chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine; "Headaches" (unspecified if ongoing), notes: Other medical history: Headaches; "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea; "Gastritis" (unspecified if ongoing), notes: Other medical history: Gastritis; "IBS" (unspecified if ongoing), notes: Other medical history: IBS. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event  covid-19 and drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight; Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight) and PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022 at 11:45 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM). On 02-Mar-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight) and PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Date the vial was initially stored in the refrigerator was 28FEB2022.
History of present illness   The Patient is a 43 year old male.  Patient presents for an ER follow-up.  At about 1900 hours 27 September 2010 while sitting in his Operations Center when he started to feel weak, shaky, developed some nausea and a metallic taste in his mouth.  He ate 2 apples, a banana and some pizza and a glass of sweetened tea.  He returned to the Operations Center and developed a chill.  He went to his barracks, covered up and the ambulance was called.  He was seen at the Emergency Department where he says he had a CXR, blood work, urine analysis and received some IV fluids.  His discharge instructions give a diagnosis of 'adverse reaction to immunizations.  He was discharged and returned to his barracks.  He says he is fine today.  He relates that he received his Influenza vaccination, typhoid and tetanus immunizations on the morning of 27 September 2010.  He ate a normal amount for breakfast today.  He denies having any abdominal pain. Allergies  Allergy information in Autocite area was reviewed and verified with patient. Current medication  Current medications reviewed and reconciled. . Physical findings  Vital signs: Vital Signs/Measurements  Value Blood pressure: Reviewed   o Temperature: Reviewed.  o RR: Reviewed.  o PR: Reviewed. General appearance: ° Normal.  ° Oriented to time, place, and person.  ° Well developed.  ° Well nourished.  ° In no acute distress. Neck: ° Normal. Palpation: ° No tenderness of the neck. Suppleness: ° Neck demonstrated no decrease in suppleness. Eyes: General/bilateral: Pupils: o Unequal.  ° Size of the pupil was normal. Ears: General/bilateral: Outer Ear: ° Normal. External Auditory Canal: ° External auditory meatus normal. Tympanic Membrane: ° Normal. Nose: General/bilateral: Nasal Discharge: ° No nasal discharge seen. External Nasal Deformities: ° No external nose deformities. Cavity: ° Nasal septum normal.  ° Nasal mucosa normal.  ° Nasal turbinate not erythematous.  ° Nasal turbinate not swollen. Lungs: ° Respiration rhythm and depth was normal.  ° Exaggerated use of accessory muscles for inspiration was not observed.  ° Clear to auscultation.  ° No wheezing was heard.  ° No rhonchi were heard:  ° No rales/crackles were heard. Cardiovascular system: Heart Rate And Rhythm: ° Normal. Heart Sounds: ° Normal  S1 - S2:  ° No S3 heard.  ° No S4 heard.  ° No click was heard.  ° No pericardial friction rub heard. Murmurs: ° No murmurs were heard. Abdomen: Palpation: ° Abdominal muscle guarding was not demonstrated.  ° No abdominal tenderness.  ° No mass was palpated in the abdomen. Hepatic Findings: ° Liver was normal to palpation. Neurological: ° Judgement was not impaired. Coordination / Cerebellum: ° No coordination/cerebellum abnormalities were noted. Gait And Stance: ° Normal. Psychiatric Exam: Mood: ° Euthymic. Affect: ° Normal.        1. visit for: administrative purpose: ADVERSE REACTION TO IMMUNIZATION,  EXACT ONE UNCLEAR. RTC prn.  Released w/o Limitations  Follow up:  as needed .
