chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a pharmacist regarding a 54-year-old female who received a dose of ZOSTAVAX on 23-Mar-2017 subcutaneously (lot # M035694, exp. 07-NOV-2017) for prophylaxis. The pharmacist reported that the patient had a small amount of bleeding, "a few small drops at injection site". The pharmacist stated that the bleeding stopped and a Band-Aid was applied to the injection site. Causality was not reported. No further information was reported. Additional information is not expected.
Ischemic stroke/Stroke; Potassium was also low; This is a spontaneous report from a contactable nurse. A 24-years-old female patient received bnt162b2 (Pfizer Covid vaccine), dose 2 via an unspecified route of administration, administered in deltoid left on 28Jul2021 at her 24-years-old (Lot Number: FE1510) as dose 2, single for covid-19 immunisation. There were no concomitant medications, no other vaccine, no medical history. Historical Vaccine included first dose bnt162b2 on 24Jun2021 at her 24-years-old for covid-19 immunisation(First vaccine, Lot: FD5613, Site: right deltoid).  The patient experienced ischemic stroke/stroke on 06Oct2021 two months after second vaccine with outcome of recovering which was assessed as serious with hospitalization, life threatening , potassium was also low on an unspecified date with outcome of unknown.  The patient was hospitalized for ischemic stroke/stroke from 06Oct2021 and still admitted. Emergency Room required and then admitted to the hospital, no physician office. No relevant tests . Therapeutic measures were taken as a result of ischemic stroke/stroke. It seemed after some treatment, the patient has improved. Patient was in the ICU.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Ischemic stroke and suspect drug BNT162B2 cannot be excluded.   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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Less than 10 min he got nausea, dizzy, turned very pale and couldn?t stand.   Laid down propped feet up and blood sugar was fine and by time they took his BP it was fine
High fever lasting hours and not responding to Acetaminophen (102F) Chills Headache Fatigue Lower Back Pain Periodic severe pain in left ear
loss of appetite; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and DECREASED APPETITE (loss of appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Lily infusion for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (body aches). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, PAIN (body aches) and DECREASED APPETITE (loss of appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
INFLAMMATION; PAIN IN JOINTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the patient experienced inflammation, and pain in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation, and pain in joints on 2022. This report was non-serious.
Pt was admitted with weakness and stroke like symptoms. Pt was also admitted with similar symptoms at time of vaccination in August. The pt was found to have an aneurysm of the circle of Willis. Also, MD wants to r/o Guillain Barre syndrome secondary to Influenza vaccine. Pt was treated with Immune globulin.
Large erythema 13 x 6 cm (L) ant. thigh at site of PENTACEL with 11 x 5 cm induration and warmth.
Fever 100.4F measured at night on 12/07/2020-resolved with Tylenol, body aches/tremendous headache lasting about 29 hours-took Tylenol and improved over time, sweating/chills-resolved over time
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. The reporter stated that patient was vaccinated with two doses of ZOSTAVAX in a one year time frame. The first dose was received on unspecified date (lot # and expiry date were not provided), and second dose was received on 27-OCT-2015 (Lot # L028284, expiry date on 28-OCT-2016). At the time of the report, no adverse effects have been reported. Additional information has been requested.
I've had to undergo cardioversion three times since, twice in June and again last week.  And I'm still out of rhythm.
3 days later chills, achy, pain, hot, fever chrinic sinus drainage, nausea, ear ache
violently ill; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA290167 (same reporter).  This case involves a patient of an unknown demographic who was violently ill (malaise), when received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination respectively.  On an unknown date, the patient was violently ill (malaise) (non-serious, Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  There will be no information on the batch number of this case.
Felt fatigue for 24 hours after shot - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration.
