chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy; the whole room began to spin/he was still wobbly; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration Date: 31May2021) via intramuscular on 31Jan2021 16:15 on right arm as single dose for covid-19 immunisation. Medical history included mesothelioma from Aug2019 and ongoing. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) reported as none. Patient took the first dose of the Pfizer covid vaccine shot yesterday at 4:15 pm. Everything was fine till about 10:30 at night when he was ready to go to bed. patient got up from his recliner, patient was dizzy and the whole room was spinning so he sat down again and tried again 5 minutes later, and he was still wobbly on 31Jan2021 22:30. Then after he sat there for a while, he was ok. patient did not have an immediate reaction. Patient asks if his reaction was serious what would they have treated him with for the dizziness. Patient asks if he should take the second dose and if the dizziness is normal. Last night patient was thinking about going to the hospital since he got panicky but then it passed. patient did not go to the hospital since there was a snowstorm. Patient did not visit emergency room and physician office. Treatment was declines any, he was drinking plenty of fluids. The outcome of the event dizzy was recovered on 31Jan2021 and unknown for another event.
Post vax, received a call from EMS, stating they had responded to a 911 call from pt's mom, stating that the pt appeared feverish and was having a seizure. EMS stated after emergency protocol was followed, they would transport pt to the hospital. On Tuesday, 5/16/00, I talked with mom about pt's condition and she reported that at ER on 5/15/00, blood and urine samples were taken and a LP with culture was done. Pt was later, admitted to the hospital that day. Mom stated that results from tests initially seemed clear and was waiting on LP culture results. On 5/18/2000, mom told me, pt was discharged on Wednesday night with instructions to follow-up with MD in 2 weeks and discharge papers indicated no further DTAP shots may be given. No other episodes of seizures were noted by mom Diagnosed also with Bacteremia
Extremely high fever; Anything touching skin was painful; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6201), via an unspecified route on 01Mar2021 (age at vaccination: 21-year-old), as a single dose for covid-19 immunization. Medical history was reported as none. The patient concomitant medications were not reported. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date, patient experienced extremely high fever and anything touching skin was painful. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included extremely high fever. The clinical outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
headache and nausea around 2am...throwing up...reso;ved by 2:30am
After the first shot, I only experienced arm pain.; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021, at 18:00 (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not test for covid prior to vaccination, and post vaccination. Medical history was none. No known allergies. The patient's concomitant medications were not reported. On an unspecified date in May2021, patient stated after the first shot, I only experienced arm pain. Patient received no treatment. The outcome of the event was unknown.
Patient stated that a large red, itchy rash appeared across her neck and chest the following day after the COVID vaccine. She has tried treating the rash with hydrocortisone cream, which has helped with the itchiness but the rash is still present.  Patient returned to the pharmacy May 13, six days after the COVID vaccine was administered, to discuss the rash with the Pharmacist. Pharmacist noticed the large rash was still present on the patient's neck and across her chest. Patient was advised to take oral Benadryl and contact her physician regarding the rash and whether receiving the second COVID vaccine dose would be appropriate. Pharmacist followed up with patient May 22 regarding the rash and patient states rash is 98% gone.
Arm pain where injection was given; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that the physician that she works for wife experienced extreme pain in the arm where injection was given. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked with US2019AMR081235, having same reporter.
Received first Moderna shot on 3/20.  Experienced severe vertigo episodes on 3/23, 3/24,  and then again on 4/8 (all with spinning, dizziness, vomiting, sweating, chills).  Visited an ENT doctor.  Did an ENG showing weakness in the right ear.  Have had ringing in the right ear for several weeks.  Have a hearing test scheduled for 4/20 and am currently on dizziness medication.  Also have an MRI scheduled.  Have the 2nd shot scheduled for 4/17 and need guidance on whether to take it.
June 8th- received vaccine. Fatigue, arm soreness.  June 9th- headache, decreased appetite June 10th- pain of both upper arms, substernal chest pain. One episode of emesis. Was admitted to our hospital for presumed COVID-19 vaccine related myocarditis.
