chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She presented to the hospital with acute typical angina approximately 72 hours after receiving her 2nd vaccine dose. The morning following her vaccine she developed fever, chills, generalized malaise, myalgias, and fatigue lasting about 48 hours. The following morning, she was awoken from sleep by a crushing substernal chest pain with associated typical anginal symptoms. Her initial troponin-I was elevated at 7.47 ng/mL and peaked at 19.19 ng/mL. An ECG demonstrated minimal ST elevations followed by an echocardiogram demonstrated preserved systolic function and an ejection fraction of 60-65%. Due to her elevation in cardiac enzymes and persistent angina, coronary angiography was performed revealing no obstructive coronary artery disease. She was diagnosed with suspected myocarditis and treated successfully with anti-inflammatory medication. In follow-up, she had an uncomplicated treatment course with complete resolution of anginal systems and improvement in troponin and inflammatory markers.
This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got their first dose of the Pfizer covid vaccine on 09sep2021 and tested positive on 12sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. The outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a 68 year old female consumer with hypertension, depression and drug hypersensitivity to a lot of medications who in 2000, 10 years ago was vaccinated with the first dose of PNEUMOVAX 23. Subsequently the patient experienced "flu-like" symptoms. On approximately 11-DEC-2009, 6 months ago the patient was vaccinated with the second dose of PNEUMOVAX 23. The patient experienced "flu-like" symptoms again after the second dose of PNEUMOVAX 23. The patient stated that she recovered fully. The patient subsequently experienced a change in mental status while on therapy with ZOSTAVAX (Merck) (WAES#1006USA01794). No further information is available.
Pt. states that after receiving the 2nd dose of Moderna 05/27/2021, started experiencing symptoms immediately of dizziness, nausea, both legs with a tingling feeling throughout, shortness of breath, arm swelling, flu-like symptoms, and chest pressure. ER visit 05/27/2021 EKG/Ultrasound, Chest X-Ray preformed (T-Wave abnormal), severe fatigue. 06/22/2021 ER due to severe tingling in both legs, sometimes in different parts of the body. 09/08/2021 Neurologist appt. follow-up in November. Symptoms still continuing to experience symptoms.
Sore arm as expected (similar to first dose), however, also pain down arm into left  hand. By 8pm, extremely tired and difficulty focusing/mentally alert, so went to bed. Could not sleep - chills all night, body ached all over - head to toe, headache. In a.m., also queasy and achiness continued throughout body, also chills continued - ironically left arm and hand feeling improved. I had the shingles a few years ago and it felt like the start of when I had the shingles - like bad flu symptoms. Forced down light breakfast and took Motrin, using heating pad  - helping alleviate some symptoms, no longer queasy but still achy, cloudy headed, headache.
I got kidney stones. I had 2 on the right and one on the left kidney. I got a liter of IV fluid to try to help flush them out and they started me on a new medicine. I went the Emergency room and then had a follow up with my Doctor. It started on 5/27/2021 at 5:15am and I work up with extreme pain on my right side with nausea and vomiting.
Sharp pains in left hip and down leg?can?t step on left leg, dizziness, fatigue
Symptoms started with high fever and body aches and continued with swelling in arm around shot area. treated with bedrest, cool baths, motrin, and benedryl per nurses suggestions.
The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief  mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.
Tingling that radiate from shoulder to upper back; burning pains that radiate to  shoulder and upper back.; Severe pain on left arm (same arm as the injection); Shoulder pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain). The patient was treated with IBUPROFEN for Shoulder pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medicines were provided.  Action taken with mRNA-1273 in response to the event was not applicable
This is a spontaneous report from a contactable medical assistant reported on behalf of a physician's assistant. A 84-year-old female patient received PREVNAR 13 (NDC number: 0005197102, lot N47827, exp. date 01Nov2017) at 0.5ml single dose via an unspecified route in the right arm on 21Nov2016 for immunization. Concomitant medications included LEVOTHROID 100 mcg, Tablet, Orally, Once a day, MYRBETRIQ 50 mg, Tablet, Once a day, multivitamin, calcium and vitamin D all ongoing. Medical history included Hypothyroidism ongoing. On 26Nov2016 the patient experienced injection site redness, bruising below the injection site and swelling below the injection site. The outcome of the events was reported as recovering. The patient received treatment for the events.
