chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhetic discharge beginning ~72 hours after injection, progressing after ~5 hours to intermittent diarrhea; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in the right arm on 18Mar2021 at 16:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included bupropion hcl xl (MANUFACTURER UNKNWON) 450 milligram(mg), fluoxetine (MANUFACTURER UNKNOWN) 80 mg and KELNOR from an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Lab tests and procedures included nasal swab test on 17Mar2021 which was found to be negative. The patient experienced diarrhetic discharge which was started after 72 hours of vaccination on 21Mar2021 at 14:30 and it was progressing after 5 hours to intermittent diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of diarrhea was not resolved. No follow-up attempts possible. No further information expected.
I am taking an antibiotic for an infection.; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (I am taking an antibiotic for an infection.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (I am taking an antibiotic for an infection.). At the time of the report, INFECTION (I am taking an antibiotic for an infection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that reporter was scheduled for their second dose of Moderna Covid-19 Vaccine tomorrow. Patient was taking an antibiotic for an infection and be concerned about an interaction with vaccine.
Intractable migraine; The patient administered with third booster dose; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Oct2021 at 11:15(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 46-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNWON) via an unspecified route of administration in the right arm on 29Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 13:15, the patient experienced intractable migraine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intractable migraine was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Arm became itchy around the injection; Round red blotch around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm became itchy around the injection) and VACCINATION SITE ERYTHEMA (Round red blotch around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm became itchy around the injection) and VACCINATION SITE ERYTHEMA (Round red blotch around the injection site). On 01-Feb-2021, VACCINATION SITE ERYTHEMA (Round red blotch around the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm became itchy around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not use any treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
1 day post vax pt experienced stiff neck, shortness of breath and enlarged lymph gland. Pt woke up with swollen node around clavicle area and was painful.
VIOLENTLY ILL FOR 3 DAYS AND ENDED UP IN THE ER; 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, start therapy date were not reported 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 an unspecified date, the patient experienced violently ill for 3 days and ended up in the er. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill for 3 days and ended up in the er was not reported. This report was non-serious.
This spontaneous report as received from a pharmacy technician refers to 13 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX lot # M035147 with expiry date: 25-OCT-2017 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 15 F to 46F (18.3F) for a duration of 7 hours and 45 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 6 F to 14 F (10.6F) for 1 hour and 15 minutes and 15F to 46F (19.2F) for 14 hours and 30 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1708USA009634:
DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included codeine allergy, and concurrent conditions included alcohol consumption, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included letrozole for drug used for unknown indication, enalapril for high blood pressure, and fluoxetine. On 23-APR-2021, the subject experienced dizziness. On 23-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and nausea. This report was non-serious.
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COPMLETION OF PRIMARY COVID VACCINE SERIES
Breakthrough case admission after 2 vaccines  Moderna 6/4/21 Lot# 041C21A;  Moderna 7/2/21 Lot#005C21A
INJECTION SITE PAIN (FOUR DAYS OF INTERMITTEN SITE PAIN) SWOLLEN AND PAINFUL ARMPIT LYMPH NODES (STILL OCCURING AFTER 5 DAYS)
pt recv vax & w/in 4 days devel an inj site rxn characterized by swelling, redness, warmth, & itching;tx w/APAP;
Patient has longstanding Yaz OCP use (over 10 years), no nicotine usage or other medications that can cause DVTs.  Patient had received the vaccine about 3 weeks earlier; had been on a 4-hour flight and subsequently developed a DVT in the right calf.  Patient reports having been on much longer flights before with no complications.  No personal or family history of hypercoagulability.
I was lightheaded and my blood pressure was really high, 200/120. It happened on April 10th and 11th, 2023. I went to the emergency department. I was in the emergency department for about 3 hours and was not treated with anything other than rest. My blood pressure came down on its own and I was discharged.
Left arm tingling from the upper arm to the hands an fingers; Trouble breathing; Asthmatic Cough; bronchoconstriction; tightness in her chest; Arms, hands and fingers turned purple; Arms were useless; Flu-like symptoms; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction) and CHEST DISCOMFORT (tightness in her chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness). At the time of the report, PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness) outcome was unknown.        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.   Treatment medications were not reported.
Patient received a Vaccine 6/18/21 MODERNA, then came to and received a 2nd dose of PFIZER on 10/07/2021. Patient had no ASE's.
About a week after receiving my second Moderna Covid shot I felt shortness of breath.  9 days after the shot I had a mild fever (100.5f), severe shortness of breath and chest pain (level 5+) and went to the emergency room.  They found D/Dima was elevated and sent me for a CT scan.  This showed a significant blood clot in the right lung and a lesser clot in the left.   I am usually extremly health, walking 2 miles at least 5 days a week and bicycing about 50 miles per week
Rec'd vaccines listed, syncope, awoke so pale, dyphoretic, posturing, hyperventilating, hypotensive (70/50), given Benadryl 50mg IM-recovered with BP 114/70, alert, able to sit up, walk-sent via ambulance to ER. F/u with ER diagnosis vagal response-discharged home.
Nine days after the vaccine I have redness in my left arm  that starts at the site of the vaccine injection and grows larger  (3 inches wide) going down the top part of my arm and stops an inch and a half  before my forearm.  I received the first dose of Covid-19 Vaccine.
