chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning her 13 year old daughter who in approximately October 2006 was vaccinated intramuscularly in the upper deltoid of left arm with the first dose if Gardasil vaccine (yeast). On an unspecified date, the patient developed lots of pain and tenderness in her arm around the injection site for a few days after receiving Gardasil vaccine (yeast). The pharmacist reported that her daughter developed three swollen and tender lymph nodes on her left side of her neck. The lymph nodes were really swollen for about three weeks and the tenderness lasted for about two weeks. The pharmacist was planning to have her daughter vaccinated again with the second of Gardasil vaccine (yeast) some time around 25-Dec-2006. At the time of this report, the patient had recovered from the events "about three weeks after the first dose". Additional information has been requested.
Patient seemed unusually fussy and uncomfortable after the shots. He is nonverbal and is not able to tell us what was bothering him but kept crying. After about 30-40 minutes that the vaccine was administered, patient had two seizures that are unusual for him and that he had never had these type before. The next day, he developed redness and warmth at both of the injection sites. Two days after, he was taken to the ER because the redness spread on the whole thigh on one leg and a large lump formed on another one. Both sites were warm, red, and swollen. ER doctor diagnosed cellulitis and prescribed antibiotics. Patient continued to have seizures for two weeks after the administration of the vaccine. He had seizures a couple times a day which is also very unusual for him because he usually has one a week. He seems constantly in pain and holds on to his head and cries which is also new for him.
pt recv vax & approx 1 1/2hr later exp severe adverse inflammatory local rxn;no tx;
pt states felt gen soreness in upper lt arm area p/vax;states 17JAN98 pain extended into thumb & pointer finger of lt hand;numbing, cramping feeling started;diff grasp objects;fingers & lt hand swelled; 1/4" bruise inj site;
Dose number 3; Reports + covid today I do not have any other details; Reports + covid today I do not have any other details; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: FF2589) as dose 3 (booster), single, administration date 24Mar2021 at the age of 51 years (Lot number: EL3247) as dose 2, single and administration date 03Mar2021 at the age of 51 years (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and it was unknown if the patient was diagnosed with COVID-19 The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Dose number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "Reports + covid today I do not have any other details". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, Booster, covid19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
(R) upper arm, red swollen, "hot" to touch and extremely sensitive to touch - painful. The swollen site where Varicella given was about size of an orange and the redness extended from there to elbow.
Patient experienced redness of bilateral palms, hives starting at hands and moving up bilateral forearms, and numbness/tingling in left arm. No other symptoms
Thrush; Nausea; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CANDIDA INFECTION (Thrush), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CANDIDA INFECTION (Thrush), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, CANDIDA INFECTION (Thrush) outcome was unknown and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. Not Provided          No relevant concomitant medications were reported. Treatment information included medication to treat thrust. Action taken with mRNA-1273 in response to the events was not applicable. On 20-Mar-2021 the patient went to the ER and was diagnosed with thrush which had been going on for 3 and half weeks, and patient took medication for thrust treatment.She went to the Doctor and did lab culture and result was negative (showed no thrush).
COVID 19 after immunization; COVID 19 after immunization; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "recovering" and all described as "COVID 19 after immunization". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN, notes: Covid symptoms.Clinical course included anti viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 10May2022, treatment stop date 14May2022, indication Treatment of COVID-19. Adverse event Five days after completing five day course of paxlovid, Covid symptoms returned, mild fever, malaise, cough, congestion.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Pt. states that after he received the vaccine to his left deltoid on Monday his left deltoid felt sore for the first 2 days and was not unusual for him since he has had similar symptoms after a flu shot in the past and symptoms seemed to improve by Thursday but then on Saturday noticed pain when moving his left  arm and shoulder a certain way (brushing his hair or lifting up his left arm to shoulder height). Pain is felt in the left deltoid area and is described as mild. Pt. denies any bruising, swelling, redness, rashes or warmth at the flu shot site after the vaccine. Denies left extremity weakness, numbness or tingling, loss of sensation. Denies any tenderness at the left deltoid and only feels it when he raises his arm. Denies decrease in mobility or crepitus. Has not tried to self treat. Denies recent injury or fall. Does work out daily but the last time he did was last Friday (chest press, rope pull, dead lifts) and has not since. Pt. not sure if this is related to the flu vaccine but wanted to report and come in for evaluation. Pt. evaluated in clinic. Active mild pain with motion only of left arm in the deltoid region and with otherwise full ROM. Left deltoid muscle non-tender with no palpable hematoma or visible ecchymosis, no edema, warmth, rashes or shoulder joint tenderness. Skin intact. Strength 5/5 in upper extremities b/l. Hand grips equal and strong b/l. Neurovascular intact. Advised to try ice, Aleve 1 tab PO BID with food for a week and activity as tolerated but avoid left arm/shoulder strain and activities that cause pain or overuse. Maintain ROM. Follow up scheduled for next week.
