chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), HAVRIX, (non-gsk) PREVNAR, FLUZONE (non-gsk). On 12 December 2008 the subject received 1st dose of INFANRIX (.5 ml, unknown), 2nd dose of HAVRIX (unknown), 4th dose of PREVNAR and unspecified dose of FLUZONE (Non-GSK). On 13 December 2008, a few hours after vaccination with HAVRIX, INFANRIX, PREVNAR and FLUZONE (Non-GSK), the subject experienced local reaction at injection site. At the injection site there was swelling and a rash around it. The physician wrote an unspecified prescription for the rash. In December 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX, HAVRIX, PREVNAR and FLUZONE (Non-GSK).
pt exp jaundice p/vax;pt was seen in ER;onset date, tx & outcome of the adverse event were not provided;
Day 1- Fever, Body Chills, Headache, Lethargic, Joint  Aches Day 2- Body Chills, Headache, Lethargic. Joint Ache, Loss of Conciousness
Initial vaccination given 06 January 2021. ?Pounding headache, chest pain, stomach pain, fatigue, fever 103.2*F, (Overall malaise, Emergency Room visit x2, out from 12 January to 25 January). Reaction to prescribed medication -  visual hallucinations described.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported. No concomitant medications were provided by the reporter.
Since my second shot, I have had ongoing pain in my arm and shoulder for the past 15 days, and it is not going away.  I wake up at night in pain, every night. I also noticed slight swelling in lymph node in my armpit yesterday, but this is not bothersome. The shoulder pain is primary problem, and not going away.
atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). The 87-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 19:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 87 years old. Medical history included Pacemaker for bradycardia x 20 years, myocarditis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Same meds for years. The patient experienced atrial fibrillation on an unspecified date. The event was reported as serious with seriousness criteria disability. Reported as: Been seeing a cardiologist for 20+ years every 6 months, now first visit since vaccine and now I have atrial fibrillation. A-FIB. Never had it in 87 years of life. I see a country is reporting a link between Pfizer and myocarditis.. I look up does myocarditis cause AFIB ? YES. I pray it is temporary. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient received amiodarone for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  Follow up attempts are possible, information about lot/batch number cannot be obtained.
experienced anterior non-blanching rash hours after on lower extremity; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 2-month-old patient received pneumococcal 20- valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "experienced anterior non-blanching rash hours after on lower extremity". Additional information: a 2-month-old patient received the first dose of pneumococcal 20- valent conjugate vaccine (diphtheria crm197 protein) and experienced anterior non-blanching rash hours after on lower extremity.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) has been requested and will be submitted if and when received.
This spontaneous report was received from a physician via a field representative, concerning a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included loratadine (CLARITIN), magnesium oxide, montelukast sodium (SINGULAIR), naproxen, mometasone furoate (NASONEX), and albuterol (VENTOLIN). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. On 24-AUG-2017, the patient received her second dose of GARDASIL 9 with lot # N017697 and expiration date on 21-JAN-2020 (strength, dose, and route of administration were not provided), administered in her left deltoid for prophylaxis. The vaccine did not have temperature excursions during its storage. On the same date, the patient also received an unspecified allergy shot. The patient had no any illness at the time of vaccination. On 10-SEP-2017, approximately two weeks after vaccination, she experienced pain and swelling of her left arm (Pain in extremity/Peripheral swelling). She developed a lump on her arm vaccination site which continued to grow and became painful (Vaccination site mass). An X-ray was performed and showed soft tissue swelling; but the discomfort and lump persisted. An ultrasound and a magnetic resonance imaging (MRI) revealed linear tract hyperemia of the area as well as intense inflammation. Subsequently, the patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) later switch to cefdinir. No product quality complaint (PQC) was involved. At the time of this report, the patient was recovering from the pain in extremity, peripheral swelling and intense inflammation, vaccination site mass, soft tissue swelling, discomfort, and hyperemia. The causal relationship between the events and with GARDASIL 9 was not provided.
Patient was administered second booster, under the age of 50. She states her father is immunocompromised, but she states she is not immunocompromised. It was realized that this was her second booster after administration.
A report has been received from a Health Professional concerning a 13 year old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 10-Jan-2014 the patient was received nasal FLUMIST QUADRIVALENT (intranasal), but the vaccine was expired on 23-Dec-2013. At the time of reporting, the outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
pt states after taking the vax he woke up with  headache and sinus congestion.  After getting up next morning he noticed a numbness on the left side of his face, mouth and teeth.  He got a tingling sensation that moved from  his arm down into his thumb and then spread into his other fingers.  He shook his hand and it seemed to disappeared.  Pt has not contacted his PCP with symptoms.
