chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sky high blood pressure; Vertigo; Nauseous; Headache; Could not stand up; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), HYPERTENSION (Sky high blood pressure), VERTIGO (Vertigo) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), NAUSEA (Nauseous) and HEADACHE (Headache). On 04-Mar-2021, the patient experienced HYPERTENSION (Sky high blood pressure) and VERTIGO (Vertigo). The patient was treated with METOCLOPRAMIDE on 04-Mar-2021 for Vertigo, at a dose of 25 mg and HYDROCHLOROTHIAZIDE for Blood pressure high, at a dose of 25 mg once a day. At the time of the report, DYSSTASIA (Could not stand up), HYPERTENSION (Sky high blood pressure) and NAUSEA (Nauseous) had resolved and DIZZINESS (Very dizzy), VERTIGO (Vertigo) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood count: within normal limits (normal) within normal limits. On 04-Mar-2021, Blood pressure measurement: high (High) high. On 04-Mar-2021, Electrocardiogram: normal (normal) normal. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD21-054606 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated email and fax number of reporter and patient Initials. On 27-Jul-2021: NNI; Sender's Comments:  MOD21-054606:crosslinked
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) (VARIVAX) (strength, dose, route unknown). On an unknown date the patient developed arthritis after receiving (Oka/Merck) (VARIVAX) and the patient contacted the pharmacist but no intervention to prevent serious criteria. No PQC was involved. The action taken and outcome of the event was unknown. The causality of arthritis and VARIVAX was unknown. Additional information has been requested.
On 2/21/21 she noticed a headache, dizziness, fatigue and low blood pressure.  She noticed the s/s because she had this same delayed reaction after the Shingrix vaccine in 2018.
Diarrhea and vomiting (dry heaves) during night 10/13. 10/14 Called nurse line who told her to drink tea and take Imodium  "did not feel it was related to flu shot.
patient started to feel dizzy and hot about 5 minutes after administration of vaccine.   We laid him down on a yoga mat, placed a cold pack under his neck.  We checked his blood pressure and it was 95/50.  We gave him water and granola bar and 10 minutes later we check blood pressure and it was 117/67.  He had sister called to come pick him up.
PATIENT STATED THEY HAVE NOT RECEIVED ANY VACCINE WITHIN TWO WEEKS . A DOSE OF PFIZER COVID19 VACCINE WAS ADMINISTERED TO CLIENT.  SUBSEQUENTLEY IT WAS DISCOVERED SHE HAD RECEIVED A MODERMA COVID19 VACCINE ON 01/05/2021 AT ANOTHER FACILITY.
Child had a 102 degree fever on 9/27/09, then a rash appeared on 9/29/09.  The rash was small red bumps on her chest, abdomen, back and face.  No itching.  She was taken to the dr, who thinks she had a reaction to a vaccine.  Vaccines were given on 9-17-09.  No fever on 9-30-09.
Soreness of arm; Light fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-May-2006. Concomitant products included AMLODIPINE for Blood pressure high.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021 at 8:00 AM, the patient experienced VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills). On 14-May-2021, VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were provided   This case was linked to MOD-2021-220987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up document was received.Secondary Reporter Information was updated. Patient's weight, height, race and ethnic group were added. Event outcome were updated from unknown to recovered, route of administration  added, relevant medical history and causality as reported was updated. Event coding has been changed from Pain in arm to Vaccination site pain. It contains significant information.
Headache, Nausea, Shaking, Dizziness, Sleepy/fatigue.
This spontaneous report as received from a registered nurse refers to an patient of unknown age gender age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (dose, route of administration were not provided)(lot #, expiration date were unspecified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever stated around 4/7/15. Rash developed on trunk and face 4/11/15. Ibuprofen and BENADRYL have been used for comfort.
Soreness to the point patient had difficulty lifting arm, very large bruise with swelling almost completely down top of arm. Lymph nodes swollen under arm on that side.
