chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red blotchy red marks on my arm that are itchy; injection site got red and itchy; injection site got red and itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Red blotchy red marks on my arm that are itchy), VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN, METOPROLOL, AMLODIPINE and VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and itchy). On 14-Jan-2021, the patient experienced RASH PRURITIC (Red blotchy red marks on my arm that are itchy). At the time of the report, RASH PRURITIC (Red blotchy red marks on my arm that are itchy), VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and itchy) 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 included Benadryl and ice.   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.; 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.
Injection site became very red, swollen, and hot. I ran a slight fever also, this lasted for 1 week. I just took Tylenol
Significant increase in severity of asthma in the months following vaccination.  Concurrent increase in the frequency of use of albuterol inhaler from weekly to daily. The asthma is not exercise-induced. The asthma does not appear directly related to pollen counts.
tendonitis on the arm; This is a spontaneous report received from a contactable consumer (patient), from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication included cyanocobalamin (B12-SHOTS) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, after vaccination, the patient experienced tendonitis on the arm. Therapeutic measures were taken as result of event included, patient's doctor prescribed a steroid shot. It was reported that, the patient received the 1st dose a week ago (at the time of report). She was asking if it was ok to proceed with the 2nd dose of the vaccine. Patient was about to receive 3 of the B12 shots. Once in a month for 3 months. She already had the 1 of 3 of the B12. The patient will have these shots in between the vaccine. Patient was asking if she should wait to have B12 before or after the vaccine. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-APR-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot# not reported). No concomitant medications reported. On an unknown date of August-2014 the patient is currently in the office for her second dose of vaccine, which was inappropriate schedule of vaccine administration. No adverse effects were reported. Additional information has been requested.
Pt. became weak and pale hours after receiving vaccine. Pt had ER visit & discharged same day. Talked with pt 9-19-11 and he is doing fine.
Fever, chills, violent shaking, rapid heart rate, breathing difficulties.  Head and body aches.
vaccine inj site reaction on 1/10 after Moderna vaccine on 1/3 Welt at injection site, hot and itchy. expanded through out the 10th started at 1-2 inches and got to about 4 inches saw an MD and has been taking benedryl.  still swollen and red and warm but has improved.
Patient began severe headache with rght eye pain which lasted for three weeks and was misdiagnosed as  a sinus infection and migraine. Patient lost complete vision in right eye and was diagnosed with optic neuritis on 5/21/2014 and hospitalized.
Local redness, bruising on Right upper arm, swelling on legs/feet. No fever reported, no rash, no breathing issues, painful arm, unable to lift arm since days after vaccination.
Rash 15 days after shingle vac; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 15 days after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Nov-2022. Reporter's Comment:  The reporter stated that it was 3rd attempt to ask about a rash development 15 days after shingles vaccine. The follow up would not possible as no contact details were available.
Nausea Vomiting hot flashes and sweating Narrative: taken by car to the emergency room, event occurred on 1/12/21 and was reported on 1/12/21. System would not accept with out a change in date.
I had mostly respiratory symptoms; mostly coughing, runny nose, and congestion. I took a COVID-19 on 11/09/2022 which came back positive. I called my doctor, informed her, and prescribed Paxlovid. The first night, I had a pretty bad episode of coughing before taking the prescription so I used my inhaler prior to taking my dose. After about 3 days, I was feeling pretty good. By the 4th day, I started feeling symptomatic and knew I had COVID-19 again. The second round I just isolated especially since the symptoms were pretty worse the second time. I knew I couldn't receive a second prescription of Paxlovid so I just rested until making a full recovery.