J96.00 ACUTE RESPIRATORY FAILURE 7/7/2022 RENAL FAILURE
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Error: Wrong Dose of Vaccine - Too Low-
soreness in the arm/pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm/pain in her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A., 031L20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in the arm/pain in her arm). On 11-Feb-2021, VACCINATION SITE PAIN (soreness in the arm/pain in her arm) had resolved.            Concomitant medication was not provided. Treatment information was not provided.    This case was linked to MOD-2021-387051 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number not reported) on 13-JUL-2012. The primary reporter was reporting that a patient received the GARDASIL doses on the following dates: 13-JUL-2012, 20-SEP-2012 and 29-SEP-2012. NO adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No current condition was reported. It was unknown if the patient had any relevant medical or past drug history. Approximately in 2014, as reported sometime after 26-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (unknown dose and frequency). No concomitant medication was reported. On an unknown date sometime after 26-SEP-2014 after the pharmacist administered the PNEUMOVAX 23 to the patient, he realized that the PNEUMOVAX 23 vaccine expired on 26-SEP-2014. It was unknown if any relevant tests were done. As of 05-OCT-2014 it was unknown if the patient will receive any additional PNEUMOVAX 23 doses and the outcome of receiving an expired vaccine was unknown. It was reported that the PNEUMOVAX 23 was possibly administered on 05-OCT-2014 but could not confirm because the pharmacist had patients waiting and did not have time to provide further information. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years 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: "Pre-diabetic" (unspecified if ongoing), notes: Pre-diabetic; "obesity" (unspecified if ongoing); "Known allergies: Yes, sulfas" (unspecified if ongoing), notes: Known allergies: Yes, sulfas; "Known allergies: cephalosporins" (unspecified if ongoing), notes: Known allergies: cephalosporins; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid treatment from 27Dec2022 to 29Dec2022. Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Low-grade fever and chills for 2 days post vaccine. Extreme fatigue and weakness still ongoing and affecting daily functions and work. Headache with sensitivity to light and sound for 1 day (no nausea).
STROKE; BLOOD CLOT; COVID-19 TEST POSITIVE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, less than a week later after vaccination the patient was at the emergency room and tested positive for Covid-19. Later the patient experienced a stroke and a blood clot on brain. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot and covid-19 test positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000200514; Sender's Comments: V0- 20211110611- covid-19 vaccine ad26.cov2.s- Stroke, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Skin reveals face, upper ext. with 5 different lesions - original lesion drying with no crust erythema surrounding central dry mark, second & third lesion with erythematous base & fluid/whitish color vesicle. Newest lesion today on forehead with erythematous papule - no vesicle or pustule; no evidence of a superinfection.
Swelling at injection site immediately after injection and slight pain. VS remained WNL and no other symptoms reported. Client refused to stay for monitoring. Advised if symptoms worsen to call 911 or go to ER for examination. Cold pack applied to L arm. Called client to follow up 10/5/2018 and has not returned my call.
Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent; Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent), WRONG PRODUCT ADMINISTERED (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent), WRONG PRODUCT ADMINISTERED (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent), WRONG PRODUCT ADMINISTERED (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent) and WRONG PRODUCT ADMINISTERED (Children received their first dose of the primary series with the Moderna bivalent vaccine booster instead of monovalent).    This case for 2nd patient of 3 patients. No concomitant medications were provided. The Pharmacist administered Moderna vaccine to a family and 3 of the children received their first dose of the primary series with the Moderna bivalent vaccine booster.   No other adverse events reported. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-664257, US-MODERNATX, INC.-MOD-2022-664266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664257: US-MODERNATX, INC.-MOD-2022-664266:
Both hands swollen and itchy and knee started 7/10/08. Patient has history of severe; Reaction to onions - she was treated for allergic reaction one week prior
VIRAL PNEUMONIA; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. 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, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. 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 patient experienced viral pneumonia. It was reported as "I got viral pneumonia after my J and J vaccine. I did not get anymore." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of viral pneumonia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221228970-Viral pneumonia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Patient was given Pentacel instead of Quadracel for her 5 year vaccines. There has been no adverse reactions per mother, who I talked with today, 03/25/2021 at 1145.
within 30 minutes of receiving vaccination, child started crying unconsolably, would not eat, drink or sleep.  24 hr later mother called PCP and was referred to the ER for evaluation of possible meningitis vs vaccine reaction,  was referred back to PCP by ER, mother states nothing was done in ER, PCP was able to introduce fluids, child was sent home with instruction to monitor temperature and signs of lethargy, instructed to return to ER if high fever occurred.  Mother reports child started eating/drinking around 1:00AM on 10/06/21 and stopped crying around 3:00am.  Still has not slept since vaccination.
Grand mal seizure shortly p/receiving  flu vax; seen @ ER & admitted to ICU @ 520PM; valium & phenob given to bring out of sz; dx grand mal sz;
Diarrhea; really sick; throwing up; heavy chest; cough; no energy almost can't get out of bed; is it possible that she had covid-19 the day she got the vaccine; This is a spontaneous report from Pfizer sponsored program, a consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter (patient) received Vaccine on Wed- Been really sick since Diarrhea and throwing up heavy chest cough no energy almost can't get out of bed. Is it possible to get covid-19, is it possible that she had covid-19 the day she got the vaccine. Events outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial and follow-up information has been received from a certified medical assistant concerning a 17 year old female with no medical history, and no drug reactions/allergies, who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot#655154/1210U). There was no concomitant medications. Subsequently, the patient was determined to be pregnant. No adverse experience was related to this event. A urine pregnancy test was positive. The patients last menstrual period was 9-Nov-2007 and her estimated delivery date was 15-AUG-2007. The patient's mother contacted the office by phone. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information indicated that the patient had an elective termination on an unspecified date. It was reported that the termination was not due to exposure to the vaccine. It was reported to be unknown if the products of conception were examined. Upon internal review elective termination was considered to be an other important medical event. Additional information is not expected.
Intense lower back pain; could only sleep sitting up; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on the left arm on 16Mar2021 at 10:00 (at the age of 76-year-old), as a single dose for COVID-19 immunisation. The patient reported that no medical history. Concomitant medications included simvastatin (ZOCOR), Vitamin D (MANUFACTURER UNKNOWN) (not specified), 81 mg aspirin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) for unknown indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 15:00 (about 4 hours after shot), the patient experienced intense lower back pain which began. She could not stand up straight, walk at 45-degree angle for 3 days and could only sleep be sitting up. The patient did not take any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events intense lower back pain and sleep sitting up were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.