Breakthrough case admission after 2 vaccines Moderna 2/6/21 Lot# 031L20A;  Moderna 3/6/21 Lot# 032M20A
18 mo or 33-34 week preemie in her USOH until 12/8/10. Pt received catch up immunizations. Pt was put to bed at 10pm. At 0300 awoke crying. Parents noticed tactile temp, but good UUP. Parents gave TYLENOL 0.8ml x1. Shortly afterwards parents noticed a 15 min seizure (generalized tonic/clonic). 911 called. Sz ceased prior to arrival of ambulance. Pt post -ictal , then normal by time of admission. In house pt had staring spell for 5-6 seconds. Pt observed and released. Ibuprofen given to decrease fever.
Pt stated that she had had swollen lymph node near clavicular bone and feels pain in left arm that has lasted almost a week.  Pt is also complaining of swollen joints and pain on her left arm not relieved by ibuprofen 400mg per day
Child developed red area of swelling, itching apprx. 20 mm within 24 hrs of Tdap, Mening. vaccination to LT arm. Parent did not give any medications for relief. Advised to give BENADRYL and ibuprofen p.o. and cool compress every 6 hrs. Bring to M.D. if fever or continued swelling occur.
About 10 minutes after the vaccine, pt's father signaled he needed help. Pt was cold and had chills. She did not speak English well, and she said she couldn't hear. Then she stated that her throat was closing up. Then she stated she couldn't see.
6-26-2022 Tested positive for COVID-19 with a home test (Roche) following 4 days of symptoms which included unusual fatigue, postnasal drip and hoarseness, one day of slightly elevated temperature of 99.8 deg. F. Symptoms abated after the 26th and I have been symptom free since about June 28. No treatment was sought or received.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5ml, single at a pharmacy. The patient medical history and the patient's concomitant medications were not reported. The patient experienced did not feel well and felt achy on an unspecified date with outcome of unknown. The events were assessed as serious per hospitalization.
bed ridden; fever; stomach pain; head pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in October 2019, refer linked case US2020AMR014559).   On 18th January 2020 14:00, the patient received the 2nd dose of Shingrix. On 18th January 2020, 3 hrs after receiving Shingrix, the patient experienced fever, stomach pain, headache and nausea. On 19th January 2020, the patient experienced bedridden. On 19th January 2020, the outcome of the fever, stomach pain, headache, nausea and bedridden were recovered/resolved.   It was unknown if the reporter considered the fever, stomach pain, headache, nausea and bedridden to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. Around 5pm, the patient had fever of 101.0, stomach pain, head pain and nausea. On Sunday, one day after receiving Shingrix, the patient was bedridden for a day. The event lasted through Sunday night and by Monday the patient was better.
Immediate swelling at injection site, severe itching, tachycardia, difficulty breathing, chest pain, lightheaded.
Approximately 24 hours after receiving the second dose of varivax, patient developed pain, tenderness and rash on upper left arm
got the vaccination, still got shingles/suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-May-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the vaccination also, but the patient still got the shingles. Most painful thing patient ever had. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept; This spontaneous case was reported by a consumer and describes the occurrence of VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) (seriousness criterion medically significant). At the time of the report, VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) to be possibly related.    No concomitant and treatment medications are provided by the reporter.  Three weeks after got his shot, patient had a blood clot in one of his legs. It is the size of a football. The doctors cannot operate on it because he'll bleed out.  Patient's gone to 7 different doctors and confident that it's his vaccination.  The doctor told him that only has 1-2 years left to live.  The patient wants to know if a bunch of people got blood clots from your vaccine. patient went to the emergency room in September 2021.  This spontaneous case report concerns a 63 year-old male whose medical history was not provided, who experienced the serious unexpected event of Venous thrombosis limb. The event occurred approximately 3 weeks after the second dose of a proper schedule of product administration (28 days between doses) of Moderna COVID-19 vaccine. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Sender's Comments: This spontaneous case report concerns a 63 year-old male, whose medical history was not provided, who experienced the serious unexpected event of Venous thrombosis limb. The event occurred approximately 3 weeks after the second dose of a proper schedule of product administration (28 days between doses) of Moderna COVID-19 vaccine. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report
Patient sat down after receiving first Pfizer Covid 19 vaccine.  Within 5 minutes she had slid out of her chair onto the floor.  When I arrive at her location, she was communicating but sweating profusely.  Her husband and I got her to the chair and gave her water to drink.  I also attempted to put cold water on her pressure points to bring down her body temperature.  After another few minutes she said she felt dizzy again and her husband and I got her to the carpeted pharmacy to lay down as she passed out again.  I told my technician to call emergency services and I stayed with the patient putting ice on her pressure points again.  She was communicating with me the entire time.  At 4:30 the fire department with EMT's arrived on scene and began assessing the patient.  Her blood sugar was 90 and her BP was 89/65.  They determined that she was having Vasovagal Syncope.  She had reported this in the past with having blood taken.  As rescue continued to monitor patient they were able to get her in a chair, drink some water and she continued to improve.  After 15 minutes of watchful waiting we determined the patient was able to return to her home with her husband.
