chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid 19) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Chronic respiratory disease (Patient had life long respiratory issues). On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. Patient had horrible cough 33 day before so received prolovid which changed cough in 2 days. The patient underwent PCR and quick tests, results not reported. It was reported that patient would take a quick test in the afternoon on day of this report. Company comment: This spontaneous case concerns a 69-year-old patient (gender unspecified) with relevant medical history Chronic respiratory disease, who experienced the unexpected non-serious  of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had severe cough. SARS-CoV-2 test was done but report was not provided. The patient was reportedly treated with Prolovid (Paxlovid) which gave relief in two days. Further details of clinical course, investigation reports were not provided. Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 remains a confounder. The patient's medical condition of Chronic respiratory disease may be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 69-year-old patient (gender unspecified) with relevant medical history Chronic respiratory disease, who experienced the unexpected non-serious of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had severe cough. SARS-CoV-2 test was done but report was not provided. The patient was reportedly treated with Prolovid (Paxlovid) which gave relief in two days. Further details of clinical course, investigation reports were not provided. Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 remains a confounder. The patient's medical condition of Chronic respiratory disease may be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach. On an unknown date, the outcome of the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The caller was cousin of the patient who received both doses of SHINGRIX. The age at vaccination was not reported. The caller reported that the patient received a dose of SHINGRIX and experienced injection site reaction including swelling and redness, was dizzy, upset stomach, shakes and sweating that lased for 24 hours and then resolved. The lot number, pharmacy information and physician information were not available. The patient had denied permission to contact their physician. The patient received 2nd dose of SHINGRIX for tolerance effect see case US2018GSK163683.
Started with mild to moderate body aches around midnight, then by 3 am I ran a fever over 103, fever continued for several hours, finally dropping below 102 around 24 hours after symptoms began. Continued running fever between 100-102 for the next 24 hours, at this point my fever is generally around 100 or less. The biggest issue now is the sore throat ear ache and cough.
it hurts; it is numb; itchy; irritated; she can't really do nothing; she has the left side of her lip swollen, the right side is not swollen anymore; right side of her jaw started swelling on that night; right side of her lip swelling on that night/she had the right side of her lip swollen/she had both sides swollen of her bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (right side of her lip swelling on that night/she had the right side of her lip swollen/she had both sides swollen of her bottom lip), LIP SWELLING (she has the left side of her lip swollen, the right side is not swollen anymore), SWELLING FACE (right side of her jaw started swelling on that night), LIP PAIN (it hurts) and HYPOAESTHESIA ORAL (it is numb) in a 30-year-old female 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 Tooth ache. Concomitant products included PARACETAMOL (TYLENOL) for Tooth ache.    On 20-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced LIP SWELLING (right side of her lip swelling on that night/she had the right side of her lip swollen/she had both sides swollen of her bottom lip) and SWELLING FACE (right side of her jaw started swelling on that night). On 24-Aug-2021, the patient experienced LIP SWELLING (she has the left side of her lip swollen, the right side is not swollen anymore), LIP PAIN (it hurts), HYPOAESTHESIA ORAL (it is numb), LIP PRURITUS (itchy), CHEILITIS (irritated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't really do nothing). On 24-Aug-2021, LIP SWELLING (right side of her lip swelling on that night/she had the right side of her lip swollen/she had both sides swollen of her bottom lip) had resolved, SWELLING FACE (right side of her jaw started swelling on that night) outcome was unknown. At the time of the report, LIP SWELLING (she has the left side of her lip swollen, the right side is not swollen anymore), LIP PAIN (it hurts), HYPOAESTHESIA ORAL (it is numb), LIP PRURITUS (itchy), CHEILITIS (irritated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't really do nothing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included birth control .  The first dose of moderna Covid-19 Vaccine taken on 20-Aug-2021 at around 11 am. The patient had right side of her lip and jaw started swelling on that night. It was stated Friday night and Saturday 21-Aug-2021, she had the right side of her lip and jaw swollen. It started going down, but on 22-Aug-2021 she had both sides swollen of her bottom lip, and jaw just in the right side. This lasted until 24-Aug-2021, but on 24-Aug-2021 she has the left side of her lip swollen, the right side was not swollen anymore.  No Treatment medications were reported.