vaccine stored out of range - in freezer for greater than 14 days; offered revaccination and patient is undecided, will not revaccinate at this point in time
positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown.  The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
no AE; product experienced multiple temperature excursions and that some of the product might have been administered to patients; This spontaneous report was received from a medical assistant, referring to a 16 years old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 18-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1637648, expiration date 19-JUN-2022 for prophylaxis (strength, route and frequency were not reported). The reporter said the vaccine experienced multiple temperature excursions and that some of the product might have been administered to patients.  The temperature excursion was of -2.09 Centigrade degrees (°C) during 37 hours. A previous temperature excursion occurred of 12.9 °C for 2 hours.A digital data logger was involved. No other adverse events were reported. This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA011511: US-009507513-2101USA009815:
Headache within one hour from time of vaccination.  Hours later:  continued headache, arms felt heavy and body aches. The following morning, woke with headache and severe body aches and fatigue.  These symptoms lasted about 48 hours.  Headache lessened and gone by day 3.
Information has been received from an RN concerning a 23 year old Caucasian female pt who in 1997 was vaccinated with a 2nd dose of Hep-B. One day, post vax, the pt's joints ached. Additionally, she experienced mild fever and nausea. The pt experienced no vomiting or diarrhea. Unspecified medical attention was sought. The symptoms resolved within 2 weeks. It was noted that the 1st dose of Hep-B was administered with no problem.
Caregiver possibly received a partial dose of the Moderna booster/Not sure what amount of vaccine the caregiver received; It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Not sure what amount of vaccine received) and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration). On 30-Dec-2021, ACCIDENTAL UNDERDOSE (not sure what amount of vaccine received) and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
urticarial rxn, arms, face, thighs, trunk;no resp cyanosis;
FATIGUE; This spontaneous report received from a patient concerned a 73 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
This adverse effect report is filed for the Moderna COVID-19 booster vaccine. The patient had received the Pfizer-BioNTech COVID-19 vaccine for the first 2 doses.  Symptoms: malaise (started on first day, persisted for 3 days), joint ache at the left knee - there is some pain when the patient puts pressure on the left leg (started on first day, persisted for 3 days), chills (started on first day, persisted for 2 days), diarrhoea (started on the night of the third day)
As the vaccine was being administered the safety feature on the VanishPoint syringe malfunctioned.  The needle retracted into the syringe and the vaccine ran down the patient's arm
given second dose vaccine on 3 Feb 2021, first dose was given on 2 Feb 2021; A spontaneous report was received from a physician concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, given second dose vaccine on 3 Feb 2021, first dose was given on 2 Feb 2021.    The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 02 Feb 2021. On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the second dose Moderna COVID vaccine was given to a patient, with the administrator unknowingly as unaware about the first dose had been administered the day before on 02 Feb 2021. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event, inappropriate schedule of vaccine administered, was considered resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
24 hours after injection developed redness, rash, swelling at injection site. Measured 10x11cm by 3x3cm indurated area, temp 101.3 at exam 48 hours after admin.
Rash. Hives over the entire body, healthcare provider told patient it was an allergic reaction. Takes Benadryl.
Received my second dose. The following day I developed a rash something akin to poison ivy on my left arm and swelling in my hand. Over the next few days the rash spread all over my body. My hand and feet were so full of the liquid filled blisters that I couldn't walk or bend my hands to even use my phone. It spread to my eyes and eventually my throat. At this point I went to the doctor.
Client report her nose hurting 3.5 hours after vaccine administration.  Her nose began to hurt, noticed some swelling, slightly red and pain in the inside.  Client report her nose was worse today in the morning.  Her nose continues to hurt on the outside, the middle and sides.  She is not having any breathing issues or nasal drainage.  No follow up done with a medical provider.
NECK STIFFNESS; HEADACHE; INJECTION SITE TENDERNESS; INJECTION SITE REDNESS; CHILLS; FEVER; LUMP BY THE COLLARBONE ON THE LEFT SIDE (LEFT SIDE WAS INJECTION SIDE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included PCOS, stomach ulcer, and hashimoto, and concurrent conditions included sensitive to food numerous, non alcohol, and non smoker.  The patient was previously treated with ethinylestradiol/norethindrone for birth control, sucralfate for stomach ulcer, and levothyroxine for hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lump by the collarbone on the left side (left side was injection side). On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) BELOW 99 F. On 09-APR-2021 10:00, the subject experienced injection site tenderness. On 09-APR-2021 10:00, the subject experienced injection site redness. On an unspecified date, the subject experienced neck stiffness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, had not recovered from lump by the collarbone on the left side (left side was injection side), and the outcome of neck stiffness, headache, injection site tenderness and injection site redness was not reported. This report was non-serious.
