chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The red itches and has spread to above my elbow.; There is a large bump at the injection site and goes; It is dark red at the site where the needle was inserted.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) 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 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.). At the time of the report, VACCINATION SITE PRURITUS (The red itches and has spread to above my elbow.), VACCINATION SITE INDURATION (There is a large bump at the injection site and goes) and VACCINATION SITE ERYTHEMA (It is dark red at the site where the needle was inserted.) had not resolved.            Hello PII(32):Aeq9Braioi0yJBuRYUX2iX2XzwooAA==.  I received my 2nd vaccine on Thursday 6/3/21. I have a large red spot on my arm   It is dark red at the site where the needle was inserted. The red itches and has spread to above my elbow. There is a large bump at the injection site and goes
Freezing, chills, sweats, nausea, dizziness, loss of appetite, tremors, extreme drowsiness. Patient stated they have never had a vaccine reaction this bad previously. They took Ibuprofen and it helped minimally but they had these symptoms for 3 days and on day 4 he still has them but they have lessened in severity.
Headache, pain at injection site same/next day after injection  Muscle pain, joint pain, swollen lymph nodes, fatigue one week after injection
He was still breast feeding and patient was fully Moderna vaccinated; No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) and NO ADVERSE EVENT (No adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) had resolved and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.            "He is still breast feeding and my wife is fully Moderna vaccinated. If it is at all of interest to see if he has the antibodies which some limited research has said is very likely, we'd be happy to discuss conducting a trial for that as well". No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A female patient of an unknown age reported to be fully vaccinated with mRNA-1273 vaccine and wanted to known If it was at all of interest to see if her son, who was still breast feeding, has the antibodies which some limited research has said is very likely. No adverse event was reported. Vaccination dates were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A female patient of an unknown age reported to be fully vaccinated with mRNA-1273 vaccine and wanted to known If it was at all of interest to see if her son, who was still breast feeding, has the antibodies which some limited research has said is very likely. No adverse event was reported. Vaccination dates were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Facial urticarial and lower lip swelling, lasted 5 hours, resolved with Benadryl was not seen in clinic until 12/14/2015. At that time sx had fully resolved.
Patient is a 85 y.o. female patient of PA-C with history of COPD, hyperlipidemia, recent ischemic CVA at left thalamus in July 2022 presents to the hospital with complaints of weakness and nausea on 12/1/2022.   Covid-19 pneumonia Acute hypoxemic respiratory failure:  Date of onset of symptoms: Unclear on exact date as she had pulmonary symptoms at the time of admission due to community-acquired pneumonia (likely bacterial).  Her COVID-19 molecular testing was negative on 11/30/2022 at outside hospital and became febrile with increased oxygen requirement on 12/8/2022, testing positive at that point in time. Date of covid positive test: 12/8/2022 Vaccination status: vaccinated (mRNA vaccines x2, no booster) Imaging: Chest x-ray on 12/8/2022 showing patchy interstitial bilateral opacities. Oxygen requirements: On 4 L nasal cannula at time of COVID-19 diagnosis  Current oxygen requirements: Room air Medical therapy: remdesivir and steroids, status post tocilizumab on 12/9/2022 Consultants following: Infectious disease Anticipated special isolation end date: 12/18/2022   Community-acquired multifocal pneumonia, bilateral lower lobes Sepsis, POA now resolved Lactic acidosis, POA CT chest abdomen pelvis personally reviewed and showing multifocal groundglass opacities most prominent in upper lobes. Treated with empiric vancomycin and cefepime on admission with improvement and de-escalated to ceftriaxone, now status post 7 days therapy Worsening respiratory status secondary to COVID-19 pneumonia as above, antibiotics discontinued   History of COPD: Without acute exacerbation Continue as needed albuterol   Generalized weakness 2/2 sepsis: PT/OT evaluated and recommend home health on discharge CT head reviewed with no acute abnormalities.   Sinus arrhythmia Patient's EKG showing sinus arrhythmia Troponin x3 negative. No chest pain.     History of CVA: Continue aspirin and statin   Nonspecific multifocal lucencies in thoracolumbar spine Incidental finding found on CT chest abdomen and pelvis Follow-up with none urgent MRI in outpatient setting  Hypokalemia Trending chemistry Monitor and replace
PRESCRIBED ONE VIVOTIF CAPSULE TWICE A WEEK; This spontaneous case (PVX2019-931) was received from a pharmacist on 19-Apr-2019. It describes a 19-year-old male consumer who was "prescribed Vivotif 1 dose twice a week". The consumer was receiving Vivotif capsule (lot number: 3003242) for an unknown indication.  Case report: The consumer was prescribed one Vivotif capsule twice a week.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "prescribed Vivotif 1 dose twice a week" was unknown.  Company's Comment: The causality of the event "prescribed Vivotif 1 dose twice a week" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "prescribed Vivotif 1 dose twice a week" was considered as not applicable.
