chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had a positive COVID test on 5/23/22 at SNF; was transported to Hospital for hypotension and leukocytosis; admitted and treated for hypotension and leukocytosis with ABX and vasopressors; peritoneal catheter placed with improvement; later, pt c/o dyspnea and was transferred to another Hospital for further evaluation and treatment; given O2 via NC; required multiple transfusions due to blood loss from colon CA; CT revealed metastatic colon CA with carcinomatosis; C. difficile, treated with ABX; dexamethasone and Baricitinib given for COVID; pt's condition declined; family decided on inpatient hospice, but pt expired prior to hospice
Body allergy, itching, fever, vomiting (1), diarrhea (1).
Patient received High Dose Flu at 6pm 10/24/11 and by 1:00am he had severe chills, labored breathing and was very pale and complained of general malaise. By 3am was completely resolved.
RIGHT CALF PAIN/CRAMPS; FEVER; HEADACHES; INJECTION SITE SORENESS; FEELING OUT OF BREATH AFTER SOME WORK/EXERTION; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced feeling out of breath after some work/exertion. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headaches. On 07-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced right calf pain/cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches, headaches, right calf pain/cramps, injection site soreness and feeling out of breath after some work/exertion was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
had hives on one side of her body (left) within 24 hours then on both thighs and down; This spontaneous case was reported by a consumer and describes the occurrence of   in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      on 14Jan2021 she reports hives on her right thigh and down.
A non-serious spontaneous report of patient inadvertently received a full dose of H1N1 LAIV in one nostril was received from a pharmacist/health professional concerning a 22-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error therefore treatment and reporter causality assessments were not applicable and the event was considered as resolved.
fever of 105.4 on 14OCT, 15OCT flu0like sx;14OCT-21OCT97 was irritable & jerking when fever was high0not sure if it was sz activity-sometimes lethargic;
On day 10 after injection painful allergic rash which started oozing 3 days later. Initially on arm, spread to other limbs and back.
Vaccine administered beyond use date; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 34 year 3 month.   No concomitant medications were reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before.  It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine.  No treatment medications were reported.
APPROX 4X4IN AREA OF EDEMA ERYTHEMA AND WARMTH TO LEFT UPPER OUTER THIGH NOTICED TODAY BY MOM AND PRESENTED TO OFFICE.  DX WITH MILD CELLULITIS AND TREATED WITH CLINDAMYCIN 30MG/KG TID.
Pt is a 39 Y with no significant past medical history came to the emergency department with above complaints. Patient reported that she felt her left upper extremity and lower extremity numbness on Tuesday at 5:30 AM, felt like her arm and leg were asleep.  Patient denied any fevers, nausea, vomiting, headaches, confusion, sick contacts She went to ED that day and got a head CT which showed:Multiple bilateral white matter hypodensities, left more than the right side, involving the left frontal, temporal and parietal and right frontal white matter with minimal surrounding edema are noted. Neurology was consulted and patient was sent to ED for an MRI which showed-Numerous intracranial metastatic lesions.   Oncology was consulted and patient was called back for a whole-body CT scan which is negative. Neurology today recommended getting lumbar puncture, which showed CSF WBC of 13, glucose 85, protein 46, lymphocytes 95   ID was consulted who recommended starting patient on Rocephin, vancomycin   Patient being admitted for IV antibiotics. If CSF serology comes back negative patient will need to be transferred to neurosurgery for a brain biopsy
12 hours after vaccination: debilitating body aches, fever, chills. Fever subsided day 3. Nausea Day 2 to present, though severity is decreasing. Periodic headache: day 2 to present. Fatigue: extreme and debilitating until day 7. Hyper sensory awareness:day 3-4. Senses affected were sight, hearing, touch, and smell. Missed 5 days work.
Our daughter received a series of HPV shots and on Dec. 17, 2012 her legs went numb at school. She was doing jumping jacks and then all the sudden couldn't feel her legs or feet. As she received the series of three shots her condition worsened; numbness on right side of face, jerking movement of left arm for seven hours. The series of shots started in October 2012 and continued until April/May 2013. She is in physical therapy currently to help use her legs but she still is numb and has muscle weakness. From time to time she gets headaches and pain in one of her ears. She uses a walker at home and wheelchair/walker at school. She is also unable to tell when she needs to use the bathroom so we have her go on a schedule and have used diapers as well. She is thirteen years old.