patient states they had a heart attack, myocardial infarction and was hospitalized and just released with a stent.  occurred approximately 2 weeks after first dose in series.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (2022) Negative, notes: tested negative for 5 days and then became positive again; (2022) Positive, notes: tested negative for 5 days and then became positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever; arm soreness; 2nd dose received late; headache; This case was reported by a physician via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020134641).   On 16th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced headache. On 16th July 2020, the patient experienced pain in arm and drug dose administration interval too long. On 17th July 2020, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and drug dose administration interval too long were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose 2 years ago from reporting date. The patient experienced headache after vaccination.  The patient experienced arm soreness on day of vaccination which was not resolved till the time of reporting. The fever was started 12 to 18 hours after the vaccination. The patient reported a fever of 101.4 degree F following vaccination that lowered to 100.4 degree F. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020134641:same reporter
extreme soreness at site of injection; unable to raise my arm over head, lasting 24 hours. Elevated temperature within 4 hours of receiving 2nd dose. Elevated temp. lasted entire day after, going as high as 102.4 (Tylenol 650mg q4h). During this time, loss of appetite, with difficulty swallowing. 48 hours after injection experienced diarrhea. Dysphagia and lack of appetite lasting 72 hours after injection.
Rotavirus detected after having received the first dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of rotavirus test positive in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced rotavirus test positive. On an unknown date, the outcome of the rotavirus test positive was unknown.   It was unknown if the reporter considered the rotavirus test positive to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as infant as per vaccine indication. The patient recently had rotavirus detected after vaccination with Rotarix. This case has been linked to US2019AMR164474, reported by the same reporter.      Lab Comments: On an unknown date, lab test was perfomed
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 168 doses were given from LOT 048C21A. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
After DOSE 2 had swelling of several body parts, lip, ear lobe, arm and ring finger( had to have rings cut off), lasted close to a month
4/22/21 about 1:55 pm I got the shot,   2:45 got a bad headache, dizzy, feeling flush and upset sumac  I left work at 4 pm and when home.  around 6 pm i started to get joint pain in my arms, legs and hip.  by 730 pm I got the chills, shivers and got extremely tired.  I when to bed around 8 pm and woke up around 730 am on 4/23/21.   I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21).    I don't know if this is related but I would like to provided the information.  Prior to the shot my blood press was between 112 to 120/ 70 to 80.  after the shot my blood pressure has been 140 to 150/ 80 to 93.  am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot  from 4/19/21 to 4/22/21.    .
About 8 hours after the shot, I started to have sharp shooting pains whenever i moved my head/neck and itching at the injection sight. The itching and the severe neck pain lasted for roughly a week.
EXTREME soreness in left arm the day after shot (Felt like I got beat with a baseball bat) EXTREME headache the day after shot EXTREME stiff neck the day after shot Shot site has very large scab
right arm is very sore; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (throwing up) and VACCINATION SITE PAIN (right arm is very sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 027B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (throwing up). On 04-Nov-2021, the patient experienced VACCINATION SITE PAIN (right arm is very sore). At the time of the report, DIARRHOEA (diarrhea), VOMITING (throwing up) and VACCINATION SITE PAIN (right arm is very sore) outcome was unknown.        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
Night of vaccine very painful, 9 out of 10 pain. Achy, headachey, chills 4/12/16, felt as though she was "coming down with something", fine 4/13/16.