chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare professional concerning a 25 year old female patient with migraines and an allergic reaction to CECLOR and SEPTRA who on 22-AUG-2007, was vaccinated IM with a first dose of Gardasil (Lot# 658556/1060U).  There was no concomitant medication.  On 26-AUG-2007, the patient experienced fever and chills.  It was reported that these symptoms lasted for several days.  On 28-AUG-2007, the patient experienced migraines.  Unspecified medical attention was sought.  On 29-AUG-2007, the patient called the office.  No laboratory diagnostic studies were performed.  After several days, the patient recovered from fever and chills but had not recovered from migraines.  It was also reported that the patient had not had a "migraine attack" for years.  No product quality complaint was involved.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. On 26-AUG-2007, the patient experienced fever, chills and migraines. It was reported that these symptoms lasted for several days. Unspecified medical attention was sought. On 29-AUG-2007, the patient called the office. No laboratory diagnostic studies were performed. After several days, the patient recovered from fever and chills but had not recovered from migraines. It was also reported that the patient had not had a "migraine attack" for years. No product quality complaint was involved. Additional information is not expected.
patient received flublok quad that is only fda approved for 18 years and up.  the patient is 14 years of age
she was too ill to get the second dose due to her underlying conditions; she was too ill; her arm hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), ILLNESS (she was too ill) and PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (2 open heart surgeries). Concurrent medical conditions included Diabetic. Concomitant products included METOPROLOL, BUMETANIDE (BUMEX), CLOPIDOGREL BISULFATE (PLAVIX), GLIPIZIDE and OMEPRAZOLE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt). In April 2021, the patient experienced ILLNESS (she was too ill). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions). On 21-Mar-2021, PAIN IN EXTREMITY (her arm hurt) had resolved. At the time of the report, ILLNESS (she was too ill) was resolving and PRODUCT DOSE OMISSION ISSUE (she was too ill to get the second dose due to her underlying conditions) 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 treatment medication was provided by reporter.
warped vision - lasted a few seconds each time - think it was both eyes - not sure; also not sure if related to either vaccine.  Nov 25, Nov 30, Dec 2
Information has been received from a physician concerning a male who was vaccinated po with the first dose of ROTATEQ. It was reported that 24 hours after receiving the vaccine the patient developed persistent diarrhea, a little fever and would not eat as much. Unspecified medical attention was sought. The outcome was not reported. A product quality complaint was not involved. No further information is available.
Office of Dr. called the pharmacy to report the patient had cellulitis following shingles shot located 2 fingers above elbow back of arm and are treating it.
Swollen tonsils, difficultly breathing, chest tightness, chest pain. Started Monday after shots Sunday afternoon and has continued to the present (Thursday afternoon). I have been gargling with salt and warm water, increasing fluid intake, and taking Tylenol.  I saw a pharmacist on Monday and would like to see a doctor to ensure that it?s just a vaccine reaction, but haven?t been able to get an appointment.
Red, indurated region on left lower extremity 9 x 14 cm after tetanus shot.
numbness on left side of face, watery eyes, could not blink eyes, speech was slurry, Bell's palsy; A spontaneous report  was received from a consumer concerning herself, a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history was not provided. No concomitant medications were reported.   On 03 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029H21A) intramuscularly in the left non dominant deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, same day after vaccination, the patient had numbness on the left side of her face, watery eyes, could not blink the eyes, speech was slurry, visited ER where the physician diagnosed it as Bell's palsy and was treated with steroids,  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "right shoulder pain" (unspecified if ongoing), notes: No other physical health related problems except right shoulder pain from an injury to my right shoulder; "injury to right shoulder" (unspecified if ongoing), notes: No other physical health related problems except right shoulder pain from an injury to my right shoulder. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "It disrupted my ability to work at my job", "My eyes were sensitive to light", "disrupting vision", "Posterior Vitreous detachment", "huge black floater on my right eye". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headaches". The event "headaches" was evaluated at the physician office visit.  Additional information: First dose, I went to my eye M.D on 4th day after the first vaccine because the problem was not going away. I still have the huge black floater on my right eye. My eye doctor called it "Posterior Vitreous detachment" on 14Nov2021, I am still dealing the big dark floaters which disrupting vision.  Follow-up attempts are completed. No further information is expected; Batch/lot number not available for BNT162B2
Shortness of breath; No taste; Dizziness; Loss of balance; Occasional inability to walk; Loss of energy; I have symptoms related to covid; Chronic fatigue; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance) and GAIT INABILITY (Occasional inability to walk) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (hospitalized for double pneumonia in April 2021). Concurrent medical conditions included Myelodysplasia since October 2021.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (No taste), DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance), GAIT INABILITY (Occasional inability to walk), ASTHENIA (Loss of energy), SUSPECTED COVID-19 (I have symptoms related to covid) and FATIGUE (Chronic fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Negative.         No concomitant medications were reported. No treatment medications were reported.    This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced unexpected non-serious  which occurred on an unknown date after the third dose of mRNA-1273 vaccination in covid -19 vaccination series. Patient is currently suffering from shortness of breath, chronic fatigue, dizziness, loss of balance, occasional inability to walk and loss of energy. SARS-CoV-2 test reported as Negative on an unknown date in 2022. Patient has been examined and treated by primary care physician, cardiologist, pulmonary physician, infectious disease doctor and oncologist. No further information of definitive diagnosis and treatment of the symptoms is available. The outcome of the events was reported as unknown. The benefit -risk relationship of mRNA-1273 vaccine is not affected by this report.
