chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFIB; Fever; headache; muscle cramping/fingers cramped; heavy fatigue; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were not reported. The patient had NKA (no known allergies). Concomitant medication(s) included: SYNTHROID; MAGNESIUM, received within 2 weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. Device Date : 03Jun2022. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "AFIB"; PYREXIA (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022); FATIGUE (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "heavy fatigue"; MUSCLE SPASMS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "muscle cramping/fingers cramped"; HYPERHIDROSIS (non-serious) with onset 21May2022 at 23:00, outcome "recovered" (2022), described as "sweats". The events "afib", "fever", "headache", "muscle cramping/fingers cramped", "heavy fatigue" and "sweats" resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of atrial fibrillation, pyrexia, headache, muscle spasms, fatigue, hyperhidrosis. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed a severe left thigh ache sometime in April although I?m not sure of the date. Consequently had a pulmonary embolism event on June 18, 2021. I didn?t realize the thigh ache was a DVT. Went to emergency room with shortness of breath and was diagnosed with multiple PE in all 5 lung lobes. I was given heparin and scheduled for clot removal but turned out clots were small and no surgical invention was necessary. I was discharged from hospital the next day and placed on a blood thinner (Eliquis). Follow up appointment with hematologist resulted in no known cause of the clot. Subsequently I?m on blood thinners for the rest of my life.
11 X 16 cm area of local erythema on the right deltoid. Nonpainful, nonindurated patch of erythema over right deltoid.
Initial misuse report received from a healthcare professional on 24 April 2013. A patient received first dose of MENACTRA at 11 years of age and second dose at 12 year of age. No adverse event was reported. List of documents held by sender: none.
THREW UP 2 TIMES; COULD NOT SIT STRAIGHT DUE TO HORRIBLE BODY PAIN; HORRIBLE HEAD PAIN; This spontaneous report received from a patient via a company representative 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: Unknown) 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 subject experienced threw up 2 times, could not sit straight due to horrible body pain, and horrible head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not sit straight due to horrible body pain, horrible head pain and threw up 2 times was not reported. This report was non-serious.
(L) arm - 4 1/2 x 3 1/2 cm red area and swelling. (L) arm - 5 x 5 cm red area and swelling. (R) arm - 6 x 4 1/2 cm red area and swelling.
Pt states: sharp pains in vaccinated arm, can't stretch or lift arm, or lay down on arm; no redness, or swelling at injection site; no fever; pt reported event on 9/13/13.
FELT SORE THROAT; BODY ACHES; This spontaneous report received from a patient concerned a 52 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced felt sore throat. On 10-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt sore throat, and body aches. This report was non-serious.
Administered a Moderna Booster dose on 3/14/22 around 2:09pm past the Beyond Use Date of 3/3/2022 and manufactured expiration date of 4/24/2022.  Learned of error today when examining number of doses remaining.
This spontaneous report as received from a pharmacist refers to an unspecified number of children of unknown age and gender. On an unknown date, reported as many years ago, the children were vaccinated with VARIVAX (Merck) (dose, route and lot number unknown). No other suspect therapies or concomitant medications were reported. The pharmacist reported that many years ago when her children were in daycare, there were an the unspecified number of children at the daycare who developed chickenpox even though they were vaccinated with VARIVAX (Merck). The pharmacist's children were not involved with any other the cases. These were cases involving other children who attended the same daycare. All cases were mild. No treatment information was reported. It was unknown whether VARIVAX (Merck) was continued. The reporters relatedness of unspecified number of children developed chickenpox to VARIVAX (Merck) is unknown. Additional information is not expected.
Swollen arm, red, knot on arm, dizziness, nausea, body aches, and chills.
Diapityriasis rosea; broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck). At the time of the report, PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included prednisone and steroid cream.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: patient's medication history, updated information of events, treatment information; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a 14 months old male patient with no pertinent medical history and drug reactions/allergies. The patient was vaccinated with the first 0.5 ml dose of M-M-R II (lot# not reported), SQ on 20-JUL-2012. No other co-suspects were reported. No concomitant medications were included. On 24-JUL-2012 the patient experienced widespread rash, which started on his trunk and then extended to both legs and face, 5 days after onset of therapy. The rash was accompanied by a low-grade fever. The patient was seen in a local emergency room and was prescribed unspecified oral steroids and BENADRYL. No lab diagnostics study was performed. The patient was seen in the office on 23-AUG-2012 and the rash in persistent but the patient was afebrile. Additional information has been requested.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Jul2021 as dose 2, single for covid-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date for covid-19 immunization with reaction head rush after the first dose but was extremely poorly with covid and was on a virtual ward and needed an inhaler. The patient concomitant medications were not reported. On 16Aug2021 the patient was tested positive for covid.  The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 16Aug2021. The outcome of event covid-19 was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Mild aches after 12 hours. Deep body  Aches tem 101-102 for another 24-36  Hours : severe bone pain, spine, hips,  ankles, upset stomach. Then low grade  fever for another 3 days with upset stomach and exhaustion.
