chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection (strength and dose were not reported) (lot # M035141, expiration date 03-AUG-2018; lot # M000996, expiration date: 07-JAN-2017; lot # M039316, expiration date: 20-SEP-2018) for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperature excursions: between > -9  degrees Celsius (C) and < 8C, and between > -15C and < -10C for an unknown time frame. No adverse effects were reported. A digital data logger was involved.  Additional information has been requested.
Hospitalization: 4/28/2023 - 5/11/2023 (13 days) Presentation to the ED: physical decline  COVID + date: 5/2/23 Treatment: no treatment. patient was asx.  Discharge to: SNF.  EL9267 2/15/2021 EW0173 5/11/2021 FJ1620 12/5/2021
Neck and body ache; Swollen left arm; No energy; Slept intermittently; No appetite; After my booster shot my hand feels like it gets paralyzed intermittentng like it was still intermittently paralysis; Left hand was numb; Rash on left arm; Fever 100.4; Headache; Body Ache; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck and body ache), PERIPHERAL SWELLING (Swollen left arm), ASTHENIA (No energy), INSOMNIA (Slept intermittently) and DECREASED APPETITE (No appetite) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21A, 0163M20A and 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Improvement A.I.C 6.8) since 2010, Blood pressure high and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood pressure, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Blood pressure high, LOSARTAN for Cholesterol, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, INFLUENZA VACCINE (INFLUENZA) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced NECK PAIN (Neck and body ache), PERIPHERAL SWELLING (Swollen left arm), ASTHENIA (No energy), INSOMNIA (Slept intermittently), DECREASED APPETITE (No appetite), PARAESTHESIA (After my booster shot my hand feels like it gets paralyzed intermittentng like it was still intermittently paralysis), HYPOAESTHESIA (Left hand was numb), RASH (Rash on left arm), PYREXIA (Fever 100.4), HEADACHE (Headache) and MYALGIA (Body Ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 11-Oct-2021, NECK PAIN (Neck and body ache), PERIPHERAL SWELLING (Swollen left arm), ASTHENIA (No energy), INSOMNIA (Slept intermittently), DECREASED APPETITE (No appetite), PARAESTHESIA (After my booster shot my hand feels like it gets paralyzed intermittentng like it was still intermittently paralysis), HYPOAESTHESIA (Left hand was numb), RASH (Rash on left arm), PYREXIA (Fever 100.4), HEADACHE (Headache) and MYALGIA (Body Ache) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) Fever 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Reporter details,patient demographics, medical history, suspect and concomitant medication, treatment medication, new events and  start date ,stop date and event outcome of paresthesia hand were updated.
Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-314573, MOD-2021-314517, MOD-2021-314793, MOD-2021-314545, MOD-2021-314805, MOD-2021-314570, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow Up received : Possible No new information.
Was unable to stand up on her own legs; Other minor side effects; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout, Diabetes, Thyroid disorder and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, ALLOPURINOL for Gout, LEVOTHYROXINE for Thyroid disorder.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects). At the time of the report, DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include diabetes drug that starts with C. No treatment information was provided.
syncopal event less than 5 minutes after dose administration. sustained facial trauma and concussion as a result of the fall. facial trauma includes upper and lower teeth cutting into buccal mucosa, associated lip swelling/cuts and bruising above top lip. ice applied immediately as well as pressure to stop the bleeding. unable to sit up after 30 minutes due to continued dizziness. decision made to call 911 as mental status not at baseline in addition to significant injuries. treated on scene by EMS. vital signs stable. was discharged from scene at 2:30pm. continues to have slight headache and pain at injury sites.
Case PHEH2015026643, is an initial spontaneous report received from a physician on 17 Dec 2015. This report refers to an female patient of an unknown age. Historical condition was not reported. Current condition included sensitivity to preservatives. Concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (last year). After vaccination, the patient experienced reaction to FLUVIRIN, she had swelling in arm. The outcome of the event was reported as complete recovery. The seriousness and causality of the event were not reported.
