chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is still hurting/ persistent pain on the arm since more than two weeks; A spontaneous report was received from the patient on 01DEC2022.  It described a 35-year-old female patient (height: 67 inches/170.18 cm, weight: 152 pounds/68.95 kg) whose "arm is still hurting/ persistent pain on the arm since more than two weeks (vaccination site pain) following the administration of BioThrax (anthrax vaccine adsorbed) (lot number: unknown) for immunisation. It was reported that the patient received BioThrax on 07NOV2022 following which her arm was paining. Reportedly, the patient still has had persistent pain in the arm, for more than two weeks now (as per report). Additionally, it was reported that the patient received no treatment for the reported event. The patient had not recovered from the reported event, at the time of this report.  Action taken with BioThrax with respect to the reported event was not applicable.  The patient had no medical history and her surgical history included gall bladder surgery (removal) and tonsils surgery (removal).  The patient's concomitant medications included Synthroid (levothyroxine sodium) for thyroid, Effexor (venlafaxine hydrochloride) for anxiety and depression, Lessina (ethinylestradiol, levonorgestrel) as a birth control, Xyrem (oxybate sodium) and Ritalin (methylphenidate hydrochloride) for narcolepsy.  No additional information was reported.  Company comment: It was reported that a consumer received BioThrax for immunization and her arm is still hurting/in persistent pain on the arm for more than two weeks (vaccination site pain). Considering the case information, the role of BioThrax cannot be ruled out and the causality of vaccination site pain is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer received BioThrax for immunization and her arm is still hurting/in persistent pain on the arm for more than two weeks (vaccination site pain). Considering the case information, the role of BioThrax cannot be ruled out and the causality of vaccination site pain is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.
cried cont w/o stopping any for greater than 1 hr; mom did not inform MD until 9SEP92;
1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on 18Dec2020 (at the age of 35 years old) as a single dose in the right arm via unknown route of administration for COVID-19 immunization at hospital facility. Relevant medical history was unknown. It was unknown if patient has any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after the first dose, the patient experienced mild headache and mild arm soreness. No treatment was received for the events mild headache and mild arm soreness. The outcome of the events mild headache and mild arm soreness was unknown. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Area of erythema, swelling, itching, and increased warmth of L upper arm where vaccine administered measuring 9.5cm x 17cm.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; JOINT PAIN; This spontaneous report received from a consumer concerned a 31 year female. Initial information was processed along with the additional information received on 14-DEC-2021. 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: 034A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. (Dose number in series was 1). No concomitant medications were reported. On 05-DEC-2021, the patient experienced unspecified symptoms and on 06-DEC-2021, the patient had confirmed covid-19 infection (confirmed clinical vaccination failure). On 06-DEC-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. On 07-DEC-2021, the patient had experienced fever and body temperature was 103.6 F (Fahrenheit). After 1 or 2 days, patient experienced runny nose, headache, joint pain, chills, itchy throat and coughing. After 3 days, patient experienced almost like a cold or a flu, really tired and severe diarrhea which was over at the time of reporting. (Dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, joint pain and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000206740. This case, from the same reporter is linked to 20211229762 and 20211232501.; Sender's Comments: V0:20211230837-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. 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
symptoms of UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (symptoms of UTI) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and SIMVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URINARY TRACT INFECTION (symptoms of UTI). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (symptoms of UTI) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment for UTII include Cranberry juice, apple cider vinegar and stopped drinking coffee. Patient received second dose of MODERNA COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 17-Apr-2021 contains significant information including event  outcome updated from unknown to recovered and 2nd dose information.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old female patient who experienced body aches, very red blood shot eyes, deep cough, pressure on her chest, and a temperature of more than 99, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 19-Sep-2018, in the evening the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ010AC, expiry date 22-Apr-2019 via unknown route in unknown administration site. On 20-Sep-2018, the patient developed a non-serious body aches one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious very red blood shot eyes one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious deep cough one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious pressure on her chest, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, patient developed a non-serious a temperature of more than 99 one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was a temperature of more than 99, pressure on her chest, deep cough, very red blood shot eyes and body aches. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for deep cough, as Unknown for pressure on her chest, as Recovering / Resolving for body aches, as Recovering / Resolving for a temperature of more than 99 and as Unknown for very red blood shot eyes. List of documents held by sender- none.
Upper eyelid swelling bilat, with erythematous papulos rash, generalized.
Swelling, rash, itching at injection site 2/19 - 2/22. Swelling past elbow reported 2/24. Follow up with MD and diagnosis of cellulitis 2/22. Prescribed antibiotic and antihistamine. Follow up revealed improvement 2/23.
I experienced all of the listed side effects (except, I didn't have an actual fever, I felt like I had a fever, but my temperature was normal). The chills and muscle pain were extremely intense 6 hours after I received my vaccine. I could not stop shivering, or get warm enough. That would be followed by a feeling that I was too warm and I would begin sweating profusely. I also experienced a few additional side effects I could not find listed:   I felt especially sensitive to stimuli as if normal sensations were heightened (e.g. hot water in a shower felt painful, running fingers through my hair felt like I was having my hair pulled, I kept my eyes squinted because the sunlight through the windows felt too bright.)  I was extremely irritable and became extremely frustrated easily. I mean frustrated to an embarrassing degree over small things that didn't matter. It was inconsistent with my day-to-day temperament. It felt like an adrenaline rush came in response to the most minor of inconveniences.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 01-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M014544 with expiration date 27-NOV-2017) orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports  received from the same reporter. Additional information has been requested.