Patient's husband called today 1/12/2021 after receiving her 2nd dose of shringrix vaccine on 1/11/2021. Patient reported headache, chills, no fever, and normal pulse. Patient also reported having a sore arm but denied redness and warmth. Patient had these same symptoms after the first dose but reported these symptoms are worse than the first dose. Patient was counseled to take ibuprofen or Tylenol to help with symptoms. Patient was directed to call back or contact doctor if symptoms do not improve.
Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was administered second booster on 19-Jul-2022. Concomitant medication list was not provided. Vaccine was put in the refrigerator on 15-Jun-2022. Treatment information was not provided.
Pt describes feeling very ill in the early morning hours. She felt very weak and sick.  This scared her.  She took some ibuprofen, felt better, and was able to go back to sleep.  She stated that she felt so bad that she considered waking her husband and going to the ER. After this there seemed to be resolution.  She said that the site of injection didn't appear to be the issue, yet just the ill episode in the early morning hours. She is 100% that it is from the vaccine, but believes it is the contributing factor to her feeling this way despite being her second and final dose.  Symptoms have resolved and no medical treatment has been pursued.  She stopped by to let me know of the matter, and I felt compelled to report.
03/24/2021-Client recieved their first dose of Pfzier on 03/24/21 at approx 9:30 am. Stated approx 6hours later her joints visibly swelled and as a result she had pain and difficulty walking. All swelling and pain subside by the following day. Has no prior medical history/ diagnoses. Was advised to consult PCP regarding 2nd dose.
Severe upper abdomen pain/burning. Patient went to hospital. Hospital admitted patient. They were unable to find cause. Labeled it as IBS.
Took 1st 3 vaccines from Pfizer, next 2 boosters Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Took 1st 3 vaccines from Pfizer, next 2 boosters Moderna". 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, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a medical assistant concerning a 5 year old female female patient who on an unknown date was vaccinated with varicella virus vaccine live.  It was noted that on 03/27/2004, the patient developed breakthrough varicella.  There was no product quality complaint reported.  No additional information was provided.  Unspecified medical attention was sought.  Additional information has been requested.
The pt developed hives four on left shoulder and axilla 15 mins after Hep A vaccination. No other complaints or symptoms. Given Benadryl and the pt recovered.
Red, warm, tender area on medial aspect of upper right arm.  Prescribed Duricef 500/5 1 tsp BID x10 days.
Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face  Head Pain Throat Tightness
A report was received from a physician's assistant on 1/3/02, concerning a 46 year old female who experienced pain, numbness, and tingling from fingertips to shoulder, two to three days after receiving Fluvirin on 11/28/01. The patient had a history of myalgia. On 11/28/01, the patient received a Fluvirin injection in her right deltoid muscle. After two to three days the patient experienced discomfort and pain throughout the whole right arm. The patient was prescribed mobic 7.5mg 1 tablet once or twice daily, however, at the time of the report, the patient was still experiencing the same, although milder symptoms. The patient received a flu vaccination of another source on 10/13/00 without an adverse event. There was insufficient information to determine the reporter's causality assessment.