Patient received vaccine while sitting w/Mother and patient fainted. Alcohol pads placed under nose, patient aroused. Taken to Stretcher w/elevated feet. B/P  99/61 Pulse 103 Completely alert within 5 min.. Patient had juice and fruit. Last VS B/P 95/61 P 92. Guardian denied further treatment. and left ambulatory.
Patient received Moderna Vaccine and immediately felt dizzy. 911 was called and recommended to go to the hospital for more observation.  Patient was discharged from the hospital with no further issues.
UrticariaPruritus Started with urticaria/pruritus around 3rd day, then redness, swelling, induration, itching started 1/2/201, resolved to redness 1/5/2021.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details were reported.  Vial size was reported as 10 dose vials. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
pt recv vax; prolonged inconsolable crying greater than 3 hrs; v & d;
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 4 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. On 7/9/03, the patient received the second injection of Infanrix (lot DTPA601A2). On 7/11/03, two days post immunization, the patient experienced injection site cellulitis. The affected area measured 7 inches by 5 inches. The patient was seen by the physician, who prescribed unspecified medications. the injection site cellulitis resolved after an unspecified period of time. The reporter considered the event to be medically serious (OMIC). Comment: the reporter indicated that another unidentified patient experienced an unspecified adverse event. No further information was available.
Complex febrile status epilepticus lasting over 30 minutes, generalized, requiring medication to stop seizure.
Pt given ZOSTAVAX vaccine 4/14/09. Pt developed painful case of shingles 4/27/09 requiring treatment in the ER (Valacyclovir, Vicodin)
Within five minutes of receiving the vaccine, I felt my heart racing and felt like I was going to pass out. I dropped my phone in my car and looked at my heart rate on my Fitbit and it showed it was in the 180s. I felt woozy and honked my horn. No one came. I am a nurse so I immediately rolled my windows down, elevated my feet, tried vagal maneuvers to slow my heart rate, and drank cold water. My heart rate continued in the 170s-180s for several minutes. I had some shortness of breath and it also felt weird and kind of challenging to swallow. The person in the car next to me was watching me once I honked my horn and no one came. I waited about 20 minutes in my car while my heart rate slowed and the woozy feeling passed before driving away.  Over the next few days I felt so dizzy and nauseous I could barely do anything. I had to nap and rest for most of the day.
Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not reported.
Approximately 9 hours after receiving my second dose of the Pfizer vaccine, the joints in my fingers on my right hand became tight and stiff. What I can imagine arthritis feeling like. I have never had a feeling like this.
Soreness onset shortly after vaccination.  Felt tingling during administration.  Soreness worsened over next 2 days and is helped by NSAID.
Narrative: On 4/12, Patient reported she started having headache rating 7/10, R sided lower extremity weakness, and R sided upper extremity numbness, a few days after receiving does one fo COVID vaccine. Patient was encouraged to go to ED. She went to ED that same day received head CT - no evidence of acute infarct or other concerns. received diphenhydramine and metoclopromide at ED. Patient was diagnosed with migraine and discharged to home without further incident.
Rash all over stomach. Started centralized in the right abdominal side and progressed over time across my stomach, to my left side.  The rash is less prominent on my upper right back side back area, however it is progressing in that direction. I took a Zyrtec to see if it would help, and the rash still seems the same.
Muscle pain from mid back down to hips. Treatment includes Aleve and heating pad without improvement.
05Mar90 pt vax w/ 3rd dose;  exp non response.  04Apr91 vax w/ 4th dose; did not respond.
Slightly lightheaded, nervous. BP 175/96 (pulse 81), 169/98 (pulse 78). O2 sat 100%.
