chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 67-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 Heart disorder and Blood pressure high.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and HYPOTENSION (Low blood pressure). In February 2021, SYNCOPE (Fainted) and HYPOTENSION (Low blood pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking some unspecified medications. No treatment reported.  The patient fainted after the second vaccine dose due to a low blood pressure. His blood pressure was low for two days after the second vaccine.  Company comment: This case concerns a  67-year-old, female patient with history of heart condition and hypertension, who experienced the unexpected events of Syncope and Hypotension. The patient fainted after the second dose and experience hypotension for 2 days. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. The medical history of heart condition remains a confounder.; Sender's Comments: This case concerns a  67-year-old, female patient with history of heart condition and hypertension, who experienced the unexpected events of Syncope and Hypotension. The patient fainted after the second dose and experience hypotension for 2 days. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. The medical history of heart condition remains a confounder.
Sore arm, hard time lying down on it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm, hard time lying down on it) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm, hard time lying down on it). At the time of the report, PAIN IN EXTREMITY (Sore arm, hard time lying down on it) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an male child.. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 16-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008214: US-009507513-1904USA010531: US-009507513-1904USA010534: US-009507513-1904USA010533: US-009507513-1904USA010535:
All symptoms lasted Saturday morning until late Saturday night and became better by Sunday. Low-grade fever ranging from 100.5 to 101; headaches in waves during the day; overall tired and sluggish.
PROQUAD was administered to a 58 year old patient; MMRV was ordered and given by mistake; Patient was to recieve an MMR vaccine, MMRV was ordered and given by mistake; This spontaneous report was received from a nurse concerning a 58-year-old female patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   Concomitant vaccines administrated varicella zoster vaccine rge (CHO) (SHINGRIX)  On 28-JUL-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter subcutaneous route on the left arm, lot number T034612 expiration date 10-APR-2022 as prophylaxis.   However, it was reported that it was intented to be vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) by mistake.  No additional adverse event was reported.
Nauseous; She has been feeling tired; Throwing up; On same day, she had diarrhea after receiving 2nd dose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (On same day, she had diarrhea after receiving 2nd dose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous) and FATIGUE (She has been feeling tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE (LAMICTAL) and TRAZODONE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIARRHOEA (On same day, she had diarrhea after receiving 2nd dose), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). On 06-Apr-2021, the patient experienced NAUSEA (Nauseous) and FATIGUE (She has been feeling tired). At the time of the report, DIARRHOEA (On same day, she had diarrhea after receiving 2nd dose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous), FATIGUE (She has been feeling tired) and VOMITING (Throwing up) outcome was unknown.            Concomitant medication also included BP medication. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Right thigh began to get red and swell with 2 papules appearing in central lesion that had fluid but dried up. I saw today about 2 weeks post vaccines and has 3 - 4 cm2 induration with central area 2 cm erythema and 2 papules with scabbed top.
Get sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient got sick evetime after she or he got a flu shot.
Very strong itchiness with raised bumps; Hhives/urticaria; Raised bumps; Very uncomfortable; Rash all over the body; Rash worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Very strong itchiness with raised bumps), URTICARIA (Hhives/urticaria), RASH PAPULAR (Raised bumps), FEELING ABNORMAL (Very uncomfortable) and RASH (Rash all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced RASH (Rash worsened). On an unknown date, the patient experienced PRURITUS (Very strong itchiness with raised bumps), URTICARIA (Hhives/urticaria), RASH PAPULAR (Raised bumps), FEELING ABNORMAL (Very uncomfortable) and RASH (Rash all over the body). At the time of the report, PRURITUS (Very strong itchiness with raised bumps), URTICARIA (Hhives/urticaria) and FEELING ABNORMAL (Very uncomfortable) outcome was unknown and RASH PAPULAR (Raised bumps), RASH (Rash all over the body) and RASH (Rash worsened) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information included benadryl 25 mg and prednisone.  On 05 Apr 2021 at 01:00 am, the rash had worsen and the patient ended up going to emergency room and was observed for two hours, and then released.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up was received on 07 Apr 2021, which consist of update contact information, new event rash aggravated and treatment information.