(name) states that "they" got their first dose and then "they" got covid that week; (name) states that "they" got their first dose and then "they" got covid that week; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and another one patient (Husband). This is 1st of 2 reports. This female consumer reported that:  A female patient of an unspecified age received BNT162B2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number: unknown) as 1st, single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that they got their first dose and then they got covid that week.She called because they are trying to get a second dose but are a little nervous about how its gonna hit us. She states her parents both had moderna and they have been around them and her parents did not catch covid.The patient inquired that someone said it can wait up to six weeks and asked if that was true.The patient thinks they caught covid from her husband work ("they" presumably is referring to her and her husband) and that it has nothing to do with the vaccine.The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Menustral bleeding commenced; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 15:45(at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 18:45, the patient experienced intermenstrual bleeding. The patient reported about 3 hours after having the vaccine administered, menstrual bleeding commenced. The patient had a very regular cycle (every 28 days), and had her last cycle only 9 days ago. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event menstrual bleeding commenced was not recovered at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
The patient reported having severe chills and extreme shaking for several hours.  He states he fell asleep and was woken by cramping in his lower back.  The pain in his lower back did not subside until he got out of bed the next morning.
patient admitted to hospital with fever and confusion. confusion reported 2-3 before vaccine. pt discharged 10/19
immed p/vax pt began to cough;as mom held pt to recv vax MD noted 4 hives on pt back;pt cont to cough & devel nasal congestion;MD given DPh & hives resolved 20min later;next day pt devel fever of 100;seen by MD;
RASHES THAT BURN; RED ITCHY RASH; BURNING EYES; BUMPY RASH ON WHOLE BODY EXCEPT FOR FACE AND VACCINATION SITE; FELT VERY HOT ( LIKE HAD A FEVER); FELT TIRED; FELT A BIT QUEASY; MUSCLE ACHES; ACHES AND PAINS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, non-smoker, fibromyalgia, and allergic reactions to antidepressants, and other pre-existing medical conditions included patient had allergic reactions to antidepressants. the patient had no drug abuse or illicit drug usage. The patient experienced swelling of throat due to allergy when treated with erythromycin, and paroxetine hydrochloride.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included pregabalin for fibromyalgia, hydrochlorothiazide, and naproxen. On 16-MAY-2021, the subject experienced aches and pains. On 16-MAY-2021, the subject experienced felt tired. On 16-MAY-2021, the subject experienced felt a bit queasy. On 16-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, the subject experienced felt very hot ( like had a fever). On 19-MAY-2021, the subject experienced rashes that burn. On 19-MAY-2021, the subject experienced red itchy rash. On 19-MAY-2021, the subject experienced burning eyes. On 19-MAY-2021, the subject experienced bumpy rash on whole body except for face and vaccination site. The action taken with covid-19 vaccine  was not applicable. The patient recovered from aches and pains, felt tired, felt a bit queasy, and muscle aches on 16-MAY-2021, had not recovered from bumpy rash on whole body except for face and vaccination site, red itchy rash, rashes that burn, and burning eyes, and the outcome of felt very hot ( like had a fever) was not reported. This report was non-serious.
Initial report received on 30 November 2007 from a health care professional. A female patient (age unknown) had received an injection of FLUZONE SV 2007-2008, lot number unknown, and route and site of administration unknown, on an unknown date. Within one hour post-vaccination, the patient developed anxiety, nausea, and itching. The event did not require medical examination. The subject subsequently recovered. The reporter in this case is the same as in case 2007-04123. In that case events were reported following administration of Tubersol 5 TU.
This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) lot # L033692, expiration date 28-FEB-2017, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "tested positive for Covid/Covid symptoms as being mild; sore throat and feeling tired". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Received a report on 02Jul22 from a family friend that tested positive for Covid-19 15 days ago. He received his last Pfizer vaccine Apr2021. He reported his Covid symptoms as being mild; sore throat and feeling tired. Sore throat symptom subsided after the first day of taking Paxlovid. He also reported experiencing diarrhea while taking Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was vaccinated on 4/14/21 with 0.5ml of Moderna which is indicated as off label use in age 16-17YO.  Pt reported no adverse reaction or side effects after dose.  Pt will have second dose as recommended by Moderna at 28 days from first dose.
Area of redness, swelling that measures 10cm x  12cm on lateral aspect of the left upper arm; no other problem, Tx - antihistamine.
