chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; sick; nausea; bruise on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 [booster], single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "fatigue"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nausea"; CONTUSION (non-serious) with onset 2022, outcome "recovered", described as "bruise on her arm".  Additional information: Reporter reported that She called on behalf of her 23 years old daughter. She stated her daughter received the booster dose of the COMIRNATY vaccine in earlier Jan2022. Caller stated her daughter felt so sick and has nausea and fatigue even 3 weeks after receiving the booster dose. She mentioned her daughter also experience these type of side effects after receiving the Flu vaccine. She asked if there was any information regarding nausea and fatigue as side effects 3 weeks after receiving the booster dose. She stated her daughter also presented a bruise on her arm were she received the dose, for about a week. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).And spoke from attached "Persons 18 Years and Older: Local reactions lasted between 1 and 2 days and systemic reactions lasted around 1 day. Swollen lymph nodes (lymphadenopathy) were also reported and generally resolved within 10 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-20-2008 - fever to 103, chills bone aches. 11-07-08 - fever to 101.7, aches, nausea, anorexia.  2/18/09 Received note from patient with symptoms, treatment & recovery status.  Had N/V, shaking chills, 18# weight loss.  Tx w/IVF x 1 L & dx w/serum sickness.  Total resolution of s/s by 11/30/2008.
c/o itching all over with intermittent red splotches all over body- intermittent bruising and cramping of thighs since recieving her 2nd covid vaccine. Also had Headache for 7days after each covid vaccine.
Cellulitis to bilateral thighs L > R. Erythematous, swelling and warm to touch left approximately 8x10, right 2x2.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, on 12Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received paxlovid from 28Jun2022 to 03Jul2022 for treatment of COVID-19. After completing paxlovid for COVID infection, 4 days without positive test, now positive again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse reaction) in a female patient of an unknown age 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 VACCINATION COMPLICATION (Had an adverse reaction). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
PATIENT RECEIVED THE INFLUENZA VACCINE IN 10/24/2013 AT 7:20 PM DURING A MASS VACCINATION. THE FAMILY REFERS THE PATIENT WENT TO SLEEP AND DURING THE MORNING OF 10/25/2013 THE PATIENT'S DAUGHTER FOUND HER DEAD IN HER BED. THE FAMILY INDICATES THAT THEY KNEW THE PATIENT HEART CONDITION HISTORY AND BELIEVE HER DEATH WAS A RESULT OF NATURAL CASUES, STILL A VAERS REPORT WAS CREATED DUE TO THE SHORT TIME BETWEEN THE VACCINATION AND HER TIME OF DEATH.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concomitant medications and pertinent medical history were not provided. On 08-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot #, dose, route and frequency were not provided), which was expired on 30-APR-2014. No adverse effect was reported. N product quality complaint (PQC). Additional information is not expected.
36hr p/vax child refused a feeding had staring episode w/stiffness 1hr then turned red & arched back stiff, foaming @ mouth;no fever;
Vaccine given in left arm 8/28/07. Fever of 103 within 24 hours, swelling 14x14cm area with erythema on the left arm. Interventions Benadryl and Tylenol - swelling g x 5 days.
Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactable consumer (reporting on himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0167 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 19May2021 18:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included, vertigo from 2019 to an unknown date. The patient's concomitant medications were not reported. Patient did not have known allergies.  Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ek8735 or ER8735 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 24APR2021 04:00, as 1st dose, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 08:00, patient experienced dose 2. sore arm, headache and fatigue first 48 hours; vertigo and significant fatigue began at 48 hour point has continued for two days. Has a bout of vertigo around 2019 that lasted weeks. Patient did not received any treatment for adverse events. Since the vaccination, the patient has tested for COVID-19. The outcome of the events was not recovered.
Red itchy rash developed on arms, flush feeling. Went to ER shortly after and was given Benadryl and told it could have been a reaction to something in the vaccine.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient herself a other health professional via other manufacturer (Pfizer Inc) concerned a 52 year old female. Initial information was processed along with the additional information received on 26-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Name of drug not reported). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administartion, and batch number were not reported) dose was not reported, 1 total administered in right arm on 08-MAR-2021 at 12:00 for prophylactic vaccination. Age at time of vaccination 51 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient additionally received two doses of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (Dose number in series 2) ( form of admin, route of admin, and batch number were not reported) doses were not reported, administered in right arm on 22-OCT-2021 at 15:00 (first dose) and in right arm on 25-APR-2022 at 12:00 (second dose) for prophylactic vaccination.  The patient was prescribed with non-company suspect drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 05-MAY-2022 and last dose on 10-MAY-2022 for covid 19. On 16-MAY-2022 at 6:00, the patient experienced rebound symptoms and positive rapid test (suspected covid-19 infection) (Dose number in series 2) and (suspected clinical vaccination failure) (Dose number in series 1). On 19-MAY-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elasomeran was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232903.; Sender's Comments: V0: 20220551133- COVID-19 VACCINE Ad26.COV2.S- Suspected Clinical Vaccination failure. 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). Therefore, this event(s) is considered unassessable.