Started developing a rash on right leg 2/3/10. Varicella lesions in L2 distribution noted. Significant case of shingles treated with acyclovir. No history of chicken pox. No exposure to varicella virus-only vaccination at 1 yr old.
Approximately 2 days later had rash/hives, pruritic to axillae, groin.
Narrative: COVID infection following COVID vaccine series 02/12, Pfizer, dose #1 03/05, Pfizer, dose #2 12/30 COVID swab, result: detected 01/4 pt cc: weakness, chills, dizzy exposure: unknown 1/7 CXR impression: Left basilar  pneumonia . 1/7 pt admit to Medicine cc: weak, not eating or drinking dx: COVID 19 infection LOS: 13 days 1/7 TROPNIN 1: 0.019 1/7CRP: 3.027 1/7 PROCALCITONIN: <0.05 1/08 FIBRINOGEN: 420 1/9 FIBRINOGEN: 420 1/9  DDIMER:5.13 1/9 ESR: 36 1/9 CT LTD OR LOCALIZED impression: Evaluation for pulmonary embolism could not be performed secondary to left arm contrast extravasation/infiltration-correlate with neurovascular examination of the  left upper extremity. Note is made of a left eccentric/multifocal pneumonia which may be seen with COVID-19, though alternative processes are not excluded. 1/9 CT A PE impression: 1. Technically inadequate examination for the evaluation of pulmonary embolism. There is no enhancement of the pulmonary arterial system. Contrast has extravasated into the left upper extremity and the intravascular contrast is predominantly within the systemic arterial circulation. 2. Bilateral groundglass opacities, left more than right, which is suggestive of atypical infection and is likely related to the patient's known Covid 19 pneumonia. 1/10 FIBRINOGEN: 405 1/10 DDIWR: 3.52 1/10 ESR: 23 1/10 SARS-COV-2 igG: 4.58 1 10 SARS-COV-2 total AB: >2500.0 1/10 US DOPPLER LOW EXT VEIN BILATERAL impression: Negative examination for thrombosis in the bilateral lower extremity veins listed above. 1/11 DI)IVIER: 2.32 1/11 ESR: 39 1/11 CXR impression: 1/11 CT A PE impression: l. Subsegmental pulmonary emboli within the right lower lobe is identified. No central or segmental embolus is seen. There is no evidence of right heart strain. 2. No significant change in the opacities scattered throughout bilateral lungs, more on the left than the right. These findings likely represent atypical infection related to the patient's known Covid 19 pneumonia. 3. Redemonstration of a partially visualized hypodense lesion within the right upper quadrant which could be arising from the kidney. Can obtain dedicated abdominal imaging for further evaluation. 1/12 ESR: 29 1/12 DDIMER: 2.94
Shortness of breath and palpitations 10 minutes after receiving injection.  Tachycardic.
No adverse event; HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 01-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.
Patient presented to the clinic with a complaint of 3 "boils" on her buttocks. MD viewed 3 vesicles on left buttock, each about 3mm in size. Diagnosed with herpes zoster infection. Patient received herpes zoster vaccinations on 10/5/00 at the age of 15 months and on 10/15/09 at the age of 10 years.
My husband had tested positive for COVID-19. I was testing myself and watching for symptoms I was coughing, had sinus congestion, a sore throat, a sinus type headache, and I could not stop sneezing. I tested on a COVID-19 Home test on the 20th. I reached out to my doctor and I cannot take the Paxlovid because of allergies so I had MAB therapy but I had to wait a day or two for my symptoms to let up a bit. I was very tachycardia the whole time. A few days after the MAB therapy I was feeling better.
