chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient was vaccinated with the Moderna vaccine despite being <16 years of age. A voicemail message was left for her, she was asked to return the call, and her employer's HR office was notified because the vaccination was given at her place of employment. No adverse events were noted and she waited the full 15 minutes under RN monitoring.
Patient vaccinated x2: 3/6/21 (Janssen), 4/14/22 (Moderna)  Patient tested COVID positive while inpatient at hospital
Tremors with First Vaccine; This is a spontaneous report received from contactable reporter (Consumer).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 12:50 (Lot number: EN6199) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: the patient had Covid with severe symptoms in Mar2020. The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "Tremors with First Vaccine". Additional Information: The reported stated that tremors should be added to the side effects because the patient had them after his first vaccine also. The patient has no additional vaccines administered on same date of the COVID-19 Vaccine. The events did not require emergency room or physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccination. As reported, the patient has no Medical History (including any illness at time of vaccination). The patient has no family medical history relevant to the adverse events and has no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021352988 same patient, different drug dose and different event.
Case number PHEH2015US003158, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 13 years old patient whose gender was not reported. This patient's medical history and concomitant medications were not reported. On 04 Feb 2015, the patient received MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was 0.4 degree Celsius for 1 hour and 16 minutes, on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Fever 101 degrees,  intense joint pain, muscle aches, headache,  swelling and tightness of hands and feet.
Post given varicella vaccine, patient went home and later that evening felt left arm feeling warm to touch and a red swollen rash about 2x1 1/2 inch.  Patient called into office today morning 8/20/19 and provider had advise patient to put ice compression
Pt came to ER c/o abdominal pain test Covid positive 4 days after covid vaccination.
Pt given vaccine on 2/5/19 that was expired on 1/29/19. Discussed with the CDC and pt will return to repeat the immunization ASAP with vaccine that is not expired.
Three - four hours after my second dose I began to feel dizzy, fluttering in my chest, and short of breath. I sat down to try to catch my breath and decided to put my heart rate monitor on (I use it when I run). My heart rate would dip into the 40s when I normally have a resting heart rate in the mid 60s.  After 30 minutes of sitting and the symptoms getting progressively worse, I decided to go to the emergency room. On the way over I started feeling weak and increasingly short of breath.  These symptoms lasted for approximately 8 hours. Since the episode I have noticed periodic episodes of shortness of breath and chest fluttering.
Feelin achy; Slight temp of 99 degrees; Felt like had the flu for couple of days; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees), INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Sarcoidosis since 01-Jan-2014. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LOSARTAN POTASSIUM (COZAAR) from 01-Jan-2010 to an unknown date for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) from 01-Jan-2010 to an unknown date for High cholesterol.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). On 10-Feb-2021, the patient experienced PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees) and INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days). On 10-Feb-2021, PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees) and INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days) outcome was unknown. On 16-Feb-2021, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Tylenol and ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Past medical history was updated. Concomitant medications were updated.
Pt. called pharmacy at 8:00 pm after receiving vaccines around noon same day complained of itching, swelling in arm and feeling cold.
First symptoms was swelling of lips a few hours after the J&J vaccine received on 04/05/2021. The 2nd symptoms was chills and then 3rd was severe dizziness around 2:30 am.
On 3/09 began vomiting after eating, including formula. On 3/11 was referred to CMC ER by Dr.   XR suggestive of ileocolic intussusception, confirmed by air contrast enema.  Reduced after air contrast enema. Tolerated feeds well and discharged after 24 hr observation on 3/12.  No h/o bloody stools.3/28/08-records received for DOS 3/11/08-DX: Intussusception. Vomiting with every oral intake since day before. 3/12/08-Seen in ED C/O vomiting. Observed in Ed and discharged to home.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:52 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.19.  Concomitant medication of the patient was not reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 06-Apr-2021 and beyond use date for the vials was reported as 09-May-2021. The vaccines moved to clinic on 15-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Patient had status epilepticus following the flu shot. No illness or trauma to explain the seizure. On Respirator due to apnea for 12 hours. Fully recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heat Disease" (unspecified if ongoing); "Allergy: Walnuts" (unspecified if ongoing); "Allergy: shea butter" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOLSUCCINAT AL, start date: 21Apr2023; GABAPENTIN, start date: 01Jun2022; XARELTO, start date: 24May2023, stop date: 12Jun2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (lot number: GG7223) from Jun2023 to Jun2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE,COVID 19) and BNT162B2.  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.
I took the Pfizer mRNA vaccine April 23, 2021 and had my second vaccine May 14, 2021. I have ethnic neutropenia and normally have a white blood cell count below average.  During the summer I had my regular annual physical with bloodwork and it was found that my white blood cell count was extremely, alarmingly low.  I was sent to a hematologist for additional tests and my doctor cannot identify why the white blood cell count is low but he states the ?critical? components of the blood appear to be fine.  I am concerned that taking the Pfizer mRNA vaccine has caused this low white blood cell count and I?ve stated this belief to my general practitioner as well as the specialist. I strongly believe the Pfizer vaccine has exacerbated my low white blood cell count condition and fear that additional doses will continue to severely reduce my count.  One of my associates also mentioned that she visited her physician for a general checkup and he determined that her immunity was low.  The physician stated that he is seeing this trend with individuals that have had the Pfizer mRNA. Note that I did not solicit any medical information from my associate.
