chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facility was informed that HCP, tested positive for COVID-19 today 9/10. HCP had called the hotline to report symptoms & schedule a test at 1400.  She had a rapid antigen test done this morning today at which resulted Positive. We are currently awaiting results from the drive thru site test. HCP is on quarantine and has been instructed to notify hotline with the results. HCP is a call in EKG Technologist. She was vaccinated on 12/22/20 & 1/11/21 (Pfizer). Last day of work was Monday, August 30.  HCP traveled with sister on 9/1 and returned on 9/9. They stayed with a friend who was exhibiting flu like symptoms during their stay. Her friend did not get tested, and just treated her symptoms at home.  HCP attended a concert on Sun. 9/5 and began exhibiting symptoms Mon. 9/6. Initial symptoms included a sore throat, runny nose, chills, fever (temp unknown, she ?felt warm?), body aches, and headache. States has lost her sense of smell and taste today and currently has a dry cough with congestion. She denies fatigue, dyspnea, chest pain, difficulty breathing, nausea, vomiting, abdominal pain, or diarrhea.  At work, HCP does wear a mask and eye protection for all patient encounters. HCP does eat alone on her breaks.  Other than her friend exhibiting flu like symptoms which was unconfirmed as Covid, she has had no contact with recent confirmed COVID positive in the community, staff, or patients. Other than the concert she has not engaged in any other gatherings. She goes to the gym occasionally and had last gone on the 28th/29th prior to her trip.  She does not work at any other jobs. HCP lives with her parents, brother, sister, and grandparents and states that she is able to quarantine safely with her own area. No household members are employees.  HCP does give consent to disclose her name for contact tracing purposes. However, since symptom onset was 9/6 and last day of work was 8/30, there is no further follow up needed.
Pt presented day 10 post vaccine with bruising and swelling of right D4 finger without history of trauma.  CBC/CMP drawn and pending. No joint involvement. No bruising elsewhere
Pt had fever, fatigue, site where vaccine admin. was red and warm to touch.  Pt felt bad in general.  Pt called concerned and was informed of how to treat reaction.
intense edema, pain & erythema limiting motion @ shoulder & elbow; urticarial lesions on forearm;
1/18/22 TEMP 100.6, OCC COUGH RAPID COVID 19 TEST POSITIVE. OUTBREAK ON DEMENTIA UNIT 1/20/22-New order cbc, BMP in AM, continue IV fluids as ordered. hold Remeron and Seroquel, Levaquin 750 mgdaily x 5 days, Regen-COV infusion.  Reviewed with guardian C. Oxendine and she is in agreement. 1/22/22 REGEN-V INFUSION ADMINISTERED CONTINUED IV HYDRATION UNTIL 1/23 HE REMOVED IV. BEGAN ACCEPTING FLUIDS PO. 1/22/22-New orders to start eliquis 5mg PO BID x2 months. Obtain US of BLE, and Obtain Chest CT to rule out PE. Above discussed with ADPOA who consents to new orders with the exception of CT scan. 1/27/22 HOSPICE CONTACTED PER GUARDIAN REQUEST, DOES NOT WANT HIM HOSPITALIZED  N.O. HOSPICE EVAL AND ADMIT AND RESIDENT DECREASE IN SEROQUEL DOSE AND STARTED MSO4 FOR PAIN MANAGEMENT, RESTLESS, MOANING, AND GRIMACING. DECREASED PO INTAKE AND INCREASEED DIFFICULTY SWALLOWING. 1/29/21 OFF COVID DROPLET PRECAUTIONS AFTER 20 DAYS ISOLATION DUE TO ACUTE EXACERBATING CONDITIONS.  COMFORT MAINTAINED AND NO FURTHER LABS OR MEDICAL PROCEDURES. PASSED AWAY ON HOSPICE SERVICES WITH DAUGHTER AT BEDSIDE ON 1/31/22
Unsure if related. On April 10 had severe cramp/popping sensation and almost passed out. Was ok after but had mild cramping sensation sense and one day of mild spotting on 4/14. Awaiting to see PCP, about events.
Fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.4) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever of 101.4). At the time of the report, PYREXIA (Fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.4 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.   Reporter did not allow further contact
This literature marketed report has been received from the authors of a published literature article and refers to 2 elderly patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical history provided. Concurrent conditions included hospitalization. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided for both) for prevention of pneumococcal diseases. The patients had less than 12 months elapse following a pneumococcal 13v conj vaccine (CRM197) dose (inappropriate time between vaccines). This is one of three reports received from the same authors.; Sender's Comments: US-009507513-1902USA011509: US-009507513-1903USA004221:
Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received Engerix B adult 20 ml and Engerix B Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter consented to follow-up. This case is for 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix B (20 mcg/ml) in right deltoid, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022191314:Same reporter
Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mouth, and inability to catch a deep breath. Patient laid down to rest, had vitals checked. Patient was moved to a sitting position after 10 minutes, and stated that she felt better. She was given some water and monitored for another 10 minutes. Vital signs were rechecked and she was released.
pain in back/body/legs, stomach pain, headaches, prominent diarrhea with bleeding, fever (102.7 F).
Pfizer-BioNTech COVID-19 Vaccine Emergency Department Visit 12/23/2020:  34 y.o. male received a Covid vaccine approximately 1430, shortly afterwards felt a flushed sensation, generalized weakness, a little lightheaded.  Rapid response team called to vaccination clinic, patient observed for 45 min there. Had another wave sensation of lightheadedness and flushing while driving home.  No rash no itching no shortness of breath no tightness in his throat.  He feels fine at this time.  He has had some similar reaction with previous vaccination back in 2018. No pertinent medical history, all vital signs normal, no orthostasis, patient dismissed.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The patient had first Shingrix shot 4 days ago. The patient had experienced fever of 101 degree Celcius for 2 days, better on day 3. Fever back on day 4 and having 101.2 degree Celcius fever on the day of reporting.
Patient was given second booster for COVID vaccine, and about 5 minutes after vaccine administration she complained of feeling dizziness/headache/lightheadedness . Patient's BP was taken and it was at 126/59. Injection site looked appeared normal. patient did not faint, and was monitored, and felt ok to leave after monitoring.
shortness of breath; stabbing pain; rash all over body; headache; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache) and MYALGIA (muscle pain) 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.     Concurrent medical conditions included Fibromyalgia.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Burning/hot at site of vaccination. Grew to the size of a baseball/hard/hot. Rash developed on (L) arm to elbow then next am rash across torso. Progressed to other arm lasted 1 wk - started w/cough/chills 3 days. later - BENADRYL helped/cortisone cream.
I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.
Extreme stomach pain within 12 hours of vaccination, nausea, longer-lasting dull/achy stomach pain for two days at this point, but improving slowly.
Information has been received from a HCP concerning 1 15 month old white "well" female who on 23-AUG-2001 was vaccinated with the third dose of Comvax administered IM in the left leg. Concomitant therapy included Prevnar administered in the right leg, DTP administere in the left leg and IPV administered in the right leg. the following morning, on 24-AUG-2001, the pt woke up with hives from head to toe on the left side of her body. The pt's mother called the Pediatrician's office and reported starting Benadryl. Subsequently, the pt recovered. It was noted that the pt received the  three doses of Comvax at 2 months, 4 months and 12 months of age. No further information is available.
Fever  Muscle and jaw pain Chills Swollen arm Rashes Headache  Body aches  Swollen lymph nodes  Stiffness of neck and shoulders  Vomiting
within 24 hours developed usual side effects experienced with previous vaccines - chills, low grade temp (99 - 100), muscle and joint aches, fatigue.  Symptoms worsened over next 2 days - temp 100.1, extreme fatigue, cough, nasal congestion, sore throat.  On 4/24 I did a home covid test and it was positive.
Patient received 2 doses of Fluzone HD on 9/8/22 and 11/17/22
Booster number 2 given along with Prevnar 20 in left arm on 4-04-2022. Much redness and swelling and pain for a week on left arm. Shingles began on my face 10 days later on my left side. I have had both Shingrix vaccines in 2018. After my first booster 10-15-21, about a month later I had shingles appear on my rectum, but I thought this was a fluke as it was several weeks later. I went to urgent care on Saturday 04/16/2022 and was diagnosed with shingles. I was prescribed and began one gram of ValACYclovir 3 times daily for 7 days. It is beginning to resove finally. I also have taken a 500mg tablet of Aalocyclovir for about 2 years due to recurrent oral fever blisters.
Fever, sleepiness, lack of appetite, crankiness, rash. Lots of sleep, Motrin, Tylenol round the clock for 3 days.