clots in her legs, heart, and lungs; clots in her lungs; high fever; triple bypass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: 8303000) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EL3247), administration date: 21Jan2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Thrombosis"; BNT162b2 (Dose: 02, Lot number: EL9269), administration date: 10Feb2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Clots in her legs, heart and lungs", "Clots in her lungs", "high fever", "triple bypass". The following information was reported: CORONARY ARTERY DISEASE (medically significant) with onset Aug2022, outcome "unknown", described as "triple bypass"; THROMBOSIS (medically significant) with onset Oct2022, outcome "unknown", described as "clots in her legs, heart, and lungs"; PULMONARY EMBOLISM (medically significant) with onset Oct2022, outcome "unknown", described as "clots in her lungs"; PYREXIA (non-serious) with onset Oct2022, outcome "unknown", described as "high fever". The events "clots in her legs, heart, and lungs", "clots in her lungs", "triple bypass" and "high fever" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Oct2022) Unknown results. Therapeutic measures were taken as a result of thrombosis, pulmonary embolism, coronary artery disease, pyrexia. Clinical course: Third dose given on 14Dec2021; lot: 8303000 or 830300D. Last one given on 05Dec2022; lot: PGJ3275 (latest booster). It was 6 weeks after her triple bypass that she got a fever and ended up in the Emergency room when they did blood work. That would have been early Oct2022. When asked outcome, reporter stated that she is on all kind of medications now because of this. She is on blood thinners. She went to her Cardiologist.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033969 same reporter, patient and event, different dose;US-PFIZER INC-202300034247 same reporter, patient and event, different dose;
Fussiness, loss of balance when walks. Not sleeping well, poor appetite, no fever, no rash, no local reaction - was admitted to hosp next day. Symptoms got worse.
Pt describe pain at site of injection that was given on 2/22/14. Pt states she has pain lifting her arm and feels pain/tingle on her fingertips.
After recieving the second shot for my COVID19 vaccine, I breastfed my 14 month old twice and then he vomited. I continued to feed and breastfeed him as usual and later that night he vomited again. The only difference from the usual day that I could discern was the vaccine.
10:25am  feel nauseated Vital signs 122/82 Pulse 67 pulse ox 99%; 10:35am patient reports feeling very anxious and dizziness; 10:50am pt reports chest pain; 911 called; BP 136/86, Pulse 77, Pulse ox 98%. 10:55 am EMS arrives patient monitored, glucose 83; no abnormalities in cardiac monitoring. 11:03 released by EMS - instructed to rest and take deep breaths.
Developed "racing heart" within 15 minutes of receiving vaccine.   HR > 100.  BP 224/102.  Denied SOB or Chest pain.  10 minutes later HR = 92 and BP 158/104.   Twenty minutes after onset, BP 182/112.  Denies hx. of hypertension, and last taken approximately 6 months ago.  Transferred via ambulance to hospital.   During stay at ER and before discharge, BP 155/88- 164/94.   Diagnosed w possible hypertension and instructed to follow up with primary care MD.
I suffered a cryptogenic stroke; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0196) at the age of 58 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL taken for hypertension; LIPITOR taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose number unknown; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 20Oct2021, outcome "recovered", described as "I suffered a cryptogenic stroke". The patient was hospitalized for cerebrovascular accident (start date: 20Oct2021, discharge date: 23Oct2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: investigation: (Oct2021) negative; (Oct2021) negative; (Oct2021) negative. Therapeutic measures were taken as a result of cerebrovascular accident. The patient reported that 20 days after he had my COVID booster, patient suffered a cryptogenic stroke and all subsequent testing was negative for any other cause of the stroke. Patient had four lab work up including anticoagulation, coagulopathy work up, complete screening at the time of the stroke. Patient was in the hospital for three days. Patient stated that he was no longer experiencing the problem and he received the "tPA" (not further clarified) at the hospital, with resolution of the symptoms.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
12/08/21 presents to ED for "right leg pain/bruising" "nausea and nonbloody nonbilious emesis, diarrhea". PMHx of "kidney transplant, recent cardiac catheter, hypertension, hyperlipidemia"
Stroke; not capable to understand or speak very well.; A spontaneous case was reported by a consumer  concerning herself and who received mRNA-1273 (Moderna COVID-19 Vaccine) for the prophylaxis of COVID-19 infection and experienced couple of stroke/ Cerebrovascular accident and not capable to understand or speak very well/aphasia.  The patients medical history was not reported. Concomitant medication details was not populated.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) 1 dosage form.  On unspecified date the patient experienced couple of stroke/ cerebrovascular accident and not capable to understand or speak very well/aphasia.  The events of  cerebrovascular accident and aphasia were considered to be serious (medically significant).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was unknown.  The treatment medication was not reported.  The outcome of both the event was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.