chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This subject is a 76 year old female who was admitted to the hospital with respiratory failure and COPD exacerbation while enrolled in a comparative randomized study of safety and immunogenocity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with aluminum phosphate when administered concomitantly with a licensed influenza vaccine in high-risk adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was 10/29/03. The first dose was 10/17/02. Subject developed increasing shortness of breath over the last month and purulent sputum, fever, chills and cough over the last 2 weeks. Subject was taken to emergency by ambulance 93 days post immunization on 1/30/04 and admitted the same day with respiratory failure. Subject was placed on BiPAP, and treated with nebulizer treatments, Rocephin 1gm, Zithromax 500mg, Decadron 6mg IV, Prednisone 40mg BID, Vantin 200mg BID. A chest x-ray on 1/30/04 showed COPD and no pneumonia. EKG is normal. There is no history of chest pain. Subject had mild improvement, however her disease is severe with an FVC of approximately 0.5 liter. Seen in consultation with pulmonary and agreed that she is in end stage. Subject declined any further BiPAP and was discharge from the hospital to hospice 4 days later, 3 February 2004. Subject discontinued the study on 2/3/04. The respiratory failure and COPD exacerbation was reported by the investigator as not related to the study vaccine. Additional information received on 3/5/04: Subject was discharged from the hospital on 2/3/4 to hospice. Subject died in hospice on 2/17/04, 111 days post immunization. The death due to respiratory failure and COPD exacerbation was reported by the investigator as unrelated to the study vaccine. Follow up on 03/24/04: "Additional information received 03/18/04. Copy of death certificate: Cause of death: Advanced Chronic Obstructive Lung Disease. No autopsy performed."
experiencing difficulty of breathing; allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction). At the time of the report, DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Heart rate: high (High) heart rate is high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
body aches; pregnant patient received BNT162B2 for COVID Prevention; pregnant patient received BNT162B2 for COVID Prevention; pregnant patient received BNT162B2 for COVID Prevention; This is a spontaneous report from a contactable physician (patient). This 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 19Dec2020 at single dose in right upper arm for COVID Prevention. Medical history was none.  Concomitant drug included unspecify drugs. The patient got the vaccine on 19Dec2020, and then that evening she had body aches. She stated that she took 1000mg of Tylenol by mouth because she was really achy, but she was fine by the next day. She was pregnant. Patient last menstrual period date was 08Sep2020. She does take another medication but she does not think it was associated with the body aches she experienced. The outcome of Body aches was recovered on 20Dec2020, of other events were unknown.  Primary Source Reporter assessed Body aches related by Method of assessment.
Patient called today (11/04/2003) states that approximately one week after she received her flu shot her arm began to hurt so badly that she had to go to the Emergency Room and to her family doctor.  She was told by her doctor that she had a hematoma where she got her shot (per patient)
His heart was racing, BP 72/35, HR 48 BPM.  Epi-Pen was injected at 12:02PM.  EMS called to scene.  BP 105/67 and HR 91BPM after Epi dose.
Dizziness, flushing/sweating, numbness fingertips, BP 145/91; HR 75; RR 16, Temp 98.6, 100% RA
Redness rash; Itching; hives/welt; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (reported as left shoulder) on 12Apr2021 12:15 (Lot Number: EW0153) as single dose for covid-19 immunisation.  There was no relevant medical history or concomitant medications. There were no additional vaccines administered on same date. There were no prior vaccinations within 4 weeks. The patient experienced redness rash and hives on 13Apr2021. Rash and hives started the day following the vaccine and was continuing. It was generally everywhere. If the knee itched and was scratched immediately, it welts up and creates redness and rash all over. Is on her back, neck, arms, feet and torso. If she scratches anywhere on her body it welts up. She clarified, it all started at the same time, the redness the rash and the itching. When asked if experience was improved persisted or worsened, she says it was worse than it was the first day. For the last 4 or 5 days it has stayed the same. She was receiving Benadryl as treatment and it seems to be calming it down a bit. She was also taking an herbal supplement from an acupuncturist. It was a mixture but she only knew the ame of one ingredient which is Huanglian. There was other stuff in the formulation too. The event did not require emergency room or physician office visit. The outcome of all the events was resolving.  No follow-up attempts are needed. No further information is expected.
Body aches,  fever less than 101,  headache,  nausea,  lymphadenopathy,  fatigue ,loss of appetite
Pt recv vax on 4/20/99;  on 4/21/99 pt exp knot in LA, feverish feeling, headache
5/14/03-fever, vomiting, diarrhea, severe stomach cramps.  4/15/03-PMD visit, hospitalized, IV's.,testing.  5/18/03 evening, sent home, very weak
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose back in December. The patient medical history and concomitant medications were not reported. The patient developed pneumonia on an unspecified date with outcome of unknown. Follow-up (31MAY2016): Follow-up attempts are completed. No further information is expected.
Patient was admitted to hospital 3 days after receiving vaccine, on 5/9/21.  She initially presented with a headache and was later diagnosed with an acute PE without acute cor pulmonale, unspecified pulomonary embolism.
