chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SNEEZING; BURNING EYES; SKIN PLAQUE; LIMBS STIFFNESS; SORE THROAT; SWELLING OF FEET; GENERALIZED ACHING; DRUG EFFECT INCOMPLETE; CHILLS; FATIGUE; ALLERGY; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, and concurrent conditions included psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 26-AUG-2020 for psoriatic arthritis; and methotrexate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported.  On an unspecified date, the subject experienced sneezing, burning eyes, skin plaque, limbs stiffness, sore throat, swelling of feet, generalized aching, drug effect incomplete, chills, fatigue, allergy, nausea, and headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and montelukast sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, and chills, was recovering from skin plaque, had not recovered from fatigue, sneezing, burning eyes, nausea, allergy, headache, sore throat, and drug effect incomplete, and the outcome of limbs stiffness and swelling of feet was not reported. This report was non-serious.
Tuesday (1-29-19) started with swelling and pain in Right arm inner arm, and back of arm. No fever or redness. Patient diagnosed with Lymphedema of Right upper extremities due to vaccine. Patient has been put on AUGMENTIN and Prednisone. Patient is to call in 1 week for update.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
On February 23 at 5am I was waken to a  ich on my right shoulder and I scratched it , and looked in the mirror at my right shoulder and it was red and swollen with a itch around the injection area with some pain, as i try to continue sleeping until about 8Pm .
It was reported in a published abstract that a 9 month old female was vaccinated with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant vaccine therapy included diphtheria toxoid/ pertussis vaccine/teta and poliovirus vaccine. It was noted that the poliovirus vaccine was given IM. Subsequently the patient experienced a generalized urticarial rash. She was referred for allergy testing regarding the completion of her immunization series. It was reported that a skin prick and intradermal testing at 1:100 dilution to HIB wand the Hep B vaccines individually with negative results, and hence subsequent vaccine administration with success. However, further testing resulted in positive intradermal skin test results to 1:100 dilution of DTaP, DT and tetanus vaccines, DTaP vaccines of two different pharmaceutical companies were used, both resulting in positive reactions. A blood sample was subsequently drawn from the patient and sent for measurement of tetanus-specific IgE antibody which resulted in a level of 5.10 kU/L (class 03 or high positive) as measured test. Considering the clinical history, skin test and the above elevated antibody level, we conclude the presence of tetanus hypersensitivity in this patient. The patient had a tetanus IgG antibody of 0.88 IU/ml which is greater than 0.10 IU/ml, and hence considered to be above the protective level. It was therefore decided to withhold desensitization and administration of tetanus vaccine at this time and serially follow the tetanus IgG level. Additional information has been requested.
heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Asthma. Concomitant products included AMLODIPINE for Hypertension, HCTZ for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased). At the time of the report, HEART RATE INCREASED (heart rate increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
DVT occurring ~1/3/2022. ER visit 1/10/2022. LLE pain/swelling. Placed on Eliquis, CBC normal 1/12/2022 without thrombocytopenia/cytosis. DVT proceeded by car travel 10 hours; however this was not unusual for patient to do and never had issue in the past. DVT occurred within 2-3 weeks of receiving the J&J COVID-19 vaccine.
09/20/22 presents to Birth Center Triage for "contractions "38w6d" PMHx of "anemia"
PT RECEIVED VACCINE AT ANOTHER CLINIC PRIOR TO THE ADMINISTERED VACCINES IN THIS CLINIC.
slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 88 years as dose 1, single and intramuscular, administered in arm right, administration date 13Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "slight soreness at injection site".  Additional information: Prior vaccination and relevant tests was reported as none. Anatomical site of injection: Arm left. Drug lot number and Expiration date: EP6955 Expiry date: 30Jun2021. Only reaction was slight soreness at injection site for both her mother and herself.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA In addition to chills, patient was pale and extremely weak, experiencing difficulty standing from a seated position and great difficulty walking. She stayed hunched over after standing and was unable to walk unassisted. With assistance it took her several minutes to walk about 15 feet. The weakness persisted for 6-8 hours after which her previous strength and mobility were restored.
This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced raised very painful arm on an unspecified date. The patient went to the emergency room (ER). At the ER, she received a shot in the arm, described as some type of unspecified painkiller. It was relieved after that.  The outcome of raised very painful arm was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
I started having strange infrequent sharp, dull pains in my left shoulder/ upper left back area around 10:00 pm (I received the injection in my left arm). Around 12:30 my body and muscles felt very tight. Around 1:00 pm I started feeling very cold, even though the temperature in my bedroom was 73. I started shaking and shivering which lasted about 20 minutes after which time I went to sleep. I had to put two down blankets over myself and that helped me feel warmer but could not stop shivering. I had imbibed 1 1/2 glasses of wine and a rum cocktail earlier in the evening.
Patient received 1st dose of Moderna vaccine on 02/04/2021 and then came through NRG mass vaccination site not realizing it was a Pfizer location and received 2nd dose of Pfizer on 03/04/2021.  Interchanged vaccines.
Case was hospitalized then died of Covid 8 months after being fully vaccinated for Covid.  Admitted 11/8/21 for Covid pneumonia, Dexamethasone/remdesivir course completed. Transitioned to Comfort care 11/23/21, died  11/27/21
Pt states pain at injection site in right arm (PNEUMOVAX) began yesterday 9/2. This morning she noticed redness and warmth, along with swelling. Pt has taken ibuprofen and is applying ice pack to the red area (approx. 5x6" in the bicep/deltoid area). I did view this reaction.
