chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracted Covid. Felt like I had a very bad cold. Maybe a fever the first night, body aches, cough, sore throat.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Shingrix for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 26th September 2018, the patient received Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 27th September 2018, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient reported that he he received the Shingrix vaccine as well as the flu shot a day before the reporting date. At the time of reporting, the patient experienced flu-like symptoms and fever.
looks like Condyloma or inflamed taste bud; m Redness at injection site; Tiny white spot that has grown under her tongue; Soreness of arm; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud), TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue), PAIN IN EXTREMITY (Soreness of arm), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (m Redness at injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (pyrexia). On 03-Feb-2021, the patient experienced TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue) and PAIN IN EXTREMITY (Soreness of arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (m Redness at injection site). On 05-Feb-2021, the patient experienced ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunization, at an unspecified dose and frequency. At the time of the report, ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud), TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue), PAIN IN EXTREMITY (Soreness of arm), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (m Redness at injection site) outcome was unknown.            No relevant concomitant medications were reported
No adverse event; Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine.  It was unknown if patient experienced any AE.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663474, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663507:Same reporter US-MODERNATX, INC.-MOD-2022-663474:Same reporter US-MODERNATX, INC.-MOD-2022-663502:Same reporter US-MODERNATX, INC.-MOD-2022-663552:Same reporter US-MODERNATX, INC.-MOD-2022-663563:Same reporter US-MODERNATX, INC.-MOD-2022-663577:Same reporter
She got her 1st shingrix 4/17/19 and she had no issues. She got her 2nd dose 7/20/19 at around 10 am and said later in the day she had arm soreness and an overall achy feeling. I told the patient that is fairly common with the shingles vaccine. She then said she woke up the next morning and felt better until she was out to lunch with friends and passed out. They ended up taking her to ER where they ran tests and saw signs that she may have had a small seizure. She said she had never had a seizure before. She did say several years ago she had a brain bleed but never had a seizure from that. She was taken to ER on 7/20/19 and is following up with neurologist. She wanted to let us know about the incident and she wasn't sure if getting the shingles shot had anything to do with it but wanted to inform us.
Patient was given SHINGRIX #2 on 11/12/2018, that evening she developed fever and chills and left arm was very sore and warm to the touch. She was seen in clinic on 11/14/2018 with possible cellulitis left upper arm. She was placed on KEFLEX.
Pt became weak, dizzy and diaphoretic after receiving injections - near syncopal episode. B/P decreased 86/50. Observed pt for 1/2 hr, gave her crackers and soda. She had not eaten much all day.
Fatigue, headache, joint pain, and muscle pain Symptoms not severe enough to seek medical attention. Just rested and took Tylenol for pains. Improved over the course of 2 days
This spontaneous report regarding a 77 years old female patient was received from the patient's daughter. The patient's medical history and concurrent conditions were not reported. On 02-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for prevention of shingles (dose number, lot number and expiration date were unknown). On the same date, she was also vaccinated with an unspecified influenza virus vaccine. Concomitant medications were not reported. On the same date, the patient developed a fever. At the time of reporting, the patient had recovered from the fever. The causality assessment between the fever and ZOSTAVAX was not provided. Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
07/27/2010 - Pt received pneumococcal vaccine - 07/28/2010:  C/o site redness 7/29/2010 - presented to office with left bicep redness/ swelling/ heat.  Instructed to ice area, monitor.
My husband who is also fully vaccinated, tested positive on 5/2 and I then tested positive 6 days later on 5/8 through an at home Covid test although I had no noticeable symptoms. I called my healthcare provider's office and spoke with the on call doctor who prescribed Plaxovid which I began that same day on 5/8. The only symptom that I think I had was moderate fatigue for two days but not even to the point that I had to miss a full day of work. After the 5 day Plaxovid regimen, I have been testing my self regularly with at home tests and they have all been negative. Yay science and yay Plaxovid and yay vaccines!
Reddened, warm, painful, itchy. Red, warm, very painful within 6 hours of vaccination. 2 days later still red, warm, itchy.
did not work; COVID-19; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered on an unspecified date at the age of (59-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got their first dose and 3 days later she came down with Covid. The patient came in like, couple of months later to get their second dose and then the doctor also said that the first dose does not count since they got covid. They were wondering if they should get the third dose as well, as they were saying first dose doesn't count.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Inflamed Lymph Nodes above collar bone on same side as vaccination.  Same thing happened last year.  Last year, CT scan with contrast showed inflammation but no problems.  I have not returned to the doctor this year, just notified them via phone.  Other lymph nodes around my neck are swollen now as well.
Immediately (5 minutes) tightness in throat, lightheaded, shaking.  2 hours out, chills, and sweats.
nausea, vomiting, light-headedness, dizziness, shakiness, inability to concentrate
Body aches and chilling started around 3:00 am on 2/18/21. They continued for about 12 hours. I took tylenol and slept most of the time.  During that evening , I then started feeling really hot.  I then sweat a lot when I slept.  All symptoms were gone the next day.
Patient woke up at one Am she was itching. She notice she was itching and noticed red spots. She took some medicine and went to the ER. When patient woke up on 7/12/21 her lip was swollen.  The rash comes randomly and flares up.
within 10 minutes of the injection, my vision blurred and I felt like I was going to faint.  the next day, I had severe anxiety attacks due to the overwhelming sensation of fainting.  I never lost consciousness or fainted, but I feel that I was very close to it.