This spontaneous report was received from a patient's mother and refers to a 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date, the patient was diagnosed with Lyme disease by a Western Blot test administered by her mother. The patient's physician did not recognize the patient's unspecified symptoms as being related to Lyme disease. The patient's parents were also diagnosed with Lyme disease on unknown dates and aware of the unspecified symptoms. The patient's physician prescribed unspecified antibiotics after the result of Western blot test. The Lyme disease was dormant prior to the patient's GARDASIL 9 vaccination. On an unknown date in November 2015, the patient received her first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) for prevention of human papilloma virus (HPV). On unknown dates, after the vaccine administration, the patient began to experience memory, loss brain fog, partial paralysis, eye sensitivity, swollen glands and nausea. The other symptoms included extreme fatigue, muscle pain, feeling dizzy and a feeling of general unwellness. The patient was also hospitalized on an unknown date for pneumonia. Therapy with GARDASIL 9 was discontinued. The patient received treatment for the events. The outcome of the events was reported as not recovered at the time of reporting. The primary reporter stated that her daughter was unable to function as she wanted and needed care from an anonymous psychiatrist. The patient has also missed school because of not feeling well on unspecified dates. There was no further information regarding the physician's course of treatment. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of pneumonia and partial paralysis were considered to be medically significant. Additional information has been requested.
Abscess left thigh-spontaneously drained at home. Rx: Cephalexin 250/5 1 tsp po tid for 7 days.
Some soreness in the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Some soreness in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Some soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Some soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2021-018929, MOD-2021-018929 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up received on 17 Jul 2021 contains no significant information.
Fever; Muscle ache (shoulder, back, butt, legs); This is a spontaneous report from a contactable consumer. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 28Apr2021(at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient past drug was reported as apple. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 14:45 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 11:00, the patient experienced fever and muscle ache (shoulder, back, butt, legs). The patient underwent lab tests and procedures which included body temperature on 29Apr2021 and the result was 100.0-100.5 (unit not specified). The clinical outcome of the events fever and muscle ache was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lethargy; I feel blah; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Significant Follow up received and outcome of events updated to recovered
Pt received ORIMUNE, DTP, PROHIBIT and experienced fever with seizure less than 24 hrs following.
Patient started to develop warmth, redness and tenderness around site of varicella vaccine a few hours after the injection. Redness spread for a little over 24 hours. No fevers, no drainage at the site.
Sadly the doctor did not provide me any information about vaccines (name/type), etc other than: DTAP IPV + Polio. After the shots (in the morning), my son quickly developed fever and complained about body aches (few hours after the shots). Then apathy (barely moving/talking). He would only cry in pain. I gave him TYLENOL (recommended by Dr) and it would ease the pain every 4 hours. In the evening, he developed hives on the face (they would come and disappear as quickly as they came) and he would cry in pain. The next day, Dr told me it was an allergic reaction to the vaccine. Sadly he never told me anything else: never mentioned me there was this registry/reporting system, never told me what would be the next step (when my son will be 11 and due for the same vaccine, what will happen)?
vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago; vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago; shivering; fever of 100°F; arm hurting; tingling of her lips; swelling of her lips; rash with light pink with dots on her chest; redness on both her cheeks.; She had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest) and ERYTHEMA (redness on both her cheeks.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced MYALGIA (She had a sore arm.). On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), CHILLS (shivering) and PYREXIA (fever of 100°F). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) and POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago). At the time of the report, PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago), CHILLS (shivering), PYREXIA (fever of 100°F) and MYALGIA (She had a sore arm.) outcome was unknown and HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: significant follow up appended : Event Updated , Patient details updated
This spontaneous report as received from a physician refers to a 65 year old female patient. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot# reported as H01996) dose 2, (route: subcutaneous) to the back of left arm. Concomitant therapies included acetaminophen, aspirin, diltiazem and dronedarone hydrochloride. On 20-AUG-2016, the patient experienced papulovesicular rash on T10, T11 and T12 distribution with pain. The outcome of the events was unknown. The causality of the events were not reported. Additional information has been requested.
