chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraine; Very ill; Dizzy in her eye; Nauseous; Freeze in the night/Cold; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freeze in the night/Cold), MIGRAINE (Severe migraine), ILLNESS (Very ill), DIZZINESS (Dizzy in her eye) and HEADACHE (Slight headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING COLD (Freeze in the night/Cold) and HEADACHE (Slight headache). On 01-Apr-2021, the patient experienced NAUSEA (Nauseous). On 04-Apr-2021, the patient experienced ILLNESS (Very ill) and DIZZINESS (Dizzy in her eye). On 05-Apr-2021, the patient experienced MIGRAINE (Severe migraine). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. On 01-Apr-2021, FEELING COLD (Freeze in the night/Cold) had resolved. On 04-Apr-2021, ILLNESS (Very ill) and DIZZINESS (Dizzy in her eye) was resolving. On 05-Apr-2021, MIGRAINE (Severe migraine) had resolved. At the time of the report, HEADACHE (Slight headache) and NAUSEA (Nauseous) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication reported was ibuprofen.
Employee experienced light headedness, weakness in legs, pallor, stomach cramps, nausea, and diarrhea.
HCP diagnosed low Potassium and "Covid Pneumonia"; did not feel well; Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well; body aches; could not eat; Patient lost senses of taste; Patient lost senses smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test negative on 14-Apr-2021.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste) and ANOSMIA (Patient lost senses smell). On 12-Apr-2021, the patient experienced MALAISE (did not feel well), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches). On 14-Apr-2021, the patient experienced COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia"), MALAISE (did not feel well), FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste), ANOSMIA (Patient lost senses smell), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood potassium: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol, Azithromycin and vitamins to treat symptoms.  Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.; Sender's Comments: Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.
I began to experience frequent irregular heartbeats on the second day after getting my second Shingrix vaccine
Approx 8 hours after vaccine, arm pain increased followed by chills, body aches, fever (over 101), nausea, and headaches. Symptoms lasted approx 20 hours, with use of tylenol and ibprof.
mouth hurts; sores in her mouth/ mouth sores; mouth blisters started to appear; teeth felt sore; got sick; very weak; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear) and ORAL PAIN (mouth hurts) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (got sick), ASTHENIA (very weak), VOMITING (vomiting) and CHILLS (chills). On 12-Sep-2021, the patient experienced TOOTHACHE (teeth felt sore). On 13-Sep-2021, the patient experienced ORAL MUCOSAL BLISTERING (mouth blisters started to appear). On 14-Sep-2021, the patient experienced ORAL PAIN (mouth hurts) and STOMATITIS (sores in her mouth/ mouth sores). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sore mouth, at a dose of 1 dosage form. At the time of the report, ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear), ORAL PAIN (mouth hurts), STOMATITIS (sores in her mouth/ mouth sores), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient stated she has never had mouth blisters like this in the past.  She stated that she doesn't take any medications daily.  She reported that she was not pregnant.     Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non significant follow up On 14-Sep-2021: Follow up information added patient identities, vaccine information, Events and treatment drug were updated.
5days post vax pt seen w/vomit & bloody stools. dx w/intuss, reduced p/air enema x3
Approximately 5 weeks after receiving vaccine, a blister-like rash appeared at injection site measuring 3 inches in diameter.
one cheek feels stiff/tight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 10:00 (Lot number: ER8733) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1 at 10:15 am administered on left arm (Lot number: ER8733)), administration date: 05Apr2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "period was about 5 days early". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Apr2021 11:00, outcome "recovering", described as "one cheek feels stiff/tight". Therapeutic measures were not taken as a result of musculoskeletal stiffness. Additional information: Patient stated that after receiving the second dose this morning (as of reporting), one cheek feels stiff/tight when I try to smile or move it. About 4 hours later, and the stiffness is subsiding. Patient had no COVID prior vaccination and not COVID tested post vaccination. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
The pharmacy uses barrier bandages for vaccinations.  The patient received her second vaccination with no incident at the pharmacy.  When she removed the bandage at home she noted it looked like it "had condensation" in the bandage and a drop of clear liquid ran down her arm. The volume of the bandage area is very small, estimated to be less than 2 mL without any leakage.  The patient returned to the pharmacy the next day for her husband to get his vaccine and asked the pharmacist at that time if she should get a third vaccine since she might have lost the second dose.  The CDC was called for clarification and it was determined through conversations with the clinical staff that a third dose is not needed. The reason was she received more than half of the recommended dose based on the volume of a full bandage.
Subcutaneous Route of Administration; 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration) 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 08-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Received vaccine rt-del on 6-11-2013 patient states she noticed a rash around the site day of. Ignored it. Extreme pain 6-13-13 edema erythema. Tood Ibuprofen, no relief. Returned to clinic 6-14-13 for care. Pt experienced N-V and SOB. Dx with cellulitis. Treated with BACTRIM DS #20, 800 mg/160mg bid x 10 days.
