chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 18 hrs after vaccination, pt woke up with injection site soreness, Tmax 104, dizziness, myalgias, athralgias.
Patient experienced DVT in right leg and pulmonary embolism. Symptoms of DVT included cramping, swelling, and pain right leg, which started 10/28/22. Patient was seen by healthcare provider on 11/3/22 and diagnosed at that time with DVT/PE then started on Eliquis and Paxlovid.
Mother reported swelling, itching, and redness. Mother reports he was taken to Pediatrician and given medication. Patient still had some swelling on 2/28/2008.
After receiving first set of immunizations patient had an episode of body stiffning with arms flexed. Patient did not have loss of consiousness or syncope. Patient started crying again and having normal infant activity after placed on exam table. VS after episode: P 112, R 40, T 99.0 axillary. Mother states this has happened in the past when patient is crying, angry, or hungry. Mother was told to take patient to ER for further evaluation.
Patient was given the wrong booster dose. Patient was supposed to receive a booster dose for Moderna but instead received a booster dose of Pfizer which was the incorrect completion of his series.
Rash on waist, chest, arms and head, similar to bug bites; Rash on waist, chest, arms and head. Similar to bug bites. Hives??; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Oct2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. The concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on 15Sep2021 for immunization. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 68-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 02:00, the patient experienced rash on waist, chest, arms and head which was similar to bug bites and hives. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on waist, chest, arms and head which was similar to bug bites and hives were unknown at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medications included: EZETIMIBE, start date: 01Sep2022, stop date: 12Mar2023; HYDROCHLOROTHIAZIDE, start date: 01Nov2016, stop date: 13Mar2023; LISINOPRIL, start date: 01Nov2016; ROSUVASTATIN, start date: 01Nov2016, stop date: 12Mar2023. 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 which included Paxlovid from 12Mar2023 to 17Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient reported getting a temperature and throwing up with body aches about 6 hours after receiving her vaccine.  She also reported testing positive for COVID the next day after receiving her vaccine.  She had to use Tylenol to keep her temperature under control and she was sick for 2 weeks.
No issues immediately after injection.  A week later, injection site was red, hard/swollen, hot to touch and spreading.  I do have photograph of the angry arm.  Went to health center, she thought it was cellulitis,  was prescribed antibiotics.   Site was marked with a sharpie to monitor spread.  Revisited health center a 3/2/21 for follow up, still warm to touch, but much better.    On 3/8/21, did read the article on Delayed Large Local Reactions to mRNA-1273 by doctor, et al.    With that research information, I was ready for the second shot (3/16/21).  Once the injection site started to turn pink, I took Benedryl and did not have angry Moderna arm as the first injection.  Much more soreness and fatigue the second time around though.
Pt recvd vax 22MAY93, mom gave APAP every 4 hrs, no fever until about 6PM on 23MAY93 which was elevated to 103.9 ax by early hrs of 24MAY93; fussy, up off & on throughout that noc of 23MAY93; exam on 24MAY93 was neg;
Extra Fluarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced extra dose administered (Verbatim: Extra Fluarix administered). The outcome of the extra dose administered 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: 01-MAY-2023 The reporter reported that the patient received an extra dose of Fluarix vaccine. The reporter was looking for the guidance on the next steps. The patient received extra dose of Fluarix in error, which led to extra dose administered.
On April 20th around 10:00pm I had been standing up all day, laid down in bed, heart started pounding hard and fast was in shock for a while for about 30 minutes. Still is dealing with rapid heart beating. On June 4th visited her doctor and On June 9th her doctor gave her a heart monitor.
Patient reports started having fever and chills at approximately 4:30 on Friday 2-26-21. Woke up on Saturday with arm itching and a rash at site(2-27-21). Rash gradually spread to all extremities by night on 2-27-21. Currently has rash on scalp and abdomen. Saw PMD today and was given a steroid shot to help dry up rash.
Patient felt lightheaded, and fainted in hallway, patient was placed on exam table, pt stated she was feeling better, BP 91/52 at 1027, at 1035 pt awake and alert, BP 113/72, pt alert and oriented x3, pt sent home.
12:50PM PT WALKING TO AFTER CARE  AND BECAME WEAK. FELT DIZZY. PLACED IN WHEEL CHAIR. GIVEN JUICE AND WATER. BP 110/70, HR 60, SP02 95%. COLOR PINK. 1PM SITTING IN WHEEL CHAIR TALKING WITH FAMILY. STATES NO FURTHER DIZZINESS. MONITORED FOR 30MIN.  FEELS BETTER. TAKEN TO DOOR - HOME WITH PARENTS. 4-2-21 9AM TC: 'FEELS FINE NOW'.
Body aches; Loss of appetite; Headache; fever of 101.8F; Nausea; fatigue; Chills; A spontaneous report was received from a nurse concerning a 60-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, fever, nausea, body aches, fatigue, chills and loss of appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the morning of 31 Dec 2020, the patient experienced headache, fever of 101.8F, nausea, body aches, fatigue, chills, and loss of appetite. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of headache, fever, nausea, body aches, fatigue, chills and loss of appetite, were recovered.; Reporter's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected pain and decreased appetite and expected headache, fever, chills, fatigue, nausea.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with paracetamol. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received an unspecified reporter via social media refers to an unknown number of male patients of unknown age with no medical history or concurrent conditions reported. On an unknown date, the patients were vaccinated "on-time" with MMR II (dose, route, lot number and expiration date were not reported) in accordance with the recommended centers of disease control (CDC) schedule. Concomitant therapy was unspecified. On an unknown date, the patients experienced autism. It was reported that "fraud at the CDC was uncovered, revealing 340% increased risk of autism that was hidden from the public". The outcome of autism was unknown. The reporter considered that autism was related to MMR II. Additional information is not expected as there is no contact details available for follow up. It has been determined that since this case is only reporting an increased risk for Autism, not an actual diverse event of a person developing Autism, this case should be voided.
Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 12-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing  was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..
55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest.  Per patient's daughter, patient was feeling at baseline today.  He got his COVID vaccine at 5 PM this evening.  He was running some errands and called his daughter at 8:40 PM.  He told his daughter he was not feeling well.  She reports he sounded out of breath and sounded as if he was slurring his words.  Daughter told him to pull over and she called 911.  She met him on the side of the road and he was gasping for air.  She arrived at the same time as EMS.  Upon arrival of EMS patient was in ventricular fibrillation.  He was defibrillated 3 times.  He also had one episode of ventricular tachycardia.  He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation.  King airway was placed and patient was brought to the emergency department.
pt presented to ED with wheezing, SOB, cough; tested positive for COVID; admitted; O2 supplementation; dexamethasone; baricitinib; severe sepsis; multiorgan failure; intubated; experienced cardiac arrest with ROSC; no clinical improvements; severe brain injury; DNR; palliatively extubated and pt passed away in the hosp; DC and med records sent per request
After administration, realized the expiration date was 5/28/22. No adverse signs or symptoms noted.
Immunizations given R deltoid- Hepatitis A, R arm SQ- varicella, L upper D- TdaP, L lower D- Menactra. Immediately after giving Menactra child stated "ouch that one hurt," then slumped back on exam table, skin pale, pupils dilated, eyes rolled back, no response from patient. Child's mom by her side calling her name, instructed mom to get help. Patient's body became rigid, legs flexed, jerking- seizure like activity for about 10-15 seconds. RN called 911. After approximately 30-45 seconds child then responds "what happened" and began crying, c/o R arm pain. Vitals at 11:30 b/p 104/63, HR 66. Child alert to person, place, and surroundings, but unsure about what was happening to her. Skin color WNL, vaccine sites WNL. EMS arrived to transport. Patient sat up on exam table still c/o weakness and dizziness. Child placed on stretcher with help of EMS. Mom with child. To be transported to Hospital.
Symptoms started almost an hour after injection.  I started to feel muscle fatigue and joint stiffness. I also started feeling random chills in a  room that's kept at about 78 degrees Fahrenheit. I also experienced a minor headache for most of the afternoon.  I woke up today at about 9:50 am, to increased joint stiffness and pain. The muscle fatigue has remained constant. There is pain at the site of the injection, similar to the feeling of being hit hard with a ball. The headache has returned, though the intensity is still minor. I have also been told that I "sound congested" when I talk.
After vaccine given, lip tingling, then swelling, angioedema noticed, Benadryl & epi given, pt taken to emergency room.  Patient observed in ED, vitals stabile and resolution of condition.
Rapid heartbeat.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included depression, low thyroid, herpes simplex virus (HSV), migraine, sleep apnea and arthritis, seasonal allergies and  known allergies to penicillin, sulfa and latex. The patient received unspecified medications within two weeks of vaccination and reported that there was not enough room for all medications. The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. 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 23Mar2021 at 14:00, the patient experienced rapid heartbeat. The patient underwent lab tests and procedures which included hear rate on 23Mar2021 and the result was rapid heartbeat. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rapid heartbeat was recovered on an unknown date of 2021.   No follow-up attempts are needed. No further information is expected.
A report was received from a consumer on 11/04/2002, concerning a 69 year old female vaccinee who experienced hives and loss of energy (two days post-vaccination) and night sweats ( 7 days post-vaccination ) after receiving Fluvirin on 10/15/2002. On 10/17/2002 the vaccinee developed eight to ten hives on her legs and buttocks and complained of having no energy. Approximately a week after receiving the vaccine the vaccinee began to experience night sweats. The vaccinee's glucose sugar level was within normal limits when she experienced the night sweats. At the time of this report the patient was still experiencing night sweats. The hives and loss of energy were reported as resolved on an unknown date.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Patient was giving a Moderna .25 (booster dose) Later it was discovered that the vial was expired, due to time out.
Heart Palpitations, tachycardia, irregular heart beat and sharp constant 5/10 left sided chest pain since receiving COVID shot.  SOB.  PFIZER COVID shots 3/23/2021 and 4/14/2021 with symptoms coming on immediately after shots.
Swelling of the feet (2x size on right leg).  Sensation of heat and needles to the plant of the feet. Continued sensitivity and numbness in right foot, heel and toes. Currently treating of the edema by compression, icing and ibuprofen and suspending all physical activity to relieve stress on legs.  Saw Dr. on June 4th.
child out of hosp 1wk feeling well, no fever, tube feedings;MD requested update of shots planning surgery;PM to ER for congestive heart failure;02 & sent home but died in sleep late afternoon;no fever or illness r/t vax;
Vaccine adjuvant without active component; Patient received vaccine adjuvant without active component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Patient received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that there was multiple patients received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered; Sender's Comments:  US-GSK-US2023058298:Same reporter/Batch case US-GSK-US2023058300:Same reporter/Batch case