chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intestinal obstruction; I developed a peri-anal abscess/abscess returned; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the second dose bnt162b2 (BNT162B2, lot number: EP7533), via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:00 (received at 44-years-old) as single dose for covid-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines within four weeks prior to receiving BNT162B2. Medical history included crohn's disease (had been in remission for several years) and ileostomy. He had no COVID prior to vaccination. Concomitant medication included vedolizumab (ENTYVIO) taken for an unspecified indication, start and stop date were not reported; esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported; loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; simeticone (GAS-X) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (TUMS [CALCIUM CARBONATE]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took bnt162b2 (BNT162B2, lot number: EN6299) in left arm on 03Mar2021 08:45 AM  (received at 44-years-old) for COVID-19 immunisation and developed a peri-anal abscess; compazine [prochlorperazine maleate] and experienced allergy; dilaudid and experienced allergy. The patient reported he has Crohn's Disease but had been in remission for several years. On 13Mar2021 ten days after his first vaccine, he developed a peri-anal abscess that required treatment via antibiotics. It resolved quickly. On 09Apr2021, one day after his second vaccine, the abscess returned and required more antibiotics. On 15Apr2021, seven days after his second vaccine, he developed an intestinal obstruction that required 2 days of hospitalization. According to him, these are all Crohn's symptoms that seem to have come out of nowhere. He had recent lab work (before vaccine) that showed no issues whatsoever. The patient underwent lab tests and procedures which included COVID-19 Virus test with negative result on 13Mar2021. Outcome of the events was unknown.
Large red injection site , whole body tingling sensation, face burning, eye lid and brow itching, eye itching, lymph nodes in neck, arms and especially groin area(hurt the most) burning on right side of foot and heal, all over body aches and tiredness, headache
Had t100-104 ax w/? febrile seizure night of 6DEC91; Talked w/MD on 7DEC91 was instructed to give APAP; pt seen 9DEC & dx w/tonsillitis; omit "p" from DTP for safety; seen in ER 6DEC91 w/febrile sz & released;
light headed; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (light headed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OCTREOTIDE ACETATE (SANDOSTATIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (light headed). On 03-Feb-2021, DIZZINESS (light headed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report from a contactable consumer, the patient.   A 76-year-old male patient received first dose of bnt162b2(BNT162B2; formulation: solution for injection; Lot number el9264) via an intramuscular route of administration in left arm on 27Jan2021 at 03:00 PM (Age at vaccination: 76) as single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products and the patient received other medications within 2 weeks of vaccination, but unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 PM (the date of the vaccination), the patient experienced sore arm other than injection site, light headedness, mild diarrhea. The patient did not received treatment for the adverse event. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 08-AUG-2013 was vaccinated with VARIVAX, (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (same reporter link). Additional information has been requested.
Pain and redness on her left eye; Pain and redness on her left eye; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Covid-19 vaccine yesterday afternoon and on an unspecified date, she has experienced pain and redness on her left eye and shortness of breath. She would like to know if it was normal and what she needs to do. The patient also wanted to know what side effects of Covid were. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & exp malaise & poss jaundice;a liver biopsy was performed which suggested an immune response: immune hepatitis;pt's sx cont
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Hives/Chronic hives; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the right arm on 28Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4176) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Jan2021, the patient reported that she has had hives since the day after the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had been to the allergist and was awaiting a dermatologist appointment. On an unknown date, the patient underwent an allergy blood testing and the allergist diagnosed the patient with chronic hives due to the vaccination. Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), and cetirizine hydrochloride (ZYRTEC). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives/chronic hives was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
pt lives in nursing home (Healthcare and Rehab Center); was routinely tested for COVID and found to be positive on 12/13/22; no sx initially; slowly developed some congestion and was given Geri-Tussin Syrup; pt was refusing to eat or drink; decrease in UOP; pt was found deceased in her bed
2 days, post/vax, Mom notices that when baby is in standing position, her legs are shaking, head is not steady. Called MD & was seen 2/4 w/same sxs. MD has referred pt to Neurologist. Mom says baby is fine now but will f/u.
Pt had inj right deltoid on 6/8, on 6/10 broke out in hives around inj site. Did have hives on chest but was itchy days before inj given. Mother used Benadryl cream and PO med for hives which relieved symptoms. On June 16 broke out in hives again at inj site used Benadryl PO and resolved.
felt different; broke out with rash; Running a chill; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt different), RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A, 046C21A, 026A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced FEELING ABNORMAL (felt different), RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt different) outcome was unknown and RASH (broke out with rash), CHILLS (Running a chill), PYREXIA (fever) and MYALGIA (body aches) was resolving.            Concomitant medications were not provided by the reporter. Caller stated that she was a caregiver for her mom.   This case was linked to MOD-2022-541566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up received contains no new information.
