chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Inflammatory marker test: Elevated.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 55-years-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of rheumatoid arthritis (AESI) that occurred approximately 1-2 months after dose mRNA-1273 administration, which was 3rd dose in COVID-19 vaccination schedule. Patient has also informed that the event was accompanied by elevated inflammatory markers. No further clinical information clinical course of the event with exact onset date and outcome, diagnostic work up, family history, concurrent conditions and concomitant medications, differential diagnosis and treatment were provided for medical review. Based on the provided information it cannot be differentiated if this event represented an instance of reactive arthritis or rheumatoid arthritis itself. Outcome of rheumatoid arthritis was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning a 55-years-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of rheumatoid arthritis (AESI) that occurred approximately 1-2 months after dose mRNA-1273 administration, which was 3rd dose in COVID-19 vaccination schedule. Patient has also informed that the event was accompanied by elevated inflammatory markers. No further clinical information clinical course of the event with exact onset date and outcome, diagnostic work up, family history, concurrent conditions and concomitant medications, differential diagnosis and treatment were provided for medical review. Based on the provided information it cannot be differentiated if this event represented an instance of reactive arthritis or rheumatoid arthritis itself. Outcome of rheumatoid arthritis was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
ALLERGIES; NASAL SECRETIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced allergies. On MAY-2021, the subject experienced nasal secretions. The action taken with covid-19 vaccine was not applicable. The outcome of the allergies and nasal secretions was not reported. This report was non-serious.
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (lot number HG4677) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing); "allergies bee venom" (unspecified if ongoing). Concomitant medication included: ROSUVASTATIN, start date: 08Jun2022, stop date: 06Oct2023. Vaccination history included: Janssen covid-19 vaccine (dose 1 (primary immunization series), lot 180S01, left arm), administration date: 16Mar2021, when the patient was 63-year-old, for covid-19 immunisation; Moderna covid-19 vaccine (dose 2 (booster), lot 93990S, left arm), administration date: 01Nov2021, when the patient was 64-year-old, for covid-19 immunisation; Moderna covid-19 vaccine (dose 3 (booster), lot 001M21A, left arm), administration date: 13Apr2022, when the patient was 64-year-old, for covid-19 immunisation; Pfizer/Biontech covid-19 vaccine (dose 4 (booster), lot GH9694, left arm), administration date: 08Sep2022, when the patient was 65-year-old, for covid-19 immunisation; Pfizer/Biontech covid-19 vaccine (dose 5 (booster), lot GJ3268, left arm), administration date: 12May2023, when the patient was 65-year-old, for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot # not reported). No adverse experience was reported. It was not specified if the patient sought medical attention. The health professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number. This is one of two reports received from the same source. Additional information has been requested.
Rash appeared on Weds (1/8/14) on back and right thigh, followed by lymph node swelling (bikini line area) on Fri (1/10/14) accompanied by fever and pain (hip to knee deep in leg).
Presented to the ED on 06/05/2021. Dx'd with Global Transient Amnesia
Client received first dose of Moderna, reported instant stomach cramping, diarrhea x3, dizziness, sweating.
Headache, Myalgia, NauseaVomiting, Chills, inability to sleep Narrative:  Employee called and stated after receiving vaccine, around 1700 developed Headache, bodyaches, could not sleep last night, this morning bodyaches are more severe, nausea and chills
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Flu like symptoms; Headache; Nausea; Feeling hot; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 12Jun2021 at 08:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date (at an unknown age) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Jun2021, the patient experienced flu like symptoms, mostly headache, nausea and feeling hot. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, headache, nausea and feeling hot were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 patients under 65 received Fluzone High Dose, no AE; 3 patients under 65 received Fluzone High Dose, no AE; Initial information received on 16-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves three patients under 65-year-old (gender not reported) who were vaccinated with dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Batch number, expiration date, dose and site of administration was not reported) for prophylactic vaccination on unknown date (PT: Overdose, Product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via a Plaintiff  from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1807USA005466), concerning a 56-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 14-JAN-2000 and 13-DEC-2000, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) (reported as hepatitis A pediatric) (dose, route, lot# and expiration date were not reported) in a clinic for prophylaxis (product administered to patient of inappropriate age).    This case was one of the three reports regarding the same patient.; Sender's Comments:  US-009507513-1807USA005466: US-009507513-2108USA001619:
Received flu vaccine in left arm by nurse.  About 5-10 minutes later was itchy and red blotches appeared on his face. Red blotches were on his forehead, cheeks, and around mouth.  He appeared pale.  He stated his throat was also itchy.  He stated trouble breathing. Parents states no previous problems with shots and no allergies. 911 called. Received oxygen and vitals were taken by paramedic.  After about 15 minutes he was getting better.  Parents did not think it was necessary for him to be taken to the hospital.