Severe joint and muscle pain, chronic fatigue, horrible stomach aches, blacking out, chronic fatigue, muscle weakness and leg weakness and legs giving out and falling down. Extreme muscle spasms.
SICK ALL DAY; This spontaneous report received from a patient via a company representative concerned a 96 year 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 14-MAR-2021, the subject experienced sick all day. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of sick all day was not reported. This report was non-serious.
Fever,  extreme soreness at injection site, chills, achy ness    Just took Tylenol and tried to sleep it out. Ongoing at this time
asymptomatic covid; asymptomatic covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431030-00. A 50-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), from 03Dec2021 (Batch/Lot number: unknown) to 2022 at 40 mg (40 mg, 1 in 2 wk), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "asymptomatic covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. The action taken for adalimumab was unknown. Clinical course: Asymptomatic covid with humira (adalimumab).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered vaccination at work on 11/09/09 as I am a healthcare worker. On 11/10/09 at 7:45 AM experienced fever 99.7, body aches, dizziness, sweating, nausea, diarrhea. Fever broke at 1:30 PM. body aches and nausea ended at approximately 5:00PM
tachypnea; bivalent, dose number=1; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 1, single (Lot number: GJ6665) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Parkinson" (unspecified if ongoing); "Chronic Afib" (unspecified if ongoing). No known allergies. No covid prior vaccination. Was not covid tested post vaccination. Concomitant medication(s) included: ASA; WELLBUTRIN; PROTONIX [OMEPRAZOLE]; WARFARIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Nov2022, outcome "unknown", described as "bivalent, dose number=1"; TACHYPNOEA (hospitalization) with onset 11Nov2022, outcome "not recovered", described as "tachypnea". The event "tachypnea" required emergency room visit. The patient developed tachypnea, Pulse OX while on rebreather mask, 88%, EKG obtained, sent to Emergency Department. Therapeutic measures were taken as a result of tachypnoea. Event treatment included EKG, anticoagulant and oxygen.  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 current available limited information in the case provided, the causal association between the event tachypnea and the use of suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
About 4 hours after the vaccine I started getting a headache. At approximately 8 hours after receiving the vaccine, I started running a fever of 100F. It went up to 101F and stayed there until last night (Jan. 27). It got as high as 102F. I also had joint pain, nausea, fatigue. I took acetaminophen and ibuprofen for the symptoms without much relief.  Today (Jan. 28) I feel much better but am very weak and tired. Arm at injection site is still very painful.
AROUND 11 am ON 9/25/19, pt called said that he have sore on his shoulder the day after his shot,  we ask him how is it site of injection, he said it was fine except muscle sore on shouders, so i told pt to take some tylenol but he said he as ibuprofen, so he took ibu. I told him to call me back in afternoon for follow up. At 1p.m, pt called and said that he felt itchy and had fever. I ask him   was he just  itching  or felt  any difficult of breathing or tounge swelling, he said he just itched. So i told him to  take benadryl ( he got nightime benadryl) and tylenol, and i will call to check on him about lucnh. I also told him if he cant breathe, he has to go to hospital. after 2pm, i called him back he said he was ok ( but still had sores on shoulders)
pt recv vax; exp HA, resp sx and malaise; Amoxil was prescribed for resp sx which resolved;HA and malaise continue;
Breast tenderness; Diarrhea; Break through bleeding; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient (age at vaccination 62-year) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6207) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 15Mar2021 14:00 PM as dose 1, single for COVID-19 immunization. Medical history included nausea (had a little stomach nausea the day before); menopause (States that she has been menopausal for 15 years) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 17Mar2021 the patient experienced break through bleeding and diarrhea; on 18Mar2021 the patient experienced breast tenderness. AE does not require to visit Emergency room/Physician office. The patient was calling about the COVID-19 vaccine. States that she had some strange symptoms after her 1st dose on Monday. States that she doesn't really like her primary care practice. They weren't offering the vaccine, and even their nurse wasn't going to take the vaccine, she said she was just going to wait and see how it played out. States that she has been menopausal for 15 years, and had break thorough bleeding for a day, and had breast tenderness for a day after receiving the vaccine. States she has never had that happen in 15 years. She also had crazy diarrhea for 12 hours; it was intense. List of other relevant diagnostic and confirmatory test results for event was not reported. The clinical outcome of the events "break through bleeding" was recovered on 17Mar2021, "diarrhea" was recovered on 18Mar2021, "breast tenderness" was recovered on 19Mar2021.  No follow-up attempts are possible. No further information is expected.