OFF LABEL USE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. 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, batch number: 180503, expiry: 30-DEC-2069) 1 ml, administered on 22-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced off label use. On 22-MAR-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Next day after second dose dark brown urine testing positive for blood now in emergency room being evaluated positive large blood urine awaiting bloodwork and ct scan
patient was given the vaccine at age 16 when minimum age for vaccine is recommended to be age 18. she had no adverse effects
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3247), on 19Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "diabetic neuropathy" (unspecified if ongoing); "restless leg syndrom" (unspecified if ongoing). Concomitant medication(s) included: INSULINA [INSULIN] taken for hypoglycaemia, start date: Apr1993; INSULIN N taken for hypoglycaemia, start date: Apr1993; METFORMIN, start date: Jan2003. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 28AUG98 & mom reported pt started to have a fever about MN;pt given APAP & started to throw up;pt unable to take more APAP;29AUG98 pt had sx x45seconds w/dec level of consciousness for 1 1/2hr;pt seen in ER;
Tiredness, chills, shaking, lightheadedness, reaction site pain (normal amount)
WATER IN EAR TYPE DIZZINESS; FLUSHING; WARM FEELING; CHILLS; TIREDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included geographic tongue, and concurrent conditions included steroids allergy, and body does not react well to foreign substances. The patient experienced geographic tongue when treated with levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced flushing. On 05-APR-2021, the subject experienced warm feeling. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021 15:00, the subject experienced water in ear type dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from water in ear type dizziness on 05-APR-2021 15:40, and flushing, warm feeling, chills, and tiredness on 07-APR-2021. This report was non-serious.
patient has had a headache since Monday; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient has had a headache since monday and wanted to take tylenol or mortin /headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the event(s) patient has had a headache since monday and wanted to take tylenol or mortin.  Treatment details included no  right now.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient has had a headache since monday and wanted to take tylenol or mortin was unknown.
Pt has received flu shots annually for years. This year's shot, FLUVIRIN, hurt much more and she had tingling and numbness down the arm that received the shot - left deltoid.
Joint pains and muscle aches in upper left shoulder and rear of left knee joint.  Shoulder pains on 1/28/2021 and knee joint pains on 1/30/2021.  Aches and pains appeared suddenly with no occurrence of stress or  injury. Had shoulder x-ray at urgent care center on 1/29/2021.  No tests on knee joint which occurred next day.   Urgent care referred me to emergency room for heart evaluation at which all tests were okay.
1)  Most significant reaction began 10 days after receiving vaccination.  Itchiness primarily on back & buttocks w/a little on arms, legs, and abdomen.  Red raised bumps appeared w/increased itchiness each day & continues to present (Day 4).  Took one Benadryl  on Day 4 w/slight but temporary relief.    2)  Additional reactions prior to outbreak of rash include:  a)  swollen lymph glands on right side of neck two days post vaccine lasting for two days. and b)  Left ear ache/pain on 4/28/21 lasting one day.
I?ve been having diarrhea vomiting headache muscle pain numbness in  feet I?ve been having heart palpitations high blood pressure lost of appetite I?ve been feeling a burning sensation all over my body I?ve developed depression anxiety as cause of this not to mention sinus ear problems as before this I was perfectly fine I wasn?t having issues at all until I got this vaccine
2 hrs after shot Roof of mouth and tongue became rough  the next morning fever up to 102 Chills down for the count  day 3 I woke up thought I had a swollen gland on left neck and developed blisters or sensitive bumps along  left side of tongue.  Today 3/4 gland back to normal bumps or blisters still there moving towards tip of tongue on left side
Terrible headache, ear ache, eye drooping, incredible jaw pain. Developed Bells palsy
In the office. Syncopal attack within 3 to 5 minutes after injection - then had a brief seizure. Tonic and clonic movement with LOC and loss of sphincter control (urinated) - lasted approximately equal to 5 to 10 minutes - regained consciousness.
Red rash  on all over body; Red rash on all over her body whic is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash  on all over body) and RASH PRURITIC (Red rash on all over her body whic is itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 decade. On 23-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash  on all over body) and RASH PRURITIC (Red rash on all over her body whic is itchy). At the time of the report, RASH ERYTHEMATOUS (Red rash  on all over body) and RASH PRURITIC (Red rash on all over her body whic is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.