Swelling and redness or induration the size of a tennis ball in area of administration.  Raised area at injection site forming scab.
On January 29, 2022 I started getting cold symptoms and on January 30, 2022 started vomiting, Then on January 31, 2022, I had Diabetic Ketoacidosis (DKA) went to the ER I was unresponsive. I was admitted in the ICU my blood sugar was over 1300 was hospitalized for 9 days (unconscious for the first 3 days). While in the hospital I received the Remdesivir by IV, I had to be incubated twice, diagnosed with pneumonia and sepsis. When I came home it was hard to eat cause of the tubing. I have upcoming appointment with a Gastro specialist to check my iron.
Lymph node on left neck side which has kind of moved up for almost 2-3 weeks.; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node on left neck side which has kind of moved up for almost 2-3 weeks.) and VACCINATION SITE PAIN (Pain at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node on left neck side which has kind of moved up for almost 2-3 weeks.) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 14-Jan-2021 for Injection site pain, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Lymph node on left neck side which has kind of moved up for almost 2-3 weeks.) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Chest X-ray: normal (normal) everything looks fine. In January 2021, Ultrasound chest: normal (normal) everything looks fine.     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 medications reported.  It was reported that the lab tests performed looked fine and the results for biopsy was pending at the time of report.
Dizzy, feeling like head was swimming. Sudden sleepiness-like I hadn't slept in 24 or more hours--felt like I could just go right to sleep if I closed my eyes. Numb lips--like they had been novacained. Round, red rash--about 3 inch diameter at injection site that evening.
whole body was itching; RASH ON PALMS OF HANDS; This case was reported by a physician via sales rep and described the occurrence of generalized pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced generalized pruritus and rash. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the generalized pruritus was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced rash on the palm of his hands and 15-20 minutes later his whole body was itching for which he took an anti-histamines.  The anti-histamines resolved the issues but then rash returned 2 months later. The reporter did not have vaccine facility details. The reporter consented to follow-up.
Information has been received from a registered nurse who reported that multiple unspecified patients received unsecured doses of improperly stored PROQUAD (lot # L050909, expired date 14-JUN-2017 or lot # M002055, expired date 11-JUL-2017; rHA; dose and route not reported). These vaccines were under 9.5 F for 3 hours and 26 minutes and then under 13.1 F for 1 hour and 24 minutes. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient given MEN B provider ordered IPV patient is fine called manufacture vaccine is approved for ages 2years - 55 years old
Throat felt swollen, no interference with breathing. Followed by severe nausea. Hour later continuous projectile vomiting and 1 bout of diarrhea. Followed by chills and shaking. Couldn't get warm. About an hour later got extremely warm. Temp was 100.9. By about 10pm symptoms began to subside and fever was slowly coming down. Next day symptoms gone but extremely fatigued and a little bit nauseated.
Swollen lymph nodes in left breast for 6 weeks; low hemoglobin; low Hematocrit; low platelets; low protein; low calcium; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 (as reported) (Batch/Lot Number: Er8731) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Batch/Lot Number: Er8730) as single dose for covid-19 immunisation at the age of 39-year-old. Medical history included migraine, allergy to Penicillin. There were no concomitant medications. The patient was not Covid prior vaccination and hasn't been tested Covid post vaccination. On 17Apr2021 09:00, the patient experienced Swollen lymph nodes in left breast for 6 weeks and continuing with no improvement confirmed by family doctor. Bloodwork showed low hemoglobin, low Hematocrit, low platelets, low protein, low calcium-never had any of this prior to vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events and the outcome of the events was not recovered.
Ct. slid out of chair and was unresponsive for approx. 10 sec., ct. incontinent.
