chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm started at 4 hours, starting at 8 hours: chills, fever 99.8, muscles aches, pains in feet, mid back, neck, burning pains in skin in linear pattern, felt faint in the middle of the night almost passed out when I got up. Next day April 13th - slept on and off most of the day, after a 3 hour nap woke up drenched in sweat, fever broke and then felt better. April 14th still felt worn out and weak. Neck discomfort on the side of the shot (left) still feel pressure and discomfort (Perhaps swollen cervical lymph nodes). Today (One week post vaccine) - feel a buzzing sensation on and off in left axillary lymph nodes and left breast (After the first dose left axillary lymph node and breast discomfort lasted for one week). Still feel more tired than usual.
Pt with a history of Guillain Barre syndrome who presents with difficutly breathing, inability to swallow, and weakness.  On mechanical ventilation, Treating with IVIG x 5 days,
Arm is sore stillbut improving; achy; felt fatigue; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (felt fatigue), FATIGUE (tired) and VACCINATION SITE PAIN (Arm is sore stillbut improving) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A, 013L20A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (achy), FATIGUE (felt fatigue) and FATIGUE (tired). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is sore stillbut improving). At the time of the report, PAIN (achy), FATIGUE (felt fatigue), FATIGUE (tired) and VACCINATION SITE PAIN (Arm is sore stillbut improving) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter.   This case was linked to MOD-2021-366366 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up document received, included Vaccination site pain added as event. outcome of events updated from unknown to Recovering/Resolving.
rash on her face and chin; face was puffy; lips are tingly; lips are itchy; she feels that she has a fast heart beat.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for an unknown indication.     Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), GABAPENTIN and Rovaxin for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.). At the time of the report, RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.) outcome was unknown.            The patient did not receive any treatment.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12 May  2021 contain information: No new information.
Information has been received from an Immunization Coordinator, concerning a female patient, who on an unknown date received the first dose of GARDASIL (lot number, route and injection site unknown).  It was reported that the patient's eyes "swelled shut" about three days after receiving the vaccine.  The patient sought unspecified medical attention.  At the time of reporting, the patient "is fine now".   Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Pre-medicated with Tylenol and Benadryl two hours prior to vaccine and took again six hours after the vaccine.
No additional AEs/no PQCs.; HCP reported that an expired dose of VARIVAX was administered to a patient on 4/17/23.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided.  On 17-APR-2023, the patient was vaccinated with one expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection (valid lot number U012222 with an expiration date on 16-APR-2023) (dose, dose number, vaccination scheme, frequency and anatomical injection site were not provided) for prophylaxis (expired product administered).  No additional (adverse events) reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 19-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse concerning a 4 year old patient of unknown gender. On an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (route and lot number not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The nurse reported that on an unknown date, the patient received an expired second dose. No adverse symptoms reported. Nurse was unable to provided dates of administration for the first and second dose as well as the lot number and expiration date for the expired second dose of VARIVAX (Merck) in question. It was unknown if the patient sought medical attention. Additional information has been requested.
Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Patient had swollen area on right posterior forearm, in arm pit, on right buttucks and bottom lip noticed  on the 16th of September.   Given 125mg Solu Medrol IV and 25mg Benadryl IV.
After 1st dose, feeling of fatigue and extreme heat, soreness in left arm and headache  After 2nd dose, headache, soreness of left arm, and night fever 24 hours later
loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a reaction to dose 1) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a reaction to dose 1). At the time of the report, IMMUNISATION REACTION (Had a reaction to dose 1) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Patient was a senior and took 4 doses of Moderna. No treatment medication was provided.      Reporter did not allow further contact
Severe persistent stomach pain; Persistent kidney pain; Persistent lower back pain; Persistent headache; Persistent chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 24Aug2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and pituitary adenoma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and cabergoline (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 25Aug2021 at 12:00, the patient experienced severe persistent stomach pain, persistent kidney pain, persistent lower back pain, persistent headache and persistent chills. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe persistent stomach pain, persistent kidney pain, persistent lower back pain, persistent headache and persistent chills were not resolved at the time of this report.
