chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; CONGESTION; HIGH FEVER; HEADACHES; COUGH; This spontaneous report received from a patient concerned a female 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 previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, Expiry: unknown) dose was not reported, frequency one total administered at right arm on 15-MAR-2021 for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received a booster of non-company suspect vaccine included: mrna 1273 (form of admin and route of admin were not reported, batch number: 939904, expiry: unknown) dose was not reported, administered at right arm on 29-OCT-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 30-DEC-2021, the patient experienced cough and headaches (Dose number in series 2). Laboratory data included: COVID-19 antigen test (NR: not provided) negative.  On 31-DEC-2021, the patient experienced body aches, congestion, and high fever (Dose number in series 2). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. On 02-JAN-2022, Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) awaiting result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with mrna 1273 was not applicable.  The patient recovered from body aches, high fever and headaches on 02-JAN-2022 and had not recovered from cough and congestion. This report was non-serious.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 22Jun2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD stage", start date: 2020 (unspecified if ongoing), notes: other medical history: 2020 - Chronic kidney disease stage; "non hodgkins lymphoma", start date: Mar2021 (unspecified if ongoing), notes: other medical history: Mar2021-non hodgkins lymphoma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received reported as Yes. No other medication in 2 weeks reported. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date:19Jun2022, treatment stop date: 21Jun2022, indication: Treatment of COVID-19. Adverse event reported as FYI the last page would not allow me to add my initial vaccination data which was J&J on 22Jun2021 My adverse event was extreme rectal burning with diarrhea and some bleeding which is why he did not finish the full 5 days. known allergies reported as no.  No follow-up attempts were possible. No further information was expected.
Redness and swelling at injection site. 6/14/17 parent noted redness extending up into shoulder with some red streaks under arm. Child c/o headache.
A day after receiving 2nd dose, patient developed a headache, muscle and body aches, low grade fever, nausea, chills.  On the 3rd day patient developed nausea and vomiting.  Over the next four days, patient was unable to keep fluids or food down.  On day 5 after 2nd vaccination, patient found it necessary to go to the ER for the extreme nausea and discomfort, where patient was given IV fluids and promethazine, and pepcid.
COVID symptoms first night September 6, 2022. Tested positive for COVID two days later, September 8, 2022. Strong symptoms the first two days then weakened symptoms. Completely clear within seven days of onset. I had a phone consultation with Dr. on September 9, 2022. No special treatment needed. No after affects.
2 days of fever, muscle pain, body aches and bone/joint aches. 1 day if heartburn and headaches
Severe fatigue, muscle weakness lasting three weeks.  Dyspnea on exertion lasted several months.
PATIENT RECIEVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS.
child received an expired DAPTACEL and ACT-HIB-DILUENT ,with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16 months old male patient, child received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and HAEMOPHILUS TYPE B (HIB) VACCINE diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 04-Apr-2023, the patient received dose 4 at 0.5ml total of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: standard, route: unknown) (lot number: C5828AA, expiry date: 30-Mar-2023) in the left thigh for Immunization and the patient received suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer (strength, formulation, route, dose, expiry date, lot number: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and on the same day child received an expired daptacel and act-hib-diluent ,with no reported adverse event (expired product administered).  It was reported, Caller is wanting to know what to do.    Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and HAEMOPHILUS TYPE B (HIB) VACCINE (HAEMOPHILUS TYPE B (HIB) VACCINE) was not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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.
Pt brought to med obs #1 via stretcher in trendelenburg position d/t brief LOC after receiving vaccine. Reports h/o syncope with previous injections, last episode approximately in high school, per his report. Reports tunnel vision with nausea, diaphoresis, and tingling sensation to BUE. Pt regained consciousness prior to arrival in med obs. Pt offered and accepted water, declined snack, reports he ate PTA. PA-C at bedside to assess patient. Orthostatic VS obtained. VSS. No s/s of distress noted. Pt refused wheelchair, opting to ambulate to exit with staff escort. VS are as follows: 1344: BP 93/58, HR 80, RR 18, O2 sat 98% on RA 1349: BP 105/71, HR 79, RR 20, O2 sat 96% on RA 1354: BP 95/65, HR 72, RR 18, O2 sat 98% on RA 1359 (lying): BP 126/76, HR 89, RR 18, O2 sat 100% on RA 1404 (sitting): BP 115/82, HR 66, RR 16, O2 sat 100% on RA 1405 (standing): BP 109/78, HR 86, RR 16, O2 sat 99% on RA
COVID WITH NO SYMPTOMS; RASH; SWOLLEN LYMPHS; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 covid with no symptoms, rash, and swollen lymphs (dose number in series 2). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) antibodies greater than 2,500. It was posted that "I developed a rash and swollen lymphs after my second vaccination. My oncologist advised me to get the quantitative antibodies test to see if I needed the booster. My antibodies (greater than 2,500) are the highest they can measure on the quantitative antibodies test (higher than people who receive vaccination) so a booster is not recommended for me by my oncologist. People who have such high antibodies usually have immunity from having had covid, so I may have actually had covid with no symptoms. Some places are accepting proof of antibodies or proof of vaccination. Other places are only accepting vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, swollen lymphs and covid with no symptoms was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217354.
