chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels terrible; Lightheaded when walking around; Worried; Missed two days of work; Could not leave the bed; Strained muscles in my abdomen and pectoral; Vomitted; Fever; Violent chills/ Severe chills (violently shaking); Completely fatigue; Dry heaves; Severe Flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), DIZZINESS (Lightheaded when walking around), RETCHING (Dry heaves), INFLUENZA (Severe Flu) and IMPAIRED WORK ABILITY (Missed two days of work) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Obesity (Considered obese due to height and weight). Concomitant products included TAMSULOSIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MELOXICAM and TESTOSTERONE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RETCHING (Dry heaves), INFLUENZA (Severe Flu), BEDRIDDEN (Could not leave the bed), MUSCLE STRAIN (Strained muscles in my abdomen and pectoral), VOMITING (Vomitted), PYREXIA (Fever) and FATIGUE (Completely fatigue). 31-Mar-2021, the patient experienced CHILLS (Violent chills/ Severe chills (violently shaking)). On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), DIZZINESS (Lightheaded when walking around), IMPAIRED WORK ABILITY (Missed two days of work) and ANXIETY (Worried). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, RETCHING (Dry heaves), VOMITING (Vomitted) and CHILLS (Violent chills/ Severe chills (violently shaking)) had resolved with sequelae. On 03-Apr-2021, INFLUENZA (Severe Flu), PYREXIA (Fever) and FATIGUE (Completely fatigue) had resolved. At the time of the report, FEELING ABNORMAL (Feels terrible), DIZZINESS (Lightheaded when walking around), BEDRIDDEN (Could not leave the bed), MUSCLE STRAIN (Strained muscles in my abdomen and pectoral) and ANXIETY (Worried) outcome was unknown and IMPAIRED WORK ABILITY (Missed two days of work) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive, Nasopharyngeal PCR. On an unknown date, Body temperature: 103 (High) 103 F and 100 (High) 100 F.         Treatment for the event included paracetamol (Tylenol).  Action taken with the drug in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient demographics updated, medical history updated, additional events reported strained muscles in abdomen and pectoral, worried, could not leave the bed and outcome of the events updated.
vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of flu vax; above sx occurred w/in 24-48 hrs p/vax
Depression; Not feeling best; Chest pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), MALAISE (Not feeling best), CHEST PAIN (Chest pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEPRESSION (Depression), MALAISE (Not feeling best), CHEST PAIN (Chest pain) and FATIGUE (Fatigue). At the time of the report, DEPRESSION (Depression) and FATIGUE (Fatigue) had not resolved, MALAISE (Not feeling best) outcome was unknown and CHEST PAIN (Chest pain) had resolved.            Concomitant medication list was not provided. Treatment information was not provided.
Swollen, red heated rash on right arm just below the injection area.  This began the second night after the vaccination. Today is day three of having the rash and it is still increasing in diameter, the arm is still swelling and it is very painful.  This is my second Moderna vaccine and the only side effect I had with the first was a painful arm, no rash or reaction at all.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) 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.   This case was linked to MOD-2021-265450 (Patient Link).; Sender's Comments: This report refers to a case of product storage error for mRNA-1273 (batch no. 039B21A) with no associated AEs reported.
30 minutes after the vaccination I experienced rapid heartbeat and shortness of breath. I called 911 and drove to the nearest fire station where I was treated in an ambulance for my symptoms. I was released to drive home and contacted my primary care physician. My side effects lasted for three hours with pulse fluctuating between 58 bpm and 106bpm.
I got the vaccine and now I have Lupus; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date,  8 days after getting the 1st shot, symptoms began, the patient had lupus. The patient stated"I have lots of documentation. Is Pfizer helping people who get lupus from the vaccine". The outcome of events was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Patient developed Right breast tenderness over superior aspect of breast 5 days after 2nd Moderna vaccine. Also noted a 3cm x 5cm area of diffuse thickening at top of breast that came on with this. Was not present at monthly breast exam before 2nd moderna vaccine. Symptoms have now been present for 1 month without any improvement.