I saw an ENT today. April 21, 2021. He is ordering an MRI to see if there is a physical cause for the ringing in my right ear only. . I had an audiological evaluation on March 25. They advised me to see an ENT.
After I got the 1st Covid shot I was sick for 3 weeks then I got the second shot an became deathly sick the next day. I thought I had the flu or Covid. I stayed in bed till October 31 2021 an my boy friend called a ambulance. I was diagnosed with congestive heart failure and I'd never had heart problems in my life. I had to undergo open heart surgery on dec 22 21 for mitral arota vale replacement valve repair
VOMITING; SHAKY; CHILLS; HEADACHE; FEVER; NAUSEA; PAIN AT INJECTION SITE; FAINTING; LOW BLOOD PRESSURE; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on 11-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fainting. On 11-MAR-2021, the patient experienced low blood pressure and pain at injection site. On 12-MAR-2021, the patient experienced vomiting, shaky, chills, headache, fever and nausea. It was reported that, the patient had bad reaction within few minutes after receiving the vaccine low blood pressure and fainting. Later, the patient was taken into stretcher, monitored vitals onsite and 45 minutes later, she drove home. The patient felt ok last night. At the time of this report, the patient was shaky, had chills, fever, nausea, vomiting, headache and injection site pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, and low blood pressure on MAR-2021, was recovering from shaky, chills, nausea, and vomiting, had not recovered from headache, and pain at injection site, and the outcome of fever was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 12-MAR-2021. Upon review, the following information was amended:  Vaccination site (left deltoid) was added into the narrative and causality statement was removed.; Sender's Comments: V1: Version created to amend vaccination site and remove causality statement in narrative. 20210325938-JANSSEN COVID-19 VACCINE-Fainting and Low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Sep2022. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Macrobid, reaction(s): "known allergies: Macrobid"; Septra, reaction(s): "known allergies: Septra". Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 11Jul2023, when the patient was 72-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
nausea/severe fatigue/chills/arthralgias/ subjective fever onset 16 hrs post vaccine administration  Supraclavicular lymph node swelling  (3cm x 5cm) on vaccination side of neck onset at  30hrs post vaccine adm. Supracavicular lymph node swelling  (3cm x 3cm) on opposite side of vaccine at neck onset at  52hrs post vac administration.  Symptoms ongoing at time of this report at 54 hrs post receipt of vaccine.
Vivid dreams; Muscle ache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams), MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ABNORMAL DREAMS (Vivid dreams), MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache). On 23-Nov-2021, MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, ABNORMAL DREAMS (Vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
I started getting symptoms of fever, muscle aches, headaches, congestion, cough, and exhaustion. Rapid test was negative but my husband got a positive test. I went and got a PCR test the next day that was positive. My symptoms lasted for approximately 4 days. I did a telehealth visit and got a prescription for an inhaler to help with cough.
Had immunization yesterday in La arm and woke today with red, warm, swollen area approximately 4x4inches which increased to 16cm x 13cm by afternoon when I examined her.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
About 36 hours after vaccine was administered pt had a suspected seizure which included shaking of arms and legs and eyes rolled back.  Lasted about 1 minute.  Pt had complained of leg muscle pain before symptoms started.  Taken to ER right after.  No previous history of seizure.
This patient was admitted to Hospital on 1/16/2022 for COVID related symptoms. This is considered a breakthrough case.
her back bone is so pain; pain in her bones and muscles; she doesn't have energy to complete a report, she is so tired; pain in her bones and muscles; she has got strong reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "her back bone is so pain"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "pain in her bones and muscles"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "she doesn't have energy to complete a report, she is so tired"; VACCINATION COMPLICATION (non-serious) with onset Apr2021, outcome "unknown", described as "she has got strong reactions".  Additional information: Patient said she got the first shot of Pfizer COVID-19 vaccine last Friday so today had been 5 days. She said she had got strong reactions. She said her backbone was so pain, she had pain in her bones and muscles, and she was so tired. She said she wanted to make sure it was ok for her appointment for second shot which was 23Apr2021. She said she was afraid because someone tell her that the second shot was stronger for side effects, and with her back pain she could not move to get off the bed, she had to move to side and hold by arms to get up. She said why, most people did not feel that this strong. She said she did not have energy to complete a report, she was so tired, she wanted to talk to someone to help her, it could be dangerous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.