19 immunizations. Patient medical history was not reported. Family history includes death of mother and father, mother had breast cancer and father had liver cancer. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration on 05Feb2021 at 14:00 PM as 1st dose, single dose for covid-19 immunizations. The patient got the virus before patient receive the second dose. After the Quarantine patient received the Second Dose. Patient was ok now (unspecified). No treatment received for reported adverse event. The outcome of the events was unknown.
15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The concomitant medications were not reported. The treatment information was not provided.
Body aches, headache, fever/chills, nausea, enlarged lymph node at arm pit
This spontaneous case, initially received from a pharmacist (reporting on himself) on 09-Feb-2018, concerning a 51-year-old, adult male patient. The patient had no medical history and no concomitant medications administered. On 11-Jan-2018, the pharmacist accidentally stuck his finger with FLUAD syringe needle after administering the vaccine (explicitly coded as occupational exposure while administering product). Most of the vaccine was empty but a little remained on needle tip. It was reported that, the pharmacist developed bruise on the finger from stick. Hence, the finger was wiped with alcohol and band aid was placed. No other adverse effect was noted. The outcome of the event bruise was resolved. The reporter assessed the event as non-serious.
This spontaneous solicited report as received from a healthcare professional and a currently (at the time of reporting) 79 year old male patient refers to himself. The patient's concurrent condition was not reported. The patient's medical history included skin cancer and vertigo. The patient's concomitant therapy included TYLENOL. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). Other suspect therapy included IMBRUVICA (capsule, 420 mg, daily, orally) started on 04-JUL-2014, for the treatment of chronic lymphotic leukaemia. On an unknown date, the patient reported that his primary care provider gave him a PNEUMOVAX 23 shot which, when mixed with IMBRUVICA, caused damage to his liver as the patient's liver enzymes were elevated (date unspecified). The patient indicated that his oncologist told him to stop taking IMBRUVICA until he could restart (date unspecified). An unspecified healthcare professional (HCP) at the oncologist's office confirmed that IMBRUVICA was on hold due to elevated liver enzymes and the patient later confirmed this report. The unspecified HCP also reported that the patient had an appointment with a liver specialist in a few days. Treatment for the liver damage was not reported. IMBRUVICA was withdrawn on an unspecified date. The outcome of the liver damage/elevated liver enzymes was not recovered/not resolved and the outcome of drug interaction was unknown. The patient and the unspecified HCP provided no causal assessment between the liver damage/elevated liver enzymes, drug interaction and IMBRUVICA and PNEUMOVAX 23. The reporters considered the events liver damage (elevated liver enzymes) and drug interaction to be medically significant. Additional information has been requested.
Alopecia barbae; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 24Mar2021 at 08:00 (Lot number: EP6955) at the age of 28 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Pyloric stenosis" (unspecified if ongoing), notes: Infantile pyloric stenosis and "Pyloroplasty" (unspecified if ongoing), notes: Resolved infantile pyloric stenosis through surgery after birth. Concomitant medication included: RIFAMPIN, stop date: an unknown date in Mar2021.  The following information was reported: ALOPECIA AREATA (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Alopecia barbae". The event "Alopecia barbae " was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. It was reported that the patient had stopped taking RIFAMPIN about 10 days prior. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included steroid injection and topical steroid for alopecia areata. The patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 13Apr2021 at 08:00 (Lot number: EW0153) at the age of 28 years as dose 2, single for COVID-19 immunisation.
Pt developed progressive weakness approx 10 days post her 2nd Hep A vaccine. Subsequently admitted to PICU 1 week later (7/28/08) with severe gen weakness, hypertension, parasthesias, and dx of Guillain Barre Syndrome. Received IVIG, now improving. Call for further details.  8/29/08 Reviewed hospital medical records of 7/28-8/12/2008. FINAL DX: Guillain Barre syndrome Records reveal patient experienced pain & tingling of hand/feet x 6 days then developed nausea & vomiting.  Seen in outside ER, dx w/UTI & started on oral antibiotics.  At home, developed ascending paralysis.  Returned to ER & transferred to higher level of care.  Reflexes absent in LEs, was notably weakin all extremities & unable to sit or stand. In PICU, tx w/IVIG.  LP done. NGT placed for abdominal distention.  Neuro consult done.  Improved slowly, was unable to perform ADLs & d/c to home with additional rehab.
