chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/8/22 pt to hospital with increasing SOB and bilateral leg edema; found to be positive for COVID; experienced PEA arrest; CPR done with ROSC; intubated on mechanical ventilation; ICU; vasopressors, steroids, empiric ABX; pt made a DNR with comfort measures and he passed away the following day
I had cold symptoms the first day. I was stuffy and my head was congested. Each day I had different symptoms. One day I was extremely thirsty, and I drank so much water. However, the next day diarrhea which lasted one day also. I was totally congested; my head and nasal passengers were congested. I completed an at home COVID-19 Test that Saturday and it positive. I contacted my primary care doctor on Monday, and he prescribed Paxlovid. I was already beginning to feel better when I started taking the Paxlovid. I recovered from all the symptoms, but I needed to be prescribed an antibiotic a week later because I was coughing up a discolored yellow and green mucus that appeared to be an infection. The antibiotic worked right.
T. 100.4 24 hours after imms.  Tylenol advised.  Call if sx. change.
WOKE UP THE NEXT DAY AND COULDN'T  WALK.; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced woke up the next day and couldn't  walk. (preferred term: Gait inability).     The outcome of the event was unknown.    The event was considered non-serious.
A spontaneous report has been received from a Health Professional concerning a 7 year old, Male subject. FLUMIST quadrivalent started on 10-Jan-2015. The reporter stated that the patient experienced expired inadvertently administered FLUMIST quadrivalent to two patients which started on 10-Jan-2015. The outcome of the event of expired inadvertently administered FLUMIST quadrivalent to two patients is unknown. The report was considered to be non-serious.
intense nausea,  headache, body ache, fever blisters, mouth sores
received a full 3rd dose and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised) had resolved.            no concomitant and treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Nonsignificant follow up appended
pt recvd vax; later in eve, exp severe HA, fatigue & inject site soreness in arm;apap given; 3 days later recovered
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "testing positive for COVID-19/she got COVID now and mentioned 2 or 3 months ago, she also got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Caller was prescribed Paxlovid after testing positive; (2022) 2 of 3 months ago had COVID, notes: Caller has COVID now and mentioned 2 of 3 months ago had COVID as well. Therapeutic measures were taken as a result of drug ineffective, covid-19. Per clinical course, patient online reporting adverse events for Paxlovid and Pfizer COVID-19 Vaccine. Patient was prescribed Paxlovid after testing positive for COVID-19 and also taking Amlodipine. She has not taken Paxlovid and was contraindicated to take with Amlodipine. She was also taking Losartan and Raloxifene. She is fully vaccinated with 4 doses and with Pfizer. While she got COVID now and mentioned 2 or 3 months ago, she also got COVID. During 2nd booster dose she mentioned that she had arm pain and felt weak for 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201117729 same reporter/patient/product, different dose/AE.
Pt c/o swelling of right arm after receiving his 2nd JEV injection on Monday.  Pt had some swelling from distal half of upper arm to proximal half of forearm.  Swelling continued to increase over the past 2 days.  Positive warmth, edema and erythema.  No fever/chills/nausea/vomiting.
Client felt light-headed and dizziness.  BP 90/40 and 102/63, HR 63.
had a urine drug screen done which came back positive for cocaine; the pain continues; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), first dose via an unspecified route of administration, administered in Left Arm on 08Mar2021 as a single dose for COVID-19 immunization. The patient medical history included pinched nerve. concomitant medications were not reported. On 10Mar2021 the patient stated that a urine drug screen was done which came back positive for cocaine and pain on an unknown date. The patient was treated for the pain with steroid shots in her back. The outcome of the events was Unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
more pain in their neck; more pain in their lower back; more pain in their abdominal area.; have to take naps a lot; Every day they wake up and are stiff; they suffer immobility; local pain/painful; so much pain in the joints; muscle pain, they cannot deal with it; very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot) and MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Penicillin).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 experienced NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), PAIN (local pain/painful), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired). At the time of the report, NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired) outcome was unknown and PAIN (local pain/painful) had resolved.      It was reported patient had physical therapy but that did not really help. No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-033559 (Patient Link).
Within 24 hours client discomfort in arm increased. Denies redness, edema, numbness. Has affected normal function, and sleep. Report rec'd after 11 days no improvement.
arm pain; diarrhea; chills; 100.3 temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea), CHILLS (chills) and PYREXIA (100.3 temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea), CHILLS (chills) and PYREXIA (100.3 temperature). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea), CHILLS (chills) and PYREXIA (100.3 temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.3 (High) 100.3 degree Fahrenheit.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received captured reporter contact details.
Tested PCR positive for COVID 7/28/21. Symptom onset 7/25/21.
blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025G202A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was treated with WARFARIN SODIUM (COUMADIN) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots) outcome was unknown.            The concomitant medications were not reported.  Patient enquired if she can take the booster dose after having blood clot post second dose of moderna vaccine.  Company Comment: This case concerns a female patient, unknown age with no relevant medical history, who experienced the serious, unexpected, AESI event of Thrombosis. The event occurred  on unknown date after second dose of mRNA 1273 vaccine and had warfarin as treatment for blood clots. The rechallenge is not applicable as patient received treatment for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age with no relevant medical history, who experienced the serious, unexpected, AESI event of Thrombosis. The event occurred  on unknown date after second dose of mRNA 1273 vaccine and had warfarin as treatment for blood clots. The rechallenge is not applicable as patient received treatment for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Patient reporting receiving Moderna Bivalent on 12/13/2022 at pharmacy. She reports having left arm pain since the administration of the vaccine. She has taken over the counter medication for pain management over the past 5 weeks. She reports having difficulty completing activities of daily living and difficulty sleeping due to the pain. Upon assessment the upper left arm is inflamed.  Treatment is prednisone 20mg 1 tab 3 times a day for 3 days, 1 tab twice a day for 3 days, then 1 tab a day for 3 days. Also, patient was informed to rest and elevate arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing), notes: Crohns disease. The patient's concomitant medications were not reported and no other medications the patient received within 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included oral Paxlovid. Clinical course was reported as rebound COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the events and suspect  BNT162B2 cannot be excluded.The case will be reviewed further with FU information. 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
I noticed when putting in deodorant that I had swelling the size of a golf ball in my arm pit
PT EXPER. LARGE AREA OF SWELLING, ERYTHEMA, SEVERE PAIN AND A WARM FEELING AT SOI.
Below vaccination site about 2 inches redness, hot, muscle ached. Could not raise arm. Hurts. Left arm.
started getting numbness in hands-fingers and lips  and then numbness to feet and fell to ground  with inability to walk - no strength in legs knees or arms.    left facial drooping and slurring of speech and severe weakness -paralyzed
No adverse event; Expired dose was administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient).    No concomitant medication was reported.    No treatment information was reported.
sweaty; sugar level went down so bad she couldn't get out of bed to eat something sweet; Redness went down through the middle of the arm; feeling like a mosquito stung her; have Carpal tunnel in it; so painful she thought the finger would explode; itchiness; terrible pain at the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her) and CARPAL TUNNEL SYNDROME (have Carpal tunnel in it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Lung cancer stage IV. Concomitant products included NIVOLUMAB (OPDIVO) and METOPROLOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Hives/rash on face, very red and itchy. Some itchiness on rest of body but not as bed. No throat/tongue swelling.
Pt felt cold, had a fever of 101.6, had chills, shaking of hands, uncontrollable full body jerks. Slept most of the next day.
On 13-APR-2016 the patient was vaccinated with an improperly stored (at 14.9 Celsius degree for 280 hours) doses of VARIVAX (lot# reported as l04688, expiration date 23-NOV-2017, dose and route unknown). There was no out of range before. No adverse events were reported. Lot number l04688 is an invalid lot number for VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Gave Novartis H1N1 vaccine (4 yrs and older) 0.5ml, IM should have given Sanofi Pasteur H1N1 vaccine (6 months and older) 0.5ml IM. No signs or symptoms of distress noted.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2022-437352 (Patient Link).
I started having my period for every day for 1 month. It is very heavy and it does not stop.
5 min after vaccination, patient complained of increase in heart rate to 133 BPM and feeling like his arm was tingling and numb.  We propped his feet up and gave supportive care such as blanket and ice packs.  Patients heart rate went back to normal (75-80 bpm) after 10 minutes.  However, 35 minutes post vaccination, pt started having chills and shakes.  Gave blanket and monitored patient for 45 min after vaccination.  Pt declined 911.  Wife took patient home 50 min past vaccination stating she felt he was stable and they would monitor at home.
10-13-09-pt. described pain with breathing and feeling of something heavy on chest throughout the day. 10-14-09-pt woke up with hives/blisters on R arm around the site of injection, arm had minimal swelling. C/O itching on ear, neck, arm and skin of affected areas felt warm to touch pt reported this to Health Dept about 2:30 pm on 10-14-09. By this time some of the hives were resolving. Still c/o itching especially R ear and neck. Instructed to take BENADRAYL.
Elevated fever > 103. Very irritable. Screaming. Cranky. - Spots on leg & back.
a patient faint after administration of a dose of GARDASIL 9; This spontaneous report was received from an office manager who was also a nurse via field representative referring to a child patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On an unknown date in 2018 (reported as about 2 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as normal childhood vaccination).  After vaccination, the patient fainted. The patient was monitored after the incident. On the same date, after resting for an unspecified period, the child recovered and did not need any further medical intervention. Therapy was also reported as dose continued. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of faint was determined to be medically significant.
mom called clinic & said on 9th day during noc t105.3;mom states doubled the dose of APAP & put pt in bath water & temp came down;states broke out w/about 50 bumps all over body;bumps never blistered;
PT received flu and Td vaccines on 11/6/02. Had pain x 6 days. Return to HD on 11/12/02. Swelling and bruising noted on left arm (had Td in left arm, flu in right arm) and pain. To MD on 1/6/03, light swelling and bruising gone but still having pain. To be treated with anti inflammatory x 2 wks and return to PMD in 2 wks.
Fever 103.2 degree,  headache,  stiff neck.  Started 10 pm  04/28/2021. Temp reduced to 101.8 degree with Tylenol 500mg. Dose repeated every 4hrs (4 doses total).  ALL symptoms resolved  by 2 pm  04/29/2021.
Around 8:15 pm, I became very fatigued and mildly achy. About an hour later, I had extreme muscle aches and weakness, in addition to a the chills and a severe headache. I became very warm and around 11pm, I had a temperature of 100.4. My temperature continued to rise as I hit 102.6 around 4:30am on 11/10/21. The muscle aches, weakness, and headache continued to be severe, with chills intermittently. The temperature normalized at 98.1 around 4pm on 11/10, but the muscle aches and weakness continued to be moderate.  Symptoms are very mild this morning (11/11) but are still present- headache, muscle aches, chills.