Migraine, heart palpitations, flushing, boiling hot, insomnia, redness and swelling at injection site, nausea, exhaustion.
Breakthrough case admission after 3 vaccines Moderna 2/22/21 Lot# 023M20A;  Moderna 3/30/21 Lot# 030A21A;   Moderna 12/7/21 Lot# 045J21A
10/3/06, Brief exam dx'd with varicella. Erythematous papules with fluid filled centers 50-75 lesions. Rx: Benadryl.
elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pain where shot was given, Redness where shot was given, Muscle pain. Feeling tired and weak, headache, shivering, upset stomach, I developed a sore on the roof of my mouth. I had pain in my left leg for a week. The sore on the roof of my mouth has finally healed after 4 weeks.
Patient had onset of chest tightness 8 minutes after vaccine. Felt kind of short of breath. He admits anxiety. he was not observed to be short of breath by nursing personnel. This resolved spontaneously after 10 minutes. Blood pressure was 166/82 pulse 71, resp 20 and pulse ox 97%.
Patient's mom stated that patient cried for "hours on end" after received Hib and PCV13.
89 y/o M with PHM of HTN, CAD, cardiomyopathy, HFrEF (EF 30%), Right Lobe thyroid nodule / L lobe cyst (declined biopsy), subclinical Hyperthyroidism, A fib, TIA, remote h/o PUD (bleeding ulcer s/p pyloroplasty and vagotomy 1999), internal hemorrhoids, spinal stenosis of lumbar region, HLD, asbestosis, BPH, anemia, goiter, osteoporosis, vitamin D deficiency, who underwent Right Hip Intertrochanteric ORIF on 6/11/20 s/p R hip fracture on 5/28/20 and was admitted to nursing home for SAR on 6/25/20.Patient reported weakness and loss of appetite on 12/29/20 18:36 s/p COVID- 19 vaccine received on 12/28 @13:09. Patient is being monitored.
Pain, swelling, itchiness, fever, migraine, dots in vision, lack of appetite, nausea, lost in balance, chest pain, cough, difficulty breathing at times, lots of mucus and post nasal drip.
Eight days after innoculation, itchy, red, warm rash developed just distal to injection site. Rash about 3" by 2". About the same the next day, except not too itchy, and by the third day resolving rash and some warmth only (Jan. 23).
3 hrs p/receiving vax pt turned blue & had a sz according to mom; taken to hosp ER; infected LR/TM w/o bulge noted; t104, WBC 30,000, neg UA, neg CXR; spinal tap done;
After receiving my 2nd shot of the Shingles vaccine, I got the shingles rash on the right T5 dermatome and extends under my right arm and across the right side of my chest.  I still have the virus as of 09/23/2019
Myalgia, Arthralgia, Tachycardia, Fatigue, numbness arms and hands; O2 Sat 94% Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, the patient was administered ZOSTAVAX, (lot# and route unknown) at a pharmacy. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-OCT-2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Information has been received from a physician concerning his adult daughter with no drug allergies, who on 01-JAN-2008 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 01-JAN-2008, the patient developed redness, pain, local heat, weakness and nausea a short time after being vaccinated. The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Hives, raised and red.  Slight itching.  Lasted for about 2-3 days.  Patient did not seek treatment. Takes daily anti-histamine (Zyrtec) which seemed to help.
Patient called about 2 hours after Fluzone HD was given. Said he thought he was having an adverse effect after the vaccine. Said he had right sided leg weakness. He does have trouble walking normally and uses a cane but usually it is his left leg. Said he was leaving the store after shopping around for a bit after the shot and though his right leg was weaker than normal.  He was just relaxing and asked what he should do.  Told him to rest for a bit and call back in an hour or so to let me know if there was any improvement or if it got worse. He never called back.  I reached out to him around 4pm and left a message for him to call me back as I was checking on him and no response. Followed up the following day at 3:30 and still not able to reach him.
I get headaches almost everyday; Fatigue; Hard time sleeping at night; Diarrhea 3 to 4 times a week; Sore jaw; Coughing; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: er8733) via an unspecified route of administration in left arm on 08Apr2021 at 08:30 (at the age of 70 years-old) as dose 2, single for COVID-19 immunization in other facility. Patient medical history included high blood pressure. The concomitant medications included ramipril, hydrochlorothiazide, amlodipine, omeprazole all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin [benzylpenicillin] and experienced drug hypersensitivity (Known allergies: penicillin). Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number: en6207) via an unspecified route of administration in right arm on 18Mar2021 at 08:30 as dose 1, single for COVID-19 immunization in other facility. No other vaccines in four weeks reported. The patient experienced, he gets headaches almost every day, fatigue, hard time sleeping at night, diarrhea 3 to 4 times a week, sore jaw, coughing on 16Apr2021 at 08:00. It was unknown that, the patient had covid prior vaccination and post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a certified medical assistant referring to a 58 patients of an unknown ages and genders. The concurrent conditions and medical histories were not provided. Between 01-NOV-2015 through 10-DEC-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (route and dose were not provided) lot # L025205, expiration date: 07-JUL-2017 and lot # L016127, expiration date: 10-DEC-2015. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. Additional information has been requested.