chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022) and PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose was administered to patient from a vial that was opened yesterday 19Apr2022) and PRODUCT STORAGE ERROR (vial was stored in Refrigerator post puncture) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. It was reported that the vial was stored in refrigerator post puncture and was received at the facility as refrigerated storage. The manufactured expiry date was reported as 11-Jul-2022. The vial was first punctured on 19-Apr-2022 at 08:45 am and was administered at 20-Apr-2022 at 10:00 am. It was also reported that the vial did not undergo any temperature excursion neither was stored at room temperature, only was exposed to room temperature at the time in between to pull up doses from the vial, at the most 10 minutes per HCP.
Patient experienced severe swelling/edema on left FOREARM, as well as rash at elbow crease.
Information has been received from a medical assistant concerning a 19 year old female patient who in July 2008, was vaccinated with her first dose of GARDASIL (Lot number not provided). The patient did not have any other vaccinations. A PAP smear on 15-JUL-2009 was positive for one or more of the following types: 16, 18, 31, 35, 39, 45, 51, 52, 56, 58, 59, or 68. Medical attention was sought in the office. At the time of the report, the patient had not recovered. Follow-up information has been received from the medical assistant concerning a female cashier. It was reported that the patient never followed up for additional two vaccines. Additional information is not expected.
A non health professional from physician's office reported that a 43 year old female received an expired FluMist vaccine on 24 Aug 05. The nurse who administered the vaccine later found out that the FluMist vaccine's expiration date on the label was 11 May 05. The patient did not report any adverse event following receipt of the vaccine. The reporter causality is not provided.
Eyesight fading in left eye /; This has caused him great distress; Felt sick; Can't sleep; tinnitus; taking his concentration away/ life has been turned upside down; life has been turned upside down / Felt awful / Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Eyesight fading in left eye /) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patients medical history was not provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down) and FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible). In May 2021, the patient experienced VISION BLURRED (Eyesight fading in left eye /) (seriousness criterion medically significant), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep). At the time of the report, VISION BLURRED (Eyesight fading in left eye /), TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down), FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep) outcome was unknown.            Patient received both doses of Moderna Covid-19 vaccine and he reported that he has felt terrible, awful and sick for 4 weeks. He cannot sleep and his eyesight is fading in his left eye. This caused him such great distress. He did not give consent for safety to follow up.   No treatmnent or concomitant medication were reported by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Significant follow up appended to AER; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded
pt passed out right after getting vaccine for 10 seconds.  Father stated this has happened before and they had hoped it wouldn't happen again.  The family did not disclose this information until after vaccine given.  Patient was monitored for 30 minutes with no additional reaction.
Extreme fatigue, malaise, nausea as well as minor sinus congestion starting at 7:45pm. Symptoms got progressively worse through the evening and night. Woke up on 11/20/2012, with sore throat, significant sinus congestion, conjuctivitis and mild cough, as well as continued malaise, fatigue and mild nausea. Symptoms began to slowly improve on 11/21/2012, with largely complete resolution by 11/22/2012.
3cm area of erythema s significant induration at site at DTaP #4 (outer thigh)
Dizzy/lightheaded about an hour after vaccine then sudden onset of extreme fatigue. Slept about 6 hrs woke up with massive chills, slept another 7 hours. Woke up with dizziness, chills, shortness of breath, weakness, achy, headache. Slept on and off all day. This continued for 2 days. The dizziness, headache, shortness of breath, fatigue and general I?ll feeling continued until day 13.  Day 14, April 16th - first day I feel somewhat normal. Still a little fatigue as day went on. Had to take a nap. The dizziness seems to have subsided. Still experiencing Mild intermittent headaches and occasional shortness of breath and  palpitations.
flu-like symptom; aches; chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he felt like he had flu-like symptoms, aches and chills on an unspecified date (Event took place after use of product). The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.