This spontaneous report was received from a nurse practitioner referring to an unknown gender and age patient with no pertinent medical history specified by the reporter. The reporter stated that on an unknown date, the patient received ZOSTAVAX vaccine (lot number and expiration date not reported) (dose, route and anatomical location not reported) at a pharmacy and at some point visited the physician's office. On an unknown date the patient developed a zoster type rash at the point of injection. The outcome of the zoster type rash at the point of injection was unknown at the time of the report. No treatment information was provided. Additional information is not expected.
presented to the emergency room with one week history of progressively worsening shortness of breath associated with pedal edema and occasional productive cough. Denies any associated chest pain, palpitations, fever, chills, GI or urinary symptoms. Reports that she tested positive for COVID-19 about 3 weeks ago and has been doing okay until the past week when her symptoms significantly worsened. She is not oxygen dependent. She is vaccinated and had a booster against COVID-19 virus. Patient admits to history of COPD and asthma. She denies any smoking. Chest x-ray done in the emergency room showed bilateral patchy airspace opacities concerning for multifocal pneumonia and nodular perihilar opacities. ABGs show pH of 7.55 with a PCO2 of 33 and PO2 of 56 with saturation of 92.9 on 3 L of oxygen by nasal cannula. Patient was febrile in the ED up to temperature of 101.4. Tachycardic on admission and hypoxic even with nasal cannula at 2 L/m with 89% saturation.
Fever up to 102.9, chills, headache, hypertension, tachycardia, dyspnea.
Injection site swelling, swollen underarm lymph nodes, bicep soreness, limited arm movement.
Order written for Hep A, MMR, Varicella. At some point it was changed to remove HEP A and give DTAP. The patient was given the original order, and he did not need another HEP A nothing happened to the pt.
it was rpt fr RN concerning pt who p/vax subsequently exp a lack of seroconversion. addl info req
Hives; Extremely itchy; The rash was still lingering and still a litle bit of an itch; Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives), PRURITUS (Extremely itchy), RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives), PRURITUS (Extremely itchy), RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks). At the time of the report, URTICARIA (Hives), PRURITUS (Extremely itchy) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks) was resolving and RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) outcome was unknown.        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.   No relevant concomitant medications were reported. The patient was treated with Benadryl (diphenhydramine).  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
TRIPLE BYPASS VEINS COLLAPSED; ATRIOVENTRICULAR NODE IN LOWER HEART CHAMBER DESTROYED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: bypass. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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. No concomitant medications were reported.  On an unspecified date, the patient experienced triple bypass veins collapsed, and atrioventricular node in lower heart chamber destroyed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrioventricular node in lower heart chamber destroyed and triple bypass veins collapsed was not reported. This report was non-serious.
Vial was diluted with 1.3mL sterile diluent. Dose of .25mL was administered to patient without complications. Error with vial was found several hours later, but no further doses were given. Vial was discarded.
The patient came into office with mother, was thought and misinterpreted patient needing Hepatitis A and Influenza. Mother notified of error, CDC called, PCP notified.
Fever, headache, chills/hot flashes, soreness extending over upper left side of body, fatigue, dehydration.
Employee due for second COVID vaccination.  Missed on his form that his first vaccination was Pfizer.  We have primarily administered Moderna at our facility.  When sitting down to document administration noted his prior immunization was Pfizer.  Spoke with pharmacy director and advised to complete VEARs form. Employee with no adverse effects. He was monitor after immunization per protocol.  Employee was notified of the error.
Mom states child woke up with a rash on his Rt. Abd. States rash is bright red, blistered, and he acts like it hurts (walking around holding shirt off of body and holding hand on rash.
