chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEAD ACHE; FEVER; 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: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 19-MAR-2021, the subject experienced head ache. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of head ache was not reported. This report was non-serious.
his mouth is dry; body pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (his mouth is dry), MYALGIA (body pain), HEADACHE (Headache) and PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN from 11-May-2021 to an unknown date for Symptomatic treatment.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced DRY MOUTH (his mouth is dry), MYALGIA (body pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, DRY MOUTH (his mouth is dry), MYALGIA (body pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided          No concomitant medications were provided.
Pt recvd vax & 1/2 later  exp itchy rash that came and went over entire body;
Fever; Headache; Chills; Body aches; Lack of strength and energy; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included benazepril (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the right arm on 29Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 09:00, the patient experienced fever, chills, body aches and headache which began the morning after second dose and lasted until the evening the following day on 22Apr2021. Fever and headache remained until morning of 23Apr2021. The patient was still experiencing lack of strength and energy at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as the result of events. The clinical outcome of the events chills and body aches were resolved with sequelae (also reported resolved with lasting effects) on 22Apr2021; while that of fever and headache were resolved with sequelae (also reported resolved with lasting effects) on 23Apr2021. The clinical outcome of the event lack of strength and energy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt was given the wrong medication. The patient received 1st dose of Covid vaccine 2/20/21 and was given other manufacturer for the 2nd dose in error. Pt was  notified, process at the clinic reviewed and amended.
Rash over entire body. Pulling at ears. Fussy. Decreased appetite. Erythemic viral appearing exanthem blanches when palpated w/rough texture cheeks, back of neck, chest and back; started where she got her shots".
01/03/22 presents to ED for "shortness of breath". PMHx of "asthma"
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "Penicillian allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VIT B12 [CYANOCOBALAMIN]; CITALOPRAM; LOSARTAN POTASSIUM. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "tired".  Additional Information: It was reported that the patient was tired for a few hours 24 hours after vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.
right inner ear sore with left & right mastoid bones very sore-bruised feeliing 3/12-3/24; fever blister-bottom lip 3/17-3/21; joint/muscle ache 3/16-3/18; SEVERE ANXIETY - internal shaking, tingling on face and head, 3/16 - 3/21 along with concerning high blood pressure 3/19 -3/21 (170-188);elevated heart rate 3/21/21 (120-147). EMTs/ambulance monitored BP/HR for approximately 40 minutes at home;  Heart rate went down to normal on 3/22 and blood pressure decreasing daily.  (145-150).   Anxiety- internal shaking completely gone 3/22/21 but has since reappeared 3/24 until present.  MD has put me on a BP/beta blocker which I began on 3/26 along with homeopathic remedies for anxiety/bloodpressure.
Flu like symptoms, body aches, fever of 102, coughing up green mucus, swollen arm.
Discharge Provider: DO Primary Care Provider: DO Admission Date: 2/27/2023 Discharge Date: 03/05/2023  PRESENTING PROBLEM: Bilateral pulmonary embolism Acute pulmonary embolism with acute cor pulmonale, unspecified pulmonary embolism type   HOSPITAL COURSE: Patient is 75-year-old male past medical history of BPH and smokeless tobacco use who presented to emergency department with severe shortness of breath on 02/27/2023.  Notably, he had recently started workup for left gluteal maximus mass felt to be liposarcoma outpatient.  On arrival he was significantly tachycardic with rates up into the 160s, appearing to be atrial flutter.  He did require IV diltiazem and then spontaneously converted back to normal sinus rhythm.  CTA thorax completed showing bilateral PE with right heart strain and multiple pulmonary masses.  He was started on a heparin drip.  Largest mass in the right upper lobe which is most suspicious for neoplasm.  He was additionally noted to be COVID-19 positive with symptoms starting about 1 week prior to admission.  Interventional Radiology consulted and completed mechanical thrombectomy 2/28 which removed 85-90% of clot burden with some improvement in pulmonary hypertension via PA pressures (from 40/8 (18) to 34/8 (16) mmHg).  Echocardiogram prior to thrombectomy with moderate-severe RV dysfunction and moderate dilation with systolic septal flattening consistent with RV pressure overload.  MRI of the left hip attempted to be obtained however patient unable to tolerate and exam nondiagnostic due to motion artifact.  He continued to intermittently revert back to atrial flutter, cardiology was consulted and initiated IV amiodarone once he had spontaneously converted back to NSR to maintain sinus rhythm.  He was transitioned to oral loading dose 3/4.  Hemoglobin noted to trend down after procedures with CTA abdomen and pelvis obtained to rule out retroperitoneal hemorrhage.  This demonstrated no active bleed but did show enlarging left pelvic and inguinal masses likely enlarging lymph nodes as well as a prior nodule in the right lower lobe that had grown significantly in size already suspicious for aggressive malignancy.  He did have biopsy completed of his right upper lobe mass as well as left gluteal mass in order to limit interruption of anticoagulation outpatient, this was completed 03/03/2023.  He did have very small right apical pneumothorax after the procedure which did improve with conservative management. Evaluated by Pulmonary Rehab who recommended home oxygen likely only needed with activity.  Hypoxemia is likely not related to COVID as his symptom onset was around 2/20. Steroids were not started.  He will continue 14 day amiodarone load with 400 mg twice per day then 200 mg daily and follow-up with Cardiology.  He was started on Eliquis will continue with starter pack on discharge.  Pulmonology to follow biopsy results and follow up outpatient.  Patient will need repeat echo outpatient.  Would also obtain complete blood count within the next 1 week.  Patient will need oncology referral outpatient by PCP once biopsy results are finalized.
