chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 76 y.o. female patient injured as a result of a fall from standing height on 10/3/2021.  Patient reports she slipped on water in her bathroom and hit her head, but denies LOC. Patient denies any difficulty breathing or chest pain at the time. She actually denies any pain from her fall. She was not able to get herself up from the bathroom floor and slept there that night. The following day she crawled into her bed room and was able to call for help. She again denies any pain or difficulty breathing, just general weakness preventing her from being able to get up from the floor.  On the day of presentation she had developed pain of her back and right hip and this was her reason for presentation.  She also reports that she had shortness of breath for the past 2 weeks especially on exertion.   On evaluation in the ED she has been found to be COVID (+) and multiple rib fractures in various stages of healing.  She was started on oxygen via nasal cannula on 10/5/2021.  She was also started on dexamethasone at that time.  She became more hypoxic and oxygen requirements increased, and she was requiring Bipap on 10/8/2021.    She was started on remdesivir on 10/8/2021.   Patient refused intubation and was made comfort measures on 10/9/2021.  The patient expired on 10/10/2021.
10+ hours of confusion, that was thought to be ictal or post-ictal confusion. Next day, resolved, but he could not remember that 10+ hours period of time.
Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4447196-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162124), subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Covid-19". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: Causality for HUMIRA(ADALIMUMAB)-The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out
Swelling of the shoulder and could not move my arm and nausea and had a shot fifteen years ago and never had a reaction at all.  It has been a year and I still have pain and can't move arm back to put seatbelt on and it radiates up my neck and gives me headaches and it is just the worst thing I ever did.  Had a Nerve Conduction Study and that was fine and had an x-ray and that showed a little Arthritis but very slight and my doctor mentioned maybe a bad batch of the shot because he had others with adverse reactions.  I am not sure what all is really wrong with me as now I have blood in urine and stool so who knows what damage it has caused but I feel like I might not get full use of my arm since I had this done and pray I get nothing else from it.  Please look into this for me as I am at my wits end and my Dr. mentioned a Cortisone shot which I don't want.  Thanks for your time and interest in this matter.
Pt recv vax on 10/14/98; on 10/24/98 pt exp aches & pains all over body w/ groin pain, frequent urination, not sleeping
This spontaneous report as received from a other health professional refers to a 21 year old male patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient as a child was vaccinated with hepatitis B vaccine (manufacturer unknown) series (dose, lot number, expiration and date were not reported). The nurse stated that the unspecified patient "has negative titers" at the time of the report. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
2nd day- overall weakness, muscle ache in both legs, diarhea, took 800 mg ibuprofin in afternoon, leg aches went away about 4 hours later, no swelling at left arm injection site, just a little sore, next day felt fine in the morning, no aches at all.
DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 18th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Initial report was received via a company representative who received the report from a health care professional on 16 September 2011. A female patient had received an INFLUENZA vaccine (manufacturer unknown; lot number, route and site of administration not reported) and an unspecified amount of time later, the patient developed MS (multiple sclerosis). The reporter believed the patient was being treated by another physician but had no additional information at the time of the report. Outcome was not reported. Documents held by sender: None.
24 hrs after vaccination in Right Arm - Right Shoulder Sore. Then 2nd Day began pain in my Right -Hip Joint,Knee and Ankle. Then 3rd day Right Hand  finger joints Very soar. This lasted about 4-5 Days.  Went on a Hike 2 times in 5 days and hard to walk-Very soar in all Joints on my right side. My left side -shoulder,.Hip,Knee, ankle and Hand where all fine.
After first shot there was minimal effects, just a sore arm and fatigue.  These went away within a day or so.   Second shot had immedate fatigue, body aches, and headache within 12 hours.  Again these subsided within 48 hours.  However within the week I developed a mild red rash across my body from my chest down to my knees, and an ache in my left ankle.  I assumed I had twisted the ankle without realizing and the rash had to do with my seasonal allergies.  I began taking Benadryl for the rash and rested the ankle, but the rash only slightly faded and while the ankle got slightly better, the ache moved to my right shoulder, then my  left elbow, then the left knee, then right knee, then to the joints in fingers on my right hand.   Finally mos recently the ache has moved to joints in the left hand.  Each time the aches move the previous location feels slightly better but isn't back up to 100 percent.  And aches seem to move every 4/5 days.   It has now been over a month since the second shot and the joints of my body still feels abnormal and strained.  And in the last few days I have developed a terrible headache that doesn't seem to go away.
Employee has history of anaphylaxis and was in the 30 min observation. C/O dizziness. Sits on gurney at 45 degree angles. No sob, chest pain or hives. VS obtained and employee hypertensive. Under observation of RN. Able to sip on water, but continues to have HTN and dizziness. Taken to the ED for further evaluation of symptoms.
Vaccine administration at 2pm. Patient complaint of nausea at213pm. Vital signs within normal. Patient felt water after drinking water. Discharged home at 1423.