This non-serious report from study was reported via OTIS Pregnancy Registry (initial receipt 19-Jul-2014) and concerns a 29 year old female pregnant patient. The patient's medical history included depression, anorexia (which resolved in 2013) Ulcerative colitis and respiratory tract infections. Concomitant medications included prenatal vitamins, folic acid, DHA (Docosahexaenoic Acid), vitamin D, vitamin C, azathioprine, amoxicillin, paracetamol, TDAP vaccine and diphenhydramine. On 10-Oct-2013, the pregnant patient received the AFLURIA vaccine (batch number not reported) 1 shot 1 day. The patient gave birth to a baby at the gestational age od 40 weeks. On the 14-Jul-2014, the baby was diagnosed as having 2 hydronephrosis (see case 2014044039). Outcome was unknown.
On day 5 armpits felt tender & sensitive, day 6 itching at injection site, day 7 rash at injection site and other parts of the body mainly upper torso area. Rash to the left and right of navel, armpit area, left & right side of chest were little more prevalent but some small red bumps on arms, should & back area as well
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported) that was improperly stored on unknown date. No adverse event was reported. This one of several reports received from the same reporter. Additional information has been requested.
Overall body weakness, dizziness, pain and muscle cramps in both arms and hands, constant headache, lightheaded, difficulty concentrating , muscle weakness in legs
Pain in the entire arm, mild swelling, minimal erythema and warmth. Vaccine taken 0630 that day and symptoms started 2300. ER physician suggested, cool compress, TYLENOL and MOTRIN.
Patient returned to clinic for smallpox check. Patient stated site swollen and sore to touch. Bandage removed to expose a quarter sized round blister similar in appearance to a 2nd degree burn blister. Site around blister with moderate redness and swelling. Patient escorted to clinic for further evaluation by physician.
Immunizations given at about 4:20 pm on 11-16-15. (PENTACEL, PREVNAR, Hep A, PROQUAD and Flu). Child cried after receiving vaccines and grandmother and aunt held and consoled child. Child already had some redness and scratches to face. But about 5 min after receiving vaccines while she was still crying, child started getting small raised bumps to her face, few on abd and 1 on arm. BENADRYL 1.5ml given po, bump and redness gone by 4:53 pm.
seizure; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program.  A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration, at the age of 15-year-old on 05Jun2021 as single dose for covid-19 immunization. The patient medical history was reported as no. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: EW0182, Expiration date was not reported), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. On 09Jun2021, the patient got seizure. The patient reported that he got seizure twice already, which never happened before. 1st time was on 09Jun2021(4 days after 2nd dose), and 2nd time was on 10Jul2021. Each time it was unprovoked grand mal seizure. Patient was hospitalized by 911 on 09Jun2021. Reports revealed no mass/bleed in head, He was given Keppra IV. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of event was not recovered.   Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
4 plus year old has only had 3 doses of Pentacel, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 plus year old patient (age between 4 and 5 years) who had three doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual medication error case due to inappropriate schedule of product administration. It was reported that the child is between 4 and 5 years of age and had 3 doses of Pentacel.  At the time of this report, no adverse event was reported.  There will be no information available on the batch number for this case  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 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
Patient had two syncopal events in The office after administration of vaccine. Both within 15 minutes of administration patient soiled himself & was difficult to arouse.
Patient was seen in COVID vaccine clinic for first dose of Pfizer vaccine. Patient has a history of penicillin allergy where she developed hives and also a contraindication to the flu vaccine when she was 6 months old.  The contraindication listed in the chart was "crying for 3 days."  Patient received COVID vaccine and 20 minutes later reported her throat felt as if it was swollen and her tongue was tingling.  50 mg Benadryl given to patient.  Vital signs all stable, pule ox on RA 100%.  Mother called PCP who recommended being seen in the Emergency Dept d/t complaint of swollen throat.  RRT called to help facilitate transfer to ED.
6 weeks from first dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine) 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 PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine) had resolved.        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 medication were provided  Treatment medication were not provided
FEVER; CHILLS; FATIGUE; SHAKING; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, batch number: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced shaking. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from fever, chills, fatigue, and shaking. This report was non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal status, dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of RECOMBIVAX HB experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.