chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Abdominal pain; Can't even get out of bed; Severe headache; Temperature of 101.2 to 103.4.; Puking for 2 days; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Can't even get out of bed), HEADACHE (Severe headache) and PYREXIA (Temperature of 101.2 to 103.4.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Can't even get out of bed), HEADACHE (Severe headache), PYREXIA (Temperature of 101.2 to 103.4.), VOMITING (Puking for 2 days) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Can't even get out of bed), HEADACHE (Severe headache), PYREXIA (Temperature of 101.2 to 103.4.), VOMITING (Puking for 2 days) and NAUSEA (Nausea) outcome was unknown.      Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous prospective pregnancy report was received from a nurse and refers to a 40 year old female patient. The patient had no drug reactions or allergies. No information about the patient's pertinent medical history and concomitant medications was provided. On an unknown date, the patient became pregnant with the unknown last menstrual period (LMP), estimated date of delivery (EDD) and gestation period. On 24-APR-2018, the patient was inadvertently vaccinated with unspecified dose of GARDASIL 9 intramuscularly, lot # N026812, expiration date 22-JUN-2020 (exact dose was not reported) instead of DTaP, while being pregnant. No adverse effects were noted. No information about trimester of exposure and prenatal tests or results was provided. No treatment was given for the events and no laboratory diagnostics or studies were performed. The events did not cause any significant disability or incapacity. The patient was not hospitalized and the events were not life threatening. At the time of the report, the outcome of pregnancy and fetal outcome were unknown.
Arm pain; temperature excursion that occurred on 17 /JUL/2021, 18/JUL/2021, and 19/JUL/2021. PROQUAD and V ARlV AX were both administered to the patient on 19/JUL/2021.; This spontaneous report as received from a certified medical assistant refers to a 4-year-old female patient. The patient's concurrent condition, concomitant medication and medical history were not provided.      On 19-JUL-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) "1 time dose", lot # T035399 was confirmed to be valid, expiration date 16-OCT-2022 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) "1 time dose", lot # T010650 was confirmed to be valid, expiration date 26-MAR-2022 (dose, route of administration, vaccination site were not specified for any of them); both for prophylaxis. On the same date, she received diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) lot # reported as 5RM39, expiration date 25-NOV-2022 in the right arm and polio vaccine inact (IPV) lot # reported as TID448IM, expiration date 22-JUL-2022 in the left arm (dose, route of administration were not specified for any of them); both for prophylaxis. The administered doses underwent a temperature excursion of 55.4 degrees Fahrenheit for 33 hours. There were no previous temperature excursions. Digital data logger was involved. On 19-JUL-2021 the patient experienced pain in arm. The outcome of the event was unknown.  The relatedness between the event and the suspect vaccines was not provided.
Patient with near syncope, provided juice, ice pack and rest, continued to feel dizzy, moved to the cot to lay down, then a syncope episode occurred, Medics on site, transfer to local Emergency Department via squad.  Vital Signs: B/P 120/73 P: 103 R: 18 Pulse ox: 100%
Multi-dose vial of Pfizer Covid Bivalent vaccination was removed from refrigeration and opened at 0815 on 01/24/23. Dose administered from that vial at 10:15 on 01/25/23.
Head and nasal congestion and swelling 1-2 days after all 3 AVA vaccinations lasting 2-3 weeks.
TREMOR/SHAKING IN BOTH HANDS; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (TREMOR/SHAKING IN BOTH HANDS) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (TREMOR/SHAKING IN BOTH HANDS). At the time of the report, TREMOR (TREMOR/SHAKING IN BOTH HANDS) had not resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of TREMOR/SHAKING IN BOTH HANDS with RINVOQ(UPADACITINIB) was a reasonable possibility No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Stroke; Bleeding; A spontaneous report was received from consumer concerning female patient of unknown age who developed stroke/cerebrovascular accident, bleeding/haemorrhage.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received their unknown dose of two planned doses of mRNA-1273 (Batch number: unknown) 26 Feb 2021 at unknown injection site for prophylaxis of COVID-19 infection.   On 28 Feb 2021 the patient experienced stroke and bleeding. The medically significant event are stroke and bleeding. Treatment for the events were not reported.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events stroke and bleeding were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
About 2 hours after the shot I started getting really bad lower back pain and I had zero back pain before getting the shot. It was a throbbing pounding pain right in the center of my lower back.  It lasted for almost 2 weeks and I had to use the heating pad at night and then those disposable heat wraps.