This spontaneous report as received from a medical assistant 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 31-JUL-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) lot # M036543, expiration date 15-AUG-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot# M041812, expiration date: 17-MAY-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported.
Patient developed intense headache 20-30 minutes after vaccination. Patient felt dizzy and nauseated. Patient lost ability to speak and think within one hour of vaccination. Patient developed an intense right eye pain, and became sensitive to light.
Back pain, body pain, headache, stuffy nouse. Went to do covid test and came positive
The pt received a PNEUMOVAX shot +2 days later (approximately) called the RX stating a red hot swollen infected looking arm, she was advised to take APAP, measure, and call if it gets larger.
no adverse effects have been reported.  Father filled out forms and pharmacist double check date of birth with child, however it was discovered that the patient is two years younger than claimed by the father. child also confirmed DOB of 03/30/2009 but child's actual DOB is 03/30/2011
Pt was given the shot and has today 10/25/19  expressed concern about his left arm and not being able to lift it to the side at right angle to the body.
vaccinated before the specified age; Kinrix received was the patient's 3rd dose of DTaP and IPV; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP and IPV.   On 26th April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Kinrix and it was patient's 3rd dose of DTaP and IPV, but she was vaccinated before the specified age in the PI, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. No further details reported at the time of reporting. The reporter consented to follow up.
Pt recv vax on 10/24/98; 1 hr later pt exp rash over body; tx=Benadryl
Headahce, swollen, bicept, painful, redness overall fatigued, hard bicepts
Pt started to get itchy about 2 days after her Tdap 2 wks ago (1-8-18). Continued to worsen through the week. Over this past weekend she noted that the area looked a bit red and the itching was worsening. Wants the site evaluated. Denies overt pain, or discomfort to touch.
PATIENT PASSED OUT FOR A COUPLE OF SECONDS.  DAD MENTIONED BEFORE PATIENT PASSED OUT GIVING HER ASPIRIN.  TOOK PATIENT BACK TO THE ROOM AND ELEVATED LEGS, CHECKED VITALS PATIENT RESPONDED IMMEDIATELY.  GAVE ORANGE JUICE, PEANUT BUTTER CRACKERS. DR EVALUATED PATIENT AND WAS DISCHARGED WITHOUT DIFFICULTIES.
Potential infection at injection site; More pain at injection site; Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too; Chills and shivering; Felt strange; Arm felt like hammer; Unable to sleep at night; Pain like getting stabbed with pins was really bad; Aches and pain in her bones; she's scared to death; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site) and FEAR OF DEATH (she's scared to death) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson (First dose (Primary series)) on 10-Jul-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEAR OF DEATH (she's scared to death). On 25-Jan-2022, the patient experienced INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer) and CHILLS (Chills and shivering). On 26-Jan-2022, the patient experienced VACCINATION SITE INFECTION (Potential infection at injection site), VACCINATION SITE PAIN (More pain at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too). At the time of the report, INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site), FEAR OF DEATH (she's scared to death), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer), VACCINATION SITE PAIN (More pain at injection site), VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too) and CHILLS (Chills and shivering) outcome was unknown.            No concomitant and treatment medications were reported. Patient  put a large bandaid around the redness.
Osteoarthritis of the left knee. OPERATIVE PROCEDURE: Left total knee arthroplasty. Hospital admission within 6 weeks of receiving the COVID vaccine.
fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN6202) at the age of 84 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "bovine heart valve" (unspecified if ongoing); "CLL" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose product=COVID 19,, dose brand=pfizer,, dose lot  number=EN9581 0.3ML,, dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Feb2021, when the patient was 84 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Sep2021, outcome "recovered" (Sep2021), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient reported he had a slight fever on 17Sep2021 after he came from gym. He took tylenol and cleared. He spent Saturday and Sunday doing normal things. Patient reported he did not had COVID prior vaccination and was tested 'negative' for COVID post vaccination. Patient had no allergies. Patient received third dose of 20Sep2021 at 13.30 in left arm.  No follow-up attempts are possible. No further information is expected.