She got her 4th vaccine, didn't have any initially.  She was taking her medications prescribed to her, and then within an hour she got really, really bad pains on her right thigh that went to her back and then going around to the left side and into the chest area, which was very very tight.  She first got palpitations while resting on her elbow, and her heart started beating fast. She then sat up and then had the pain going from the right side, around her back and her stomach hurting really bad.  She has had this since that point, which was 5/10 or 5/11.  She did call the NP who sent her for an US and it came back with gallstones and supposedly she is to be scheduled for surgery.  Prior to being on those medications and getting the booster she did not have any problems.    When she gets a gout flare it affects her left ankle.    She still has the pain on the left side, is on a liquid diet and when she tries to eat it irritates her stomach.  She can tolerate salads, but otherwise has cramping.  Her lower back also hurts her as well.
fever, chills, severe pain in left arm and entire left upper side of body, including trunk and neck; headache, nausea
1.  Subactue large right MCA stroke. 2.  AKI 3.  Atrial fibrillation 4.  ARDS 5.  Multiple DVTs 6.  COVID-19 PNA on the ventilator  Currently very sick in ICU and still on the ventilator.
Metallic taste in mouth starting on 12/13; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Dec2021 (Lot number: unknown) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism/Hashimotos and "Hashimoto's disease" (unspecified if ongoing), notes: Hypothyroidism/Hashimotos. Concomitant medications included: TIROSINT; PROBIOTICS NOS; FISH OIL; ZINC and VITAMIN D. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: Right arm), administration date: 05Mar2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown, vaccine location: Left arm), administration date: 26Mar2021, when the patient was 31 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "Dose received: 3"; DYSGEUSIA (non-serious) with onset 13Dec2021 at 08:00, outcome "not recovered", described as "Metallic taste in mouth starting on 12/13". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
RIGTH ARM ITCHING AND BUMPS POST RECEIVING IMMUNIZATION. Benadryl IM GIVEN.
petechiae on breasts & right arm; bruises on breasts and now right arm; This spontaneous case was reported by a nurse and describes the occurrence of PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm). At the time of the report, PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had notice few bruises and petechiae on her breasts and right arm, it was 3 in the morning and went up to 5 afterwards. Patient was not on any blood thinner medications and did not remember bumping onto anything. No treatment medications were reported.  Company comment: This spontaneous case concerns a 34-year-old female patient with no medical history of reported, who experienced the unexpected non serious events of Petechiae (AESI) and Contusion after mRNA- 1273 vaccine. The event occurred approximately 3 days after the booster dose of mRNA- 1273 vaccine. The patient noticed few bruises and petechiae on her breasts and right arm. Very limited information is available regarding clinical course, diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient with no medical history of reported, who experienced the unexpected non serious events of Petechiae (AESI) and Contusion after mRNA- 1273 vaccine. The event occurred approximately 3 days after the booster dose of mRNA- 1273 vaccine. The patient noticed few bruises and petechiae on her breasts and right arm. Very limited information is available regarding clinical course, diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 53-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   This case was linked to MOD-2021-369083, MOD-2021-369095 (Patient Link).
