chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 19 yo female who presented to clinic for Hep B vaccine series and Varicella series due to upcoming medical program. Patient was seen and given Engerix-B (Hep B) vaccine 1.0 mL in the left deltoid by APRN.  APRN did do typical safety checks including checking vaccine name, lot, and exp with patient. Pt tolerated immunizations well and left clinic after 10-15 min sit time. On 6/27/23 APRN was speaking with another provider about Hep B vaccine age and realized that a 1.0 mL dose was given when the vaccine guidance states that anyone 19 years and younger should receive 0.5 mL dose. This was reported immediately to direct supervisor. APRN called manufacturer and based on their guidelines clarified that there is no clinical evidence to suggested that this will result in harm. Patient should receive 0.5 mL dose at their 1 mo repeat, and 1.0 mL at their 6 months as they will be 20 years old at that time. Called patient 6/28/23 after clarifying schedule and guidance with manufacturer. Verified 2 identifiers and advised patient of error, guidelines, and new dosing schedule. Patient stated that ?I am not worried about this at all?.
Severe stomach pain for 4 hours after injection.; This is a spontaneous report from a contactable consumer (patient herself).  This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3429), via an unknown route in the left arm, on 19Feb2021 10:30 (at the age of 75-year-old) at single doe for COVID-19 immunisation. No other vaccine was received in four weeks. Medical history included lyme disease and allergy to NSAID. Past drug history included allergy to acetylsalicylic acid (ASPIRIN), penicilin, doxycycline, ceftriaxone, tramadol, trandolapril, prochlorperazine maleate (COMPAZINE), and ceftriaxone sodium (ROCEPHIN). Relevant concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE), azithromycin (ZITHROMAX) and estradiol. On 19Feb2021 11:00, the patient experienced severe stomach pain for 4 hours. No treatments were given for the patient. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had recovered from the event on 19Feb2021 15:00.  No follow-up attempts are needed. No further information is expected.
She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; This is a spontaneous report from a contactable female nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unspecified) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was asking if it is safe to get the second dose of the vaccine after being exposed to or having COVID? She reported being exposed to her husband (on an unspecified date), who tested positive for COVID, and that she tested positive following her first vaccine dose. She got her Covid-19 vaccine on the 23Dec2020 and tested positive for Covid-19 on the 28Dec2020. She was scheduled to get the next dose on Wednesday and wants to know if she should still get it.  Outcome of the events drug ineffective, COVID-19 and Exposure to COVID-19 was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 28Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID test was likely associated with being exposed to her husband, who had COVID-19.  Further information is needed for full medical assessment.
1 days p/DTP approx mid afternoon pt exp generalized sz lasting 10 min, & low grade temp;
No additional AEs or PQC reported; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) PNEUMOVAX 23  U034712  7/30/2023        ?    Temperatu; This spontaneous report was received from  a medical assistance, referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-JUN-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine was stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
Whole arm where the patient got the injection went numb, from the shoulder to the fingertips; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
shortness of breath, 2 days hoarseness 1 day dizziness 1 day tired 2 days
Information has been received from a licensed practical nurse concerning a patient who during the second week of November 2009, was vaccinated with a dose of PNEUMOVAX 23. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) at a different site. The patient was scheduled to be seen in the office on 11-NOV-2009 for a severe local reaction. At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from a licensed practical nurse who reported that the lot number of PNEUMOVAX 23 is 663214/0037Y. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a license practical nurse concerning a 50 year old patient with hypertension, type II diabetes and hyperlipidemia and with no known allergies who on 06-NOV-2009 at 11:56 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 6631214/0037Y) IM in the left deltoid. On 07-NOV-2009 at 12:00, the patient experienced swelling pain and warmth. The patient was seen by a physician on 10-NOV-2009. Her symptoms had improved but still had some mild erythema, slight warmth and mild tenderness. This is one of several reports from the same source. Additional information is not expected.
Area of (R) upper anterior thigh swollen, firm, slightly red, slightly warm. Needled -> no pus.
Pt. presented to pediatric fast track clinic on 5/17/13 with mother reporting c/o left arm redness, warmth and swelling that started after vaccines given on 5/15/13. Pt. started on oral KEFLEX and scheduled to follow-up in 3 days.
Fever +4 degrees to 101.5 labored breathing excessive sweating  chills nausea swollen, red, itchy injection site
The day after given vaccines-DTaP and IPV, Patient had his first afebrile seizure.-fell, convulsing for 5 minutes, with postictal sleepiness for 45 minutes and bladder incontinence. He was seen in the Emergency Room-still afebrile, normal glucose. He was later evaluated by Pediatric Neurology. Family history febrile seizure-paternal grandfather.