Narrative:  86yo male patient with bladder cancer and heart conditions died on 12/30/2021 during inpatient at hospital (non-facility). PMH: Bladder cancer (SCT 399326009) Atrial fibrillation (SCT 49436004) Low back pain (SCT 279039007) Cardiac defibrillator in situ (SCT 441769002) History of coronary artery disease with CVA (ICD-9-CM 434.91) Glaucoma (SCT 23986001) Cardiomyopathy (SCT 85898001) Benign essential hypertension (SCT 12010Erectile Dysfunction (ICD-9-CM 302.72) Elevated PSA (ICD-9-CM 790.93) Hyperlipidemia (SCT 55822004) Benign prostatic hyperplasia (ICD-9-CM 6 Pt had received covid vaccines from outside facility site on 1/21/21, 2/23/21, & 11/2/21 from health dept This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Discharge Provider:  PA-C Attending Physician:  MD Primary Care Provider at Discharge: None Physician, DO  Admission Date: 9/10/2022 Discharge Date: 09/15/2022  PRESENTING PROBLEM: Hypoxia  COVID-19    HOSPITAL COURSE: Patient is an 80 year old male with past medical history of CAD, HLD, HTN, hx of left preauricular squamous cell carcinoma with mets to lymph nodes s/p resection, chemo and radiation, memory impairment, and chronic back pain with history of compression fractures s/p vertebroplasty. He presented to ED following recurrent falls. In the ED, he was found to be hypoxic and placed on 3 L NC. COVID positive. CBC showed mild leukocytosis. CMP unremarkable, ProBNP found to be elevated. CXR clear with mild coarsening of lung markings. He was admitted for further treatment. He was given one dose of IV lasix and admitted for further care. He was started on remdesivir and decadron. Supplemental oxygen was weaned to room air at rest but did require supplemental O2 with activity. He was seen by pulmonary rehab who recommended 2 L NC with activity. He completed 5 days of remdesivir. He will be discharged with decadron to complete 10 day course.    He underwent echo with showed preserved EF without significant valvular disease. Orthostatics notable for elevated BP when lying flat, however patient reported worsening back pain when flat. No significant change in standing BPs. He was seen by PT/OT who recommended return home to his independent living facility where he resides with his wife. He was felt stable for discharge home on 9/15 and his son/DPOA was also informed and in agreement with this plan. He was advised to arrange follow up appointment with his PCP within 1 week. PCP to determine duration of supplemental oxygen use as it is expected he will continue to improve and may not need this permanently.
; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt under the weather for 2 days) and VACCINATION SITE PAIN (sore left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine)  No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING ABNORMAL (felt under the weather for 2 days) and VACCINATION SITE PAIN (sore left arm). On 18-Feb-2021, FEELING ABNORMAL (felt under the weather for 2 days) had resolved and VACCINATION SITE PAIN (sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   No treatment information was provided.
sick; not quite feeling himself; not receiving 2nd dose of the Moderna COVID19 vaccine; COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19), ILLNESS (sick), MALAISE (not quite feeling himself) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, SIMVASTATIN, TAMSULOSIN, LISINOPRIL and FINASTERIDE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (COVID19). On an unknown date, the patient experienced ILLNESS (sick), MALAISE (not quite feeling himself) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine). The patient was treated with METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; ZINC for Adverse event, at an unspecified dose and frequency; ASCORBIC ACID (VITAMINS C) for Adverse event, at an unspecified dose and frequency; VITAMINS NOS for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID19), ILLNESS (sick) and MALAISE (not quite feeling himself) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was scheduled to receive the 2nd dose on April 17th2021 but he got COVID19, he was sick & in quarantine and did not receive 2nd dose
Patient fore arm itch really bad; Patient fore arm swollen; there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger; Patient had administration error and was injected under the skin in the fore arm instead of the shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen), VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.     Patient did not have any allergy. Patient did not have COVID positive test or diagnosis. Patient did not have medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.     On 21-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen), VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder). At the time of the report, VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen) and VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) was resolving and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder) outcome was unknown.            Patient had previous doses of Moderna covid-19 vaccine -1st dose on 17-Mar-2021 (route intramuscular and lot 038A21A), 2nd dose on 19-Apr-2021 (route unknown and lot 017B21A) and 1st booster dose on 21-Sep-2021 (route unknown and lot 048F21A).  Patient was not under any concomitant or regular medication.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience a similar event in the past. Symptoms were improving. Currently lump was gone but it felt weird like a little lump if patient rubbed with the finger.  Patient did not take any treatment.   This case was linked to MOD-2022-662412 (Patient Link).
ischemic stroke; This is a spontaneous report from a contactable consumer (patient's child). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) via unspecified route on left arm single dose for COVID-19 immunization on 27Mar2021 12:45 at 57-year-old. Medical history included high blood pressure, ongoing hospitalization. There were no concomitant medications. The patient had an ischemic stroke on 30Apr2021 12:45; reported as serious due to life threatening illness (immediate risk of death from the event), prolonged hospitalization (vaccine received during existing hospitalization), and disability or permanent damage. Emergency room/department or urgent care visited. The patient was hospitalized for 7 days. The patient was treated for a stroke, currently in rehab. Outcome of the event was resolved with sequelae in 2021.