Pt has felt tired and clammy with sweating since the shot. The sweating occurs at bedtime. Her arm is red with a raised rash 3 inches from the elbow. Daughter mentioned the pt has had a severe NEOSPORIN allergy. Pt may have not noticed neomycin is NEOSPORIN. Pt called on 10/2, shot given on 9/30.
having body aches; chills; headache; fever (100.9°F); A spontaneous report was received from a consumer concerning a 26-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having body aches/ Myalgia, chills, headache and fever (100.9°F)/ pyrexia.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 11 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 012LZ0A) in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, after receiving mRNA-1273, the patient experienced having body aches, chills, headache and fever (100.9°F).   Treatment for the events were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, having body aches, chills, headache, fever (100.9°F) were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt given vaccine at 2:22 pm on 11/20/22 to right deltoid. Given per Pfizer instructions and all patient rights followed.  At 3:32 pm patient's mother stated her child felt tired, dizzy, and is sweating. Vital signs taken and they were all within normal limits. Mother states the patient did not have breakfast or fluids all day. Patient monitored for 15 more minutes. Mother gave Tylenol and sports drink to drink. Pt responded well to treatment. Pt stated she felt better.  Vitals normal.  Instructed mother that patient should increase fluid intake, rest, and monitor at home. If symptoms worsen, patient should seek immediate emergent care. Mother verbalized understanding.
Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-JAN-2013, at age 67, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a nurse practitioner for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Pt suffered 3 seizures within 1 hour of receiving vaccine, and then had several more in the next 24 hours according to her mother. Pt has a seizure disorder, but had not had a seizure in several months.
Began with a headache at around 8 pm.  Had chills, fever (101) and body aches by around 9:30 - 10 pm. Symptoms at 9 am the following day include Low grade fever (100.9) chills, aches and nasal congestion.
Patient was 17 years old at the when he received the Pfizer booster dose on 10/27/2021.  Father, called and was informed on 10/28/2021 about event. CDC criteria for receiving a booster dose reviewed with father. Father verbalized understanding and asked if his child's condition of type 1 diabetes made his child eligible for a third dose. Educated on difference between a booster dose and third dose and CDC's list for people eligible for 3rd dose. Father verbalized understanding. Informed to monitor for side effects/adverse events beyond slight swelling, redness, or pain at the injections site and to contact provider shall any concerns arise as well as report it to us..  Father stated that both he and his child were very fatigued and his child did not go to college due to fatigue. Informed him that that is an expected common adverse event and to continue to monitor .
Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Mar-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.            Concomitant and treatment medications were not reported.
Case number PHEH2015US026032, is a combined initial spontaneous report received from a consumer and pharmacist on 09 Dec 2015. This report refers to a 34 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUCELVAX (batch number and expiry date: not reported) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. On 27 Nov 2015, patient developed bursitis from the injection. Seriousness, outcome and causality of the event bursitis were not reported. Seriousness of the event bursitis was upgraded as medical significant based on available information in the source document.
09/19/22 presents to ED for "anxiety, confusion, SOB". PMHx of "anxiety, depression, and a colon cancer treated in 1998 with surgery and chemotherapy, and recently diagnosed with breast CA on Letrozole"
This spontaneous report was received from medical assistant via company representative regarding unspecified number of patients of unknown demographics. There was no information regarding concurrent condition and historical medication. It was reported that on an unknown date, an unknown number of patients had been administered with GARDASIL outside the recommended time frame (dose strength, route and lot number was unknown). No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
I experienced this after both the first and second doses.  Within one to two minutes after the injection a burning sensation of the tongue and mucus membrane lining of the nostrils developed which then persisted for 36 hours after the first injection and at least that long after the second injection (still ongoing at the 36 hour mark).  The burning sensation was more intense after the second injection compared to the first.