headache; felt warm in the head; aches, particularly in my lower back; chills; I had pain at the injection site; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 04:30, at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 19Jan2021 04:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines in 4 weeks. The patient experienced pain at the injection site on 10Feb2021, after receiving the second dose and would compare the feeling to a bad bruise approximately after 17 hours the patient had chills and approximately after 19 hours the patient started to develop aches, particularly in lower back. The aches were not severe and were more of a nuisance. Approximately after 21 hours the patient, developed a headache and felt warm in the head. The headache slowed her down and was bothersome for the remainder of the day. The headache was almost completely gone when she woke up the next day. My head no longer felt warm when I woke up. Events were not treated. All the events were recovered when she wok up next day.
recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 2 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226054:same reporter US-GLAXOSMITHKLINE-US2021225649:same reporter
Moderately severe vertigo on the morning after the vaccine.  I rested that day.  This symptom has waxed and waned irregularly since then, at some points making it difficult for me to walk (I likely wouldn't pass a field sobriety test on the most severe days).  Most of the time the symptom is mild.
2 hours of intense chills and shaking, loss of appetite, muscle aches for 12 hours. Mild arm soreness at injection site. Symptoms largely resolved after 12 hours (overnight), but still feel a bit "beat up" from the flu-like symptoms.  Anticipate full recovery by end of day 2.
Swollen lymph node in left armpit (beginning 2/10-present) Radiating (constant) pain in left armpit (2/11-present) Mild itching at injection site (2/13)
Gross haematuria 24 hours after vaccination.; I still have brown urine from my 4th dose; feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FR9893) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Sulfur" (unspecified if ongoing), notes: other medical history : None, known allergies : Sulfur. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EH8027, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 07Nov2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov2021", "feverish"; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization. The following information was reported: HAEMATURIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "Gross haematuria 24 hours after vaccination."; CHROMATURIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "I still have brown urine from my 4th dose"; PYREXIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "feverish". The events "gross haematuria 24 hours after vaccination.", "i still have brown urine from my 4th dose" and "feverish" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of haematuria, chromaturia, pyrexia.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Since the vaccination, has the patient been tested for COVID-19 was no. List of any other medications the patient received within 2 weeks of vaccination was yes. Gross haematuria 24 hours after vaccination. This occurred on both the 3rd dose (1st booster on 07Nov2021) and the 4th dose (2nd booster on 418Apr2022) of my Covid 19 shots. After the 3rd shot, my urine cleared up after 8-10 days. I still have brown urine from my 4th dose. I was also feverish and down for 36 hours with both these vaccines. What treatment received for the adverse event was CT scan of lower abdomen   No follow-up attempts are possible. No further information is expected.
Confusion, inability to concentrate. "Brain Fog", very forgetful. Example, difficulty navigating normal local routes while driving; placing bread in toaster oven while still on paper plate; can't recall if daily medication was taken or not
ADACEL was given to a 12 month-old. Caller thought they were giving the DTAP but Adacel was incorrectly administered with no reported adverse event; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who experienced adacel was given to a 12 month-old. caller thought they were giving the dtap but adacel was incorrectly administered with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad); hepatitis a vaccine INACT (Havrix); and HIB VACCINE CONJ (TET TOX) (Acthib).  On 12-Apr-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE lot C6003BA, 01-Jun-2024 via intramuscular route in the left thigh for Immunization.  On 12-Apr-2023 the patient developed a non-serious event of adacel was given to a 12 month-old. caller thought they were giving the dtap but adacel was incorrectly administered with no reported adverse event (wrong product administered) same day following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable.   At time of reporting, the outcome was Unknown for the event adacel was given to a 12 month-old. caller thought they were giving the dtap but adacel was incorrectly administered with no reported adverse event.   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.