chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient noticed  slight itching on her arms in the middle of the night. The next morning 10/10/2019 aroung  7:10am she noticed swelling and redness aroung injection site.  Swelling gradually increased . Patient went to Dr. and physcian prescribed  a Medrol Dose Pack for the redness and swelling.   The patient was also prescribed levaquin as a preventative measure. Patient never showed signs of fever or other reactions
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored either ROTATEQ orally, lot # L008057, expiration date: 01-DEC-2016 (dose was not reported) or RECOMBIVAX HB lot # J014855, expiration date: 16-APR-2016 (dose, dose number, route of administration and anatomical location were not reported). There were no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 166801, expiry date 31st May 2018). On 2nd February 2017, the patient received BEXSERO .5 ml. On 2nd February 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient had complained of still feeling soreness at the injection site 11 days after the vaccination with BEXSERO. There was no sign of swelling, redness or bruising. The nurse called to find out if there had been other reports. She was given the number for medical information. Follow up was urgent as the same patient was scheduled for another vaccine on 2nd March 2017. The reporter also said that she had given 10 shots from the same lot without any other complaints.
Severe sneezing and runny nose.  right eye was swollen and then 2 days later other eye began to swell. Sneezing and runny nose started 4 days after 1st shot, but major reaction of eyes swelling occurred about 2 weeks later after running.  The sneezing and runny nose would occur every time after running and the severe reaction was after running a 5k race.
vaccination pain near site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 96 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Lot number: EL3247) at the age of 96 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Cholestrol" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccination pain near site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility type is reported as Hospital. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Patient received first dose of Moderna COVID-19 vaccine on 4/1/2021. On the evening of 4/17/21 patient developed right hand numbness and word-finding problems . Patient presented to the emergency department about 40 minutes after symptom onset. After neurology consult, patient was given tPA (administered on 4/17/21@ 2200)  for suspected acute ischemic stroke. Patient's symptoms initially did not improve, but a couple hours after, patient had resolution of pronator drift and word-finding difficulties.
Initial onset of generalized itching then within 1 hour developed large purplish whelps on neck and arms. Rash/ whelps occurred behind knees, around ankles, and along belt line, periodically blurred vision occurs with whelps. Pt continous to have these symptoms every 1-2 days and symptoms diminishing after taking Benadryl and Prednisone were mildly effective on rash.
I have a previous VAERS Report. VAERS ID: 1939748/ E-Report Number: 741016. My right arm began throbbing around 7:00 p.m. Thurs., Jan. 6, and I began feeling queasy. I went to bed and woke up around 1:00 a.m. with a headache, shivering, rigors, nausea, body aches, that just increased as the night wore on. I wasn't able to sleep again until the early morning of Sat., Jan. 8. I slept 4 or 5 hours and awoke to more of the same. I felt better yesterday, Sunday, Jan. 9, and was able to sleep through the night. I'm very tired now. I didn't get the ice-pick headache, but I still had a bad headache. I have a dull headache today, Mon., Jan 10. This time, I made sure to drink a lot of water and take Motrin, but the same thing happened as with shot #2. I guess I'm hypersensitive to the shot, but it was hell. I don't usually moan when I'm sick, but I was moaning out loud with shots #2 & 3. If it had just been a very sore arm, I could have cared less, but it was all the other symptoms and the sore arm that made me report my incident to VAERS. Thank you.
pt recv vax 1125AM & 6MAR96;1130AM c/o of dizziness & fainted & was unconscious for approx 30 seconds;was given ammonia inhalant was breathing w/regular pulse,but was incontinent,diaphoretic & cont to c/o blurred vision,dizziness & h/a
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age (reported as 18) and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives on skin/ itching on an unspecified date with outcome of unknown.
target shape wheals to all 4 extremities & face;body was clean;lasted for 3-4 days;cleared w/no treatment;
Flu like symptoms; A sore arm; Headache; Fever; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (A sore arm), HEADACHE (Headache), MYALGIA (Aches) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced MYALGIA (Aches). On 27-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (A sore arm), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (A sore arm), HEADACHE (Headache), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This is a spontaneous report from a contactable Other HCP (patient, self-reported). A 35-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6202 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 07:00 AM, as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination: 34 years). The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included spironolactone (SPIRONOLACTONE), Sambucus nigra (ELDERBERRY EXTRACT), daily vitamin. The patient did not receive any other vaccine in four weeks. It was unknown that the patient had covid prior vaccination. The patient was tested for COVID post vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263 and expiry date were not reported) via an unspecified route of administration, in Arm left on 28Jan2021 at 11:30 AM as a single dose for COVID-19 immunisation and experienced blurred vision, dizziness, extreme pressure/pain to ears, Chest pain, bruised arm and tingling and numbness in hands/feet. On 28Feb2021 at 07:30 AM, the patient experienced tongue and throat itchy, tingling in her feet and on 16Mar2021, had swollen lymph node. Further explained that there was a permanent pins and needs in both feet up to her calves all day every day. She also has a swollen lymph node under her left armpit that has appeared as of 16Mar2021 that has increased in size as of 10Apr2021. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included RAPID SARS COV 2 AG, QL IA (SARS-CoV-2 test) Nasal Swab with negative result on 12Apr2021. Outcome of the events were recovered with sequel on an unspecified date. No follow-up attempts are needed. No further information is expected.
I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chills around 3-4pm fever was low grade stayed around 99.8 the following day which was the 23 of dec i had a headache all day and felt fatigued on the 24 i felt normal. My arm was sore VERY sore for about 4 days.   I did test positive for covid on 11/2/2020 with moderate symptoms
Sore arm  Three weeks after vaccine developed a rash on right hip down to right leg.
I mean out in the bed, can't wake up; Lethargic; Took second one got sick again; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I mean out in the bed, can't wake up), LETHARGY (Lethargic) and ILLNESS (Took second one got sick again) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Was hospitalized for 21 days on ICU but not intubated.) in June 2020. Concurrent medical conditions included Asthma, Prediabetes, Obesity and Blood pressure high. Concomitant products included SERTRALINE for Anxiety, MONTELUKAST, METFORMIN, LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2020 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Took second one got sick again). On an unknown date, the patient experienced SOMNOLENCE (I mean out in the bed, can't wake up) and LETHARGY (Lethargic). At the time of the report, SOMNOLENCE (I mean out in the bed, can't wake up), LETHARGY (Lethargic) and ILLNESS (Took second one got sick again) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-368965, MOD-2021-369059 (Patient Link).
type one diabetes; vomiting Ike crazy; This spontaneous report was received from a consumer and refers to a male child patient. No information regarding the patients medical history, concurrent conditions or concomitant medications was provided.  On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis.  On an unknown date, 12 hours after the vaccination the patient started vomiting. On an unknown date, four weeks after the vaccination the patient had blood sugar of 980 (units not provided) and  was diagnosed with type 1 diabetes mellitus. The patient was taken to the ER.  The outcome of type 1 diabetes mellitus and vomiting was unknown.       The causality assessment was not reported. The event of type 1 diabetes was considered life threatening. Upon internal review, the event of type 1 diabetes was considered to be medically significant.
Significant edema at injection site, L arm 5X5cm, Redness, hot to touch, occasional discomfort, hives above and along site, pruritis for 5+ days. Denies systemic symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative, notes: tested negative on 09Jul and was without symptoms for 3 days; (13Jul2022) Positive, notes: on 13Jul  runny nose, headache and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid (Lot number: GA9630) was started in 04Jul2022 till 08Jul2022 for the COVID-19 Treatment. After completing a round of Paxlovid on 08July2022, the patient tested negative on 09Jul2022 and was without symptoms for 3 days. On 12Jul2022 02:30PM runny nose started, again and on Jul 13 runny nose, headache and the patient tested positive. The patient was not recovered. The patient did not have any allergies and did not have a treatment adverse event.  No follow-up attempts are possible. No further information is expected.
