chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liver failure; developed a clot in her portal vein; This spontaneous case was reported by a consumer and describes the occurrence of PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) and HEPATIC FAILURE (liver failure) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) (seriousness criteria death, hospitalization and medically significant) and HEPATIC FAILURE (liver failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Liver failure. It is unknown if an autopsy was performed.            It was reported that the reporter believed that her mother passed away as a result of a complication with the vaccine. Patient's mother received first dose on 28-JAN-2021. Patient received second dose one 26-FEB-2021. The patient was 85-year-old with hypertension and diabetes and developed a clot in her portal vein. Patient was hospitalized. The clot made her go into liver failure which was the cause of death. The date of the reported events remained unknown at the time of the report.    Treatment information were not provided by the reporter.  Concomitant medications were not reported by reporter.  Company Comment: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Sender's Comments: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Reported Cause(s) of Death: Liver failure
Patient experience lethargy, weakness, and vasovagal episode following booster vaccine (Janssen) at 10:20 AM. Vital signs initiated, legs elevated, PO fluids given, ice pack provided. Patient was observed for 40 additional minutes, minimal change in mental status, patient followed commands with spouse present. Patient verbalized feeling better at 11:00 AM than initial assessment. EMS activated for further assessment. Patient left via EMS ambulatory and accompanied by spouse at 11:22AM. Patient transferred to hospital per spouse request.
Right arm with erythema from shoulder to mid-forearm with significant edema 2 X the size of left arm. Also non-pitting. Significant edema of elbow.
4 hrs p/inject pt exp rash & itching @ extremities & scalp; no other sx; no allergy to eggs; advised to call MD; h/a x 1 wk;
Swollen lymph nodes in vaccinated arm nearly two weeks after vaccine. under arm pain lasted about one week and then came muscle pain in the entire top of back of arm.
25APR92mom phoned clinic & reported pt vaxed 23APR92 had a t106 R & kept vomiting; mom instructed to take pt to ER; next day pt exp runny nose, acted like had a cold, asthma;
Woke up on 3/13 with itching in an area 1inches below the injection spot. But it was not that bad, so just rubbed it with my fingers and went back to sleep. I did not notice the rash after I woke up until around 7pm on 3/13. I was also feeling nausea on 3/13 from 1 or 2pm onwards, which lasted until around 11pm or midnight. The place of the rash was a bit hot, red and swollen like  a bug bite. I kep an ice pack on it for 30mins before going to bed at 4am. When I woke up on 3/14, I didn't feel any nausea but when I checked my arm, the rash was still there. In fact, the rash seems a little bigger that the previous day.
Tingling starting in left arm and then progressed to right arm. Pt states "felt strange". VS 152/96-P-68 at onset, VS 178/84-P-64 after 20 min.
her arm hurt/had a sore arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that after the shot her arm was hurting/had a sore arm. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The patient's relevant medical history included: "Metabolic syndrome" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "depression-stable" (unspecified if ongoing), notes: depression-stable; "Insomnia" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "bmi almost 30" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
came out positive for covid-19 after first dose.; came out positive for covid-19 after first dose.; This is a spontaneous report received from a contactable female consumer (Wife) reported for a patient (Husband) via Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at single dose on Feb2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid-19 2 weeks (on an unknown date in 2021) after first dose. It was also reported that patient went to emergency room and was back home with covid symptoms. Outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Headache, Myalgia, Fever, LOW GRADE FEVER BODY ACHES, FATIGUE, HEADACHES Narrative:
Individual received first dose of the two dose series of COVID-19 vaccine - Moderna - on 1/20/2021.   Individual received second dose of two dose  COVID-19 vaccine - Moderna - on 2/9/21.  Second dose of vaccine was due to be administered 2/17/21.  Vaccine error - second dose of Moderna administered 8 days earlier than recommended.   Physician contacted Infectious Disease Specialist, Dr. who advised no additional dose needed.  Individual reports no adverse side effects related to second dose.
Fever and chills, headache, body aches, fatigue.  The onset of the symptoms occurred the evening after getting the 2nd dose of the Moderna vaccine (May 6) and then occurred again the following week, on May 12. The first time, the symptoms lasted for about 36 hours, the 2nd time, for about 24. I treated the symptoms with over the counter ibuprofen and tylenol.
woozines; ear pain; Headache/ear sensations; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozines), EAR PAIN (ear pain) and HEADACHE (Headache/ear sensations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Allergy to Mackeral), Thyroid cancer (2005) in 2005, GERD since 2018, Osteopenia since 2015 and Osteoporosis since 2015. Concomitant products included LORATADINE (CLARITINE) for Headache, RISEDRONATE SODIUM (ACTONEL) for Osteoporosis, PRUCALOPRIDE SUCCINATE (MOTEGRITY) and MAGNESIUM OXIDE for Overgrowth bacterial, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D low, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache/ear sensations). On an unknown date, the patient experienced DIZZINESS (woozines) and EAR PAIN (ear pain). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (woozines) and HEADACHE (Headache/ear sensations) had not resolved and EAR PAIN (ear pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) NORMAL. On an unknown date, Body temperature: 101 (Inconclusive) INCONCLUSIVE. On an unknown date, Magnetic resonance imaging: normal (normal) NORMAL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced other symptoms like brain fog and wild dreams.
she didn't stick me in the upper arm  it was more in the middle, now it has swelled up and very red and very hot to touch.
After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and lightheadedness. Patient was given water/juice. Patient was instructed to wait an additional 15 minutes for observation but declined and left against medical advice
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions or medical history were not reported. On an unknown date, one dose of ROTATEQ oral suspension, which was exposed to temperatures outside of the recommended range, was administered to an unspecified patient (route defaulted to oral by Merck, dose, anatomical location, lot number and expiration date not reported). No adverse experience had been observed or reported. Additional information has been requested.