Administered Pfizer dose in left arm and had patient wait for 15 minutes. Patient started to complain of feeling faint and seemed disoriented. We gave patient some cold water. We moved him to a cooler area in the pharmacy, then his hands started to lose all color and became very cold. We called 911 for further assistance. They arrived soon after. This situation was approximately over 30-45 minutes.
I had taken a sleeping pill like I always have for years. I started to experienced AFIB in and couldn't breath. After about 45  mins I drove myself to the emergency room. They did a couple of EKGs. They advised I was in AFIB. They gave fluids and a medication via IV to slow my heart rate down. I was released with a regular rhythm around 04:30AM. I'm still taking blood thinners and blood pressure medication.
Severe vomiting; severe fever; severe pain all over body; Sever neck pain; Severe head pain; Cannot sleep; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received 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 31Aug2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccination within two weeks prior to the COVID-19 vaccine. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 31Aug2021 at 22:00, the patient experienced severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep. The 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 result of these events. The clinical outcome of the events severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep were not recovered at the time of this report.
She got her vaccine, didn't bother her at first.  Later that evening her arm continued to bother her.  When she was trying to sleep she would roll over and would hurt and would also make a cracking noise which continued.  She had an APT for her yearly APT in February and she looked on the computer and there was no record of her having received the vaccine.  She gave her our # which she did not call us at that time.  She did an x-ray of the area, and it is still bothering her with the popping sound.  It feels like it is in the  muscle like when she got the vaccine like she just got the vaccine.  Her doctor suggested that she not get the 2nd booster, but does have an appointment on Monday, 6/13/22.   She does have some problems with motion, possibly in the rotator cuff.    She was diagnosed with COVID on 12/6/21, went to the drive-thru clinic and tested and came back positive.   She did not have a real bad case, and recovered pretty quickly.  Had a runny nose, no fever, really tired, fatigued.
Full body and muscle aches  Slight Fever Stuffy Head Chills Bad dreams Headache  Sore Arm Cold Sweets
Pt reports a dry cough starting about 1 week after injection. Has continued to persist about 6 weeks. Coughs about 3 times an hour. Unkown correlation, she is following up with ENT next week.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: PT received vaccine at 1602, reported itchiness at 1635, pt was given 1 dose of 25mg benadryl and continued monitoring. At 1645 pt had cough and reported throat itchiness, was given another dose of 25mg benadryl and emergency services was called. Pt's vitals BP 128/80mmHg and HR 83. PT transferred to EMS care at 1700.
NO ADDITIONAL ADVERSE EVENTS; Medical assistant reported AE related to VARIVAX. Reported patient received only half of the dose, due to moving during administration. No additional AE/no PQC.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X002100, expiration date: 19-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   It was reported that, on that day, the patient received only half of the dose, due to moving during administration (Vaccine underdose). No additional adverse events were reported.
Thirty minutes after receiving the vaccine the patient reported that the palms of her hands were itching.  A few more minutes passed and the patient stated she was experiencing tightness in her chest.  Her breathing also became more labored.
Anthrax shot given; had fever and flu like symptoms (diarrhea/vomiting) for several days. Then developed chest tightness, cough, hemoptysis. Evaluated 11/99 and asthma confirmed. Continues with RX. Belief is vaccine triggered in asthma condition. Symptoms continue to present. 11/01/02 Per review of medical records add: large, local reaction to Anthrax vaccine described as swelling from shoulder to elbow, heat, streaking, intense pruritis, and pain. Confirms diagnosis of asthma and adds diagnosis of allergic rhinitis. Severe, large local reaction to Anthrax dose #1 given on 4/9/99 and to dose #2 given on 2/23/00, described as pruritis, swelling, heat, redness with streaking. Rhinorrhea and asthmatic reaction triggered after Anthrax dose #1. 60 day follow up states pt has not receovered. Continued to have ongoing allergies and has daily treatment for asthma.
Bad headache, fatigue.  Started about 15 hours after vaccination.  Fever 100.1.   Normal ?shot hurt? pain in arm.  Took Advil.  Slight improvement. Submitting this form  17 hours after injection.
Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced redness and swelling of the arm at the injection site after receiving the vaccine. The patient had sought unspecified medical attention. On an unspecified date the patient recovered from redness and swelling of the arm at the injection site. Additional information has been requested.
Patient received the second dose of Pfizer Covid19 vaccine 9 days after the first dose
Around April 27 2021 she noted muscle aches and pains in neck and shoulders. Dr diagnosed Lupus, this has not been confirmed.
