chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; This is a literature report for the following literature source(s): "Surveillance of Myopericarditis following COVID-19 Booster Dose Vaccination in a Large Integrated Health System", medRxiv, 2022; DOI:10.1101/2022.02.08.22270635.  An adult male patient received bnt162b2 (BNT162B2) (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), CHEST PAIN (hospitalization, life threatening), CARDIOGENIC SHOCK (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "chest pain, myocarditis, and cardiogenic shock after his booster dose". The patient was hospitalized for myocarditis, chest pain, cardiogenic shock (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: sinus tach; left ventricular end-diastolic pressure: 35-40 %; troponin: 17.8 ug/L.  The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
No additional AE reported; nurse calling to report a temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U026796, expiration date 28-JAN-2023 (dose and route of administration not reported) as prophylaxis, underwent a temperature excursion of 48.8 Fahrenheit for 96 hours. No adverse event was reported.  No previous temperature excursions were reported.  This is one of 4 cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA002142: US-009507513-2203USA002143: US-009507513-2203USA000257:
Shortly after sitting down in post vaccination area, patient's stomach was upset and he vomited small to moderate amount of brownish colored fluid.  Color pale, VSS - 118/70-94-20, Oxygen Saturation 96% on RA.  Vomiting passed and patient was released to home accompanied by son
stopped talking, head banging, stopped making eye contact, brain iflamation, blank stares,
Symptoms of left shoulder pain started the next day. Ibuprofen has not helped and if anything it has gone from a generalized shoulder joint pain to possible rotator-cuff injury. My left shoulder was fine before the vaccine but I had right shoulder rotator-cuff surgery about 18 months ago.
Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms.  She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sudden death on school playground.  3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent's vehicle & collapsed over the car.  Parent & other bystanders witnessed event & called 911.  Parent told ER patient was gurgling, color drained from face & eyes glassed over.  Transported to ER where resuscitation unsuccessful.    3/25/08 Reviewed pcp medical records of 12/31/07.  Only complaint was of slight pain right knee s/p bike crash.  Pt wt 148 lbs, ht 63.5 in, BMI 25.8.  BP 100/60.  Vax record supplies lot #. Family hx: parent w/HTN.
Severe muscle/joint pain, trouble walking, severe nausea, trouble lifting left arm. No fever, but having severe chills. Symptoms lasted from 5pm 7/12/16 to am of 7/14/16.
Pt recvd 3 doses of Hep B vax on 6NOV90, 4DEC90, & 23APR91 & following 3rd dose exp sinus infect, fever, malaise; pt was seen by MD & given ATB; x-ray of sinus showed abscess;
CHEST TIGHTNESS; HOT FLASHES; FAST HEARTBEAT; STOMACH PAIN; SHAKY AND NERVOUS; SEVERE DIARRHEA; NERVOUSNESS; RASH ON TOES; GLASSY EYES; WHOLE BODY VERY WEAK /FELT VERY WEAK; SPOTS ON THE BODY; RIGHT ARM SWOLLEN; LIGHT HEADED; BREATHING DIFFICULTY; SEVERE PAIN IN RIGHT TEMPLE; ACHY; SHARP PAIN IN RIGHT ARM; CHILLS; SEVERE HEADACHE; NAUSEA; VERY TIRED; SORE THROAT; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 143 pounds, and height was not reported. The patient's past medical history included sinus surgery, carpal tunnel surgery, and viral infection, and concurrent conditions included allergic to antibiotics, allergic to prednisone, non alcoholic, and non smoker, and other pre-existing medical conditions included patient is allergic to lots of medications, antibiotics, prednisone, other medications there was no drug abuse or illicit drug usage patient is non-alcoholic and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 19:00 for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, loratadine for drug used for unknown indication, and sodium chloride for drug used for unknown indication. On 09-APR-2021, the subject experienced breathing difficulty. On 09-APR-2021, the subject experienced severe pain in right temple. On 09-APR-2021, the subject experienced right arm swollen. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced spots on the body. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced sharp pain in right arm. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced glassy eyes. On 10-APR-2021, the subject experienced whole body very weak /felt very weak. On 14-APR-2021, the subject experienced shaky and nervous. On 14-APR-2021, the subject experienced severe diarrhea. On 14-APR-2021, the subject experienced nervousness. On 14-APR-2021, the subject experienced rash on toes. On 14-APR-2021, the subject experienced hot flashes. On 14-APR-2021, the subject experienced fast heartbeat. On 14-APR-2021, the subject experienced stomach pain. On 15-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from glassy eyes, was recovering from sharp pain in right arm, nausea, light headed, stomach pain, severe diarrhea, and spots on the body, had not recovered from severe headache, achy, severe pain in right temple, very tired, whole body very weak /felt very weak, and chills, and the outcome of breathing difficulty, shaky and nervous, fast heartbeat, right arm swollen, sore throat, chest tightness, hot flashes, rash on toes and nervousness was not reported. This report was non-serious.
I received my influenza vaccine at 11:30am on October 15, 2020. At 6:00pm I began to have extreme heaviness in all 4 limbs, followed by chills. By 7:00pm, I had a fever of 103 degrees. Throughout the night, I battled fever, chills, severe headache, and heaviness in my limbs. By 7:00am on October 16, 2020, the fever was down to 102 degrees, the headache remained, but the chills and heaviness had stopped. By noon on October 16, 2020, the fever was gone, and I was feeling mostly back to normal despite the headache that lasted until 2pm at which point I was symptom-free. I have never had a reaction like this to a flu vaccine and felt I should report it.