Knee replacement surgery; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4114081-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Lot number: 1150526) and second regimen oral (Lot number: 1154506) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Second dose. (1 in 1 Once), Route of admin:  Intra-muscular), administration date: 22Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Urinary tract infection", "Patient cut knuckles", "had knot in arm", "vacine caused a sore arm", "feels pain when the temperature was cold", "Sinus infection"; Bnt162b2 (Dose 1, First dose. (1 in 1 Once), Route of admin:  Intra-muscular), administration date: 27Feb2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Urinary tract infection", "Patient cut knuckles", "had knot in arm", "vacine caused a sore arm", "feels pain when the temperature was cold", "Sinus infection". The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 14Oct2021, outcome "recovering", described as "Knee replacement surgery". The action taken for upadacitinib was unknown.  Additional information: On 02Dec2021, received updates to event information, reporter opinion of causality and narrative description. The events of "Laceration of Finger" and "Vaccination Site Nodule" were added. On 30Dec2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "Vaccine Injection Site Was Sore" was added. On 27Jan2022, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "Feels Pain When the Temperature Was Cold" and "Sinus Infection" were added. The event of "Vaccine Injection Site Was Sore" was amended to "Vaccine Caused a Sore Arm".  Causality Reaction: Total knee replacement (Knee arthroplasty) Action(s) taken with drug: Unknown; Causality as per reporter (Drug/Vaccine): Not reported; Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and close temporal association there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.
This spontaneous report was received from a pharmacist and a licensed practical nurse referring to a patient of unknown ageand gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 08-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9, intramuscular, in the hip muscle (drug administered at inappropriate site), lot # N017832; expirtion date: 16-NOV-2019 (strength was not reported)  for prophylaxis. No adverse effects were reported.
Fever 102.7 rectally, began 10 days after MMR given.  Rash on trunk began 12 d after MMR.
This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PEDVAXHIB for prophylaxis (lot number L002867, with an expiration date of 11-NOV-2017; lot number M001813, with an expiration date of 14-OCT-2018 and lot number M020100, with an expiration date of 03-JUN-2019) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003014: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003225.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JUL-2017, the patient was vaccinated with GARDASIL 9 dose 1 (route, dose, frequency, lot number and expiration date were not reported) for prophylaxis. Then, on 16-JUL-2018, the patient was vaccinated with GARDASIL 9 dose 2 (route, dose, frequency, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
102.5 fever day 1 poster vax 2; This is a spontaneous report from a contactable consumer (on behalf of patient). A 12-years-old female patient received second dose of bnt162b2 (COVID VACCINE, formulation: solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date (at the age of 12-years) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation.The patient received first dose of bnt162b2 (COVID VACCINE) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 102.5 fever day 1 poster vax 2. The patient underwent lab tests and procedures which included body temperature: 102.5. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Mixed series vaccine given to patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccine given to patient.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 17-May-2021, the patient received second 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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 17-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccine given to patient.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccine given to patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   co-suspect OML required after MR
Menveo reconstituted with sterile diluent instead of liquid vial that Menveo comes with. No patient c/o symptoms at this time.
weak/fatigued; weak/fatigued; He fell and could not get up; he couldn't keep his head up. He has no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 13:00 (Lot number: 30130BA) at the age of 85 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Quadruple bypass 11 years ago" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine.; "Asthma" (unspecified if ongoing), notes: His heart and lungs were checked out in June and July 2021 and all related tests showed they were fine. Concomitant medication(s) included: LIPITOR. Past drug history included: Aspirin, reaction(s): "Drug allergy", notes: Known allergies: Aspirin. The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "weak/fatigued"; FALL (non-serious) with onset 27Sep2021, outcome "not recovered", described as "He fell and could not get up"; ASTHENIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "he couldn't keep his head up. He has no energy". The events "weak/fatigued", "he fell and could not get up" and "he couldn't keep his head up. he has no energy" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This was the booster shot. The patient had received other medications in 2 weeks with lipitor and some supplements. The patient had not received other vaccine in 4 weeks. The adverse event resulted in emergency room (department/urgent care). Patient had not covid prior vaccination and had not covid tested post vaccination. Adverse event, fine the day of the shot. The next day patient was so weak/fatigued patient fell and could not get up. An ambulance took him to the ER. All vitals, CT scan, blood work and urine test was normal. He was released with a walker and he could not keep his head up. Patient is still very fatigued and needs the walker. He never used a walker before this. He has no energy.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Baby crying uncontrollably x few hrs - Stopped 30 min after ibuprofen.
pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphoid leukemia.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm). The patient was treated with PREDNISONE at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. On 25-Mar-2021, VACCINATION SITE PAIN (pain at injection site left arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive for the COVID-19 virus..     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 concomitant medications were not provided.
Skin rash all over his body starting sunday 3/12, gave him motrin on 3/14 at ER and within 30 min his eyelids and lips were swollen