VOMITING; SWEATING; BODY CHILLS; FEVER; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, sweating, body chills, fever, headache, fatigue, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body chills, sweating, headache, fatigue, nausea and vomiting was not reported. This report was non-serious.
Severe painful stomach cramps for 4 hrs then off and on for 3 days Extreme fatigue, extreme exhaustion for 3.5 days only got out of bed to go to the bathroom,  Severe nausea for the first day and nauseous off and on for the next 3 days.  I did not eat for 3.5 days.  Heart palpitations - my heart was pounding through my chest at times off an on for 3 days  Lost peripheral vision in my Left Eye on day 3 post vaccine and my peripheral vision has not returned Headaches Muscle pain Muscle weakness Joint pain and aches Fever and chills  It took 7 days for me to feel back to some what normal
I have frequent sneezing due to itching in my right sinus.  It quiets down if I'm still and increases greatly if I move around.  Otherwise I feel fine.
weak; Fever 100 degrees; Pretty Darn Weak and Dizzy; Arm Pain; This is a spontaneous report received from a contactable consumer reporter. This reporter reporting for his 56-years-old wife (patient) that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 06Apr2021 at 10:30 (at the age of 54 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not have adverse event prior vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955) on 17Mar2021 (at the age of 54 years old) for covid-19 immunisation and patient experienced arm pain. The patient experienced arm pain on 06Apr2021. She stated with this one the patient was pretty good for the afternoon but in the middle of the night she got weak and dizzy and this morning she was still pretty darn weak and dizzy and had a 100 degree fever on 07Apr2021. She stated he gave her Tylenol and it was starting to go down. She stated he figured he would call, he doesn't know that 100 was something to worry about. Reporter stated he was calling to report it and secondly in the packet they got, it just says fever, tiredness, muscle pain and lists possible side effects. He stated this doesn't seem to be a severe allergic reaction. Reporter stated the packet says what should a person do about side effects, if severe go to the hospital, report side effects, and call the provider if there are side effects that bother or don't go away. He was asking how common this was? he would say let her spend the day in bed and if fever never goes above 100 degrees it will be alright. He doesn't know what doesn't go away means, how long will this last? Therapeutic measures were taken as a result of Fever 100 degrees and included treatment with Tylenol. The patient underwent lab tests and procedures which included pyrexia: 100 degrees on 07Apr2021. The patient did not visit emergency room or physician office. He stated that was why he was calling to see if he should take her to the doctor. No family medical history relevant to adverse events was provided. The outcome of arm pain was unknown, weak, pretty darn weak and dizzy was not recovered, fever 100 degrees recovering.  No follow-up attempts are needed. No further information is expected.
Hospitalization nos; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization nos) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization nos) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization nos) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild; symptoms lasted 0 days
I tested positive for COVID-19 in August 2022. I had a very high fever with cough and congestion. It lasted about 5 days. I only slept and drank fluids for my treatment. My fever got up to about 104 before it broke. I did have trouble breathing but my pulse oxygen level remained normal. After this I was feeling so very fatigued and bruising very easy with overall weakness. I went to the doctor to find out what was causing this. The tests showed that my platelets were very low and was told to watch for 6 months. After 6 months we tested again, and I am now considered "chronic". The next for me is to have my blood drawn every two weeks to determine any other auto immune issues or deficiencies and blood cancers.
Hand feeling cold; Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb; First dose on 01-Apr-2021 and second dose on 02-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Hand feeling cold), CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022). On 16-Sep-2022, the patient experienced PERIPHERAL COLDNESS (Hand feeling cold) and CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb). At the time of the report, PERIPHERAL COLDNESS (Hand feeling cold) and CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in COVID-19 vaccine Trial. The reporter causality for the event cold hands with cosuspect humira  was assessed as probable. The reporter causality for the event cyanosis peripheral with cosuspect humira drug was assessed as probable. No treatment medications were reported.
At about 10 minutes after receiving his second vaccination, patient stated his had started itching. About a half hour later, patient states he felt he was having some difficulty swallowing. He was given 50 mg. of Benadryl and felt better.
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown).  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.