Fatigue, headache, and soreness in the arm, back, and leg shortly after administration of vaccine
Hospitalized overnight for severe shortness of breath along with a COPD attack; Hospitalized overnight for severe shortness of breath along with a COPD attack; feel unwell; headaches; very tired; some dizziness & weakness; some dizziness & weakness; This is a spontaneous report from a Contactable Consumer (patient). This 82-year-old female patient received the third dose of BNT162B2 (Lot number unknown) at arm left at single dose for COVID-19 immunisation on 12Oct2021 at 10:15. Relevant history included AFib (Atrial fibrillation), COPD (Chronic obstructive pulmonary disease) and Arthritis. The patient had allergy with Lovastatin. Concomitant drug included warfarin, lisinopril, sertraline hydrochloride (ZOLOFT) and simvastatin. The patient previously received the first dose of BNT162B2 at arm left for COVID-19 immunisation on 03Feb2021 at 10:30 am, the second dose of BNT162B2 at arm left for COVID-19 immunisation on 24Feb2021 at 8:30 am, both for COVID-19 immunisation. No other vaccine was received in four weeks. The patient felt unwell, headaches, very tired, some dizziness & weakness since 13Oct2021 at 11:00 AM. The patient hospitalized overnight for severe shortness of breath along with a COPD attack. The patient still had some shortness of breath at the reporting time. AEs resulted in Emergency room/department or urgent care and Hospitalization (1 day). Outcome of events was not resolved. Treatment therapy included Oxygen & Breathing treatments.The patient had covid test (Nasal Swab) on 14Oct2021 with negative result.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Patient received 1st pediatric covid vaccine at 10:30am. Patient's questionnaire was filled out with all answers as "no". Patient had no history of fainting. After vaccine was administered, patient, sibling and mom went to their vehicle. When patient walked outside, he said "I'm really hot". He got into the back seat of his car continuing to complain of heat and then he passed out. Mom sent sibling back in to store to make us aware where we called EMS and sent out 2 CPR trained employees. When we got to patient, he was no longer unconscious. EMS arrived and evaluated patient. When asking questions, mom stated that patient did in fact have 1 seizure in 1st grade which was not disclosed on the  questionnaire. EMS determined there was no need for the patient to go to the ER and did not believe reaction was vaccine related but instead heat related. Patient was ok at this point and mom took him home with no further incident.
This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II.; Sender's Comments: US-009507513-1707USA010527: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010526: US-009507513-1707USA010528:
Patient is not able to move her arm; loss of appetite.; warmth; hardness; redness; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache). The patient was treated with CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE SULFATE, HYALURONIC ACID, METHYLSULFONYLMETHANE (FLEX 5) for Joint pain, at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also include: Vitamin alkaloid
Bodily rash, red itchy bumps, slight swelling in fingers and toes.