This spontaneous report as received from a pharmacy student refers to a 81 years old female patient. The patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown) in April 2010. No other co-suspects were reported. No concomitant medications were reported. The patient developed "a few lesions on her neck about 2 weeks ago" approximately on 07-NOV-2012. The patient sought medical attention by office visiting and was evaluated by her unspecified physician and was diagnosed with shingles. Valacyclovir hydrochloride was prescribed and the patient completed therapy on 20-NOV-2012. The outcome of shingles was reported as recovered/resolved on 20-NOV-2012. No lab diagnosis studies performed. Additional information has been requested.
Variable Lymphadenopathy in the axillary, clavicular, and inguinal areas.   Joint pain in shoulders, back,  pelvis and hips.
C/O bruising, pain at site of injection and limited ROM in left arm. Also with palpable hematoma dime size above site of injection
Pt was administered Fluzone intra-dermal vaccine.  About 30 min after administration - pt came back to pharmacy w/ a lot of redness on the upper arm and a raised area where the medication was administered.  Approximately another 15 min later, pt came back to pharmacy again w/ red, blotchy patches on skin from neck down to legs.  Pt reported no itching, no severe allergic reactions, only slight pain at site of administration.  Pt was administered 25 mg liquid Benadryl and 500 mg Tylenol.  Within 30-45 min after treatment - all redness was gone.  Pt reported no other problems post-vaccination.
46 days since first dose and has not yet received second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days since first dose and has not yet received second dose) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days since first dose and has not yet received second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days since first dose and has not yet received second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported. Treatment information was not available. Patient has refused to take the second vaccination dose, later again patient wanted to have the second dose which was after 46 days.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: NNI; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered. for mRNA-1273, lot # unknown with no associated AEs.
10 mins after receiving vaccines Pt started to have a small allergic reaction around her thighs where the shots were given. Soon after pt could not breathe and started to wheeze. Pt was started on oxygen, albuterol, PULMICORT 0.5 mg treatment and was given SOLUMEDROL 4.0mg, epinephrine 1ML, BENADRYL 25 mg and was taken by ambulance to ER.
passed out 3 separate times and had 3 seizures right on their floor; passed out 3 separate times and had 3 seizures right on their floor; Initial information received on 17-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a 16 years old male patient who passed out 3 separate times and had 3 seizures right on their floor after receiving vaccine Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (with dose, strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylaxis.  In JUL-2022 the patient developed serious events of passed out 3 separate times and had 3 seizures right on their floor (loss of consciousness) (seizure) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. This event was assessed as medically significant.  No relevant lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the events (passed out 3 separate times and had 3 seizures right on their floor, passed out 3 separate times and had 3 seizures right on their floor).  Outcome: Unknown.  Seriousness Criteria: Medically Significant; Sender's Comments: Sanofi Company Comment dated 21-Jan-2023: This case involves a 16 years old male patient who passed out 3 separate times and had 3 seizures right on their floor after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi]. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding, medical history, past and concomitant medication, any concurrent conditions, any family history of cancer precludes the comprehensive case assessment.
arm  swelling; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (arm  swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm  swelling). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form twice a day and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of 1 dosage form twice a day. At the time of the report, PERIPHERAL SWELLING (arm  swelling) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERIPHERAL SWELLING (arm  swelling) to be related.    Concomitant medication included Over the counter medication. Patient took steroids for 7 days as treatment and then Zyrtec and Allegra together, twice a day. Patient stated that the symptoms came back when she stopped taking the medicines.   This case was linked to MOD-2022-525727, MOD-2022-525739 (Patient Link).