25 mins post vaccine outer rim of Left ear became warm, itchy and turned red for approx 1 1/2 in in length. Redness continued to spread toward inner part of ear for about 30  more mins.   Woke with redness on 2/4.   I applied topical Benadryl on 2/4 and 2/5.  Redness resolved on 2/6. Other sides effects on 2/3:  soreness at injection site, chills during night and difficulty sleeping.  Took 1 Tylenol at 5:30 pm and 1 at 11:59 pm.      Side effects on 2/4 : low grade fever (99.2 - 2+ degrees for me), fatigue, general feeling of un-wellness.   All resolved by 2/5 except red ear, and fatigue which continues mildly today 2/7.
Mother reports to RN as follows: 45 minutes post injection c/o headache. 5 hrs post injection c/o itching on face. Noted pinpoint rash (raised) over chest, arms & face which resolved by next day. No fever. No observable local reaction. Advise have MD administer next dose. Did not consult provider after injection.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body and it is getting worse) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 004M20A and 026L20A) for COVID-19 vaccination. No medical history were provided by the reporter. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced URTICARIA (hives all over her body and it is getting worse). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at a dose of 25 milligram and FAMOTIDINE for Adverse event, at a dose of 40 milligram. At the time of the report, URTICARIA (hives all over her body and it is getting worse) had not resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No medical history was reported. No concomitant medication was reported.  This case was linked to MOD-2021-404816, MOD-2021-404817 (Patient Link).
Low grade fever; fast heart rate; she sweated so much; she has body aches still; This is a spontaneous report from a contactable nurse (patient). This 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/lot number: EH9899) via an unspecified route of administration on 20Dec2020 10:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient took COVID vaccine because she was exposure in hospital. Patient said she experienced reaction from the first dose of COVID vaccine. The patient got the first dose of vaccine by injection once on 20Dec2020, later clarified as COVID vaccine, and overnight she had a low grade fever on 20Dec2020, and she checked her heart rate from her Watch, and it said 108 to like low 100s, stated not her usual resting heart rate, and she woke at 4AM and felt a fast heartbeat, other than that, she thought it was from fever. Low grade fever was right before going to bed around 10PM: she had body aches, headache, she was not feeling well, she was very hot, At 4AM, she thought to sleep it off, as her whole body ached, and she couldn't really move, and she looked at her Watch to check and her heart rate was 103 resting, and she didn't take her temperature again, but she sweated so much, and she turned down the temperature and as of today, she has body aches still, and a little bit of fast heart rate. Outcome of the events was unknown. Reporter seriousness for Low grade fever and fast heart rate was medically significant. Primary Source Reporter assessed Low grade fever and fast heart rate related by Method.; Sender's Comments: A causal association between BNT162B2 and the events pyrexia and heart rate increased cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Member informed MDG via telephone with complaints of swelling, redness to posterior upper extremity arm, hot to touch, area growing larger.
Administered vaccine and within 10 minutes patient fainted. BP was 86/43 and HR was 51 after a few minutes when patient came to. Very flushed, shaking. EMS visited her, her BP was still low 10 minutes after I took the measurement.
Information has been received from a consumer that read an article "maybe last summer" concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown) and she was "messed up". The consumer did not remember what specific adverse effects the patient experienced but the patient could no longer work. At time of this report the patient outcome was unknown. Mess up/adverse event was considered to be disabling. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.
Swollen raised area right deltoid area, sl warm, central swollen area raised, red, peripherally upper arm swollen
Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died.
Seenin ER yesterday for severe pain and swelling. Pain moving across neck and collar bone (right arm). Pt stated given IV. BENADRYL and pain meds. Seen in our office 6/1/13 pt in agony crying. Cries with touch, decreased movement. Treatment hydrocodone/APAP 5/500mg x3 days, then 2 tab x3 days, then 1 tab x3 days.
arm sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm sore at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (arm sore at injection site). At the time of the report, INJECTION SITE PAIN (arm sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-407544 (Patient Link).
shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 21-MAY-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the patient to be vaccinated. Alternatively, on or about 21-MAY-2014, the patient's pharmacist at the pharmacy, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine and believed that it was effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sleeping, and started vomiting and shivering. Checked temp, and gave a warm shower. Went back to sleep and vomited again. Gave a small cup of water, went back to sleep and vomited again at 8 am.
