chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The caller and his twin brother both have thrombocytopenia.; stage I varices; Something is getting in the way in his throat; This is a spontaneous report received from a contactable consumer(Consumer or other non health professional Specify Consumer or other non health professional: brother). This consumer reported adverse events with similar suspect for 2 patients. This report is One of two patients. A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included thrombocytopenia. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced thrombocytopenia. On an unspecified date in Mar2021, the patient experienced stage I varices/ some type of clot or thrombosis, Something is getting in the way in his throat. This was 2 days ago. It was reported that patient read an article that there is a link between the Pfizer COVID vaccine and thrombocytopenia patients producing clots and reporter declined safety report because they don't know if it is related or not. The lab tests included test: Blood work, result: Excellent (blood work is perfect so far and It can't be cirrhosis because he has excellent blood work); Test : EGD, result : had nothing like this when they did the last one in 2018; Test: EGD, result: Abnormal (They found stage I varices/ some type of clot or thrombosis). The outcome of the events was unknown.  Information on the lot/batch number has been requested
Immunization was administered too high and patient presented with severe pain. Patient stated she was unable to move her arm and went to see her physician. Doctor stated vaccine was administered too high.
Fever 103 at 10:45 am 3/26/09, shaking. Poor sleep night of 3/25/09.
Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
She had a little reaction, little redness, and soreness and  warmth, tenderness, (2 days) red rash 7 cm X 13 cm occurring at the injection site.; Red rash 7 cm X 13 cm occurring at the injection site; Tenderness at the injection site; Redness at the injection site/red at the injection site; Soreness at the at the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (She had a little reaction, little redness, and soreness and  warmth, tenderness, (2 days) red rash 7 cm X 13 cm occurring at the injection site.), VACCINATION SITE ERYTHEMA (Redness at the injection site/red at the injection site), VACCINATION SITE PAIN (Soreness at the at the injection site), VACCINATION SITE RASH (Red rash 7 cm X 13 cm occurring at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.   Concurrent medical conditions included Allergy to insect sting (Sensitive to mosquito and flea bites).  On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site/red at the injection site) and VACCINATION SITE PAIN (Soreness at the at the injection site). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (She had a little reaction, little redness, and soreness and  warmth, tenderness, (2 days) red rash 7 cm X 13 cm occurring at the injection site.), VACCINATION SITE RASH (Red rash 7 cm X 13 cm occurring at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). On 30-Jan-2021, VACCINATION SITE PAIN (Soreness at the at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (She had a little reaction, little redness, and soreness and  warmth, tenderness, (2 days) red rash 7 cm X 13 cm occurring at the injection site.) had not resolved and VACCINATION SITE ERYTHEMA (Redness at the injection site/red at the injection site) and VACCINATION SITE RASH (Red rash 7 cm X 13 cm occurring at the injection site) was resolving.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a little reaction, little redness and soreness went away after a few days and 9 days later (28-Jan-2021) she had COVID arm: warmth, tenderness, (2 days) red rash 7 cm X 13 cm occurring at the injection site which had faded to a pink at the time of this report.  Treatment information were not provided.; Sender'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.
19 hours after the injection there was fever, rigors, sweats, headache, nausea, myalgias. This lasted for approximately 30 hours then resolved. Tylenol 1000 mg q 6H and
Chills,  joint pain (especially in hands), muscle pains, headache.  Symptoms resolved by 48 hours post vaccination.
13SEP93 pt recvd vax & began breaking out w/whelps that look like burns, 1 day p/vax; only 1 whelp on lt wrist 31AUG93; pt had fever, is lethargic, sound like affected pts lungs;
Injection site red, warm, swollen, painful 6" in diameter. Fever 101 degrees F, tiredness, muscle & joint pain. Cough with asthma Sx.
Note that this case meets vaccine breakthrough criteria.  Patient presented with ~10 days of nausea, vomiting, decreased appetite.  Hx gallstones, now with intermittent diarrhea and abdominal pain.
Started losing eyesight in early August, doctors thought it was nothing. Then intense pain in my legs, then a week later I try to get out of bed and I'm paralyzed from the waist down. Uncureable, I'm in a clinical trial now for treatment. But I have to wear diapers all the time, I can't play sports, chronic fatigue, major depression. Can't work ag62, waiting for disability. Devics disease.
No additional adverse effects reported; A patient received expired VAQTA on 8/25/2020; This spontaneous information has been received from office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 25-AUG-2020, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) injection as prophylaxis, lot number S019435 with expiration date 23-AUG-2020 (strength, dose, frequency, route of administration and anatomical location were not provided) (expired vaccine used).  No additional adverse effect reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; Devicelotnumber: S019435; expirationdate: 23-AUG-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 suggest a causal association with the device or device constituent
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003725, MCM-003726, MCM-003724, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003763, MCM-003766, MCM-003761, MCM-003769, MCM-003767, and MCM-003770, due to same reporter.  No further information is expected.
