chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired, after vaccine; This is a spontaneous report from a contactable consumer (patient's daughter from a Pfizer sponsored program. A female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tired, after vaccine on an unspecified date. Caller reported that her parents, were tired, after the vaccine for Covid. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021431971 Same reporter/diff patient
flu-type symptoms for 2 weeks ( exhaustion, vomiting, headache, loss of appetite, fever- accompanied w pain in left arm around the injection site, Today the pain can escalate  to a 8 out of 10, off and on during the day and will wake her at night.
On the day of administration , the Moderna vaccine was past its 30 days of refrigeration. We reached out to the manufacturer and they responded with the following, "Thank you for your patience. Analysis of the vials associated with your storage excursion is complete. The vaccine administered on February 14, 2022, February 15, 2022, February 16, 2022, February 18, 2022, and February 21, 2022 from lot number 042J21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-MAR-2016, the patient was vaccinated an improperly stored dose of ROTATEQ (lot # M002252, expiration date 28-FEB-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses of ROTATEQ was improperly stored in a temperature of -1.4 C, the time frame was 1 hour. There was no previous temperature excursion reported. The vaccines involved included ROTATEQ (lot # L027070 (exp 30-APR-2017) and (Lot # M002252, exp 28-FEB-2017). No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient was receiving the Moderna vaccine and jerked his arm. Medication was not administered and was wasted. Patient was not harmed or injured. Parent authorized re-administration. Fresh vaccine was drawn and administered without complications. Post vaccination, patient was monitored for 30 minutes without any adverse events/ complications.
ache; fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (ache), PYREXIA (fever) and CHILLS (chills) in an 18-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-353342.
Severely and ongoing swollen and painful armpit radiating down left arm and left breast and up left side of neck and shoulder.
Right after vaccine she thought she had 3 spider bites with 3 red dots, itchy on mid to R chest. Later developed vesicles. Rx antiviral for a week, ending today. Rash extended laterally and to upper R arm.
Presented to urgent care with chest pressure,  abdominal pain, and low back pain beginning last evening
The patient was given a routine booster shot at work on 08/10/2004.  The patient came back into the nurse on 08/12/2004 and complained of having fever, chills and sweats on 08/11/2004.  These symptoms had subsided but the patients arm was still a little sore.  The patient called the nurse again on 08/13/2004 and told her he ad to go to the ER with his arm.  It had swelling all the way down to the wrist.  The diagnosis at the ER was Cellulitis and the patient was treated with antibiotic, type unknown at this time.  The patient is to follow up with the nurse again in a few days. Follow up received by the manufacturer on 08/27/2004: The nurse said that she hadn't see the patient in over a week but last she saw him his arm was normal.  According to the nurse the patient was back at work and doing fine, the nurse did not know which antibiotic the patent was give for treatments and said the patient was not hospitalized at the time of his visit to the ER.
After the shot, I began to have mild joint pain. But instead of going away, the joint pain steadily increased and became moderate/severe throughout my whole body. In May, I decided that the pain was not going to go away on its own and made an appointment with my primary care physican. He presribed hydroxychloroquine.  In June, the joint pain began to subside.
This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 2 (orange cap), single (Lot number: FL8094, Expiration Date: 15Aug2022) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "Hemophilia" (ongoing), notes: Bruises Easily. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid 19 Vaccine for 5-11 year olds Orange Cap; First Dose; Lot: FL8095; Expiration Date: 31Aug2022; 59267105504), administration date: 06Jul2022, when the patient was 5-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Fever"; SOMNOLENCE (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Sleeping all day"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Aug2022, outcome "unknown" and all described as "received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap". Therapeutic measures were not taken as a result of product preparation error, overdose, somnolence, pyrexia.  Additional information: Nurse called to request revaccination guidance for Pfizer BioNTech covid-19 vaccine (orange top) administered undiluted. Nurse stated that a 5 year old male patient received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap as the first dose. Had an incident today where the Pfizer 5 to 11 years old was administered without dilution. Concerned, reporter stated, "I am calling because I work for (Institution name (State name) and I am calling because we had an incident today where the Pfizer 5 to 11 years old was administered without dilution and they were wondering if there is a procedure or protocol or what is the apology regarding the administration of Pfizer (COVID-19 Vaccine) without dilution." QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default (as reported). Upon recent follow-up, they had an incident yesterday and she called yesterday and reported it and spoke to someone in Medical, but she was informed by a colleague at (Facility name Withheld) that it was the patient's first vaccine, when it was actually his second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (04Aug2022 and 05Aug2022): This is a spontaneous follow-up report from same contactable Nurse. Updated information included: patient information (height, weight); medical history; historical vaccine; concomitant medication; suspect drug details (lot number and expiration date); event details (new events: Sleeping all day and Fever); and additional information. Additional information has been requested.