felt under the weather; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient felt under the weather for one month after her first dose of Shingrix. The reporter stated that the patient does not want the second dose. The reporter consented to follow up.
upon going to be had severe hot and cold flashes followed by head ache. Lasted all night long. Threw up in the early morning of the Jan. 25, 2022 and again that same afternoon. Arm has lots of bruising. Threw up again today Jan. 26, 2022 in the am, before 8:00 am
About 20 minutes after the vaccination, the patient experienced globus sensation of the throat. She felt as though her tongue was also swelling up, although no visible angioedema was noted. Her symptoms began to worsen over the next 10 minutes. She was treated with epinephrine 0.3mg and cetirizine 10mg, and she stated that she began to feel better, with complete resolution of symptoms in about 40 minutes. The patient was released to home.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received SHINGRIX. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site pain, fever, fatigue, feeling unwell and chills. The patient was treated with TYLENOL. In April 2018, the outcome of the injection site pain, fever, fatigue, feeling unwell and chills were recovered/resolved. The reporter considered the injection site pain, fever, fatigue, feeling unwell and chills to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The caller was reporting on behalf of her husband (patient). The patient received SHINGRIX in the left arm. The caller stated that the patient experienced soreness in his left arm. The caller stated that the patient took TYLENOL for these symptoms, which helped a little and the patient experienced these symptoms for approximately 3 days and then the symptoms resolved. The patient had denied permission to contact their physician.
choking, apnea, cyanosis-hospitalized x5days & IV ATB x72hrs; (ampicillin & ceftin;presently on apnea monitor approx 6-10day
experienced anaphylaxis and had to go to urgent care.; her stomach was "beet red."; first dose 2.5 years ago, has not received her second; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), erythema and incomplete course of vaccination. On an unknown date, the outcome of the anaphylaxis was recovered/resolved and the outcome of the erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the anaphylaxis and erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after receiving the first dose of Shingrix 2.5 years before reporting, she experienced anaphylaxis and had to go to urgent care. The patient stated that her stomach was beet red. The patient received unspecified treatment and anaphylaxis resolved. The patient had not received her second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
I came down with a cold virus symptoms. I remember having headaches, chills, body aches. No fever. I developed a cough that was strong that I ended up with a compression fracture in my spine.
Have been spotting (menstruating) after not having had a period in 2.5 years; This is a spontaneous report from a contactable consumer or other non hcp.   A 56-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:00 as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:00 (Batch/Lot Number: ERB733) as dose 1, single for covid-19 immunisation. Medical history and concomitants were not reported. It was reported that, the patient experienced have been spotting after not having had a period in 2.5 years on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 28Jul2021 Nasal Swab.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
No adverse event; Patient was administered Moderna Covid 19 Bivalent after 30 day use by date; Patient was administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-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 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication was reported. No treatment medication was reported.
I ended up with petechiae since the beginning of March on my shoulders, under my armpits, and in between my elbow on both arms. They also seem to ache and come with any type of pressure or lifting of heavy objects. They come and go and have occurred for almost 2 months now.
I'm having squeezing chest pains; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (I'm having squeezing chest pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced CHEST PAIN (I'm having squeezing chest pains). At the time of the report, CHEST PAIN (I'm having squeezing chest pains) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA005346: US-009507513-1701USA004799.