This case was reported by a physician and described the occurrence of not responding to therapy in a 61 year old male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included depression.  In 2003, the subject received Engerix B vaccination series.  On an unspecified date in 2007, approximately 4 years after vaccination with Engerix B vaccine, the subject experienced not responding to therapy.  Antibody titer was less than 5.  The vaccination series was repeated.  When the second dose of Engerix B was being administered, the medical assistant noticed blood in the needle and syringe upon withdrawal of the needle from the subject's arm.  A swollen area appeared at the injection site.  Two pediatric Engerix B vaccines were also used for one adult dose.  At the time of reporting the outcome of the events was unresolved.
Dizziness dizziness within 2 hrs; 1/5 dizzy, 1/6 seen in OHC 1/6 temp, body ache, fatigue, dizziness;out 1/6, 1/7, 1/8. sat 1/9 same sx, 1/10 dizzy, body ache, fatigue, "felt like crud" Mon 1/12 came to work, then went to OHC, was sent to ED, 1/12, 1/13 had fatigue, Narrative:  Emp was seen by OHC on 1/6 and 1/11; was sent to ED by OHC on 1/11. EKG done; employee not aware of any abnormalities. Flu and COVID tests neg done in ED. No meds taken for reaction; no IV in ED.
Patient came into the pharmacy on 4-6-18 to show me her arm, it was swollen the diameter of a softball. It was warm and itchy. She said the evening she received the shot she got a headache and nausea & vomiting. She took 2 doses of EXCEDRIN and did get some relief.
Skin on right anterior thigh with scattered pink, maculopapular eruptions. Few lesions on trunk and bilateral cheeks.
Within 1 week of receiving the 1st and 2nd Lymerix injection on 6/2/99 and 6/30/1999, the pt experienced knee and back pain. The most recent information received on 2/17/2000, indicates that the pain is reportedly "so bad that he cannot run and has a constant and dull ache in his knees". Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JUN-2013, the patient was inoculated  with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 28-JUN-2016, the patient was treated by a nurse practitioner (at a skin institute), for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer had also reported that the patient was inoculated with the ZOSTAVAX vaccine for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX vaccine and suffered serious physical, emotional and economic damages as a result of her shingles and associated injuries. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 60-year-old female who on 27-JUN-2007 was vaccinated with a 0.65 milliliter injection of ZOSTAVAX (Lot# was not provided). Concomitant therapy included methotrexate and prednisone (indication and total daily dose not provided). On 28-JUN-2007, a day after getting the vaccination, the patient experienced a rash on the face which was determined to be shingles. Unspecified medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information received on 02-Aug-2007 indicates that the patient did have a rash after getting the ZOSTAVAX, but it was determined later by the family physician that the patient did not have shingles. The patient was not given any antiviral medicine as treatment. Additional information is not expected.
The same day the immunizations were given, mom reports daughter had fever with eyes crossed to midline, pursed lips, funny breathing, decreased responsiveness on and off 30 minutes. A follow up report received 10/23/2003 adds: Please add decreased level of consciousness (somnolence). Meds include Tylenol and Rocephin. Sepsis was ruled out. Baby observed overnight and discharged next day. The hospital records received on 1/23/04 reviewed physician stated final diagnosis as adverse reaction to immunization, "poss. seizure secondary to immunizations, likely pertussis in DTaP."
Left arm upper turned bright red - bright patch that extends down arm about 5-6 inches swatch about 1/4 normal size; Felt warm & sore telephone conversation on 01/06/03; Has appt with doctor on 01/08/02 to have stitches removed.
Pt was given an expired dose of vaccine. Vial was placed in frig on 3/24/22 and punctured on 4/11/22 at 1254 pm  and expired on 12/12/22 at 0054. Dose was drawn up on 12/12/22 at 1230pm. Provider was notified and Moderna company was contacted for support and I am awaiting their call back on plan of care. No adverse reaction occurred.
SHINGRIX vaccine caused a flu like illness, a red injection site so painful I could not raise my arm. I had a fever 101 on second day. I was ill for 7 days.