2 days after vaccination patient was very lethargic (slept for 8 hours straight), did not want to eat, very fussy, crying and pulling knees to chest and her tummy felt rock solid. She did not have any stools til 3:30pm. When we saw DR. at 4pm she decided to test stool after hearing her symptoms. Her stool tested positive for blood. Was sent to Emergency Room where they performed an ultrasound. They diagnosed her as "Possible intussusception" that had fixed itself. Patient has had bloody stools for over 4 weeks now. She has tested negative for all viruses, infections, bacteria and allergies.
large red circle (approx 4-5 inches) surrounding injection site / patient experiencing itching redness and sore throat
STEMI, chest pain started around 8 PM the day of receiving 2nd dose of COVID 19 vaccine.  COVID 19 vaccine received at 11 AM.  Patient presented to ED 2/17/21 AM with chest pain, ECG reveled ST elevation, proceeded to PCI
I do not know if I had an adverse reaction to one of my covid vaccines or booster (I have had 3 total) or to Covid itself, which I had a positive test January 2 2022 but sometime between  a June of 2020 and a January of 2021 echo stress tests my ecg had a t wave inversion.  This caused my cardiologist to do lots of tests which show that I have heart tissue damage of 6% scarring on my left ventricle.
having an allergic reaction, non-severe; Itching; Rashes; Hives; Headache; Raw feeling of not well; Arm soreness; No appetite; Tiredness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 62-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (at the age of 62-years-old) as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Apr2021, after 2 days of vaccination, the patient experienced having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, arm soreness, no appetite, tiredness. The patient did not receive any treatment for the adverse events. On 21Apr2021 the outcome of event arm soreness was recovered, while outcome of other events having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, no appetite, tiredness was not recovered.  No follow-up attempts are needed. No further information is expected.
Heart Palpitations after first shot.; This is a spontaneous report from a contactable Professional (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on 31Dec2020 at the age of 40-years-old as dose 1, single dose for COVID-19 immunization. The patient's medical history included allergies. The patient's concomitant medications included unspecified medications received in two weeks of vaccination. Facility type vaccine was hospital. The patient did not receive other vaccine in four weeks of vaccination. Other vaccine same date vaccine date was 21Jan2021. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Jan2021 at 07:00, the patient experienced heart palpitations after first shot. The patient did not receive treatment for adverse event. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
patient who received only partial of the Pentacel vaccine, just the Hib portion; 2 month old received vaccine in arm; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received first dose of 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ134AA, expiry date- 11-Oct-2020 via intramuscular route in upper lateral limb site on 29-Jul-2019. The patient only received HIB portion of the vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and  ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique and Vaccine administered at inappropriate site.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received Moderna vaccine at 10:30 am on 4/21/21.  within 15 minutes felt tightness in throat and "flush" from the neck up.  One hour later became diaphoretic and arms swelled.  The swelling to arms is similar to the reaction he has with pecan allergic reactions
08/11/2021, 02:00pm: Chest and back between shoulder blades began; patient thought it was indigestion. 08/11/2021, 05:30pm: Blood Pressure taken at home, 145/81; pulse 88; shallow breathing 08/11/2021, 05:56pm: Blood Pressure taken at home, 161/89; pulse 98; shallow breathing 08/11/2021, 06:08pm: Arrive at Hospital Emergency Room; Blood pressure 163/91; extreme pain; initial diagnosis in emergency room was a heart attack.  Pericardial Effusion: Please contact Cardiologist, Dr.  for additional detailed clinical/medical information regarding this event and follow-up patient care.
fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a spontaneous report received from a contactable (reporting on herself). A 78-years-old Non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201 and Expiry date not reported), via an unspecified route of administration in Arm Left on 11Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included penicillin allergy. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283 in Arm Right on 22Jan2021 17:15 for COVID-19 immunization. Concomitant medication(s) included Liothyronine/Levothyroxine T3/T4, and usual vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 12Feb2021 at 13:00 symptoms started (at 20 hours after the injection) Chills for 3 hours, fever up to 101 degrees, weakness, body aches, headaches, exhaustion. Patient did not received any treatment for adverse event. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Case number PHEH2013US018379 is an initial spontaneous report received from a health care professional on 26 AUG 2013, with a follow-up received on 01 OCT 2013. This report refers to a 14-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) on 22 APR 2011 and was well tolerated. He was inadvertently vaccinated with another dose of MENVEO (batch number: A12128/X12128) intramuscularly on 07 AUG 2013 instead of receiving GARDASIL (other manufacturer, batch number: unknown) on 07 AUG 2013. It was reported that the patient had no adverse reaction but received meningococcal shot too early. Now he was only 14 and need the booster dose at 16. Follow-up was received on 01 OCT 2013, patient demographics, vaccination history, and MENVEO vaccination date with batch number was updated.
High pitched screaming despite Tylenol. Screaming lasted until he fell asleep and returned every time he woke up. He slept poorly, waking often throughout the night. It is now 815 AM the next day and the high pitched screaming is continuing. This is in a child who rarely cries.
Patient came in with a reaction on her right arm. It was red, blotchy, and warm to the touch. The reaction did not look like a cellulitis but an allergic reaction. The reaction was spread out and not in a  circular area. The patient said that it does not itch. The reaction started two days after the vaccine was giving. The patient also had a SHINGRIX vaccine in the left arm. We called today to notify Dr. Told the patient to take two benadryl 25mg at tonight. We are calling to follow up with the patient tomorrow to see if the reaction got better or spread. We will then call the doctor tomorrow depending how the patient feels.