Patient presented to urgent care with symptomatic COVID19. He presented with fever, chills, headaches, body aches, sore throat, and cough. He was given the Casirivimab/imdevimab monoclonal antibody infusion 05/12/2021 which is the day of his positive test.
Moderna COVID-19 Vaccine EUA --- I could feel the vaccine going through my system almost immediately.  It went up my neck on the left side, into the gland and into my ear.  I used Flonase once a day for 5 days beginning on 3/6/21.  I was dizzy off and on for about a week, like my equilibrium was affected.  I had this same event occur with the 2015 and 2016 Flu Vaccine.  When my ear "acts up" my doctor has had me use the Flonase once a day for 5 days, even though Steroids can cause Cushing's symptoms.  My ear is still "stuffy" and the gland in my neck "feels funny".  Hearing does not seem to be impaired.  I also developed "Covid Arm" on 3/14/20 and reported both events to my doctor that evening - 3/14/21
Mom stated it is a really hard lump, size is about a inch, minimal pinkish color, very itchy but, stated that itchiness had went away just the  hard lump is still there, no increase in size, and minimal warmth.
He kind of got sick; He felt lethargic; He felt feverish, he had a fever; He felt feverish, he had a fever; He felt clammy; He felt nauseated; This is a spontaneous report from a Pfizer sponsored program reported by consumer (patient mother). A 16-year-old male patient (reporter son) received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0182), via an unspecified route of administration on 02Jun2021 (at the age of 16-years-old) at 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that the patient experienced he kind of got sick, he felt lethargic, for he felt feverish, he had a fever, for he felt clammy and for he felt nauseated on an unspecified date in Jun2021. The reporter stated that it took him 3 days to get better and she is not sure what to do and she does not if she, if her son should get the second dose even after experiencing these symptoms. The outcome of all the events was reported as resolving.  Information on lot/batch number was available. Additional information has been requested.
No Adverse Event; Temperature excursion   ?; This spontaneous report was received from an administrative refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-APR-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# W035464, expiration date: 06-MAY-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On 27-APR-2023, administered dose of vaccines was exposed to the temperature excursion of -10 degrees Celsius for 59 minutes (product storage error) No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Patient was administered a prefilled Covid-19 vaccine injection in L deltoid. Patient was monitored for 15 minutes following vaccine administration. Post injection the clinic soon realized the injection was empty without the vaccine present. The "prefilled' Johnson and Johnson vaccine was pulled back to 0.5 ml and individually packed and appeared to be a single use vaccine. The patient was called and notified via phone call of the situation and that the patient unintentionally did not receive COVID-19 immunization. Advised patient to FU for any questions or concerns. Pt was advised to continue to social distance until vaccine can be received. Health department was notified. The patient  was understanding and denies any concerns.
Injection-site reaction. Lt. Deltoid, redness, swelling, itchy, 20x20cm sized. Unable to follow-up due to pt's night shift work hour.
JAN92 glucose intolerance; OCT92 Hep B vax 1 wk later diffuse urticarial rash; NOV92 Hep B shot DEC92 rash worsens;
No additional adverse events; An adult patient was administered a pediatric dose of VAQTA; This spontaneous report was received from a Licensed Practical Nurse referring to an approximately 56-year-old patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 27-JUL-2020, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) (dosage regimen, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were experienced by the patient.
Experience slight numbness around the lips and nose.  It was very very similar to the effects of receiving a novocaine shot at the dentist that was wearing out.  Not fully numb but not entirely normal.
Severe reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe reaction to DTPa vaccine and was too dangerous to go back to and if the new one did not work.
In addition to pain at site of vaccine, Intense stomach pain and nausea began on morning of 13 Mar 2021 (received vaccine on 8 Mar 2021),  Took Pepto Bismol late that night and vomited shortly afterward.  Pain and nausea continued for approximately another 12 hours after vomiting and then slowly subsided and I was able to eat again.
Stroke like symptoms including tingling and numbing of left hand traveling up the arm and into the neck and face, weakness in left hand, difficulty with speech, nausea and vomiting, difficulty retreiving information (didn't know mother's name, sister's age, home town), difficulty reading and writing, later tingling and weakness in left leg.
Currently 11.5 weeks pregnant, due August 21st. The night of the first dose I began to get cramps/muscle pain in both legs from the hip down. Next day the pain moved to only the left leg. Going on day two and still have consistent pain in the left leg.