Given 4 Year Old Child a Dose of Heplisav-B; Initial Report Received on 23-Feb-2023.  A registered nurse reported that a 4-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported.  Allergies were unknown.  On 27-Jan-2023, the 4-year-old patient received a dose of HEPLISAV-B vaccine (Lot # 941060, expiration date 02-Dec-2024; NDC # and route not reported) in the left deltoid at a pharmacy. No adverse effects were reported.  No further information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recvd Engerix-B on 24MAR92 & 22APR92 & exp pressure over scapula, tingling; pt went to ER & it was found that pt's bone protrudes in scapula; pt is being worked up for MS;
ITCHY, RED RASH TO BOTH SIDES OF NECK (LEFT AND RIGHT). DRY, IRRITATING COUGH.
Child started to have numbness and tingling in arm where vaccine was administered in, as well as both legs bilaterally. Later in afternoon child had upset stomach and headache. The headache and tingling/numbness sensation continued through next day. Headache resolved on day 3. On day 2 post vaccination the child had generalized malaise. Child continued to have numbness and tingling sensation in legs bilaterally and right arm through day 3 post vaccination administration, but symptoms sensation were becoming less. Today, 1 week post vaccination client continues to have tingling sensation in right hand and both feet.
Pt felt burning when vaccine was administered in left arm.  Burning continued for 3 minutes, itching began immediately afterward and lasted for about 72 hours.  Today presents with a raised palpable nodule about 4mm.
immed p/vax began running fever 103-104; on 4FEB93 t104.5 seen by MD was told ear infect & sinusitis; was give rx ATB; today much improved, has low grade fever;
Sore arm; Sensitivity in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and SENSITIVE SKIN (Sensitivity in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and SENSITIVE SKIN (Sensitivity in her left arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and SENSITIVE SKIN (Sensitivity in her left arm) outcome was unknown. Not Provided          No concomitant medications provided.Treatment information was provided was steroids for 10 days.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported0 which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
No adverse event, but vaccine administration error. Patient had already received Menveo at 11yo.
Moderate deltoid soreness, Body aches and fatigue for around 12 hours. Bilateral sub conjunctival hemorrhage.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose was not reported, (Dose number in series 01), 01 in total was administered on an unspecified date for prophylactic vaccination.  No adverse events were reported following vaccination covid-19 vaccine ad26. cov2.s (Dose number in series 01). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, (Dose number in series 02) 01 in total was administered on 14-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 23-FEB-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient started to experience fever, head and chest congestion, coughing which resulted in suspected COVID-19 (Coronavirus disease-19) infection. On the same day, the patient experienced stomach ache (Dose number in series 02). On 26-FEB-2022, the patient tested positive for COVID-19 virus test (NR: not provided) (using the iHealth rapid take home antigen provided by the federal government) which resulted in suspected clinical vaccination failure (Dose number in series 02). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected COVID-19 infection and stomach ache was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (RA): 90000219343.; Sender's Comments: V0: 20220260810-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical Vaccination Failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related.
About 10 days after the vaccine, I started feeling a "cotton mouth" (dry mouth) and a cough that I could not get down. I also wanted to say that I had a metallic taste in my mouth that then developed into the dry mouth. I drank a lot of water and in a couple of hours the taste went away and the dry mouth went away but the cough persisted. Tried the over the counter Dayquil did not work and then decided to do the telehealth visit with a doctor.  They prescribed me some antibiotics and steroids and it solved the problem
Sore Arm; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ATENOLOL, LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR), SIMVASTATIN (ZOCOR), ESTRADIOL and CLOBETASOL for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills) outcome was unknown.            Concomitant medications included water pills.  Treatment details included Tylenol. atenolol, lisinopril, water pill, singulair, Zocor, estres cream, Clobetasol.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Followup received on 10-May-2021. Outcome of event updated.
Vaccine was administered at 12:12pm and patient was sitting in waiting room when she fell on the floor, entered myoclonus, and become unresponsive, I offered to call 911 but the patient's friend explained she was a nurse and that we do not need to call since this has happened before. The patient remained on the floor in a postictal state for about 15 minutes before leaving with her friend feeling normal.
neck pain; back pain; difficulty in breathing; flu like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (medical heart condition reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills). At the time of the report, NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills) outcome was unknown. Not Provided          No concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: 26-apr-2021: updated reporter details; 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.
Fine macular rash over trunk and proximal extremities. No other symptoms and non-pruritic.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
HIV disease/ HIV positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: HIV INFECTION (medically significant), outcome "unknown", described as "HIV disease/ HIV positive". The patient underwent the following laboratory tests and procedures: HIV test: Positive. Patient also received COMIRNATY 2023-2024 formula on an unknown date. Clinical course: A 79-year-old male patient just had a COVID vaccine from a (Pharmacy name withheld), he had asked for a Pfizer vaccine which was what he had been provided from his previous 6 shots. He was HIV positive. After he got home, he realized that they had given him Comirnaty vaccine. He was asking if this was appropriate or should he had gotten something different? He had gone online and said there's lots of information he found like the 6 months to 11 years, and 12 years old etc. He said his previous Covid vaccines were also Pfizer's. Advised that for his age, Comirnaty 2023-2024 formula was really the appropriate formulation/dose for him. Also told him that the 6 months to 11 years was called Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) which was only authorized for emergency use while the Comirnaty 12 years and up was the approved one which was what he's given. Further explained to him that the study or the clinical trials they had for the Primary Series COMIRNATY included participants with confirmed stable human immunodeficiency virus (HIV) infection. And so, reassured him that he was given the appropriate formulation based on the information he's provided about himself. He understood and said he felt better.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.