chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortly after receiving his second Pfizer shot in the left arm, he was sitting outside the pharmacy  waiting the required 15 minutes with his mother and said that he felt like he was "trying harder to breathe" and said his heart started beating faster. We asked about any other symptoms he was having and said he felt like his chest was heavier. I gave him a dose of Benadryl and told him he could take his mask off so it would be easier to breathe and told him to stay here for longer until he started to feel better and to let us know if he feels any different. after another 20 minutes he said he was feeling better and didn't have either of those symptoms anymore. We counseled on other symptoms to look out for and to let us know if anything else happens and to contact urgent care or his md if anything else happens. especially breathing issues. He left a few minutes later saying he was feeling better.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 6 December 2021,  Lot 012H21B vials was placed in refrigerator. No concomitant medications information were reported. No treatment medications information were reported.
Patient is deceased (12.10.21); hospitalized (11.29.21); COVID-19 positive;  fully vaccinated  Admission Date: 11/29/2021 Discharge Date: 12/09/2021 DISCHARGE DIAGNOSES 1. Atrial fibrillation with RVR 2. Bilateral pulmonary emboli 3. Altered Mental Status 4. COVID-19 5. E coli UTI 6. Left distal femur fracture s/p ORIF  7. Acute on chronic macrocytic anemia 8. Dysphagia 9. Hypertension 10. Type 2 diabetes 11. BPH 12. GERD 13. Hx gout 14. Sensorineural hearing loss DETAILS OF HOSPITAL STAY: HOSPITAL COURSE:   Atrial fibrillation with rapid ventricular response Patient was admitted to the hospital from his nursing home in AFib with RVR.  This required a Cardizem drip in the intensive care unit.  Echo showed EF of 50%.  This was transitioned to Cardizem 360 mg long-acting and 50 mg metoprolol long-acting.  If transition to hospice was not made, he would have required additional rate control medications. Bilateral pulmonary emboli On CT angiogram in the emergency department, bilateral pulmonary emboli were seen.  He was started on therapeutic Lovenox, which was transition to Eliquis.  This was likely a provoked PE secondary to being nonweightbearing after recent ORIF of left distal femur fracture on 11/13. COVID-19 Patient became hypoxic during his stay requiring briefly 1 L of oxygen.  COVID testing was completed which was positive.  Patient was placed in isolation and started on Decadron. Urinary tract infection Upon chart review, patient had a positive urinalysis with a culture growing E coli couple days prior to admission.  This does not appear to have been treated and patient was treated with a course of Keflex.  Over the course of his stay, his condition deteriorated. He did try to get out of bed on his own and fell 12/7, CT head negative for intracranial process; no other injuries sustained. Xray of surgical site left hip negative for new fracture.  He was A&O x0 yesterday morning.  Hospice meeting was held yesterday at noon with patient's son/DPOA and patient was transitioned to hospice upon discharge.
These events occurred on 07/29/21. I gave the patient the shot at 5:05 pm, about 2 minutes later she said she wasn't feeling good and asked if it was normal. I told her that I would grab the Pharmacist on duty and get her some water. When the pharmacist came over the patient was increasingly getting worse. The patient said that she felt like she was going to pass out. She took sips of water and the pharmacist put ice packs on her to cool her down. We had an EpiPen on hand ready to administer if she was feeling like she couldn't breathe. About 2 minutes passed and the pharmacist decided it was time to call 911. Her heart rate increased and she was sweating. After 10 minutes the ambulance arrived and assessed her vitals. When the ambulance arrived she was visibly better and able to stand and walk around. She did not have to go to the hospital and she ended up going home with her husband driving. I called her this morning 07/30/21 and she said she felt fine.
hepatitis B pediatric vaccine date given 27-MAY-1999/hepatitis B pediatric vaccine date given 09-NOV-1999; hepatitis B pediatric vaccine date given 26-APR-1999/hepatitis B pediatric vaccine date given 27-MAY-1999; This spontaneous report has been received from a physician via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (2303USA004466), concerning a 5-week-old, female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 26-APR-1999, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection (exact dose, lot #, expiration date, site and route of administration were not provided). On 27-MAY-1999, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection (exact dose, lot #, expiration date, site and route of administration were not provided) (inappropriate schedule of product administration). On 09-NOV-1999, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection (exact dose, lot #, expiration date, site and route of administration were not provided) (inappropriate schedule of product administration). Between the vaccinations with hepatitis b vaccine (recombinant) (manufacturer unknown), the patient received additional vaccinations on following dates: hemophilus influenzae B (HIB) vaccine (01-JUL-1999; 23-AUG-1999), inactivated polio virus (IPV) vaccine (23-AUG-1999), hemophilus influenzae B (HIB) vaccine (09-NOV-1999).   This is one of three reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2305USA001540: US-009507513-2303USA004466:
Raised, red, hot, painful golfball size knot at injection site. Severe joint pain, head ache, fatigue and malaise.