The injection was too high on the deltoid muscle. The bursa fluid isn't meant to have a flu virus antigen mixed in with it. I may need an MRI to see if my rotator cuff is damaged and physical therapy. (SIRVA).
Had a sudden strong wave of nausea and felt very hot. That went away after a minute. Have had consistent mild nausea since then.
Information has been received from a physician concerning an 11 year old male who on 23-AUG-1999 was vaccinated with the first dose of MMR II and on 28-AUG-2002, was vaccinated with the second dose of MMR II (HSA). On 04-DEC-2009, the patient experienced mumps, and was diagnosed on the same date. The patient was afebrile and as other symptoms he presented pain lower jaw. The first blood work was not done. The outcome from mumps was not reported. This is one of several reports received from the same source. No further information is available.
headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HEADACHE (headache) and CHILLS (chills). At the time of the report, HEADACHE (headache) and CHILLS (chills) had resolved.            It was also reported that these events /symptoms experienced after second dose were worse than the ones she experienced after the booster shot.  Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-365182 (Patient Link).
feeling light headed; arm is  swollen; cannot touch her armpit; it hurts to use her arm; arm is sore; armpit is sore; pain in her shoulder and down her arm,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling light headed), PERIPHERAL SWELLING (arm is  swollen), PAIN (cannot touch her armpit), PAIN (it hurts to use her arm) and PAIN IN EXTREMITY (arm is sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (feeling light headed), PERIPHERAL SWELLING (arm is  swollen), PAIN (cannot touch her armpit), PAIN (it hurts to use her arm), PAIN IN EXTREMITY (arm is sore), AXILLARY PAIN (armpit is sore) and ARTHRALGIA (pain in her shoulder and down her arm,). At the time of the report, DIZZINESS (feeling light headed), PERIPHERAL SWELLING (arm is  swollen), PAIN (cannot touch her armpit), PAIN (it hurts to use her arm), PAIN IN EXTREMITY (arm is sore), AXILLARY PAIN (armpit is sore) and ARTHRALGIA (pain in her shoulder and down her arm,) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided Action taken with mRNA-1273 in response to the event was unknown
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on an unspecified dates were administered the improperly stored VARIVAX (merck) (doses and routes not reported) lot # reported as H013181, exp: 05-JUL-2014. The reporter stated that a satellite office had experienced an ongoing temperature excursion from December of 2012 through September of 2013. During this temperature excursions VARIVAX (merck) was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; 3 infant patients received doses after the beyond use date; vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION; vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION), PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION), PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION).    It was reported that 3 infant patients received doses after the beyond use date  lot- AR9236B Moderna COVID19 vaccine monovalent, 6 months to 5 years, which vials were also affected by a temperature excursion. Compliance inspector wanted to report and asked for an assessment in regards to pediatric patients (6 months to 5 years old) receiving doses of the Monovalent Moderna COVID19 vaccine after the beyond use date. HCP wanted to know if the patients should be revaccinated or not. Dose were administered after 30-day use by date. Individual vials or unbroken cartons were stored in the box 4. Vial size was unknown to the reporter. The vial was initially stored in the refrigerator on 13-Sep-2022. The vial underwent temperature excursions were monovalent, uring excursion vials were stored in refrigerated storage 3. Maximum or minimum temperatures reached was 6-degree Fahrenheit and 45.3 degree Fahrenheit. Excursion duration was 2 hours and 21 minutes 8. Vails were maintained in fridge. No concomitant medication were reported. No treatment medication were reported.
Bell's palsy. Developed L facial droop on 3/29/2021; COVID vaccines on 1/16/2021 and 2/8/2021.
RASH THAT LOOKS LIKE PSORIASIS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash that looks like psoriasis. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rash that looks like psoriasis. This report was non-serious.
ear infection; 10-month old patient received quadracel; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 months old female patient who experienced ear infection after receiving diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] and it was reported that 10-month old patient received quadracel.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine; and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) both for Immunisation.  On 28-Mar-2023, the 10-month old patient received 0.5 mL of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] Suspension for injection (batch/lot number: C5970AA; expiry date: 02-Feb-2024; strength: standard; 1X) via intramuscular route in the left thigh for immunization (product administered to patient of inappropriate age) (latency: same day).   On an unknown date, the patient developed event ear infection (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (ear infection).  At time of reporting, the outcome was Unknown for the events.  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.
Fevers, Chills, and facial swelling with previous facial fillers. Treatment: tylenol, benadryl & steroids.
Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   It was reported that patient took vaccine on 08-Apr-2022, after the expiration date i.e on 02-Apr-2022. The BUD date was reported as 02-Apr-2022. The vaccine was moved from the fridge on 08-Apr-2022. No additional information provided. Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high -1 degrees F low on 04-JAN-2022.   No treatment medication were reported.