Rectal bleeding started 2 days after receiving "jab". 3-5 drops after going poop lasted approx 2 weeks after first noticing. Have not noticed any other bleeding. Scheduled appointment with doctor on 5/3/2021. Dr visually inspected rectum and observed no irregularities. Referred to Gastroenterology for consultation.
Beginning with  itching and redness near bicep on 8/27 and by the morning of 8/28, the rash had spread to the entire upper left arm, to the elbow bend. As on the evening of 8/31, the rash/itching had receded to around the injection site and part of the bicep.
Information has been received from a physician concerning a 11 year old male patient who was vaccinated with the first and second dose of MMR II on 18-NOV-1997 and on 20-JUL-2000. On 10-NOV-2009 the patient developed afebrile mumps. The patient was diagnosed on 30-NOV-2009. Parotitis counted 136. The outcome of the patient was not reported. Follow up information has been received. On 30-DEC-2009 the patient developed mumps and on 11-DEC-2009 the patient was diagnosed with mumps. The patient was afebrile and had right parotitis. On 31-DEC-2009 the first blood work was performed. IgM was <1:10 (normal range <1:10), IgG was 7.59 (normal range >1.10). At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Extreme swelling at injection site Extreme Itching at injection site Rash at injection site Pain and hard lump at injection site
Information has been received from a registered nurse concerning a 10-year-old male with a history of "NKAM", tracheo-oesophageal fistula, multiple congenital abnormalities, macrosomia and hydrocephalus who on 28-AUG-2007 was vaccinated subcutaneous in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658177/1012U). Concomitant vaccine administered on 28-AUG-2007 included a second intramuscular dose of Havrix (lot # AHAVB18ZAA) administered in the left arm. On 30-AUG-2007, the patient developed a red, swollen painful local at injection site (duration 24-48 hours) that was treat with a cool compress and ibuprofen (manufacturer unknown). On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Terrible swelling at injection site (like a softball) with horrific pain in the muscle and shoulder joint!  Red, patchy rash covering almost entire upper arm from elbow to shoulder joint!
dizziness,  head pain, brain fog, shortness of breath, high blood pressure, feeling of fainting, chest pain
10 days after my booster I ended up in the hospital for five days with an previously unknown heart condition requiring two stents.   My cholesterol levels were all in the green and other than being overweight had no red flags for the condition.
High blood pressure since they got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (since they got the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED. At the time of the report, BLOOD PRESSURE INCREASED (since they got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-131922 (Patient Link).
On 5/10/01, AM vaccinated. In the PM, had swelling deltoid, achy, sleepiness. On 5/11/01, AM, swelling shoulder to elbow, red deltoid, arm "achy" PM. Area on right at 1st injection reddened and swollen, deltoid region. On 5/12/01, arm swollen decreased into hand. Warm compresses applied and took Benadryl and Advil. On 5/13/01, both arms, "itching", lasting until Thursday. Raised areas on both arms at injection site until then, too.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (oesophageal), Lisinopril- HCTZ for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol blood excessive, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, GABAPENTIN (NEURONTIN) for Restless leg syndrome, TRAZODONE for Sleep decreased, BUPROPION HYDROCHLORIDE (WELLBUTRIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), METOPROLOL SUCCINATE (TOPROL XL), Tumeric, FENOFIBRATE, MULTIVITAMINS & MINERALS PLUS LUTEIN and CALCIUM for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue) and INSOMNIA (I could not sleep). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot). On 11-Apr-2021, ILLNESS (I felt sick) had resolved. At the time of the report, VACCINATION SITE PAIN (Upper left arm started to hurt very badly), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue), INSOMNIA (I could not sleep), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information include Tylenol extra strength.
Severe headaches, (pustules) impetigo on left chest lasted approximately 10days before it began to heal Treated extreme itching at home with eczema cream/cortisone cream , then covered with large sterile  gauze and bandages (only cetaphil cream soap fragrance free for shower but not touching the pustules) .  I experienced this condition only once in my lifetime after traveling with open acne sores that my hands were always touching, and using public facilities that had not been cleaned and disinfected . I recognized this condition without seeing my doctor
Pt got cellulitis pt came in and said she got cellulitis, pain, rash pt came 5:30pm 6/10/2018.