I received my injection in my left arm on 10/14/2022 at 5:20.  The next day (10/15/2021) around 10am, I had minor pain down my left leg that gradually increased throughout the day into Sciatic nearve pain until i couldnt walk or have anything touch my leg without having excruciating pain.  The excruciating pain lasted until 10pm saturday night (10/16/2021).  A week later i still have minor pain in my leg that increases with activity.
My respiration was getting worst, like if I was having an asthma attack, it got progressively worst, to the point that I could not walk. I went to the doctor and have been in the hospital since Saturday. They said if I put in the ventilator I will not be coming out. I am at a local medical center. I am under medication to regulate my heart.
Pt. was seen at Detention Center for Covid vaccination. Pt. was given a Moderna Bivalent booster after previously receiving a Janssen on 10/27/21, a Moderna primary on 8/25/22 and a Pfizer Bivalent booster on 10/31/22.
Fever of 102F, night after vaccination, with erythema and swelling of right thigh with vesicles.
hoarseness of voice; coughing; sneezing; sore throat; chest pain; body ache; I feel a little breathless; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat) and CHEST PAIN (chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O1ZAZ1A and O46A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless). At the time of the report, DYSPHONIA (hoarseness of voice), COUGH (coughing), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain), PAIN (body ache) and DYSPNOEA (I feel a little breathless) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant follow up received on 16-JUN-2021, no new information
Face and neck all hot; rash had spread throughout her body; Face was really flushed; tachycardia; fever 99.9-102F; A spontaneous report was received from a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f.  Medical history was not reported. Concomitant medication was not reported.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in left arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia with seriousness criteria life threatening and fever 99.9-102f.  Treatment medication included Benadryl at a dose of 50 milligram.  Action taken with mRNA-1273 in response to the face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was not provided.  The outcome of the events face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of severe allergic reaction, tachycardia, rash, flushing, and skin warm, and NS expected event of fever. The events occurred the same day as the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. 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.
Patient came in for Pfizer bivalent booster dose, but patient was given a Pfizer monovalent dose.
This is a 60y.o. female with PMHx of HFpEF, Afib, and chronic lymphedema who presents to ED for abnormal labs. Patient has a home healthcare worker who draws scheduled labs and was notified today of Hgb 7.1 with instructions to go to the ED. This morning, patient had x1 episode of red blood with a bowel movement. She denies any prior episodes aside from this one, denies black tarry stools, denies coffee-ground emesis. Patient was previously admitted to this facility 2 months ago for anemia, though was found to have Bacteremia due to Pseudomonas and was treated accordingly. At the time, she also underwent EGD with gold prob cautery for suspected GI bleed. Patient states that she has been more fatigued lately, though attributes this to her mother's recent cancer diagnosis. Since discharge, she has been gaining weight, approximately 15-20lbs. She has also had decreased urine output, measuring approximately ~2L/day, from her normal ~3-4L/day. She denies fevers, chills, changes in vision, chest pain, SOB, abdominal pain, N/V/D, constipation, difficulty urinating, or weakness. Patient previously had Covid approximately 1 year ago, has been fully vaccinated with Pfizer vaccine.    ED Course: BP 106/76, HR 63, RR 20, T 97.9F, SpO2 97% on RA. Labs remarkable for Na 133, Cr 1.46, Hgb 7.4, Cortisol 22.5, TSH 6.52, Covid detected. CXR shows cardiomegaly w/ mild pulmonary vascular congestion. Plain film of abdomen shows no acute process. Patient is admitted to Internal Medicine with consult to Gastroenterology.
[Pfizer COVID-19 Vaccine] use for COVID-19 under Emergency Use Authorization (EUA):Pfizer vaccine administered to patient who had received two doses of Moderna vaccine three months prior.
Case received COVID vaccine #1 on 3/2/21 and #2 on 4/1/21. On 11/11/21 she developed COVID symptoms . Her condition worsened until she was hospitalized on 11/17/21 for COVID pneumonia, at which time she tested positive by PCR.
pt recvd vax & had headache; d; v; severe stomach cramps; no fever;adm to hosp; dehydrated; all tests neg;