Client is a 50 y.o. female who received the Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/23/2021. The patient experienced the following reaction(s) during the immediate   of observation:  1023am: pt c/o feeling "dizziness, faint, and palpitations".  Patient was treated/managed as follows:   1025am: Pt was seen in treatment area. 1st set of VS are as follows: BP-166/88,HR-64, R-18, 02 sat-97%. Pt offered water for hydration. Pt symptoms began to resolve. Pt states feeling better and not c/o dizziness, faintness, or palpitations any longer. 1035am: 2nd set of VS completed: Bp-142/62, HR-66, R-18, 02-98%. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. 1045am:Pt reports symptoms have subsided. Pt escorted to car by  RN.
Bleeding nose; This non-serious case was reported by a consumer and described the occurrence of epistaxis in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced epistaxis (Verbatim: Bleeding nose). In AUG-2023, the outcome of the epistaxis was resolved.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.     It was unknown if the company considered the epistaxis to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-AUG-2023 The reporter stated that the symptoms were treated. The reporter consented to follow up.
fever, Fatigue and Chills, Treated with Tylenol and Advil to ease the symptoms and lower the fever. Symptoms persisted for two days after taking the first dose of the vaccine.
Pt told me he wasn't feeling well as we were driving home from the doctor's office and then fainted in the car. We returned to the doctor's office where they monitored him until he was feeling normal.
Returned approximately 90 minutes after getting injection stating her arm was itching. Arm where it was given is blotchy. No hives.
dizziness and flushing, waited in recliner with legs elevated, symptoms resolved in 20 minutes
I did not have a reaction to the vaccine. In 02/2022 I developed hives on my chest area which was very hot and itchy. It moved to my arm and legs. It lasted about 8 months. I took CLARITIN and ALLEGRA which helped with my symptoms. As of today, I do not have hives and feeling better.
myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), VENTRICULAR TACHYCARDIA (NSVT episodes) (seriousness criteria hospitalization prolonged and medically significant) and CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, MYOCARDITIS and VENTRICULAR TACHYCARDIA. At the time of the report, MYOCARDITIS (myocarditis) and VENTRICULAR TACHYCARDIA (NSVT episodes) was resolving and CHEST PAIN (chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: high (High) 4 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. In 2021, Ejection fraction: abnormal (abnormal) 53%, inferolateral hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Inferior, anterolateral STelevation. In 2021, imaging: abnormal (abnormal) Edema, delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: high (High) baseline-1327 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and high (High) Peak-1433 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) to be possibly related.    Discharged in stable condition. Treatment information not provided.  Company Comment : Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.
Pain in L/A unassociated with injection site and now calls it "hyperesthesia"; pain in right side of neck with neck stiffness. Using Ibuprofen PRN. This is an ER physician.
11-28-08 Mom reports body rash for 9-10 days and vomiting 1-2 times daily from 11-28-08 until 12-2-08; also "change of attitude" screams loudly at times during night; concurrently family sick with "stomach flu".  1-20-09 Dx with left hip Synovitis by Dr.
t103-103.6 x 24 hrs APAP was given q 4 hrs according to mom; fever began approx 6 hrs p/vax; pt also had what mom states was sore arm; pt would not use it very much; but did not notice redness or swelling;
gallbladder stones; broke out with blisters; pain in arm / sore arm; This spontaneous case was reported by an other and describes the occurrence of CHOLELITHIASIS (gallbladder stones), BLISTER (broke out with blisters) and PAIN IN EXTREMITY (pain in arm / sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (two to three glasses of wine or champagne. No tobacco.) and Drug allergy (Allergy with Codeine manifested by break out with rash on the palm and hand.). Concomitant products included SIMVASTATIN for High cholesterol, LISINOPRIL for Hypertension, UPADACITINIB (RINVOQ) for Rheumatoid arthritis, KRILL OIL (MEGARED OMEGA 3 KRILL OIL) for Vitamin supplementation, HYDROCODONE BITARTRATE;PARACETAMOL for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (pain in arm / sore arm). On 29-Mar-2021, the patient experienced BLISTER (broke out with blisters). On an unknown date, the patient experienced CHOLELITHIASIS (gallbladder stones). In March 2021, PAIN IN EXTREMITY (pain in arm / sore arm) had resolved. At the time of the report, CHOLELITHIASIS (gallbladder stones) and BLISTER (broke out with blisters) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm / sore arm) to be possibly related. No further causality assessments were provided for CHOLELITHIASIS (gallbladder stones) and BLISTER (broke out with blisters).