Complained of feeling pale, lightheaded, sweaty, "normal for him after getting a shot."  Vital signs obtained every 15 minutes for 30 minutes and were normal. Laid him on  cot, monitored VS, gave powerade drink and granola bar. After 15 minutes had patient sit up from supine position. Rechecked vital signs. Had him continue to sit up and then rechecked VS in another 15 minutes.  Disposition: Pt feeling well, denies any dizziness or sweating. Vital signs stable. Pt relaxed and discharged to home from post vaccination waiting area.
CAN'T BREATHE; FELT LIKE NECK WAS TIGHT AS SOMEONE WAS STRANGLING; CHEST HURTS ON THE LEFT HAND SIDE; WEAKENED LEFT LEG; FEVER; DIFFICULTY SWALLOWING; COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2O7A21A expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced cold, difficulty swallowing, and fever. On an unspecified date, the patient experienced can't breathe, felt like neck was tight as someone was strangling, chest hurts on the left hand side, and weakened left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, and the outcome of cold, can't breathe, weakened left leg, felt like neck was tight as someone was strangling, chest hurts on the left hand side and fever was not reported. This report was non-serious.
Patient described reaction as chills, alternating hot and cold sensation, fever (unknown - patient did not measure), muscle pain (especially calves and thighs), felt like "lying on bed of pins and needles," eyes watering and burning, sweating.  Patient reported this to the dispensing clinic in AM on 10/27/10 and saw her Primary Care Provider 10/27/10 at 2:30 PM.  She stated no treatment was received.  She was told by her PCP she could return to work when she felt better.  She returned to the clinic on 10/28/10 feeling "85%" and ready to work.  "Slight" muscle aches, headache" were still present.
Patient had complaint of itching no redness no edema, left arm. Vital signs stable, Temp 97.9 R 20  O2 sat 100 P 59.
This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029K20A and 011J20A) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication. It was reported that patient is not pyretic. The patient's past medical history included Dementia (History of early dementia). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions). At the time of the report, DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient experienced two episodes, which were the same occurring after the 3rd and 4th doses of the vaccine and received flu vaccine simultaneously with the 3rd dose of the vaccine. No medications or treatments have been provided for patient current symptoms. This case was linked to MOD-2022-532977 (Patient Link).
Pain in left arm (injection site); Pain in left arm (injection site); Mild headache that lingered most of the day (16 hours or so); Mild headache that lingered most of the day (16 hours or so) along with tiredness; Lack of energy; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm left on 03Apr2021 at 14:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration the left arm on 13Mar2021 at 17:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient woke up on the morning with pain in left arm (injection site), mild headache that lingered most of the day (16 hours or so) along with tiredness and lack of energy. The symptoms were gone by the next day. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events pain in left arm (injection site), mild headache, tiredness and lack of energy were recovered on the 05Apr2021.   No follow-up attempts are possible. No further information is expected.
Pt devel low grade fever, pain, & a large area of erythema, swelling & induration @ inject site p/receiving Typhoid vax;
Significant body aches; Dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 23Oct2023 as dose number unknown, single. Past drug history included: Epinephrine, reaction(s): "Drug allergies: Epinephrine". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering"; PAIN (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering", described as "Significant body aches"; FATIGUE (non-serious) with onset 01Nov2023 at 03:00, outcome "recovering". It was unknown if therapeutic measures were taken as a result of pain, dizziness, fatigue.  Additional information: Significant body aches within 24 hrs. Dizziness and fatigue has persisted 7 days later.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of tinnitus-bilateral in a 63-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject had not previously received any flu shots. The subject's medical history included breast cancer. In 1975, the subject declined Td (tetanus and diphtheria vaccine) due to known reaction. "PPD" in August 2007 and was negative on 14 October 2008. Concurrent medications included FOSAMAX, PAXIL, FEMARA and XANAX. On 16 October 2008 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 17 October 2008, 24 hours after vaccination with FLUARIX, the subject experienced tinnitus-bilateral. The physician's assistant reported that the subject developed the tinnitus greater in the left ear than the right ear and it was more annoying at night when things are quiet. At the time of reporting the events was unresolved. Follow-up information received on 13 February 2009 indicated that the event was still unresolved as of 27 January 2009. In the reporter's opinion, the event was possibly related to treatment with FLUARIX.