The day after the vaccines was given, she felt some abdominal pain, nausea, severe fatigue, headache.  This lasted for over 5 days, and at the time of this report she is still having some abdominal pain and nausea
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported for seven patients. This is the fourth of the seven reports. A 72-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Batch/Lot #L60103 and expiration date:Dec2016) possibly subcutaneous in left abdominal on 03Sep2015. Relevant medical history included multiple myeloma and concomitant medications were not reported. The patient experienced, on 03Sep2015, rash, pain, hot to touch, tenderness, chills, redness and cellulitis on unknown date. The events were described as follows, the patient complained of rash (7 inch diameter) in abdomen where vaccine was given, tried cold, ibuprofen was done but site getting worse with redness, pain and hot to touch. Patient come into clinic, cellulitic area in left abdomen (where patient received injection) continued to spread outside of borders. Patient received IV vancomycin, switched to oral CIPRO 500mg. The outcome of all the events was unknown. Follow-up (02DEC2015): Follow-up attempts are completed. No further information is expected. Follow-up (14Dec2015) Additional information received from the same contactable pharmacist includes age and gender of the patient, batch/Lot and expiration date, date of vaccination, events onset date and medical history. Tenderness, feeling hot, cellulitis, redness added as adverse events. Case upgraded to serious.
Client was advised to get TDP by his PP. The birthdate on the forms had the wrong year of birth so there was no record. When the client # was entered into record it showed that he had been given a TDP on 8/16/2016.  The client is deaf and his wife said he did not have a TDP in 2016. I told her to contact pharmacy in regards to this matter.
Severe pain in arm of injection beginning about 12 hours after vaccine, joint pain in back and hips, chills
On 1/22/2021: Received Moderna Vaccine #1 On 1/ 25/2021: Experienced left clavicle pain/soreness and  felt a "bump"/lymph node within left clavicle area. On 1/26/2021- 1/29/2021: Intense left arm pain going down left arm, swelling of left arm around injection site and on 1/29/2021 red splotches began on left arm and left clavicle and continued until 2/1/2021.
4am, had severe stomach pain, 8am threw up bile (1 time only), no fever.  Fever has progressed rapidly with chills - high of 102.4 - no sore throat, no stomach pain, high fever.  Not concerned about 102.2 fever when contacted.  Right index finger and middle finger started going numb.  (left arm was injection arm).  Weakness, dizziness, upper back pain and headache.
I had my vaccination on 10/09/2022. On 04/03/2023 I started to experience symptoms sore throat cough headache and fatigue. I tested COVID-19 positive on 04/03/2023 and I contacted my physician that same day. I was prescribed PAXLOVID. I still have a sore throat with fatigue on 04/12/2023.
Pt was diagnosed with autistic disorder at the age of 5. Parents and pt's doctor believe it is due to mercury in the immunizations he received. Lab and hair tests show pt is toxic with high levels of several heavy metals. Pt is currently being detoxed.
it is red and hot; it is red and hot; her right arm became sore; 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.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bitten by red ants" (unspecified if ongoing); "Highly allergic to red ants" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "her right arm became sore"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 02Oct2023, outcome "unknown" and all described as "it is red and hot".  Additional Information: It was reported that patient experienced right arm became sore on an unspecified date in 2023. On 02Oct2023, it was now red and hot. Patient was inquiring if this was okay and if she needs to see a healthcare professional.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
unable to smile, ataxia.  12/23//09 Hospital records, discharge summary received. Service dates 11/3/09 to 11/5/09. Assessment: Guillain-Barre syndrome, hypertension, electrolyte imbalance due to self-forcing of free water, allergic rhinitis, hyperlipidemia. Patient presented with progressive onset of difficulty in balancing, falling episodes, low back spasms, beginning prior to flu shot. Has been drinking lots of fluids. Now showing bilateral facial nerve palsy, proximal and peripheral muscle weakness, difficulty with balance and perception. Slurred speech. Fall with blunt head trauma. Abrasion on nose. Deep tendon reflexes are absent except for left biceps which is diminished. Cerebellar ataxia. Distal sensory loss in feet. Transferred to higher level facility.  12/29/09 Hospital records, discharge summary recieved. Service dates 11/5/09 to 11/15/09. Assessment: Acute inflammatory demyelinating polyneuropathy. Patient was admitted with bilateral lower extremity weakness, bilateral facial weakness, paresthesias. Hyponatremia. Aspiration Pneumonia. Plasmapheresis performed. Discharged to acute rehab facility.
swelling in the lymph nodes in my right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: Er2613) via an unspecified route of administration in the arm right on 29Mar2021 at 16:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 06:00 the patient experienced swelling in the lymph nodes in right arm pit. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of swelling in the lymph nodes in right arm pit was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.