Day after injection low grade fever, body aches and chills. Swelling (3" diameter) & itching at injection site. Hot & hard to touch. Swelling down to 2.5" 5 days later. Fever and body aches resolved the fo
COVID booster; my husband same symptoms/Body ache; my husband same symptoms/Cold chills; my husband same symptoms/Cold chills; my husband same symptoms/Headache; my husband same symptoms/bad cough; my husband same symptoms/ sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2, Solution for injection), (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "COVID booster"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Body ache"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "my husband same symptoms/Cold chills"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Headache"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/bad cough"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/ sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated she and her husband got the COVID booster (clarified as Pfizer COVID-19 vaccine) from Pfizer on Tuesday. The reporter was not feeling good up until today like the body ache, cold chills and headache the whole 'night' (word not clear). So they wanted did a home test for COVID the PCR that you bring home and her husband was having the same symptoms, his test is negative, and the reporter test was positive. Could that be a false positive?. Paraphrased the concern: Consumer stated, Body ache, cold chills, bad cough, sore throat but reporter did not have any symptoms up until she got the booster. She just wanted to know if they could be a false positive and those are really symptoms neither just all side effects from the shot.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858979 same reporter/product/event, different patient
BODY ACHES; LOWER BACK PAIN; JOINT HURTS (COULD NOT ROLL OVER AT NIGHT/HURTS TO WALK); This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. Patient did not have any medical history. She stated that she was healthy in all other ways. She was walking every day and was not overweight or anything. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number was not reported) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in JAN-2022, 10 to 14 days before booster, the patient thought patient had Covid (didn't get a test), but patient's son had Covid and he tested positive and patient had same symptoms hence, coded as suspected clinical vaccination failure and suspected covid-19 infection with first dose of covid-19 vaccine ad26. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, 1 total, administered on 04-FEB-2022 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-FEB-2022, in the middle of the night the patient experienced body aches. She reported that her body aches were pretty severe. Her lower back and joints hurt (she could not roll over at night/hurts to walk) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, lower back pain, and joint hurts (could not roll over at night/hurts to walk). This report was non-serious. This case, involving the same patient is linked to 20220216238 (case for dose number in series 1).
The vaccine was given outside the provider on 08/29/2000. The pt develoed chickenpox.
His left arm "was hanging" just like he had a Stroke; He cannot raise it up and cannot make a fist but he can move his fingers; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (His left arm "was hanging" just like he had a Stroke) and HYPOKINESIA (He cannot raise it up and cannot make a fist but he can move his fingers) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MOVEMENT DISORDER (His left arm "was hanging" just like he had a Stroke) and HYPOKINESIA (He cannot raise it up and cannot make a fist but he can move his fingers). At the time of the report, MOVEMENT DISORDER (His left arm "was hanging" just like he had a Stroke) and HYPOKINESIA (He cannot raise it up and cannot make a fist but he can move his fingers) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Fever of 101 on and off for 5 days. Rash on stomach and face.
pt recv vax 5OCT98 & low grade fever 6OCT-7OCT;devel rash over trunk on 10OCT;cont fever & h/a, increasing temp;13OCT temp @ office visit 13OCT was 101.6;pt treated w/APAP & bed rest;
Dtap/IPV (supplied diluent) given ONLY- Hib component not used
Patient attended a clinic to receive medical services. Anthrax and typhoid were administered. Upon checking out, it was suggested she get a pregnancy test performed, which resulted in a positive result. RN at event recommended she seek evaluation by an obstetrician. Patient is currently scheduled for an appointment on 10/8/18.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, vaccination site swelling (injection site arm is swollen), headache and pyrexia (mild temperature) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 19, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced vaccination site swelling (injection site arm is swollen). On an unknown date, patient experienced  vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, headache, pyrexia (mild temperature), vaccination site erythema (red) and vaccination site pain (sore). At the time of the report, vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, vaccination site swelling (injection site arm is swollen), headache, pyrexia (mild temperature), vaccination site erythema (red) and vaccination site pain (sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant product use or treatment information provided.
Received vax on 02/21/00. Eight days post vax, she developed a runny nose which stopped 03/04. Fever of 101 F for three to four days then returned to nml.
Patient had a seizure after being seizure-free for several years. It resolved without intervention. However it lasted longer than usual  approximately an hour and 45 minutes. Neurologist was notified. Levetiracetam levels taken within in the month was WNL.
Cardiac arrest (Ventricular Fibrillation) - heart stopped and immediately collapsed.   Treated by first responders for 10 minutes with CPR, ventilation,  and 2X defibrillation.  Followed by 5 days of hospitalization.
body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked how long does the side effect of body aches last after the Shringrix vaccination.