Not eating, losing weight, severe stomach pain, fever, the inflammation caused Crohn's disease. He has never had any symptoms prior to the vaccine.
Firs stop shot 3/27/2021, second 4/17/2021Lightheaded, accelerated INR of 4.7within 48 hrs. Of first shot.Low grade fever on and off sometimes accompanied wit chills. Increasing fatigue and leg weakness, eventually shortness of breath, pain in center of chest when breathing, couldn?t lay down due to pain in neck and chest, diagnosed with pericarditis May 31 2021. Out of work since may 28 2021
VERY dizzy/faint and it's getting worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (VERY dizzy/faint and it's getting worse) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (VERY dizzy/faint and it's getting worse). At the time of the report, DIZZINESS (VERY dizzy/faint and it's getting worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that the event they experienced was too bad to drive. No relevant concomitant medications were reported.  Treatment information was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No new information was provided.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient was asking could we take ibuprofen for the fever associated with the shingles shot. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
3/11 to 313 - Flu like symptons...no fever. Chills, aches and severe fatique 3/14 to present day - Vertigo - non stop dizziness, foggie vision
This report was received from the investigator of a trial on 06 May 2010. A 41 year-old male subject received the following vaccines on 29 July 2009: ACAM2000 (lot number not reported); TYPHIM VI (Lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and hepatitis B vaccine (other manufacturer, lot number not reported). One day after vaccination, the subject was diagnosed with cardiomyopathy. No additional information was provided and the outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study). List of documents held by sender: None.
pt recv vax & approx 4 to 5 months post vax pt exp a mild varicella-like rash w/10 lesions;No further details were provided;
pt recv vax 22AUG96 & 24AUG96 exp a allergic skin rxn in the form of gen hives;there was no fever, no resp distress, no nausea or vomiting, no diarrhea, & no h/a;seen by MD who prescribed DPH;
This spontaneous report was received from a Nurse Practitioner refers to a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2000, the patient was vaccinated with first dose of VARIVAX, (lot number, expiry date and dose not reported) for prophylaxis. On 12-DEC-2016, the patient was vaccinated with second dose of VARIVAX, (lot number, expiry date and dose not reported) for prophylaxis (inappropriate schedule of vaccine administration). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Hives, temp of 100.3. Dx with erythema multiforme on 11/18/13.
Redness, itching, small bump under skin at injection site, Dr told her it was infected gave Doxycycline.
arm is still really sore; Soreness, body aches; Fatigue, Fatigue (the typical that they had the first time); Headache, headache (the typical that they had the first time); Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still really sore), MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 004M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm is still really sore). 26-Oct-2021, the patient experienced MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches). At the time of the report, PAIN IN EXTREMITY (arm is still really sore) had not resolved and MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches) had resolved.      Concomitant medication was not provided.  Patient experienced fatigue, headache, the typical that they had the first time, and also soreness, body aches, joint aches, for 24 hours or maybe 48 hours.  Treatment information was not provided.
The pt received immunizations on 5/3/00 at 8:30 am. On 5/5/00 around 8:30 AM, the child's mother noted the left leg was swollen twice the size of the right leg. The left leg was hard with red streaks. Low grade fever was experienced. The mother took the child to see their MD. The child developed a rash around 3:30 PM on 5/5/00. Called mother on 5/8/00, the leg was still swollen but "softer now". Still has rash, some areas have scabs (? Varicella). Mother states some areas were blisters, child also had diarrhea.
Patient reported feeling dizzy and had 2 emesis Patient seen by medical team and vitals were stable Patient stated symptoms improved and refused medical transport and signed AMA form Patient stated having past history of similar reactions and having past syncopal episodes
Felt warm per paramedics, ER at hospital. Seizure Activity 11/25/04 6:00am S2 at home.
This spontaneous report was received from a consumer refers to an unspecified number of patients of 40 year old and unknown gender enrolled in a market research. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL (route, dosage, lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer informed that on an unknown date a physician was discussing patients he vaccinated with GARDASIL and said that he vaccinated 40 years old people, which was potentially off label usage. This is one of several reports received from the same reporter. Additional information has been requested.