Patient arrived at the covid vaccine site for first dose of moderna. Patient was instructed to wait in the observation room for 30 min due to previous allergic reaction to Tramadol and depo. Allergic reaction to Tramadol includes anaphylaxis and rash.  Hives and swelling occur with depo shot. Patient reported her throat was feeling tight and itchy. rapid response  called and patient was taken to ED. Vitals BP 156/121, HR 83, 100% SPO2)  In ED, patient scoped  with +Mild swelling to arytenoid noted though only trace. Patient received diphenhydramine and famotidine and was observed over night before being discharged.  Scope introduced into nares after topical 4% lidocaine and phenylephrine were atomized intranasally. No lesions noted in the nose. Epiglottis without obvious lesions, false vocal folds normal, true vocal folds normal, mobile vocal folds bilaterally, no piriform sinus abnormalities b/l and clear supraglottis and glottis. No foreign bodies noted. Airway appears without obvious obstruction, no active bleeding. Mild swelling to arytenoid noted though only trace
Narrative:  Patient admitted to the hospital within 30 days of receiving MODERNA COVID-19 vaccine. Patient is admitted for alcohol withdrawal with suicidal ideation.
This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization.  Medical history included asthma.  Concomitant medication included salbutamol (ALBUTEROL) for asthma.  The patient experienced left side of his face went numb, his eye became swollen on 09Jan2021 with outcome of recovered. Caller stated this lasted 8 hours and then went away. Caller stated he used an ice pack during the reaction. The outcome of the events was recovered on 09Jan2021.
2nd dose Moderna Covid 19, sat in waiting room for about 5 minutes then notified me of rash developing on lower arm, below injection site. Gave the patient diphenhydramine 25mg and had her sit to be monitored. rash continued to worsen, no shortness of breath or other symptoms, just painful, fine, red rash and slight swelling. 2nd dose of diphenhydramine given in liquid form and sent to immediate care clinic with person accompanying.
A week after receiving the vaccine I woke up with hives like symptoms at the injection site (right arm) and on my chest. There is also a lump that developed on my right collarbone within the past two days.
Pt seen 10/3/02 dx: urticaria tx: Zyrtec. Pt seen 10/5/02 with erythema multiforme minor-no symptoms, no F/uri/v/d. No meds, no travel, no new exposures/food. Presumed MMR results. Did not treat with steroid as received Varivax 9/23/02.
Sharp pain in left chest around my heart.; This is a spontaneous report from a contactable consumer (patient himself). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Ew0150), via an unspecified route of administration, administered in left arm on 23Apr2021 14:00 (age at vaccination: 40 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ew0150), via an unspecified route of administration, administered in left arm on 02Apr2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. The vaccine was administered in a Student Health Clinic. The patient did not receive any other vaccine in four weeks nor other medications in 2 weeks. On 01Jun2021, the patient experienced sharp pain in left chest around his heart. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 01Jan2021. The patient did not receive any treatment for the adverse events. The patient did not have covid prior to vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
BLEEDING; CONDITION AGGRAVATED; INFLAMMATION; HUMIRA PRODUCT TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a consumer via another pharmaceutical company concerned a 30 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 09-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 30 years old. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported), citrate free, dose, frequency, and therapy dates were not reported was administered for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced bleeding, condition aggravated, inflammation, and humira product temperature excursion issue. The icepack was completely liquid but was cool to touch even though the little thermometer strip was in or on box received like that from pharmacy with Humira. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from condition aggravated, and inflammation, and the outcome of bleeding and humira product temperature excursion issue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220548649-COVID-19 VACCINE AD26.COV2.S-Bleeding. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
large abscess pocket on vaccine arm.; Left posterior flank with soreness; This case was reported by a physician via sales rep and described the occurrence of abscess limb in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced abscess limb and flank pain. On an unknown date, the outcome of the abscess limb and flank pain were unknown.   It was unknown if the reporter considered the abscess limb and flank pain to be related to Shingrix.  Additional details were provided as follows: The patient had an adverse reaction to first dose Shingrix within the last 30 days from  the time of reporting. The left posterior flank of patient was with soreness and large abscess pocket on vaccine arm..
Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive; (18Jul2022) Negative; (23Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: HCP shared his personal experience with Paxlovid Viral Rebound. Tested positive: 11Jul2022.Started Paxlovid from 11Jul2022 to 15Jul2022.Tested negative: 18Jul2022.Tested positive: 23Jul2022. COVID antigen test correlated with symptoms. Initial symptoms includes headache, sore throat, fatigue, diarrhoea for 24hrs, loss of appetite  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 the information in the case, an association between the reported events Vaccination failure, COVID19 and bnt162b2 cannot be ruled out.
Adverse Event: Joint pain in knees bilaterally within the first 12 hours after receiving injection. Right knee joint pain subsided after 24hrs. Left knee joint pain has been constant for more than 48hrs.  Treatment: Extra Strength Tylenol 500mg x 2 q6hr and left knee joint pain has not subsided  Outcome: Still left knee joint pain after more than 48hrs
An itchy rash,  hot to the touch in the area of the injection and diarrhea.
Patient's father brought him to the clinic on the morning of 7/27. Stated his (Rt) upper arm was very red the evening of 7/26. At this AM was hard and warm to touch. No lymph nodes were palpated. Started on warm soaks 15" tid and Augmentin 200mg BID.
Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 83rd out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients were involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED
Patient fainted and fell while standing, hit head on floor, brief loss of consciousness, pupils PERRLA. Minor head pain, BP hypotensive (80/54) in wheelchair. Gave juice and crackers (hadn't eaten that day), glucose 91. Patient stable upon leaving, recommended ER visit for head evaluation.