As  was sitting in the kitchen, he fell forward but my wife & daughter were able to break his fall so he went to the floor gently.  When he got up he began throwing up a little bit.
Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Boostrix below temperature excursion, which led to incorrect storage of drug. This is 1 of 20 linked cases reported by same reporter for different patients.
left armpit mild lymphadenopathy (pea-sized), fatigue, malaise, chills x 24 hours. Bed rest and full recovery.
Patient reported initial tingling in hands and feet that she could "feel" the vaccine being injected. hours later she started developing a rash that progressed across her chest and neck over the past 48 hours. denies any other symptoms. Consulted with Dr. from PCP's office and instructed patient to take Benadryl tonight. if life-threatening symptoms develop, report to Emergency room, if rash present - schedule appointment with the office.
Rigors, chills, arthralgias, myalgias, headache, nausea, low grade fevers to 101.1 F.  Incapacitated for 36 hours.  Could not get out of bed.
Patient was born with a congenital ventricular septal defect. She had an echocardiogram which was normal almost 1 month to the day after her vaccine. However, she just had a recent abdominal ultrasound and there was an incidental finding of a pericardial effusion.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19.  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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events COVID-19 & Drug ineffective which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
1st one she got dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6199) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st one she got dizzy".  Additional information: It was reported that, her doctor and pharmacist were not sure if she should receive the booster dose and she was told to call us. She was wear a mask everyday until another vaccine comes out because she cannot be dizzy again while driving and going up and down the stairs again.   No follow-up attempts are possible. No further information is expected.
had them once got the shot/Suspected Vaccination Failure; have them all over my body; worst pain ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had them once got the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: have them all over my body) and pain (Verbatim: worst pain ever). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the worst pain ever.  The patient had shingles once got the shingles shot then now a year later, he/she had shingles worst than when he/she got the shingles shot.  The patient had shingles all over his/her body like chicken pox. 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.  The follow up would not possible as no contact details were available.
Within 15 minutes of recieving vaccines, the child developed a rash on the soles of both feet. A few lesions were noted on the back and abdomen (2). Lesions disappeared within 45 minutes. A few recurred 15 minutes later. Baby remained without any other symptoms.
02/25/22 presents to Cardiovascular Surgery for "planned TAVR procedure". PMHx of "severe aortic stenosis, chronic diastolic CHF, DM II"
STUFFY NOSE; FELT TO THROW UP BUT SHE DID NOT; DIZZY; LUNG CONGESTION, COUGH; This spontaneous report received from a patient concerned a 57 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A,expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 12:30 p.m. in right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 03:00 a.m., the patient experienced lung congestion, cough. On 09-APR-2021 11:00 a.m., the patient experienced dizzy, felt to throw up but she did not. On 11-APR-2021, the patient experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and felt to throw up but she did not and was recovering from cough, lung congestion, and stuffy nose. This report was serious (Other Medically Important Condition).; Sender's Comments: V0--covid-19 vaccine ad26.cov2.s-Lung congestion. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2 urticarial lesions on back after final dose. Given H1N1 in split dose protocol. She tolerated 1/10th dose. After 9/10th dose she had mild urticaria only. Has known egg allergy. Otherwise well.
On January 13, 2021, 10 days after the shot was administered,  a red rash appeared at injections site.  Oval, approximately  2"  x 1 1.2 " and slight bump.  At the time it was notices, my doctors office was closed for the weekend.  No pain, or itching and no other symptoms.  Rash is verry light and almost gone today, Sunday January 24, 2021.
Patient was completely vaccinated 3/12/2021. On July 26th 2021, patient was tested positive for COVID-19. On July 23 he started having symptoms of weakness, chills, fatigue, cough and congestion that worsened leading to  him getting tested on the 26th.
Patient complained of swollen upper arm.  5x7 firm, nonmobile lesion/mass on left upper arm 7 days after first Gardasil. No redness, edema, rash. Positive tenderness with palpation. Watch reevaluate in one week. Ibuprofen for tenderness.
24 hours after getting the shot, the normal side effects of feeling unwell, the side effects ended the following day. Six days after the shot , I suffered from extreme vertigo to the point that I could not walk without assistance and felt almost paralyzed . While lying in bed the dizziness got more intense but subsided about 6 hours later. It was one of the scariest things that I have been through.
8 days post vaccine I got a cellulitis infection where vaccine was administered, which needed antibiotics to treat
No adverse event; First dose on 22-JAN-2021 and second dose on 1-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Drug allergy (Name of Drug as Reported-No).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication was reported.  Patient received third dose as Moderna vaccine on 29-OCT-2021, and anatomical location was reported as right arm.  Patient received fourth dose as Moderna vaccine on 05-May-2022,  anatomical location was reported as right arm and vaccine administration time was 02:00 PM.  Patient started Pfizer Paxlovid drug on 6-SEP-2022 and stopped at 10-SEP-2022, indication used as treatment of COVID-19.  On 13-Oct-2022 Patient had Rebound COVID positive and outcome for this was reported as recovering/resolving.  No treatment medication were provided.
Rash appeared on back, and leg about 7 days after 1st dose. Was treated with Predisone for 12 days and Hydrooxyzine. Rash  started to get better. 24 hours after 2nd shot on 3/4/2021 the rash reappeared, much more severe, it is on his back, legs, arms, hips with severe itching. He also has the chills.  he saw the doctors and was put back on predisone,for 13 more days, Cefuroxine Axetil 500mg twice daily for 10 days, and told to continue to take Hydrooxyzine. he was also told to apply Aquafor and Cetaphil  daily to skin. The doctor thought it my be Grooves rash.