Patient had no known side effects; Temperature excursion for ROTATEQ which was supported. 1 dose of ROTATEQ was administered to a patient; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.   On 04-JAN-2022, patient was vaccinated with a temperature excursion for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which was supported, one dose, lot number 174228, was confirmed to be non-valid to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), expiration date: 09-JAN-2022 (product storage error). The caller reported that one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to the patient. The patient had no known side effects.
pregnancy  after receiving FLUZONE QIV PFS with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Agency (Reference number- 00880415) and transmitted to Sanofi on 01-Dec-2021.  This case involves a 23-year-old female pregnant patient after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient medical history, past medical treatment, family history and concomitant medication were not provided. On 01-Dec-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [frequency: once, strength: standard, lot UT7336NA, expiry date: 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant after received FLUZONE QUADRIVALENT vaccine.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Information has been received from a physician concerning a 69 year old female who on 03-FEB-2009 was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). Around 20-OCT-2010 the patient came down with shingles. It was reported that therapy with ZOSTAVAX (Merck) was discontinued. At the time of reporting, the outcome of shingles was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from the physician concerning the patient. The patient received the ZOSTAVAX (Merck) (lot # 662997/1619X) at 9:00 AM on 03-FEB-2009. On 20-OCT-2010 the patient developed shingles. Outcome of the event was not reported. No further information is available.
PATIENT IS EXPERIENCING REDNESS, SWELLING AND SEVERE PAIN AT  THE INJECTION SITE. SHE STATES IT IS PAINFUL TO MOVE HER ARM OR SLEEP ON IT.
More than the 42 days window patient got his first shot of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than the 42 days window patient got his first shot of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than the 42 days window patient got his first shot of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than the 42 days window patient got his first shot of vaccine) outcome was unknown. Not Provided      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.   Concomitant and Treatment medications were not provided by reporter.
exposed to chickenpox-3wk prior to developing mild varicella lesions (25 total);
Severe nausea lasting from march to may Dizziness  Racing heart rate that would max at 120
About 3 months after my vaccination I started getting really bad neck pain that led to my entire left side being numb my pain was so bad I decided to go to the er hospital 1-17-22 they thought I had a stroke and then confirmed after testing that I had an adverse reaction to my vaccination
Information has been received from a physician reporting that the mother of the patient contacted the physician's office by phone on 01-JUN-2011 and reported that her 18 year old daughter with no medical history or drug reactions or allergies, on 31-MAY-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication. On 01-JUN-2011 the patient's feet were bloated and swollen. No labs/diagnostics studies were performed. No treatment was given at the time of reporting. At the time of reporting, the patient's outcome was not recovered. Additional information has been requested.
Patient had a seizure episode within 15 minutes after receiving 2nd shot of Pfizer Covid-19 vaccine. Patient's mother started to scream suddenly after patient fell on the floor and started to seize. Patient did not have any ADR to the first dose of same vaccine, reported no history of seizures or health conditions. Pharmacist saw patient lying on the floor, eyes bulging and having difficulty breathing, asked manager to call 911 and administered EpiPen 0.3mg IM shot into the right upper thigh. Patient was able to breathe and talk within around 2 minutes. 911 arrived and took patient to the hospital for observation
Arm left arm has been throbbing on and off for two weeks; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 06Apr2021 at 16.30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medications included loratadine (CLARITIN) on an unknown date for allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 16 Mar2021 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, two weeks after the second dose of vaccination, the patient's left arm has been throbbing on and off for two weeks near the original site of vaccination. The patient did not have any side effects immediately after the second shot but the symptoms began two weeks later. The patient was not sure if it was a muscle strain or related to the vaccine. The patient did not received any treatment for the event. The clinical outcome of the event left arm has been throbbing on and off for two weeks near the original site of vaccination was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended treatment received in event tab and narrative.
I had vaginal spotting and bleeding after BOTH doses.  After my first shot I had one day of bleeding,  and after this 2nd shot, I am on day 4 of vaginal spotting and bleeding.  This is concerning because I just had a baby in January, I am currently breastfeeding, and due to my PCOS, I rarely have periods in general.
Immediate fatigue worsen daily... pain in left breast. left arm pit back left shoulder blade for several days then the shingles blisters appeared saw emergency dr on may 1st 2021. Were told this shingles outbreak is directly from the vaccine. Told can have second covid19 vaccine in few weeks but primary care dr said not safe to have second covid19 vaccine because it could be more serious effects next time. What should this patient do regarding second dose?
Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 02Jan2021 at 15:15 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were unknown. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Jan2021 at 19:00, the patient experienced tiredness, headache and muscle pain. No treatment was provided for the events tiredness, headache and muscle pain. The outcome of the events tiredness, headache and muscle pain was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt called complaining of swollen lymph node under her arm causing discomfort as well as fever w/ excessive sweating
About 9 days after injection in the evening I started feeling fatigued. the 10 day I  and ran a temperature of 100.2 so I took ibuprophen I also had some hip pain. I Called the urgent care and scheduled PCR COVID test for 1/8/21. 1/8/21 I started feeling better. No fever. i think it was a delayed reaction