Positive covid test; harsh cough; sore throat; some difficulty breathing; fatigue; achy joints; A spontaneous report was received from a Patient, HCP  and other HCP concerning a  63Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints, positive Covid test.  The patient's medical history was not reported.  No Relevant concomitant medications were reported like    On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.      On date 21st Jan 2021, The patient experienced the event like  harsh cough, sore throat, some difficulty of breathing, fatigue, achy joints. On date 22nd Jan 2021, The patient was tested positive for Covid-19  Laboratory details not provided.    Treatment information was provided.   Nyquil Tylenol    Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events are unknown.; Reporter's Comments: This case concerns a 63-year-old female who experienced nonserious unexpected events of COVID-19 along with NS unexpected events of cough, dyspnea, sore throat and NS expected events of fatigue, arthralgia.  The events occurred 12 days as after the first dose of mRNA-1273. Treated with Nyquil and Tylenol. Event outcomes unknown. 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 was warm, with a slightly raised body temperature, she had mild nausea and a sore throat.  This lasted for 24 hours.
Body aches; sore L arm; Restless; hang over; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired) outcome was unknown. Not Provided          Patient was taking vitamin for unknown indication. Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-078318 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078318:DOSE1
1/22/21: pressure at site x day 1 of dose; mod to min soreness x day 2-5; bruise x days 6-7; bruise up to 28 daysk.  Narrative:
A lump in my armpit - on my right armpit. I noticed it about 2 1/2 months ago. I saw my GYN ( for regular check up) and she thought it was a reaction to COVID vaccine. At about the beginning part of this month - it got really painful. They told me to take ibuprofen and to use warm compresses. The warm compressed do seem to help. The pain was worse when I was on my menstrual cycle. The lump is still there but I don't have as much discomfort when I'm not on my cycle.
Immunocompromised patient given 0.25 ml for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient given 0.25 ml for 3rd dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 036B and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient has been currently going through active chemotherapy for the past six months) since an unknown date. Concurrent medical conditions included Immunocompromised.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient given 0.25 ml for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient given 0.25 ml for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
The pt experienced a localized reaction at the left deltoid injection site with warmth to the touch, painful movement and localized deltoid swelling. Worsens each day. Has not tried anti-inflammatory or other over the counter medications or used heat/cold.
Information has been received from a health care professional concerning a 13 year old female who on 2/17/99, was vacinated with a 2nd dose of Hep-B vaccine recombinant and 15 minutes, post vax, her left arm turned purple down to her fingers and her wrist to fingertips felt numb. Subsequently, the pt recovered from the arm discoloration and the numbness is resolving. Additional information has been requested.
swelling & redness @ the site 3" below p/24hr & lessened p/that;took DPH;11MAY98 noticed itching of affected extremity & swelling under eyes;has devel new allergies in past year;
Patient experienced nausea, dizziness, blurred vision,  and loss of balance X3 days post dose. Patient seen at ER X2 for Sx. Will follow up with PCM for dizziness and loss of balance. Will follow up with ophthalmology for vision issues.
I started with extreme sleepiness and fatigue which continued until Monday. Then I got a cough, sore throat, runny nose and an earache. I went to the doctor on Thursday. The doctor thought I had an ear infection and placed me on Amoxicillin. I started to take it about 24 hours ago and can not tell the difference. I had lab test on Friday prior to getting my vaccine. These symptoms started right after I got my vaccine. I was not tested for COVID-19 during this process.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M031807 with expiration date on 02-APR-2018 and lot# reported as M038724 with expiration date on 24-APR-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 degrees Celsius and 25 degrees Celsius for 19 minutes. A digital data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009262: