chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
had a stroke from Pfizer's vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "had a stroke from Pfizer's vaccine". Clinical course: The patient had a stroke because of Pfizer's vaccine. This was the second time he had called. He previously spent 20 minutes giving information before the call was disconnected. Caller was recording this call because he thought Pfizer was hiding something and didn't want people to report this. He was getting really frustrated because he couldn't call and speak to anybody. He was supposed to be sent information and never did. He thought it was a cover up. He thought something was getting covered up. He had a stroke and caller mentioned somebody else had a stroke, but unable to clarify who this person was.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling at injection site, pain, body aches, general malaise . Pregnancy #2 due date 2-5-23
The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023; No adverse event; The patient received expired dose after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 29-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 29-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023).    No concomitant medications were reported.  The pharmacist confirms that 5 patients received expired doses. The vial size was 2.5 mL. The vial did not undergo any temperature excursions.  No treatment information was provided.
suspected vaccination failure; shingles; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's sister. The age at vaccination was not reported. The patient got the shingle shot and still got shingles that were very painful. The reporter stated that vaccines weren't a cure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; 29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; sunny nose; cough; sneezing; dose 3; This is a spontaneous report received from a non-contactable reporter (Nurse) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient receive other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021"; RHINORRHOEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "sunny nose"; COUGH (medically significant) with onset 29Dec2021, outcome "recovering", described as "cough"; SNEEZING (medically significant) with onset 29Dec2021, outcome "recovering", described as "sneezing". The events "29dec2021 covid sx ha sunny nose cough sneezing and tested + - found out 30dec2021", "sunny nose", "cough" and "sneezing" were evaluated at the physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, cough, sneezing.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events immunization, Vaccination Failure, Covid-19, Sneezing, rhinorrheoa, cough and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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
Patient developed dizziness, fever 99, headache and stiff neck. She vomited once. She went to hospital. She was tested positive for flu and was given Tamiflu.
Started with back pain at night, radiated to chest. After about a week of nightly pain, went to the emergency room and was diagnosed with a blood clot in lungs.
Bruise 5 inches in length; Pale; Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise 5 inches in length), PALLOR (Pale) and ERYTHEMA (Red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Bruise 5 inches in length), PALLOR (Pale) and ERYTHEMA (Red). At the time of the report, INJECTION SITE BRUISING (Bruise 5 inches in length), PALLOR (Pale) and ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM  (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
Janssen COVID-10 Vaccine EUA  About 5- 10 minutes after the vaccine, I started getting numbness in my left hand and my ears began getting hot. By the 25 minute mark, I noticed numbness in my cheeks, around my mouth and my forehead. I turned around and went back to the Health Department for observation. I sat with a nurse until I passed the hour mark for after the vaccine had been given. By that point, the numbness was gone around my mouth and forehead, but the numbness remained in my cheeks and they were visibly red where they were numb. At this point, I left the health department because my symptoms were getting better. It took about 2.5 hours for the numbness to gone in my cheeks.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted while getting the COVID bivalent shot. She was unresponsive for few minutes and than woke up and was fine. Said this happens when she receives vaccinations.
Pain; Body really sore; Super tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired). At the time of the report, PAIN (Pain), MYALGIA (Body really sore) and FATIGUE (Super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  Concomitant medications were not reported.
gardasil vaccine was given then a few seconds later she passed out falling off the table hitting her face on the cabinet.six stitches in her lip and her front tooth got knocked loose and a week later it needed a root canal
This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of swollen joints in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (intramuscular). The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced swollen joints, vomiting, general body pain and nausea. On an unknown date, the outcome of the swollen joints, vomiting, general body pain and nausea were unknown. The pregnancy outcome was unknown. It was unknown if the reporter considered the swollen joints, vomiting, general body pain and nausea to be related to BOOSTRIX. Additional details were received as follows: The patient experienced swelling in her arm, from her elbow to her shoulder, when receiving BOOSTRIX in 2009 at the time of her last pregnancy. The patient was pregnant again at the time of reporting, at the age of 34 and would like a recommendation regarding whether or not she could receive BOOSTRIX during this pregnancy. The date of last menstrual period was 12th September 2015 and estimated date of delivery was 27th June 2016 for this pregnancy. The reporter's call was escalated to Medical Information Scientist for requested information.
Intense, heavy bleeding one week exactly after second Moderna dose.  My period is not due for 2.5 more weeks.  I had JUST finished a period right before receiving 2nd shot.
hives, Diaphoretic, clammy skin, sensation of facial warmth, numbness in face and extremities, tremors. Vitals @0900: 166/104, HR 90, O2 98%, chewable benadryl given at 0905. Repeat vitals @ 0925: 141/86, HR 71, O2 95%. Given juice and released with wife.
Patient has localized redness, swelling, and tenderness on right deltoid at injection site.
Seizure, localized cellulitis-left thigh.  MD suspected a pre-existing fever but mother denies this.
1991 or 1992; Military records hard to obtain. Mother's recall of event "sketchy".
extremely ill; temperature going up 100.7°F; has been throwing up; His whole body hurts; His whole body hurts including all his joints.; He feels like he's going to die; This is a spontaneous report from a contactable consumer (parent). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot number was not reported) via an unspecified route of administration on 01May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced extremely ill, temperature going up 100.7degree F, has been throwing up, his whole-body hurts, his whole-body hurts including all his joints and he feels like he's going to die. Any unaddressed medical questions referred or forwarded to medical information reported as yes. The patient underwent lab tests and procedures which included body temperature 100 .7 degrees F on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a currently 74 year old female patient with diabetes and drug hypersensitivity to unspecified steroid. On 03-NOV-2012 the patient was vaccinated with ZOSTAVAX lot # H013943 expiration date 25-OCT-2013, 0.65 ml, subcutaneous. Concomitant medication was unspecified. On an unknown date after the vaccination, the patient experienced recurring sharp pains in her calf "along her shin line". The patient was seen by her unspecified primary care on an unspecified date, who performed multiple tests including an MRI. Neuropathy was ruled out. The reporter stated that the patient did not develop a rash of any kind. The pharmacist stated: "the pain has caused significant disability to the patient". The outcome of recurring sharp pains in her calf "along her shin line" was reported as not recovered. Additional information has been requested.
Legs hurt, thighs and knees - child screams at night.  Still hurting after 4 days.  Tylenol and Motrin ineffective.  No redness or swelling.
Hospitalization for COVID19 8/01/21 and death 8/09/21
pt states he had severe pain in the left arm. he was evaluated by his doctor and they believe he had a reaction to the vaccine. his arm was very painful and unable to move.
Got the vaccine / get slight cases/ suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included abnormal vision (almost went blind from shingles), herpes zoster (they were in hair and face) and pain (took forever to ease the pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles vaccine and now he/she only gets slight cases when nervous about anything, stated that was tolerable. The patient stated one should get vaccinated. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
H1N1 was given 11-2-09 - pt called 9 AM on 11-3-09 and stated that this morning she saw a rash to arms and buttocks and legs. States that the rash was red fine bumps accompanied by itching. Encouraged pt to call her doctor. Mother states that the rash went away the same day.
Left arm was swollen and VERY sore. Symptoms lasted until this morning. Also Got the chills when I was trying to go to sleep and very vivid dreams.
The patient had a raised area where the vaccine was administered immediately following the injection. A few seconds later the patient reported not feeling well, claiming to be light-headed. He was light-headed for a few minutes and then reported feeling nauseas. A few moments later the patient vomited.  He took a few sips of water and reported feeling much better after vomiting.
anxiety; Depression; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety) and DEPRESSION (Depression) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included VENETOCLAX (VENCLEXTA) for Cancer.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ANXIETY (anxiety) and DEPRESSION (Depression). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and ESCITALOPRAM OXALATE (LEXAPRO) at an unspecified dose and frequency. At the time of the report, ANXIETY (anxiety) and DEPRESSION (Depression) outcome was unknown.            Treatment for the events included alprazolam and escitalopram.   This case was linked to MOD-2021-109824 (Patient Link).
10 days post MMR/HIB vax pt devel high fever; parents gave APAP; during evening of 10th day pt had a 5min convuls; parents took pt to hosp; pt was adm & CXR & blood work done-results neg; p/2 day adm pt was d/c w/ATB & Phenobarbital;
Child developed fever and seizure CPR was performed 911 called seen following day in office where her pargina dx cl.