chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Feeling of anxiety (like tachycardia); Doesn't feel well; Patient feel sweaty; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Patient stated that she was immunocompromised.  Concomitant medication was not provided.  Treatment information was not provided.
Headaches, body aches, exhausted feeling, diarrhea upset stomach, insomnia
pt states she woke up with chills, body aches and vomiting.   She had a very sore arm  that was red and swollen for about three days. The vomiting subsided the next day but she was still nauseated and had loss of appetite.  By 3/2/21 these body aches, chills and vomiting had sub sided but she had loss of appetite for a few more days.  She was ill for about 5 days total but she had brain fog for about a week and a half.
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite .  Extreme sweating.  Extreme sweating of the under arm is still and issue. No fever now.
Patient developed burning and redness, heat at proximal right arm. Erythema and very slight tenderness. Spreading along the corner of minor vein and medial right arm to flex or forearm crease. Dr. prescribed KEFLEX 500 mg/ 1 tablet 3x daily. Pt will contact if symptoms are not cleared within 48 hrs.
Patient, who wears a hearing aid, claim that his hearing was affected.   He said sound had diminished and was slightly dizzy.
Fever up 104.8 x about 12 hours. Ear thermometer. Fever 100-104 during this time. Crying, inconsolable x 11-12 hours, not eating during fussy period.
day 11 post vaccination: patient had erythematous rash.Appearance of contact dermatitis. day 12 post vaccination: rash spreading.  Major complaint is itching. Several large patches on upper and lower extremities and back that are raised and pruritic. Pt given Atarax and Pepcid. day 13 post vaccination: patient improving. Impression: probable nonspecific rash.
rash / hives on neck and chest on right side within. Given 2 benadryl and monitored, on site physician asked me to go to ER to be checked.
all of a sudden my face felt really tight/Looked into the mirror and it was swollen; face very flushed; throat started to close; feel tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included LEVOTHYROXINE and VALSARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen) (seriousness criterion medically significant), FLUSHING (face very flushed) (seriousness criterion medically significant), THROAT TIGHTNESS (throat started to close) (seriousness criterion medically significant) and FATIGUE (feel tired) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) outcome was unknown.        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.; Sender's Comments: This case concerns a 74 Y/O F with a serious unexpected event of facial swelling along with throat tightness, flushing and fatigue.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Improperly stored vaccine administered - recalled; RECOMBIVAX HB that was recalled; This spontaneous report has been received from a nurse regarding a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled improperly stored dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 mL, lot # T00798 for prophylaxis and expiration date 01-NOV-2022 (dose and route of administration were not reported).  This report is one from multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009762: US-009507513-2010USA009823: US-009507513-2010USA009853: US-009507513-2010USA010090: US-009507513-2010USA010095: US-009507513-2010USA010216: US-009507513-2010USA010884:
Pt states she was fine all day yesterday after vaccine, states she woke up this morning  and eye was swollen, no pain, no trouble breathing no other symptoms. Pt was told to go to Urgent Care at facility to be seen, she is an employee and this was done for Employee health reasons
Information has been received concerning a pt who was vaccinated with varicella vaccine on 04/24/96 and on 06/15/2000 the pt developed chickenpox like lesions on her trunk. On an unspecified date the pt recovered.
PINL SKIN LESION; SKIN REDNESS ON THIGH AND UPPER BODY; RINGWORM; This spontaneous report received from a health care professional concerned a 3 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pinl skin lesion, skin redness on thigh and upper body, and ringworm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pinl skin lesion, skin redness on thigh and upper body, and ringworm. This report was non-serious.
I got my first vaccine but I missed my 2 one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my first vaccine but I missed my 2 one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my first vaccine but I missed my 2 one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first vaccine but I missed my 2 one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand other: J&J; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand other: J&J; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (04Sep2023) Negative; (06Sep2023) Negative; (08Sep2023) Negative; (10Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Rash at site of injection, chills, joint pain, muscle pain, fatigue , headache , numbness in pointer finger, tingling in hands
Report 2001003418-1 describes arthritic-like joint pain in a female who received Lyme disease vaccine. The patient participated in a Lyme disease vaccine clinical trial; the protocol was not specified. The arthritic-like joint pain was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a 1996 clinical trial of Lyme disease vaccine. After the blind had been broken, the patient reportedly was offered and accepted open-label Lyme disease vaccine in 1997. The number of injections of Lyme disease vaccine received by the patient was not specified. At some unspecified time after she had received Lyme disease vaccine, the patient began to experience arthritic-like joint pain. The study investigator reportedly told the patient that Lyme disease vaccine "had nothing to do with the pain". The outcome of this event was not provided. The adverse event of arthritic-like joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per June 28, 2000 letter.