This case was reported by a pharmacist and described the occurrence of injection site rash in a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7329G, expiry date 30th June 2015). Previously administered products included flu vaccine (no reactions at previous vaccination). Concomitant products included PNEUMOVAX. On 1st November 2014, the patient received FLUARIX QUADRIVALENT (injection). On 2nd November 2014, less than 24 hours after receiving FLUARIX QUADRIVALENT, the patient experienced injection site rash, fever, chills and general body pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, fever, chills and general body pain were recovering/resolving. The reporter considered the injection site rash, fever, chills and general body pain to be probably related to FLUARIX QUADRIVALENT. Additional information received: RPh called to report that their patient received FLUARIX QIV on 11/1/2014 and less than 24 hours later developed fever, chills, body ache, and "apple" sized rash at the injection site. The patient received FLUARIX QIV on the right arm and the rash is also at that injection site on the right arm. The patient also received PNEUMOVAX on that day as well this was given in the left arm. After the onset of symptoms the patient took ibuprofen and the symptoms have improved but has not completely resolved.
Myalgia, Fever, NECK PAIN Narrative:  HAD TO LEAVE WORK
Information has been received from a registered nurse who was also the patient's mother concerning a 44 day old male patient who on 25-MAR-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot number 662825/1168X). Concomitant therapy included PEDIARIX (lot number AC21B208AA), ACTHIB (lot number UF614AB) and PREVNAR (lot number 037016). On 26-MAR-2009 the patient was pulling up his legs and screaming in pain. The patient experienced pain on his stomach that lasted for about 3 days. On 28-MAR-2009 the patient had 3 stools with specks of blood. The stools had the same consistency. The stools were not tested for blood. The stools with specks of blood were present for one day only and the patient recovered. The registered nurse reported that the patient will not continue with the ROTATEQ series because the patient was very sensitive. Upon internal review, blood in stool was determined to be an other important medical event. Additional information is not expected.
On 4/10/2023, patient presented to the emergency department at local Community Hospital for shortness of breath. Patient had had onset of COVID-like symptoms on 4/9/2023; She was given a COVID-19 NAA test, and it resulted positive. While receiving care in the emergency room, patient's condition deteriorated; Her EKG indicated ST-Segment Elevation Myocardial Infarction, so she was transferred via ambulance to alternate Hospital for additional treatment. During the transfer, patient had respiratory arrest and lost pulses, so chest compressions were started by EMS. Further resuscitation efforts were made upon arrival to in the emergency department at Hospital. Patient's condition did not improve, and she died on 4/11/2023 in the hospital emergency department. Her primary diagnosis was Cardiac Arrest with additional diagnoses of COVID-19 and Acute hypoxemic respiratory failure due to COVID-19.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the hospital emergency departments.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX on 31-OCT-2012 with and expire date of 09APR2012. No other co-suspects were reported. On 31-OCT-2012 the patient experienced expired drug used. No treatment information was reported. No adverse effects were reported. Expired drug used is not related to ZOSTAVAX. Additional information has been requested.
Information was received from a pharmacist regarding a 61 year old female patient with an allergy to sulfa and ramipril. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (lot # K011003, expiration date November 2015) in an unspecified arm. On an unspecified date in December 2014, the patient experienced a localized injection site reaction, described as a 5 inches by 4 inches raised red infected area in the arm. The pharmacist also reported the injection site reaction was swollen and itchy. The patient visited her physician (no treatment reported). The outcome of the localized injection site reaction/raised red infected area, swollen, itchy was reported as not recovered. No further information is provided. Additional information has been requested.
This spontaneous report was received from a pharmacist via Pfizer refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient had an allergic reaction to PNEUMOVAX 23. The reporter enquired if the patient will have an allergic reaction to PREVNAR 13. The outcome of the event was unknown. Additional information has been requested.
Janssen COVID-19 Vaccine EUA  Strong fatigue, brain fog, pain throughout body, strong flare up of fibromyalgia symptoms.
The patient is post menopause and ten days after receiving the second dose of the Moderna COVID-19 vaccine, she started a menstrual cycle with heavy flow. Up to the current date the bleeding has not stopped.
Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL. Subsequently, the patient learned that she is pregnant. The pregnancy was confirmed by a pregnancy test. Concomitant therapy included injection with the first dose of VARIVAX on 16-NOV-2007. Other concomitant therapy included HAVRIX and MENACTRA. No adverse side effects were reported as a result of this exposure. The patient sought unspecified medical attention. Follow up information was received from the nurse via phone call. It was reported the baby was "fine", healthy and normal. The reporters now see the baby was well. The baby was born by C-section (Caesarean-section) with no complications but the reporter did not know the indication for the C-section. The baby weighed 7 lbs 9 oz and was 18 and a half inches long. Upon internal review, "the baby was born by C-section" was determined to be an other important medical event. No further information was available.
My husband got shingles in November 2021 around his left ear, neck and upper chest
This case was reported by a other health professional via call center representative and described the occurrence of eye allergy in a patient who received FLULAVAL QUADRIVLENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced eye allergy. On an unknown date, the outcome of the eye allergy was unknown. It was unknown if the reporter considered the eye allergy to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The pharmacy technician called to report that the patient was given a GSK Flu Quadrivalent (did not get which one) vaccine that was allergic to Thimerosal, which caused a reaction to her eyes,. The reporter placed the call on hold before getting additional information. He called back again, but was told to call back in 10 minutes. After 10 minutes, again the reporter was called back and was told it was a very long wait.
Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of COMVAX (lot # J002621, expiration date 29-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Dizziness at 230pm, subsided by 7pm 02/19/2021 12 midnight chills, subsided by 10am 02/20/2021 Body aches, throbbing pain in finger joints, subsided by 4pm 02/20/2021
a 53 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 016B21A on 3/30/2021. The patient experienced the following reaction(s) during the immediate   of observation: 2:20pm Patient c/o feeling "hot flashes" in observation. Ice pack provided. Patient wheelchaired to treatment area. Patient was treated/managed as follows:   2:24pm VS BP 140/80, HR 76, RR 18, O2 sat 99% on room air. Patient reports symptoms subsiding. 2:34pm VS BP 128/78, HR 74, RR 18, O2 sat 99% on room air. Patient reports feeling better and symptoms resolved. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 2:38pm Patient escorted to car by RN.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 28-AUG-2013 the patient was vaccinated with a 0.5 ml dose of expired PNEUMOVAX23 (lot # 1071AA, expired on 20-MAR-2013) (route not reported). No adverse effect reported. This is one of several reports received from the same source. It was linked to MARRS#1309USA004457. Additional information has been requested.
Screaming, inconsolable crying and fever. Doctors office and ER both said was normal reaction. To give Tylenol and Motrin.
Fatigue, headache, chills, body aches sleeplessness, dehydration.
Tightness in the throat , Numbness in fingers. tingling on the lips and tongue symptoms were gone in a matter of 30 minutes no treatment.
NOT FEELING WELL; FATIGUE/SYMPTOMS OF FATIGUE; ENERGY LEVEL LIMIT DAILY ACTIVITIES; ENERGY LEVEL LIMIT DAILY ACTIVITIES; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant neoplasm of prostate, and other pre-existing medical conditions included: The patient had not symptoms of hand and foot syndrome. The patient previously received first dose of non-company suspect vaccine covid-19 vaccine (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: enzalutamide (tablet, oral, batch number: EW4300 expiry: 31-MAY-2024) 160 mg, 1 time every 1 day, from JUL-2021 for malignant neoplasm of prostate. No concomitant medications were reported. On an unspecified date, the patient received second dose of covid-19 vaccine (dose number in series 2) (unspecified manufacturer) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, the patient experienced moderate fatigue/symptoms of fatigue (reported as level 2 out of 10) but energy level did not limit daily activities. The patient did not feel better after resting. On an unspecified date, patient rated 6 out of 10 for his fatigue, felt better after resting and energy levels did limit daily activities (loss of personal independence in daily activities and asthenia) (dose number in series 1). It was unknown if physician was aware of the events. The enzalutamide was temporarily stopped for a week and later restarted on 1 tablet daily. The patient later received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, following administration with covid-19 vaccine ad26.cov2.s, the patient was not feeling well for a while (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with enzalutamide was withdrawn. The outcome of the fatigue/symptoms of fatigue, energy level limit daily activities and not feeling well was not reported. This report was non-serious.
Donor described nausea approx. 1/2 hrs after 1st immunization. Donor described stomach pain, light headiness, chills, nausea and vomiting with headache and malaise approx. 1-2 hrs after 10/21/05 immunization. Symptoms lasted for approx 5 hrs
The patient was given 0.2 mL of an undiluted pediatric COVID vaccine. It was discovered that the vial had not been diluted when a different pharmacist went to pull a dose for a different patient and thought the amount of liquid seemed small given the number of shots given that day. Upon investigating, it was confirmed that the morning pharmacist who pulled the dose had not diluted/mixed the vaccine prior to withdrawing the 0.2 mL. It was administered by a technician after the morning pharmacist pulled the dose and checked the Vaccine Administration Record. The patient's mother was notified of the error and given recommendation on what to monitor for. Upon her request, Dr. (the doctor on call) was spoken to regarding the error. The patient has not had any symptoms as of yet. Dr. recommended monitoring for side effects including local site reactions, fatigue, fever, blood flow through the limbs and treating as they come  up. Dr. stated that she would follow up with the mother and it was later confirmed that she had received that call.
at the time receiving the vaccine she felt a pain shoot up to her neck, days after she had body pain, fever, chills and tiredness which went away 2 to 3 days later. loss of focus had to quit her job. increasing headache took bc powder to cope. last week had low grade fever and high heart rate. tongue became swollen and high fever started again along with chills. went to urgent care. went to hosptial after urgent care sent her home her head was hurting bad to where she couldn't see.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases; "other autoimmune diseases" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "severe generalized burning type pain", "pruritis in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "had minimal symptoms with the 2nd, 3rd and 4th doses". Therapeutic measures were taken as a result of pain, pruritus.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.;
1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus  3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine  5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!