The patient's leg became very swollen and red approximately 24 hours following the vaccination. The patient was treated with steroids.
4 mm and 6 mm kidney stones passed 2 weeks and 4 Weeks after vaccine.   (This also happened after doses 1 and 2.)
Information was received from a male consumer. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX. The patient reported that after he and his wife (MARRS# 1311USA004568) they both experienced "a little redness and itching at the injection site". He also reported that his wife experienced these symptoms "a little more" than he did. The patient reported that the symptoms lasted about three days and the injection site was sore after that. Additional information is requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 as dose 5 (booster), single at the age of 82 years, in right arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 26Dec2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective which includes Paxlovid on 26Dec2022 to 30Dec2022. Clinical course: the patient had other medication in 2 weeks which was benzonatate. He had no known allergies.  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.
minor soreness at vaccination site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (22Mar2021), this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL92U2) intramuscular, administered in Arm Left on 04Feb2021 23:30 (at the age of 85-years-old) as 1ST DOSE, SINGLE DOSE and second dose via intramuscular, administered in Arm Left on 23Feb2021 12:45 (at the age of 85-years-old) (Batch/Lot Number: EW6203) as 2ND DOSE, SINGLE DOSE both for covid-19 immunisation at Hospital. Medical history was none. The patient's concomitant medications were none. The patient experienced minor soreness at vaccination site on an unspecified date. It was reported that the two shots resulted in absolutely no reaction beyond a minor soreness at the vaccination site, which was gone within 24 his after each shot. patient was scheduled for a dental procedure 16Feb2021 that will require predosing with amoxicillin and a bone graft. Patient wants to know if either of these things will interact with his second dose of vaccine. He stated he had dental appointment for surgery, the strength of the Covid-19 Bone graft to repair the bone where the teeth come out- go back in an put implants into my lower jaw and attach crowns to it I have to take 3 days worth of amoxicillin TID, then day of surgery take a dose of 4 amoxicillin. Prior Vaccinations were reported as none. The outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Was travelling out of the country and started having a dry cough. A week later was congested and had a high fever. Went to Doctor and was prescribed Antibiotics (not sure of name). Gradually got better, but still has a scratchy throat.
Swollen throat; Strep throat; Headache behind the eyes; she was given another dose due to breakage of needle; she was given another dose due to breakage of needle; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), PHARYNGITIS STREPTOCOCCAL (Strep throat), OVERDOSE (she was given another dose due to breakage of needle), DEVICE CONNECTION ISSUE (she was given another dose due to breakage of needle) and HEADACHE (Headache behind the eyes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced OVERDOSE (she was given another dose due to breakage of needle) and DEVICE CONNECTION ISSUE (she was given another dose due to breakage of needle). On 22-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat), PHARYNGITIS STREPTOCOCCAL (Strep throat) and HEADACHE (Headache behind the eyes). At the time of the report, PHARYNGEAL SWELLING (Swollen throat), PHARYNGITIS STREPTOCOCCAL (Strep throat) and HEADACHE (Headache behind the eyes) outcome was unknown and OVERDOSE (she was given another dose due to breakage of needle) and DEVICE CONNECTION ISSUE (she was given another dose due to breakage of needle) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Medications for heart disease and bone disease.
pt recvd vax; on 16nov95 devel chicken pox; md felt exp related to vax;
Similar to first dose, had a bad Lyme disease flare up. This time was worse and was unable to sleep or get out of bed due to horrible pain in spine, rest of back, and joints. Experienced a debilitating migraine that made my skin painful to the touch. Began to develop oral ulcers three days after the second dose on tongue and gums in the back of the mouth.
Received the shot around 9:45 am and started feeling adverse symptoms around 8:00 pm. My whole body started to hurt very badly, my breathing became troubled as it felt like there was a tightness/shrinking feeling in my throat. My whole body was radiating heat and I felt like I was burning up.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided.  It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 20-AUG-2012 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  On or about 04-JAN-2016, the female patient was treated by an unspecified health professional (It was not clear if physician) for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed FAMIR (It is unclear if this is famciclovir (FAMVIR)) for management of her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later.  Red rash disappeared within 1.5 hours after taking ibuprofen.
Child one minute later vomited immediately and then became hyporesponsive. Responded well to Epi, O2 and Albuterol treatment. Transported to ER.
has an infection; This is a spontaneous report from Pfizer-sponsored program female patient reported for(herself). A Non-contactable female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via unspecified route of administration on unspecified date as dose number unknow, single for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. It was unknown patient was pregnant. On unspecified date, patient taken the vaccine and has an infection and was wondering if she could take a medication called macrobid. Patient was explaining her problem caller stop responding and few minutes later hanged up. The outcome of the event was unknown.  No follow up needed. No further information is excepted.
MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid- 19 infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.