patient was swabbed and tested positive for Covid-19 infection; C symptoms; This is a spontaneous report from a contactable Nurse reported for herself in response to HCP letter sent. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EK5703; Expiration date was not reported), via intramuscular, administered in Deltoid Right on 21Dec2020 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Clinic. Medical history included obesity, polycystic ovarian syndrome (PCOS), hypertension (HTN) from an unknown date and unknown if ongoing, obstractive sleep apnea (CDAD use while sleeping) from Nov2015 to an unknown date, left ankle surgery in 1995 and 2012. Concomitant medication(s) included metformin (METFORMIN) taken for PCOS from Nov2016 to an unspecified stop date; spironolactone (SPIRONOLACTONE) taken for hypertension, PCOS from Nov2016 to an unspecified stop date; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for PCOS from Mar2016 to an unspecified stop date; acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had the first dose on 21Dec2020. The very next day (on 22Dec2020), patient began C symptoms. Patient thought they were related to the vaccine, and on 25Dec2020 patient was swabbed and tested positive for Covid-19 infection after an exposure at her place of employment listed below. Patient was out of work for 3 weeks with the Covid infection and returned to work with the instruction to get the vaccine (2nd), which she did on 22Jan2021. The patient was not deceased. The patient did not visit Emergency room and Physician Office. Clinical outcome of events was unknown. Reporter did not consider the Pfizer product had a causal effect to the adverse events.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax 3FEB94 &  high fever 104.9 started next morning was giving APAP 4 hrs; mom had RH neg blood & did not receive Rho-GAM;
No adverse event; 4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.).    Concomitant product use was not provided by the reporter.  4 doses were administered after 30-day Use by date or after Manufacturer Date of Expiry in a health center nearby. This happened at a different location, not at the facility were he works, so reporter states he did not had any additional information. Expiry date of suspect vaccine was reported as 12-Jul-2023. Dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 2nd out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733816 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733816:Master case (patient 1)
Itching in mouth, facial redness and swelling. Swelling of lips and hands.
immunocompromise patient received a booster instead of a Third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was mentioned that patient had no Allergies to medications, food and other products. Patient had not experienced similar events in past.  Concomitant medications details were not reported by the reporter.  Patient did not seek any medical care (office visit, Urgent care, ER and hospitalized) for the adverse event.  Reportedly, Bone marrow specialist recommend the patient to get the booster.  Treatment details was not reported by the reporter.
Burning sensation skin; a series of rashes on the back of my hands, fingers, ankles ,lower wrist and forearm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning sensation skin) and RASH (a series of rashes on the back of my hands, fingers, ankles ,lower wrist and forearm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029K20A) for COVID-19 vaccination.     No past medical history was provided.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SKIN BURNING SENSATION (Burning sensation skin) and RASH (a series of rashes on the back of my hands, fingers, ankles ,lower wrist and forearm). At the time of the report, SKIN BURNING SENSATION (Burning sensation skin) outcome was unknown and RASH (a series of rashes on the back of my hands, fingers, ankles ,lower wrist and forearm) had not resolved.            No concomitant medication was reported. Treatment information was included topical cream prescribed by dermatologist for a week.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended
chilling, body aches , nausea, headache, exhaustion.  Woke up at 1 AM chilling so bad I thought I was going to break my crowns off.  Could not stop for over 2 hours.  Whole body aches   The chilling lasted from 1-5 am and the exhaustion all day.
inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA419169(CLUSTER).  This case involves a 11 years old male patient who was inadvertently given expired product influenza usp trival a-b subvirion no preservative vaccine [Fluzone] with no reported adverse event.   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 dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (lot: UT7378MA, expiry date: 30-Jun-2022) (Strength: unknown) 300mg total at once via intramuscular route in the left deltoid for immunization.  On an unknown date the patient was inadvertently given expired product with no reported adverse event (expired product administered) (unknown latency) following the administration of vaccine.  No lab data reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient came in a couple days after the shot with swelling and redness (about 3 inches in diameter) closer to her bicep (about 4 inches below injection site). Patient reported having a similar reaction to an influenza shot, which went away.  I recommended that she took Benadryl and to seek urgent care if it gets any worse. Patient told me afterwards that she went to the hospital.
PATIENT WITH HISTORY OF SEIZURES WENT INTO A SEIZURE ABOUT 5 MINUTES AFTER ADMINISTRATION. PATIENT ALSO HAD SEIZURE WITH 1ST DOSE.
Patient stated he did not get flu-like symptoms until 4 days after vaccination.  He stated that 30 hours after his first Moderna dose he experienced increased heart rate and pulse. He felt as though he was going to pass out and his vision was altered and extremities were numb. He called 911 and went to hospital where he was admitted. He was told his blood work was normal except for elevated glucose and cholesterol. For 5 days after this episode he continued to experience tightness in his chest and pressure in the back of his head.
Syncopal episode approximately 4 hours following vaccine admin. REaction included seizure like activity.
patient had the flu; Initial information received on 25-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves an adult (unknown gender) patient who had the flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I haven't gotten a flu shot in almost 40 years... That's been how long it's been since I had the flu."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Woke up with major sore throat, cough. Fever, achiness and just a feeling of pure sickness. Total time of sickness was 14 days but still have bad cough.
Headache; body aches/pains; chills; fatigue; This is a spontaneous report from a contactable other hcp (Patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL3247) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 09Feb2021 at 03:15 PM as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EL3247) on 09Jan2021 at 03:00 PM in Left arm for COVID-19 immunization. No known allergies were reported. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 09Feb2021 at 09:00 PM the patient experienced headache, body aches/pains, chills, fatigue. No treatment was received for the adverse events. The clinical outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.