dizzy; blood pressure; foggy headed; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills) 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.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Terrible headache/severe headache; chills with no fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix (left arm). On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Terrible headache) and chills (Verbatim: chills with no fever). The outcome of the headache and chills were resolved.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.     It was unknown if the company considered the headache and chills to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 23-APR-2023. The reporter was the husband of the patient.  The reporter stated his wife received Shingrix and she woke up this morning with a terrible headache and chills but no fever.  The reporter did not consent to follow-up. MI phone number provided. Referred to HCP
Delayed reaction; Arthritis is ten times worse; very lethargic; Became very tired; Had a low grade fever; Worsen muscle pain; Worsen joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Delayed reaction), ARTHRITIS (Arthritis is ten times worse), LETHARGY (very lethargic), FATIGUE (Became very tired) and PYREXIA (Had a low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: shingles vaccine (Symptoms (associate with the COVID-19 vaccination) are similar to symptoms when patient received shingles vaccine several years ago ). Concurrent medical conditions included Arthritis. Concomitant products included CELECOXIB (CELEBREX), FOLIC ACID, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, LOSARTAN POTASSIUM, LAMOTRIGINE (LAMICTAL) and QUETIAPINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Delayed reaction), ARTHRITIS (Arthritis is ten times worse), LETHARGY (very lethargic), FATIGUE (Became very tired), PYREXIA (Had a low grade fever), MYALGIA (Worsen muscle pain) and ARTHRALGIA (Worsen joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Delayed reaction), LETHARGY (very lethargic), FATIGUE (Became very tired) and PYREXIA (Had a low grade fever) outcome was unknown and ARTHRITIS (Arthritis is ten times worse), MYALGIA (Worsen muscle pain) and ARTHRALGIA (Worsen joint pain) had not resolved.            It was reported that after the second vaccine patient had arthritis,  ten times worse with her muscle and joint pain.
Client reported painful injection site and a flare-up of her carpal tunnel symptoms in her right hand.  Client reported reaction the morning after the injection and contacted her doctor who advised her to use a cool compress and take Ibuprofen for the pain. Client had pain to the point that she sould not go to work on 9/13/11 and 9/14/11.
Five and 1/2 months after vaccination of 3rd dose, I started having a sore throat, fatigue, body aches and a runny nose. Two days later on 5-14, I went to a pharmacy and I tested positive for Covid. I did not seek any care and just took Advil and Sudafed. On May 17th, I developed a cough. I am feeling better today with a lingering cough and fatigue. I am reporting my breakthrough case of Covid.
Pain in left arm; slight fever; lots of chills for 1 1/2 days; fatigue; generally feeling lousy
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD albumin status: recombinant human albumin (rHA) (dose, anatomical location and route of administration were not reported) lot # N025926, expiration date: 18-MAR-2019 indicated for prophylaxis which was reconstituted with sterile diluent (MERCK) properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes on unspecified date called by a data logger. There were previous excursions reported of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA002899.
Fast heartbeat; chestpain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Mar2021 13:45 (01:45 PM) (at the age of 58-year-old) as a single dose for COVID-19 immunization. The patient medical history included COPD. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient experienced fast heartbeat, chest pain on 05Mar2021 22:30 (10:30 PM). The patient underwent lab tests and procedures which included heart rate was fast on 05Mar2021. The patient had not tested for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient was seen in the ER on the morning of 11/27/21 with croup, negative for Covid
Dizziness and Weakness.  Hot flashes and Sweating. Swelling of the face and throat. 4hours of time span.
Numbness [and tingling] of extremities; Inability to lift the arm past their shoulder; Tingling in extremities; This is a spontaneous case initially received from other health professional (nurse) on 26-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date in Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39107 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day after vaccination, the patient was unable to lift the arm past her shoulder and experienced numbness and tingling in her extremities.  The outcome of the events was recovered (2 weeks or more after administration date).  This case is linked to 201804876, due to same reporter.  The reporter assessed the case as non-serious.; Reporter's Comments: A female patient of an unspecified age experienced numbness and tingling in her extremities and was unable to lift her arm past shoulder, on the same day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.