About 5-10 minutes after receiving the vaccine, the pt complained of a slight headache and feeling dizzy. Her BP was 150/70, P 72 (prior to vaccine bp was 140/56, P 68) 5-10 minutes later she reported she was fine. She went and had lunch. About 1 1/2 hours after vaccine she had a syncope spell when driving and had a minor leg injury. She called me about 1 1/2 hour later and was advised to go to the ER, while there, she was given Nuban, which she had a reaction to and was then hospitalized. 10/31/06 Received medical records from hospital which reveal patient admitted 6/10/06-6/12/06.  Presented to ER after syncopal episode involving a minor car accident.  Given Nubain in ER for pain control where she developed AE.   PMH: hypothyroidism; HTN; hx of a fib; GERD; OA; DM; & osteoporosis.  S/P nephrectomy for renal cell ca, 1979.    Final Dx: syncope, no clear etiology. Cardiac arrhythmia cannot be r/o.  loop monitor to be done as outpatient; mild bradycardia; severe reaction to pain med, Nubain, w/N&V; developed rapid a fib s/p IV Nubain, & converted to NSR. Secondary Dx: hypothyroidism; HTN; PAT; GERD; OA; & osteoporosis./ss
Pain in the arm; Tingling; Numbness in the finger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
injection site reaction (swelling, hot, red/purple, knotting up), migraine, fever, throwing up, throat swelling, blood glucose of 800. pt was treated in the ER over a course of approximately 12 hours, then discharged
(L) arm where he received MENACTRA is red & swollen 3-4" in diameter. Itchy, hard.
Neon green loose stools 5-6x/day for 13 days following Rotavirus vaccine.
Child received Tdap on 3/1/07. Also Varicella and Hep A on the same day. Mother indicated on our questionnaire that child had reaction to Pin DTP at age two months. On 3/1/07 after receiving immunizations at our facility child started to run temp. Temp on 3/2/07 at 11 o'clock 103.
Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Now having diabetes issue; Two trips to ER in June with abnormal heart beat and breathing issues; Two trips to ER in June with abnormal heart beat and breathing issues; Having reactions to anything with sodium over 50mg.; Sea salt allergy went from mild to anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021(age at vaccination:44 Years) as single dose for covid-19 immunization. Patient didn't received other vaccination within 4 weeks prior to vaccination. Medical history included iodine allergy from an unknown date and unknown if ongoing, food allergy sea salt allergy from an unknown date and unknown if ongoing. Concomitant medications included testosterone (TESTOSTERONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested to COVID-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number EN6204) via an unspecified route of administration in Arm Right on 21APR2021 as single dose for covid-19 immunisation. It was reported that blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis. Trip to ER on 29May from Turkey with sea salt. Since then having reactions to anything with sodium over 50mg. Went on low sodium diet. Two trips to ER in June with abnormal heart beat and breathing issues. Now having diabetes issues. Doctors are puzzled that it all started with first Pfizer shot. Was given Benadryl shot with second Pfizer shot on 12May2021. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm. Patient went for Emergency room and physician office visits for the events. The outcome of the events anaphylactic reaction, diabetes mellitus, heart rate irregular, dyspnoea, hypertension, heart rate decreased, reaction to food additive was not recovered.  Information on the lot/batch number has been requested.
Tonic clonic movement of arms & legs 30sec, w/post-ictal period; This occurred x 2 @ 55 & 63 hrs post vax; Assoc tmep 102.3(ax); previous cough, rhinorrhea;
dizziness; severe musculoskeletal pain, especially upper and lower back pain; Arthritis in wrists, hands and feet; Severe inflammatory and auto-immune response; 20-point rise in Blood pressure; CRP is 6.7 (normal is under 3); This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 09:00 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunisation (Age at vaccination was 79-year-old). Medical history included HLaB27 gene and known allergies. Patient was not pregnant. Concomitant medication included other medication in two weeks. Historical vaccine included 1st dose of BNT162B2 on 15Feb2021 at 09:00 am (lot number: EM9809) on left arm for Covid-19 immunization at age of 79-year-old. Patient did not experience COVID prior vaccination. Patient experienced one month of dizziness (first month). 6 months to date of severe musculoskeletal pain, especially upper and lower back pain. Arthritis in wrists, hands and feet. Severe inflammatory and auto-immune response. CRP was 6.7 (normal was under 3). 20-point rise in blood pressure. At this point all symptoms appear chronic. Adverse event start date: 12Mar2021. Adverse event start time: 12:00 am. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment included occupational therapy. COVID tested post vaccination PCR: negative on 20Jul2021. Patient was not recovered from the events. This case was reported as serious with seriousness criteria: disability.
Intense contractions level cramping and back pain. Including, but not limited to ovulation and menses. Attributed to previously completely asymptomatic adenomyosis.  Disabling cramping and back pain continued intermittently more days than not for over 2- 2.5 months.
mom called @ 1SEP93 to report that pt devel hives & a red & swollen arm on 31AUG93 p/receiving vax on 30AUG93 in late PM (poss 5:00); pt was taken to ER PM & seen by MD & given med for reaction;