Information has been received from a medical assistant referring to a 5 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1901USA008772: US-009507513-1902USA007537: US-009507513-1902USA007538: US-009507513-1902USA007539: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Eczematous dermatitis of  forearm papular erythematous pruritic rash warm to touch rough in touch rough in texture occurred within 24 hours of first dose rash persistent at  one  month  SIMILAR REACTION FTER 2 ND DOSE given in opposite arm
pt vaxed 10SEP92 following day exp inject site react of erythema, induration & tenderness- 1 1/2" in diameter; treated w/ice & APAP;
literally quit getting the flu when I quit getting the flu shot; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a patient (unknown age and gender) who literally quit getting the flu when quit getting the flu shot while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Immunisation. There will be no information available on the batch number for this case.  On an unknown date the patient developed a non-serious event "literally quit getting the flu when i quit getting the flu shot (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "This case is received from Social media. Hello, The following potential adverse event has been found on a public post for Flu Shot Social media page. Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I literally quit getting the flu when I quit getting the flu shot. Patient ID: Not Provided. It is unknown if patient's physician provided consent to be contacted Age group is actually not provided It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza Vaccine: Sanofi flu shot".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (literally quit getting the flu when I quit getting the flu shot).  At time of reporting, the outcome was Unknown for the event literally quit getting the flu when i quit getting the flu shot.
The patient also reports a sore left injection site arm.; patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7185B and 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2023, the patient experienced VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023). At the time of the report, VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient received her first Moderna covid 19 vaccine primary series on 31-Mar-2021 with lot number 039A21A and expiration date was 14- Sep-2021 in left arm and did not have adverse reactions. The patient received her second Moderna covid 19 vaccine primary series on 30-April-2021 with lot number 004C21A and expiration date was 19-Oct-2021 in left arm and did not have adverse reactions. The patient received her first Moderna covid 19 vaccine booster dose on 16- Jun-2022 with lot number 056M21A and expiration date was 12-Aug-2022 in left arm and did not have adverse reactions. The Nurse thought that the patient was counting injections rather than identifying monovalent versus bivalent vaccine and that this led to the error. The patient also reports a sore left injection site arm.
08/26/2004 red, indurated skin over left deltoid area. Warm to touch, no fever. 8/26/04 5P increased redness and hotness left deltoid, temp 99.8PO.
Morning after the booster shot (given at ~4pm Thursday) woke on Friday at 7 am with sore arm and slight headache. By 10 am headache was moderately severe - took Tylenol By noon felt cold, was experiencing shivering and worse headache - the shivering lasted an 1-2 hours on and off.  Took temperature with electronic probe under tongue and it was normal. Injection site was very sore and could not lift arm too high. Was improving by ~ 4pm and went to sleep for about two hours.  I do not normally sleep in the afternoon. By evening headache was subsiding. Next morning - lesser headache and not shivering - improved throughout day.  Injection site was still quite sore limiting arm motion. 48 hours later minor headache and some fatigue.  Took max allowed Tylenol extra for ~ 48 hours from onset of symptoms.  Two days later some fatigue.  The only reaction I had to the first two Pfizer vaccines was minor soreness at the injection site.
Arthralgia Employee reports:  ""So, yesterday I just started feeling really warn out but immediately my throat got a little scratchy. I cam home ~6pm I started feeling really run down, I had the chills, joint pain, my stomach was upset & dull headache. Then my arm Narrative:
Sore arm, fatigue, uneasy in general. Injection site turned red gradually. The area expanded over a few days. These symptoms lasted for about 10 days.
I  received the Pfizer COVID-19 vaccine during my second trimester of pregnancy. I received my second dose on 11/6/21, and began experiencing severe chest heaviness and difficulty breathing on 11/8/21. The severity of the chest heaviness prevented me from inhaling a full breath. I went to the ER, where a CT was performed and ruled out a pulmonary embolism, pneumonia and pneumothorax. EKG showed non-specific abnormal T wave. Troponins were normal. Blood work showed very mild anemia. Discharged from ER. Obstetrician referred me to a cardiologist, who reviewed the EKG and scheduled an echocardiogram for the end of December.  Still have mild shortness of breath that worsens with activity or even talking.
I just got a wave of sickness, wanting to vomit, stomach hurting, bad head ache, little trouble breathing (It began to hurt not a lot but enough to notice it), runny nose and when I got the vaccine it began to sting or burn where the vaccine was injected (all though my other two vaccines for different stuff did not hurt a bit).
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), EATING DISORDER (cannot eat), BEDRIDDEN (bed ridden), HEADACHE (headache) and VOMITING (vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 028A21A) 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 LATANOPROST for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Dizziness), EATING DISORDER (cannot eat), BEDRIDDEN (bed ridden), HEADACHE (headache), FATIGUE (weary) and ASTHENIA (lapse in energy). 28-Apr-2021, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), EATING DISORDER (cannot eat), BEDRIDDEN (bed ridden), HEADACHE (headache), VOMITING (vomiting), FATIGUE (weary) and ASTHENIA (lapse in energy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.