Approximately 10 days after the immunization, the child developed high fever of 103 and 10 spots, Had fever on and off for 1 month. Was into emergency rm 3x in the month. Was placed on Amoxillin x1. 3 weeks after immunization had vomiting for 1 week, swollen lymph glands in groin and rash. During this time, child would hold breath, turn blue and passed out.
severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient (age reported as "67" unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. Medical history included irritable bowel syndrome (IBS) from an unknown date and ongoing. The patient concomitant medications were not reported. The patient has a history of IBS but diarrhea has been worse today (17Mar2021), had severe diarrhea for the last couple of hours. She is scheduled for second dose this morning. She asked if she should still get the second dose and stated that she did not know what to do because she had a hard time getting an appointment for the vaccine. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Gave 2nd dose of COVID-19 as Pfizer. 1st dose was Moderna (9/13/2021). No reaction in 15 minutes.
dizziness; This is a spontaneous report from a Pfizer-sponsored program Covax US Support, received from a contactable consumer (patient's daughter). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Feb2021 as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The patient experienced horrible dizziness on 08Feb2021 that resulted in being hospitalized on unknown date. Outcome of the event was unknown.  Information on batch/lot number was requested.
SEVERE HEADACHE, 103 FEVER, SEVERE JOINT PAIN, THRUSH INSIDE OF MOUTH DOWN BACK OF THROAT, ARM PAIN JOINT STIFFNESS ALL OVER BODY RASH BREAK OUT ALL OVER LEGS STARTING ON DAY 5 AFTER SHOT. SEVERE MUSCLE SPASMS OVER ENTIRE BODY
This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 32-year-old male patient who received TWINRIX adult (batch number 3J3R4, expiry date 19th February 2016). Concomitant products included TWINRIX adult. On 30th October 2014, the patient received the 2nd dose of TWINRIX adult. On 30th October 2014, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: Per the nurse the patient received the first dose of TWINRIX on 23 October 2014 and inadvertently received the second dose on 30 October 2014.
Seizure episode; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure episode) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure episode) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure episode) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Axilla lymph node swelling  with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days
Moderna vaccine booster given at a clinic and at this time we were unaware of the 20 dose limit for punctures of each vial.  The vial was punctured 28 times.   She did not report any advers events
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Public fund. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 11-Mar-2022 at 3:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was stated that patient received booster shot. It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Pneumonia; This is a solicited report from a contactable consumer, based on information received by Pfizer (Mfr. Control Number: 21K-163-3826688-00), from a non-Pfizer marketing program (marketing program name not available). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for COVID-19 immunisation and ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 420 mg daily for chronic lymphocytic leukaemia.  Medical history included diabetes mellitus and allergies IV-dye, both from unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included apixaban (ELIQUIS); lisinopril (LISINOPRIL); loperamide hydrochloride (LOPERAMIDE HYDROCHLORIDE); pantoprazole sodium anhydrous (PANTOPRAZOLE SODIUM ANHYDROUS); tamsulosin hydrochloride (TAMSULOSIN HYDROCHLORIDE); colecalciferol (VITAMIN D3); all taken from unknown dates for unspecified indications.  On 11Mar2021 the patient experienced pneumonia. The patient was hospitalized for pneumonia from 11Mar2021 to 19Mar2021.  The action taken in response to the event for ibrutinib was temporarily withdrawn on an unspecified date. The outcome of the event pneumonia was recovering. The causality assessment for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event pneumonia was not provided by the reporter.  The reporter's assessment of the causal relationship of the pneumonia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.  Follow-up (18May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information, the event Pneumonia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.
ELBOW PAIN; PAIN IN LEFT ARM FROM SHOULDER TO ELBOW; PAIN IN THE RIGHT ARM; This spontaneous report received from a consumer concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 06-APR-2021 at 10:30 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced elbow pain. On 06-APR-2021, the subject experienced pain in the right arm. On 06-APR-2021 22:00, the subject experienced pain in left arm from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the right arm, and the outcome of elbow pain and pain in left arm from shoulder to elbow was not reported. This report was non-serious.
Individual started coughing wheezing and had a headache on 1/21,  2 days after second COVID vaccination. She went to urgent care on Friday 1/22 who tested her for Covid which was negative. Urgent care did and chest x-ray and stated that she had bronchitis and they gave her a Z pack and steroids shot. Reports headache. Symptoms continued 1/23 and 1/24 and COVID testing repeated on 1/24 and test negative. As of 1/25, reports cough only and other symptoms improving.
sharp pain in stomach, gurgling noise, whistling noise, comes and goes, lasts awhile
soreness in her arm that lasted a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm that lasted a few days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder (platelet disorder that requires a daily chemotherapy pill.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in her arm that lasted a few days). At the time of the report, PAIN IN EXTREMITY (soreness in her arm that lasted a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant or treatment information  were reported.   This case was linked to MOD-2021-294231, MOD-2021-294229 (Patient Link).
she's pretty sick/ not feeling well; headache; threw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she's pretty sick/ not feeling well), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU SYRINGE) for an unknown indication.    No Medical History information was reported.   On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU SYRINGE) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced ILLNESS (she's pretty sick/ not feeling well), HEADACHE (headache) and VOMITING (threw up). At the time of the report, ILLNESS (she's pretty sick/ not feeling well) and HEADACHE (headache) had not resolved and VOMITING (threw up) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient asked if she could take Motrin, Excedrin or something.  No treatment drug was reported.
My arm has been sore ever since the injection.  It has radiated out to my neck & chest.
pt recv vax & approx 1030AM 29APR98 & mom noticed pt felt hot about 3-4PM;gave APAP 730PM, T104.5 (ear) came down quickly w/motrin;