COVID-19; COVID-19; Vaccine brand other=Moderna/ Vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 020B21A), on 28Apr2021 as dose 2, single (Lot number: 002C21A) and on 22Nov2021 as dose 3 (booster), single (Lot number: G27H21B) for covid-19 immunisation. The patient's relevant medical history included: "General Anxiety Disorder" (unspecified if ongoing); "ovarian cysts" (unspecified if ongoing); "suspected endometriosis" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE HCL; JENCYCLA. Past drug history included: Ceclor, reaction(s): "known allergies Ceclor", notes: known allergies Ceclor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine brand=Pfizer/BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Headache; Fever; Body and muscle aches; Body and muscle aches; light headed ness; Rash appeared on vaccine arm several days later and lasted for several days; Menstrual cycle started 4 or 5 days earlier than usual; Menstrual cycle started 4 or 5 days earlier than usual and was heavier; Menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first does of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021, the patient experienced headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started four or five days earlier than usual and was heavier and more painful than usual. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.
Dose was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In August 2021, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the patient started Flulaval Tetra Pre-Filled Syringe Device. In August 2021, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The reporter stated that Flulaval Quadrivalent 2020,2021 was inadvertently administered to an unknown patient last week and the dose was expired,which led to expired vaccine used. Health care professional did not provide more information. The reporter did not consented to followup.
BRAIN FREEZE SENSATIONS; TINGLING; NUMBNESS; UPSET STOMACH; SLOWER THAN HIS NORMAL LIFE; WEAKNESS IN HANDS AND BODY; NAUSEA; HEADACHE; TIREDNESS; SORE ARM; BODY ACHES; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 05-JUL-2021, the subject experienced brain freeze sensations. On 05-JUL-2021, the subject experienced tingling. On 05-JUL-2021, the subject experienced numbness. On 05-JUL-2021, the subject experienced weakness in hands and body. On 05-JUL-2021, the subject experienced upset stomach. On 05-JUL-2021, the subject experienced slower than his normal life. On 05-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, headache, and tiredness on 11-APR-2021, and upset stomach, slower than his normal life, and nausea, and had not recovered from brain freeze sensations, weakness in hands and body, tingling, and numbness. This report was non-serious. This case, from the same reporter is linked to 20210728775.
guillain-barre- progressive numbness, weakness lower extremities starting about 6 days after vaccination
Administered Fluarix to 16 1/2 year old patient vaccine is for 18 years and older.
gross hematuria, protein in urine, high blood pressure, IgA nephropathy, acute kidney damage
malaise; muscle and joint pain; muscle and joint pain; headache; had trouble concentrating; fatigued; mild soreness in my left arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection) and MYALGIA (muscle and joint pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued) and VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection). On 30-Jan-2021, the patient experienced MALAISE (malaise), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache). At the time of the report, MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided
Febrile seizures x 2 on 10/24/12. Patient was seen at hospital after having a seizure. Prescription for MOTRIN & ? KEFLEX was given later on the same day he had another seizure. His parents took him to ER. Noted to have fever there as well.
Initial misuse report received from a healthcare professional on 08 May 2013. ACTHIB was reconstituted with sterile water and administered (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Vaginal Bleeding / (Early) Menstruation Lasted for 5 days It began earlier than would be expected, I typically have bleeding every 2 months since beginning use of the IUD, I'd had bleeding 2 weeks before the vaccination date already.
Pt called on 12/16/03. Redness. Warmth and tenderness to site of injection. This was a revaccination due to cold in relief. Last injection was 7/7/03.
Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney infarct.admittance to local  hospital for 5 days and ongoing follow up testing and multiple specialist visits for months
First dose given 08/2019. Second dose not yet given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not wish to disclose adverse event information. The reporter did not consent to follow up.
REdness and itching approximately 7 cm diam around injection site. No fluctuance but some warmth
Seen in ED for hives, itching and feeling flushed.  Given diphenhydramine 50mg with resolution.  Discharged to home from ED.
w/in 30sec p/vax pt eyes deviated to lt & appeared to have a transient loss of consciousness;pt remained in a sitting position, was not able to speak nor follow a finger w/eyes;had 2 more identical episodes w/in 15min;pt had fainting spell;
nausea and vomiting alongside typical body aches, chills, and fever immediate body aches that spread though body after injection. Progressed to chills then fever upon night fall (5PM) At 1 AM become nauseous. vomiting lasted 1 hour (4-6 times.). No medications taken at that time. Persisting bodyaches into second day. no nausea.  Ibuprofen taken. Immediate dulling of clinical signs.  Last clinical signs noted: 48 hrs after injection.
vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm soreness, full body aches, chills, fever of 102, lymph nodes swollen the size of a racquetball, headache.  all symptoms peaked in severity on Wednesday. improved on Thursday. resolved by Friday.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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's relevant medical history included: "multiple myeloma" (unspecified if ongoing). Patient had no known allergies Concomitant medication(s) included: LENALIDOMIDE oral (Celgene Corporation), start date: Feb2022, stop date: 17Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.