17 YEAR OLD MINOR WAS ADMINISTERED VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced 17 year old minor was administered vaccine. On 12-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 17 year old minor was administered vaccine and off label use was not reported. This report was non-serious.
Symptoms I have felt is pain in the left arm. I have also felt fatigued and have had body aches.
Intense bitter strange taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 12:00 (Lot number: EW0179) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: phenergan, compazine, vistaril" (unspecified if ongoing), notes: Known allergies: phenergan, compazine, vistaril. Concomitant medication(s) included: PREVACID; DOXYCYCLINE; ALPRAZOLAM; BUPROPION. Vaccination history included: Bnt162b2 (lot number=ER8733, administration time=04:00 PM,, dose number 1), administration date: 26Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 17May2021 13:00, outcome "not recovered", described as "Intense bitter strange taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received no treatment for ae. Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from registered nurse referring to a 50 year old female patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant medications. The reporter informed that an unspecified date (reported as "years ago"), the patient had negative titers (no further details provided) and for that reason on 29-JAN-2018, the patient was vaccinated with VARIVAX lot number: N021581 (expiration date: 09-AUG-2019), for prophylaxis (strength, route and dosage schedule were not reported). In January 2018, after receiving VARIVAX, the patient experienced a red and warm bump induration, with no blisters (induration). The patient did not seek medical attention and no treatment was given for the adverse event. The outcome of induration was reported as recovering. Causality assessment was not provided.
Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil vaccine and developed herpes. The patient recovered from herpes. Additional information has been requested.
Following the vaccine had a slight itch starting on Saturday, red bumpy rash around the vaccine site.  Not a bad itch, but feels good once it's scratched.  Still has the rash today, 3/8/21, and feels as if it is worse today.  Has not taken anything for the symptoms or called her doctor.
coughing, short of breath, vomited x 1 - pt given 0.3mg of epinephrine  was given VS 152/87 HR 50 and pulse ox 87% - pt developed tremulousness and chest pain following epinephrine injection.  ambulance was called and was transported to ED
This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (strength, unit and frequency not reported, oral route, lot # L010126 with Exp. date 22-JAN-2017 and lot # L026741 with Exp. date 18-MAY-2017). Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact the physician.
Rash about 1 inch in diameter appeared on left arm at injection site on day 8 after injection. Itchiness, swelling, and redness. Lasted one day.
Sore arm at site of vaccine, body aches, headache, nausea, fever, chills , muscle soreness
Mouth started tingling within 15 min of receiving the shot. Was extremely tired within an hour, slept all day until following morning. I woke up with neck pain, headache, tension and pain behind left ear. Pain got worse as the day passed. Following day the pain was unbearable and I went to the hospital. They provided medication for pain and antibiotics in case of infection. Medication was not working and pain progressively got worse. A day after going to the hospital the numbing in my mouth got worse and progressed to the entire left side of my head. By the evening , the left side of my face started dropping, at which time I went to the hospital again. The physician at the hospital advised I had Bell?s palsy and gave me pain medication, which did not work. The following day I saw my personal physician and he provided me with prescription medication for pain and relief of Bell?s palsy.
It was reported that an 18 month old female received vaccines on 10/18/99. Then the pt's "arm (was) warm and swollen". This lasted for 2 days. The pt has recovered. Correspondence was returned on 11/22/99, as having been reviewed with no additional information. From mailed correspondence received on 07/23/01, it was reported that the patient recovered from this experience. No further information available regarding this patient or this case" This case is closed.
Marked swelling, erythema, tenderness and moderate induration appearing within 24 hours of administration. Symptoms resolved within 72 of onset.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4526929-00. A 12-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown), in Nov2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Bloody stool"; DRUG LEVEL DECREASED (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: Drug level: Humira levels were on the low end of normal, notes: Humira levels were on the low end of normal. The action taken for adalimumab was unknown and BNT162b2 was not applicable. The reporter's assessment of the causal relationship of "bloody stool" and "drug level decreased" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "fever" related to BNT162b2. Clinical course: Solicited report by a consumer of an adolescent male with events of non-serious Humira levels were on the low end of normal, Bloody Stools and Fever with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Humira levels were on the low end of normal, Bloody Stools and Fever. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if she was enrolled in a Covid 19 vaccine trial. Primary reporters contact for lot number information was unsuccessful. Follow-up attempts are completed. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events bloody stool, drug level decreased and fever Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
injection site still hot; injection site still red; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2OT) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) 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.   Concomitant medication included unspecified blood pressure medication.  Treatment medication included Tylenol.
High fever (101.8 and rising stopped by medication) and chills lasting 12 hours) headache, extreme fatigue lasting several days (5+ And not resolved yet), diarrhea lasting 2 days, sore arm   Ibuprofen helped fever
Information has been received from a medical assistant concerning a female patient who on unspecified dates was vaccinated with 2 doses of MMR II (lot number not reported) but still had low titers to rubella. Medical attention was sought via office visit. It was unknown if there were lab studies performed. The medical assistant stated that the patient was a new patient to their office. Additional information has been requested.
Stiff anterior, posterior Deltoid, and supraspinatus muscles, very tender, and painful, unable to lift arm. Seen again 10/19/2015, and large ecchymosis of ant. deltoid, softer muscles.