I CAN NOT REMEMBER EXACT DATE BUT HE WAS GIVEN THE MMR AND CHICKENPOX VACCINATIONS AND TEN DAYS LATER HE HAD HIS FIRST FEBRILE SEIZURE. HE WAS ONLY ONE. HE IS NOW FOUR YEARS OLD AND HAS HAD UP TO TEN SEIZURES IN HIS LIFE. HE ALSO HAS SEIZURES IN HIS SLEEP. AND NONE OF THIS STARTED UNTIL HE HAD THAT VACCINATION.
Patient reports that the day following vaccination he developed "severe sharp shooting pain from his right hip to his toes" which has persisted and "changed his life".  He has not sought medical attention for this problem.  He admits to a history of hip problems.
had swelling around left nipple area; had tenderness around left nipple area; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL03249, NDC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 14Jan2021 at 10:40 in left arm as a single dose for covid-19 immunization. Patient received the second dose on 4Feb2021. There was no medical history reported. There was no history of previous immunization with the Pfizer vaccine. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no AE following prior vaccinations. Caller wanted to report a side effect from his first Pfizer dose. After 2-3 weeks the first dose, patient had swelling around the left nipple area and tenderness and wanted to know if this was a side effect. Clarified that it is for the Pfizer Covid 19 shot. AE did not require a visit to Emergency Room/Physician Office. There were no relevant tests done. Outcome of the event swelling around left nipple area was recovering while that of tenderness around left nipple area was unknown.
Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing), notes: Early onset of rheumatoid arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HENOCH-SCHONLEIN PURPURA (hospitalization) with onset Apr2022, outcome "not recovered", described as "Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine". The event "developed henoch-schonlein purpura  as a direct result of the second covid vaccine" required emergency room visit.   Clinical course: Dates when patient was in hospital for Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine was reported as unknown. Other conditions were reported as yes; investigation was not provided. Reporter confirmed she (Reporter) was calling about the Pfizer Covid vaccine and confirmed her son (patient) developed HSP, as a direct result of the second Covid vaccine. Clarified HSP as: Henoch-Schonlein Purpura. Caller states the (Redacted) clinic, there was a team of doctors, with multiple specialties. Reporter Stated her son Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine and her son was in the emergency room twice, and hospitalized as an in patient 3 times. Happened 11 weeks after his Covid vaccine. Caller stated she does not have her sons vaccine card readily available at this time and did not had information about the first dose. Reporter (Patient's mother) enquired why were they taking that report and asked if Pfizer compensating people who take the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash in middle of back then neck, shoulders, legs and forehead. Went to the ER, and was some medicine, Zyrtec and EpiPen.
Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive); Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing), notes: other medical history: Childhood asthma and anemia; "Childhood anemia" (unspecified if ongoing), notes: other medical history: Childhood asthma and anemia; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "known allergies: seafood almost" (unspecified if ongoing), notes: known allergies: seafood almost, severely. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Retested positive for Covid within 5 days of testing negative (on day 7 since testing positive)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Covid within 5 days of testing negative; Positive, notes: Retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Patient did not receive other medication in 2 weeks. Anti-viral details: product COVID 19 Treatment, Brand: Paxlovid, treatment start date was on 22Nov2022 and stopped on 26Nov2022, Lot number: 1919257A, Indication: Treatment of COVID-19.
pt recvd flu vax & 1 mo later, devel rash, cough, pleuritic chest pain & an inflitrate was seen on cxr; found to have vasculitis; tx w/steroids; pt died; autopsy is pending;
itching at injection site; Moderna arm where it was a red site and warm around area about 4 days after getting the; fatigue; Headache; muscle ache; redness at the injection site; swelling at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) and VERAPAMIL for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.278 (Inconclusive) 38.278.         No treatment medication details were provided.   This case was linked to MOD21-073350, MOD21-073379 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Added reporter email address. Added concomitant medications(Xanax, xerapamil).Added patient DOB, age. Added events (ever of 100.6F, headache, muscle ache, and itching, swelling,redness at the injection site).; Sender's Comments:  MOD21-073350: MOD21-073379:
Information has been received from a registered nurse concerning a child who was vaccinated with an initial dose of varicella vaccine. Subsequently, the pt failed to seroconvert. Unspecified medical attention was sought. No further info is available.
I have intermittent high pitched ringing in both ears. I've never had this before. I noticed it a few days after I received the vaccine and didn't think much about it, but it has continued since then and is starting to worry me a bit.
bronchitis; feeling flu-ey; low grade fever/99-100°F; Covid-19; breakthrough infection; felt bad; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat) and BRONCHITIS (bronchitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced FEELING ABNORMAL (felt bad). 18-Jul-2021, the patient experienced THROAT IRRITATION (scratchy throat). On 23-Jul-2021, the patient experienced COVID-19 (Covid-19) and INFECTION (breakthrough infection). On 24-Jul-2021, the patient experienced BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 30-Jul-2021, COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat), BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Jul-2021, Body temperature: 99-100 (Low) Low grade fever 99-100°F.
Redness, itching to site on 7-26-08. Family gave BENADRYL. Improved. Smaller area and no c/o itching today.