COVID Vaccine Breakthrough Case Moderna Dose 1 3/18/21 (lot NA) Moderna Dose 2 4/15/21 (lot NA) COVID Negative 11/13/21 COVID Positive 11/27/21  11/27/21:  The patient presents with Patient came to the ED by ambulance after his visiting home health nurse came to the house and found him lethargic and generally weak. He was just discharged from HOSPITAL 2 days ago where he was treated for C. difficile diarrhea and a Klebsiella UTI. He has one more day of Levaquin 750 mg to take and 5 more days of vancomycin 125 mg PO before completing his treatment. Upon arrival to the ED patient is noted to be very weak, awake, answers questions with an almost inaudible voice, and oxygen saturations of 85% on room air. No known fever, injury, loss of consciousness, chest pain, or other symptoms.  12/6/21: patient has improved respiratory status but is still too weak to do ADLs and requires extensive assistance and wound care not able to care for self at home will be admitted to skilled to continue to work on strengthening and evaluate if needs longer term care placement.
Patient experienced a brief period of syncope with nausea,  darkened vision, a feeling of numbness, but no loss of consciousness.  Patient then vomited a very small amount of fluid and after a few minutes of waiting reported feeling much better.  After a few more minutes of waiting, they walked around the store and then left without further incident.  Entire incident from vaccine administration to patient leaving was approximately 20 minutes.
patient was treated for ocular shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced ocular shingles (ophthalmic herpes zoster), which led to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for ocular shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), 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.  Upon internal review, ophthalmic herpes zoster was determined to be medically significant.  Additional information has been requested.
On 8-4-20 pt. came to clinic to speak to doctor re: syx. Was advised to use cold compressions and take Tylenol, Ibuprofen or Advil. On 8-5-20 I called pt. to follow up. Per pt. went to a doctor and was prescribed Ibuprofen 600mg x 6 hr d prn for pain. Advised to take until pain is better.
Difficulty breathing, drop in oxygen, closing of the throat; I had to be given a EpiPen and had to be taken to E-R.
her tight feeling tight and 'weird, sore and achey'; her tight feeling tight and 'weird, sore and achey'; Throat tightness; Cough; Ear felt swollen and was red; Ear felt swollen and was red; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on an unknown date at 1ST single dose for covid-19 immunization. Medical history included allergy skin disorder. The patient's concomitant medications were not reported. On an unknown date, 2 weeks after having the 1st dose, her throat felt tight and she had a cough, her ear felt swollen and was red. It was stated that this occurred twice and each time she took Benadryl and it got better. Also stated that this was what happened whenever she has an allergic reaction to something. Patient felt tight and weird, sore and achey. She did pre-medicate with Allegra and Pepcid AC and asked was that okay to do. She heard not to take Motrin before getting the vaccine, so she wanted to make sure that it was okay to take the Allegra and Pepcid AC. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
At about 5:00 pm had extreme sore arm and lymph nodes hurt - started feeling  feverish temp 101.9.  Extreme headache and ears hurt - at about 9:30 pm I started violently vomiting bile and diarehea at the same time.  It is 10 feet from my bed to the bathroom I was unable to walk without holding onto wall. extremely weak felt like I was going to fain - my husband wanted to take to to ER vomiting/diareaha . I lasted about 4 hours off and on.  Splept until 4:30 pm the next day.  Still have some weakness in my arm where shot was administered.  Had shooting pain down that arm for about a week after the injection
Patient had 1st dose of Moderna COVID-19 vaccine on 5/10/2021.  Several days after he complained of "not feeling well" and fatigue, but did not give more specific symptomatology.  On 5/17/2021 he had a sudden collapse at home and was transported to local hospital, where he was pronounced dead.  Case accepted as medical examiner jurisdiction due to no apparent medical history and sudden death after vaccine administration.  Full autopsy completed on 5/19/21 revealed obstructive pulmonary thromboemboli as cause of death, with lower extremity DVT.  Both portions of the pulmonary thromboembolus and the DVT show organization, thus raising question of whether this process started before or after the vaccination.   No known history of thrombophilic disorder, recent injury, or prolonged stasis/immobility.  Not known to be current smoker.  See below for additional autopsy information.
Case number PHEH2016US028861, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Returned to vaccinator 10-15 after injection, c/o nausea, feeling hot with burning sensation at injection stite. BP 164/112, P 100 and P 120, T 97.8 R 22. c/o feeling shaky, moved to floor from chair. Paramedics called. BP by first responder 132/86 and P88. Transported by ambulance to ER.