Child brought back to clinic < 2 hours post vaccination with 3 0.5 cm hives located on left temple, no wheezing or signs of respiratory distress. Given 7.5 mg PO Benadryl by MD after complete examination. Sent home with rx for Bendaryl 7.5 mg PO q 6-8 hours until urticaria resolve and instructed to seek prompt medical attention for any worsening of condition.
Breakthrough bleeding for 1 week. Occurred 2 months in a row after vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported.On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore). At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore) outcome was unknown. Concomitant and treatment medication details were not reported by the reporter.This case was linked to MOD-2021-388689, MOD-2021-388705 (Patient Link).
11AM pt recv vax;330PM pt fussy, irritable laid down for nap;4PM found unresponsive-family called attempted resus;Time of death 5PM;hx of poss sz per mom;
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported.   Information about lot/batch number has been requested.
My eyes were almost closed.  I was seeing things double vision and appearing in 3-D and they were also slanted.  My equilibrium was off also. It was quite scary, as I live alone. I had to have some one come and drive me home.  I slept and vision is a little better, but reading is still impaired somewhat.
Pt arrives from Dr's. office and asks to receive her Prevnar. State shots and chart checked.  Order in chart.  VIS provided and reviewed with pt and she signed VIS without further questions.  Vaccine administered and nurse went to enter in computer and order had been completed.  Call to Dr.s office and discovered pt had received Prevnar in that office before arriving at clinic. Pt therefore had duplicate dose. Pt retained in office and informed of above.  Pt insists she just has TDAP in office.  VS assessed and stable. Reviewed again possible side effects and when to call MD.  MD notified and pt discharged home.
Starting on the day of the vaccine, within a couple of hours, I felt mildly tired. About 13 hours later, my arm felt tender. On 3/24/2021, I had drainage and runny nose, quick chill and noticed a metallic taste in my mouth. I called the doctor and was advised to take acetaminophen to get rid of metallic taste. I had symptoms on and off of feeling tired, fatigue, running nose, drainage, low grade fever, mild back achiness and by day 16, the symptoms went away.
pt recvd vax & w/in 24hrs pt presented to MD because exp local erythema & shoulder to elbow pain;MD stated concern w/lot of vax involved in report;pt also exp swelling from shoulder to elbow & fever;
Severe constant Lower back pain began after 4 weeks after vaccine. Unable to stand/walk/sit without difficulty. Went to see chiropractor 2 days ago. Got a back adjustment.  Will need to return in one day. Pain med only works temporarily.
No patients have reported any adverse reactions at this time; it expired 6/8/23 but was administered to a patient 6/17/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23) and NO ADVERSE EVENT (No patients have reported any adverse reactions at this time) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-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 17-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No patients have reported any adverse reactions at this time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23) and NO ADVERSE EVENT (No patients have reported any adverse reactions at this time) 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 patients have reported any adverse reactions at this time) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729716, US-MODERNATX, INC.-MOD-2023-729696.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow up received contains Nonsignificant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729716:Same reporter US-MODERNATX, INC.-MOD-2023-729696:Same reporter
Extreme fatigue starting 24 hrs after shot. Slept most of April 4. Nausea, vomit,and chills starting April 5. Still fatigued.  Slept 22 hrs into April 6. Couldn't lift left arm past waist. Woke April 7 w occasional nausea, but mostly recovered
woman gets hers every year-sick as dog for 6 weeks EVERY time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involved female patient who gets hers every year-sick as dog (illness) while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that knew a woman got hers every year-sick as dog for 6 weeks every time. In 50yrs reporter's have had the flu 1 time  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine,  batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient developed petechiae (experienced petechiae on her extremities that went away on its own), and lethargy (went away on its own), with outcome of recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt received vaccine (HepBVax) on 1/24/2000 and had rash covered with erythema multiforme starting on 1/25/2000. No fevers.
WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25  MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.
This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210;  1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
2 HOURS AFTER  RECEIVING SHOT  MY SON WAS DIAPHORETIC,PASTY,PALE AND FELT DIZZY,CHEST AND UPPER BACK PAIN AND HEART PALPITATIONS WITH TACHYCARDIA AND CHILLS.  FOR THE NEXT 2 DAYS HE HAD INCREASED HEART RATE UPON STANDING WITH CHEST TIGHTNESS AND UNABLE TO TAKE A "SATISFYING BREATH"HE IS STILL SUFFERING WITH CHEST TIGHTNESS AND INCRE