Information has been received from a medical assistant and a physician who reported that a female consumer, age unknown, started RECOMBIVAX HB on 07-Jan-2009 for unknown indication. The patient's relevant medical history, relevant concomitant medications and relevant past drug history was unknown. On 08-JAN-2009 the patient experienced a rash around her trunk area. It was unknown if there was any relevant laboratory data. As of 12-Jan-2009, the patient continued to experience having a rash around her trunk area. It was unknown if she continued to take the RECOMBIVAX HB.  Additional information has been requested.
Swelling, heat, tenderness of right thigh lasting 5 days. Subcut nodule (about 1 cm) remains.
some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Hypertension (more than 10 years in treatment). Concomitant products included OLMESARTAN MEDOXOMIL (FLUXOCOR [OLMESARTAN MEDOXOMIL]) for Hypertension.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, 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 experienced PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.). The patient was treated with BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL (DAIVOBET [BETAMETHASONE DIPROPIONATE;CALCIPOTRIOL]) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PSORIASIS (some spots of psoriasis in June/the end of year 2021 psoriasis getting worse and worse. He has 30% of his leg covered, and his arms. "It is growing hard, whole leg covered and arms.) had not resolved.            Patient stated in June 2021, he did his annual check up and also went to the dermatologist. At that point he had some spots of psoriasis and they went away with the usual treatment: an ointment. Patient has used this ointment to treat his psoriasis before the vaccine and it had always worked. Towards the end of the year 2021, that psoriasis is getting worse and worse. The treatment is not working. Patient says that the ointment, it usually lasts for a whole year before he buys another one. He states that the ointment he bought in June 2021 is already all used up, that is the extent of his psoriasis.
This spontaneous report has been received from a pharmacist referring to unspecified patients of unknown ages and genders. Medical history and concurrent conditions were not provided. On an unknown date, the unspecified patients were vaccinated with two doses of improperly stored of VARIVAX (Merck) (lot # L029466 expiration date on 06-Aug-2017) (lot # reported as L030160 expiration date 11-AUG-2017) (Lot # L027287 expiration date 21-JUL-2017) (Lot # L019124 expiration date 27-MAY-2017) (strength, dose and frequency were not provided). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
It's a little bit warm to the touch; it itches but not painful; Swelling of about 3 inches long at the injection site; hard swelling of about 3 inches long on the COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's a little bit warm to the touch), VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm), VACCINATION SITE PRURITUS (it itches but not painful) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol total abnormal NOS and Blood triglycerides abnormal. Concomitant products included VALSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN for Cholesterol, FENOFIBRATE for Triglycerides abnormal.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's a little bit warm to the touch) and VACCINATION SITE PRURITUS (it itches but not painful). On 28-Jan-2021, VACCINATION SITE INDURATION (hard swelling of about 3 inches long on the COVID arm) and VACCINATION SITE SWELLING (Swelling of about 3 inches long at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's a little bit warm to the touch) and VACCINATION SITE PRURITUS (it itches but not painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used ice pack as a corrective for swelling.   This case was linked to MOD-2021-214969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome updated. On 09-Jun-2021: Dosing and event details updated.
pt recvd vax & exp allergic react rt arm-FU; pt states slept a lot; some warmth; pt noticed some redness around rt elbow w/swelling & ince warmth; exp some abdo pain & chills; bowel movements watery x 6; poss cellulitis vx urticarial;
within 5 minutes flushing feeling of overall heat throughout body nausea headache throat tightness left arm below injection site tingling, numb elevated blood pressure