Numbness in her lower left calf (from her knee to her ankle).; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness in her lower left calf (from her knee to her ankle).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) a cyst in her liver.  No concomitant medications were provided.  No treatment information was provided.  Patient started experiencing numbness in her lower left calf (from her kneel to her ankle). Patient saw a neurologist to look at her leg.  Company Comment - This is a spontaneous case concerning a 43 years old, female patient with no clinical history who experienced the unexpected event of HYPOAESTHESIA The event occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 43 years old, female patient with no clinical history who experienced the unexpected event of HYPOAESTHESIA The event occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
felt like he had a terrible cold; This is a spontaneous report from a Pfizer-sponsored program, received from an other-HCP (parent). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patients medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization and experienced sleepy. On an unspecified date the patient experienced terrible cold. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Developed a rash, 4 days after 2nd dose of Pfizer vaccine series, described as beginning to LT side of her back, then spread to her LT anterior chest region and down her LT arm which became painful and itchy.
1/16 vaccination 1/17 Woke up at 3am. Fever 102.2. Called OBGYN. Body aches, fatigue, chills. Tylenol. Cold shower to bring fever down. Got fever down to 101.  Fever lasted till afternoon; 4PM.  99-100 till Monday morning.  EDD; May 9th  2nd pregnancy
blood pressure is higher than usual; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2022, the patient received the 1st dose of Shingrix. On 21st July 2022, 1 days after receiving Shingrix, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUL-2022. Reporter's Comments: The patient stated she received her dose of Shingrix yesterday (from the date of reporting). She stated this morning (on the day of reporting) she took her blood pressure and it was higher than usual. The reporter did not consent to follow-up.
Swelling and redness at site of injection, flu like symptoms, achy, tired, on 07/23/2010 developed a rash on body.
RANDOM WEIRD INFLAMMATION IN UTERUS; PAIN IN UTERUS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced random weird inflammation in uterus, pain in uterus, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, random weird inflammation in uterus and pain in uterus was not reported. This report was non-serious.
The vaccine was administered without dilution (reconstitution).  The patient had pain on injection. The patient's parents report no adverse effects one hour after or one day after, upon follow-up. The parents made contact with the doctor, poison control and Pfizer.
After 4 days I started having shortness of breath, itchiness when breathing and chest pain. At the one week mark I started having palpitations and high blood pressure.
Began vomiting with a severe HA, nausea, stomachaches. No diarrhea no muscle stiffness. Went to the ER on 8/17 at 10:45 pm c/o HA vomiting and "pins and needles" in her toes. Rec'd IV fluid, Zofran and Toradol, then discharged home.
Possible Vasovagal Syncope: passed out, red, clammy face, confusion, weakness, muscle spasms
For three days I couldn't sit up in bed for more than a minute or so, couldn't stay wake long enough to eat or drink, was shaking so much that I had to hold on to walls or furniture to get out of bed.  I couldn't focus enough to hold even a brief conversation.  I basically just slept for three days.  After that I gradually improved, but it was a week before I felt like I could function even close to normally, probably closer to 10 days before I was truly recovered.
Post vax, the pt developed weakness in lower legs especially in calf area. Pt complained of feeling tense all over. States he also feels lightheaded.
Numbness and tingling in left shoulder, arm, and hand for 48 hours starting the day following the vaccine. Lasting 24 hours.
Mild muscle tremors/spasms in arms and legs.  Occurs on daily basis, but is not constant.  No treatment to date.  Visited Pediatric Dr. at Clinic to discuss during annual physical.  Pediatric Dr. referred patient to Neurologist.
I had a lot of the usual adverse events, but yesterday (a week after the 2nd dose) I got a very bad, burning rash, a raised, red area, on my brow, an area where I sometimes have dermatitis. It doesn't burn as much today but is still puffy and red. I think the vaccine supercharged (for lack of a better word) the dermatitis.
Approx 12 hours after ZOSTAVAX vaccination, patient developed 103.7 degree F temp, chills, myalgias, headache, prostration, and heavy sweats, lasting approx. 24 hours.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-APR-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-JAN-2015 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed acyclovir (ZOVIRAX) for the management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.     Additional information has been requested.
never symptoms of heart condition  with no medication ,age 65, the day after shot, I had severe chest pains left side of chest.  went to hospital and had 99% blockage widow maker and another blockage.  6 living siblings, no heart condition in family, neither  parent with heart condition prior to mother at age 90. Not sure if its connected to vaccine, I would like to know others had same, hopefully help other people
Moderna COVID?19 Vaccine EUA chills, fatigue, headache, body aches, joint pain in left shoulder, severe arm pain/temporarily unable to raise left arm
Enlarged lymph node above left collar bone; This is a spontaneous report from a contactable nurse (patient herself). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included insulin aspart (NOVOLOG). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The patient had enlarged lymph node above left collar bone on 14Jan2021. Clinical outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Increase phlegm and mucus; Increased mucus; muscle aches; Sporadic fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ELP266) via an unspecified route of administration on 13Mar2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma and hypertension. The patient was allergic to iodine and shell fish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and emtricitabine (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021, the patient experienced increased phlegm, increased mucous, occasional muscle aches and sporadic fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events increased phlegm, nasal mucous increased, occasional muscle aches and sporadic fatigue were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Started morning after 2nd Moderna Vaccine  Headache continuous. Back neck and shoulder muscle soreness constant. L arm pit sore. Chills on and off, no fever . Constant low back pain (aching) pain not due to injury
rash left forearm with mild vesiculation 2 weeks following vaccine. developed severe pruritis for 2-3 months. reoccurred following two years in early spring.
An initial spontaneous report was received on 29OCT2015 from a registered nurse. The reporter stated that improperly stored doses of GARDASIL 9 lot # L025737 expiration date 28JUL2017; PEDVAXHIB lot # L014426 expiration date 08MAR2018; and VAQTA lot # L028666 expiration date 04NOV2016 were administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects were reported. No further information was provided. Additional information has been requested.