Hospitalized 05/10/2022-05/14/2022; COVID-19 positive 05/10/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Admission Date: 5/10/2022 Discharge Date: 5/14/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 Pneumonia due to COVID-19 virus   HOSPITAL COURSE: Patient is a 53 y.o. female with a complex past medical history who presents today with a fever. Patient reported onset of fever was yesterday afternoon and later developed generalized body aches and fatigue. She denied any chest pain, shortness of breath, change in her chronic cough, abdominal pain, nausea, vomiting or diarrhea.  Today she presented to the emergency department and found to have COVID-19. She was felt stable to discharge home. Later tonight she returned to emergency department for shortness of breath and hypoxia. Her home pulse oximeter was reading 83-88% on room air. She required 4L 02 to maintain sats above 90%. Repeat chest x-ray significantly worse, demonstrated worsened patchy airspace opacities in both lungs.  She was given 6 mg Decadron and hospitalist services were contacted.  She was admitted for acute respiratory failure with hypoxia due to COVID-19 pneumonia.     5/14:  Patient did well during this admission.  She was weaned off supplemental oxygen.  She continues on steroid which will be continued for total of 10 days.  Patient completed 4 days of IV remdesivir.  She was feeling well on day of discharge and wanting to go home.  She has remained hemodynamically stable.  Her inflammatory markers continued to improve.  Her mild renal insufficiency resolved.  Patient is stable for discharge.  She was given COVID-19 discharge instructions.  She is asked to follow up with her primary care provider next week.  She will continue with bronchodilators as per her asthma regimen, and CPAP at night for sleep apnea.
Myalgias and arthralgias throughout body.  Has lasted at least to the 24th. There were still ongoing.
Felt palpitations of fast heart beat with some shortness of breath  about 10 minutes after the vaccination.  Lasted about 20 minutes with gradual resolution.
Fatigue, dizziness, weakness.  Issues with breathing caused hospitalization 3 days after shot. Blood clot located in lung and 2 in right leg. Hospital stay 11 days, step down facility roughly 2 weeks, PT/OT upon arrival home.
Redness, swelling and warm to touch at injection site. Left bicep and deltoid muscles are sore. 3"x 1" hard ball-like mass under skin of injection site. Reporting nurse advised her to monitor temp and if fever develops to contact her doctor. Recommended Benadryl to help with reaction.
Bad headache and nausea for about 24 hours starting almost 24 hours after I got the vaccine.  I took ibuprofen for the headache.
OBSTRUCTIVE SLEEP APNEA 11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recv vax 9AUG97 & exp an inj site rxn (3 1/2-4inches) described as red, swollen & hard;rxn lasted approx 2 to 3 days & resolved;
Rashes and hives chronic urticaria and dermatographia appeared after 10 days. with fatigue and stomach upset. that continues until the time of filing this report.
The child had rash about 10 days after MMR vaccination. Pt could have other viral illness on top of it. Pt also developed otitis media and was admitted to a hospital on 04/18/2002 with no definite diagnosis. Pt recovered.
Severe aching of head, neck and back followed by weakness of arms and legs.  This started 24 hours after the shot and has continued for 5 days.  Physical exam and neurologic examination is completely normal.
Administration site swelled with redness and felt warm to touch. MD gave pt antibiotic to ward off infection.
PAIN AT INJECTION SITE WITH HEAT TRAVELING TO NECK/CHILLS Narrative:
Employee complaining of swelling in joints, hands, intermittent pain, progressive fatigue post flu vaccine in October. Employee went to primary MD and tested for rheumatoid arthritis and result was negative inflammatory markers. Chest xray was negative as well.
has a reaction in her arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (has a reaction in her arm) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (has a reaction in her arm). At the time of the report, VACCINATION SITE REACTION (has a reaction in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had a reaction in her arm. It had been two weeks since her first shot  No treatment medications were reported
vaccine had been stored more than 30 days past the initial thaw date; No adverse event; Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date) and PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date).    No concomitant medications were reported.  On 09-Aug-2022, the vial was thawed and was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Patient has not reported any symptoms. Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider.  No treatment medications were reported.
Mild itching, stiffness, redness around injection site. Covers an area approx 8 inches by 4 inches
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, on or about 2016, the patient was treated by a physician for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
Got GARDASIL #3 vaccine 1-26-10. That night woke up at 0100 with chills/dizziness. Temp 101 @ 0430 with nausea.
Pt received 2nd ANTHRAX on 28 Apr 10 in right deltoid.  On Sunday, pt states rash began on left rib and as of Tuesday 4 May 10, rash is beginning to spread to back and towards left torso.  Pt has not been seen by provided yet & no medications have been used or taken.
1:32: patient reported throat feeling tight, dizziness, tingling in lips and tongue. Called squad. At 1:42 squad arrived, patient ambulated  to squad with assistance.
Severe cough, whelps on face. Visited emergency department and was given epinephrine, Benadryl and Rx for prednisone.
Having a lot of weakness in the legs which started the next day after the vaccine and today he is still weak in the legs. Unable to walk without a walker or he will fall.
Son had a several fevers throughout the month of May after his shots were administered that were 100 or higher. He stopped eating regularly as well, and stopped gaining weight. In July 2012 almost two months after his shots he was diagnosed with neutropenia, not sure what kind. Was admitted to hospital in July and he received antibiotics and fluids. He had not gained weight, grown in height and was more tired than usual throughout the month of June.
Vaccine was incorrectly reconstituted by LPN with 0.8mL of NS instead of 1.8mL. After reconstituting with 0.8mL of NS, a dose of 0.3mL was given to patient. After injection, patient waited in office for 15 minutes. No adverse events were reported after administration.