Patient is reporting of swollen arm below injection site. She said it is warm, swollen, and painful to the touch. Counseled her to seek medical care in the event of infection
these symptoms began around 8 pm on 4/5/21 - Headache - severe; chills; muscle aches in neck and upper back; nausea;  dizziness upon awakening on 4/6/21 such that when brushing teeth in morning, I blacked out and fell to the floor hitting my head. fatigue all day on 4/6/21  above symptoms resolved at 11:00 pm on 4/6/21
rash,  Itchiness and swelling  for 3 weeks after the vaccine.  pain and aching for over two months and still occurring
Information has been received from a pharmacist concerning a male in his 70's who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was noted that the dose was given IV instead if IM. Subsequently, on 11/23, the patient experienced shortness of breath and his skin was bright red. It was reported that the patient was hospitalized and given Solumedrol. No other information was available. Additional information has been requested.
about 5-7 minutes after injection I began to feel dizzy and very weak with tachycardia. ~140 BPM, seeing stars, and unable to concentrate (feeling as I will pass out) Symptoms lasted for about 10 minutes and recovered gradually on its own.
expired dose of ACTHIB was given to a patient with no adverse event; Initial information received on 05-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00712752).  This case involves a one years old female patient who was vaccinated with the expired dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] for immunisation.  On 05-Aug-2021, the patient received a 0.5ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAC and expiry date: 28-Jun-2021) (oral solution) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter "asking if patient will need to be revaccinated."  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Heart Racing.......for no reason.  did this to me the first time as well....but not as pronounced
I had a sore arm after receiving the vaccine but nothing to bad. On May 28 I started slight cough and a sore throat. It wasn't terrible but I noticed it. On the morning of May 29, I tested positive for Covid 19. On May 30 and 31 I had more symptoms. I felt cold, a cough and a far amount of fatigue. Monday night I didn't sleep very well. As of today, I'm feeling better but still feeling fatigue. I took cough medication and Tylenol to relieve my symptoms.
Temperature excursion that occurred on the 25 Oct 2021. Fridge went out of range for 7 minutes/Patients given doses out of temperature range; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Pt awoke next morning 18SEP91 w/t104.9; Was seen @ ER; blood test OK; was put on meds; pt OK on 20SEP91;
Hospitalized (12.25.21); COVID positive (12.25.21); fully vaccinated  Admission Date: 12/25/2021 Discharge Date: 12/29/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  Pneumonia of both lungs due to infectious organism, unspecified part of lung Congestive heart failure, unspecified HF chronicity, unspecified heart failure type (HCC) COVID-19 virus infection  Pneumonia due to COVID-19 virus  HOSPITAL COURSE: Patient is a 64 y.o. female, PMH of Afib on coumadin, Ashtma, COPD, Severe MS, CAD, CVA, DM-2, Moya moya disease, Pharyngeal dysphagia who presented to a local hospital with SOB. Patient  received her Moderna COVID-19 immunizations in March- April of this year.  Onset of symptoms 4 days ago of upper respiratory infection type with nasal congestion, a sore throat, initially a nonproductive cough that is become more productive over the past day.  She has had increasing shortness of breath with the cough with generalized weakness with fevers, chills, malaise myalgias.   On arrival she was hypoxic. CXR noted patchy infiltrates greater on the left consistent with COVID pneumonia.  There is increased interstitial markings consistent with the elevated BNP in congestive heart failure. Procal mildly elevated at 0.27. CRP at 186.6. Patient has h/o CVA with pharyngeal dysphagia. Concern for superimposed bacterial infection. Started on ABx in addition to decadron. Admitted for further care. Patient required 3 L of oxygen to keep her sats above 90%.  Unasyn was continued for possible aspiration pneumonia given her pharyngeal dysphagia.  HCF was consulted and evaluated for swallow dysfunction.  Patient was continued on dexamethasone and remdesivir.  Patient had improvement in her symptoms.  However she was unable to be weaned off of supplemental oxygen.  She was evaluated by respiratory therapy and was found to require 2 L of oxygen to keep her sats above 90% both at rest and on ambulation.  Patient agreed to go home on supplemental oxygen until she could be weaned of a new feature.  Patient was evaluated by PT OT and was recommended home with home health.  She was discharged home in stable condition on supplemental oxygen.
10/10/04 joint, hip, neck pain, fever 100.9, continued to increase hip/joint pain, referred to urgent care Rx with Motrin.
The patient had a mostly uneventful pregnancy.  She was treated at one point for depression, but stopped the medication and coped well.  She received the vaccine on 8/5 and reported a very active baby that day.  Five days later, she felt the baby move for the last time, and came in for evaluation the next day, and the baby had passed away.  I am uncertain if the vaccine had anything to do with the stillbirth, but I wanted to report it as everything was healthy and normal leading up to it.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX (subcutaneous, lot# reported as K016132, expiration date: 24-SEP-2016, 0.5ml). The vaccine product was administered post temperature excursion (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received pneumonia vaccine 10/31/2001 in AM. By that same evening, noticed swelling at injection site. Swelling increase to elbow joint. Called doctor's office on Friday. Assessment of edema. Recommended ice, elevation and Benadryl.