Chill, lethargy, nausea, slight fever of 98.6F, muscle soreness  lasted about 20 hours  symptoms improved after taking  Advil, a total of 4 pills, each with 4~6 hours apart
Mother reports that 1 day post vax pt's (nonspecific) skin condition worsened. Prior to vax, the condition existed around his neck and in the fatty folds. He was treated with Keflex prophylactically "for a reaction." Since receipt of Prevnar, pt's condition spread to his face and over his body. The pt does not sleep well. Info from the pt's dermatologist indicated that the pt was diagnosed with group B Strep intertrigo on his first visit of 5/9/01. At his second visit on 6/4/01, pt had multiple, erythematous, hyperkeratotic crusted plaques, some annular on cheeks, neck folds, umbilicus, axilla, groin, exterior folds of lower extremities and a few pustules. On third visit 6/13/01 pt presented with scattered erythematous papulopustules and scaly plaques in neck folds, central abdomen, and flexoral aspects of lower extremities. After tests, a diagnosis of "psoriasiform dermatitis favor psoriasis" was made. At the pt's last visit on 7/11/01, he presented with erythematous plaques, small pustules on anterior trunk, cheeks and flexors.
anaphylactic reaction; Had heartburn; significant rash; facial swelling; This is a spontaneous report from a contactable physician. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer covid vaccine 2 days ago. Patient had heartburn then significant rash then facial swelling. Gave her Benadryl and ice and keeping an eye on it, did not give prednisone yet. They were asking for recommendation on how to manage anaphylactic reaction and the time course. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association and known safety profile, a contributory role of the suspect product bnt162b2 to the reported Anaphylactic reaction cannot be excluded. Case will be reassessed upon receipt of additional information.
Left forearm and finger tingling, slight numbness akin to a "dead arm" when one falls asleep; Every 15-30 min. the first 4-5 days after injection; has become less intense and less frequent over the last 3 weeks; still occurs 5-7 times a day and is more localized to the left pointer finger (most intense) and left hand
Post nasal drip 4 weeks on going, started 6 months after vaccination. Discolored tongue; itchy throat. Very infrequent coughing and some times congestion.
started with woozy head and extreme hyperactivity, followed by extreme fatigue, weakness, hunger, dizziness, chest pain, very jittery and the jittes get alot worse if i take my thyroid med. i have been unable to take them and i am now hypothyroid. the fatigue and weakness lasted a week. the chest pain and jitters continue today 3 weeks post vaccine. i am concerned for a possible heart attack or something. how long will these symptoms last? should i see my cardiologist? what should i do about thyroid medication?
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 31 year old female. 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, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 15-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210913164, 20210916401, 20210916415, 20210916520, 20210916300, 20210916520, 20210916129, 20210916312, 20210916553, 20210916697, 20210916658, 20210916910 and 20210916959.
asymptomatic urinary tract infection; threw up; Passed out; defecated on themself; A spontaneous report from was received from a healthcare professional concerning a 64 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Passed out, defecated on themself and threw up very hard and had asymptomatic urinary tract infection.  The patient's medical history was not provided.The patient was taking sitagliptin phosphate, ezetimiab, dulaglutide, glipizide as concomitant medication.    On 27 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 batch no: 025L20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient passed out, defecated on herself and threw up very hard.  On 01 Mar 2021, the patient passed out again and threw up. Went to emergency room and was told she had an asymptomatic urinary tract infection.  Laboratory details was not provided.  The patient took antibiotic and nausea medicine administered at ER as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: This refers to a loss of consciousness case of a 64 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was taking various hypoglycemic agents as concomitant medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) in 2008. Subsequently, two to three weeks after vaccination (2008), the patient experienced generalized vesicular rash and big spot on his right forehead. Follow up information was received from the physician reporting that the 80 years old male patient received a dose of ZOSTAVAX (Oka/Merck) on 30-JUN-2008. On 18-NOV-2008 the patient developed zoster on the left fifth chest wall with diffuse vesicular rash. Cultures of vesicular fluid were negative for virus and bacteria. The patient recovered in December 2008. Additional information is not expected.
She developed varicella rash on trunk and extremeties 13 days post varicella vaccination.
poor circulation in toes and fingers. Fingers will go numb and tingle. I have also had sudden weight gain (fat) and internal tremors in my chest, lower abdomen, and pelvic region. I have also had a lot of brain fog and disruptions in sleep patterns.
Subjective fever (felt feverish), Chills,  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Sore throat,  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Nausea or vomiting, Hospitalization
Rash both upper arms bumps itchy burn pus   BlotchesHeadache
No adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.