It was reported that a 26 year old female received a Rabies Imovax IM vax on 1-12-2000. Reportedly that same day the pt developed a fever, chills, joint aches, headache and fatigue that lasted for 12 hours. As of 1-13-2000, pt only experienced residual fatigue; Tylenol was given as treatment. The pt reportedly recovered from this experience.
Fever.  (Also, muscle soreness at site of injection.) [ caused to miss a day of work ]
My right arm hurt really bad for a month, then it got somewhat better, but it has hurt for almost a year.
Patient received a J&J dose even after getting a full Pfizer 2 doses. Patient is fine, reporting because of DSHS requirement
Admin error. Vials that were left out too long, were administered to two patients. No patient have contacted us about an adverse event at this time.
This spontaneous report was received from a healthcare worker and refers to a female patient of unknown age. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. In 2013 (exact date not reported), the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiration date, route of administration and indication were not reported). On 20-JUL-2015 (reported as "today"), the patient was in the office to receive her second dose of GARDASIL. No adverse effects were reported. It was reported that therapy with GARDASIL was not discontinued. Additional information has been requested.
About four months after receiving my third dose of the Covid vaccine, Pfizer, I started bleeding out my nipple which turned out to be a crystal in my breast. I went to see my GYN and they sent me for a diagnostic mammogram. They thought it was just debris and to get monitored again in six months. My doctor didn't like their answer, so he sent me for an MRI and that is where they noticed something. I was sent to for a biopsy and a breast specialist. That is where they found the breast cancer. It was located deep in the center of my breast. They looked at the mammogram again and they were able to locate it. I did not need chemo, but I did have a lumpectomy and then four weeks of daily radiation. Now, I have to take hormone pills, Tamoxifen, for the next 5 years. I did get another vaccine after.
"52 Y O male presents with fever, night sweats, headache 7/10, cough, decreased exercise tolerance, numbness/tingling to left arm, back pain, joint stiffness, neck stiffness, muscle pain/weakness. He received the 2nd dose of covid vaccine yesterday. Injection site is very sore to the touch and warm."
uveitis/iritis; uveitis/iritis; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 16:00 (Batch/Lot Number: FC3183) at the age of 42-years-old as dose 1, single for covid-19 immunisation. Medical history included diabetes insipidus, central hypothyroidism, pituitary brain tumor, sleep apnea, trigeminal neuralgia, ovian cysts, growth hormone deficiency and glucose intolerance. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug hypersensitivity, sulfamethoxazole and experienced drug hypersensitivity, cephalexin hydrochloride and experienced drug hypersensitivity. On 01Sep2021, the patient experienced intense pain in the left eye, when exposed to light her left eye felt like it was being stabbed with a knife, her eye also looked almost like blood shot and the white part of her eye looked pinkish. The doctor diagnosed her with uveitis/iritis. The patient received steroid eye drops as treatment. The outcome of the event was recovering.  Follow-up (27Sep2021): Follow-up attempts are completed. No further information is expected.
I was called by the vaccination RN to the station where she had just administered a Moderna, 2nd booster vaccine to patient. His arm immediately swelled up to the size of a silver dollar.  I immediately applied an ice pack to the right arm and made an encircling make around the swelling.  Pt stated he had had no prior incidences with his other vaccines.  Pt also said he had Covid 19 in January, 2022.  Pt was walked over to the paramedic station where vital signs were taken, B/P - 140/90,  heart rate 72, O2 saturation 96%. Pt. was observed for 30 minutes by paramedics.  Oral benadryl (25 mg) administered .  Pt was very stable, sitting in a chair and  paramedics retook VS, B/P - 136/90, HR - 64, O2 sat 96
Patient developed extreme arm pain, heat, swelling in arm that radiated to fingers - developed cellulitis that required antibiotic given on 03/07/18.
The injection site developed a large bruise. Then a few days later the injection site and the 1-1.5 inches around the site became red, inflamed/swollen, hard to the touch and painful.
Severe headache in upper right side of head with light and sound sensitivity followed by a shingles outbreak on right side of face and head.
10 minutes, post vax, pt complained of dizziness and feeling faint. Several hours later, she began vomiting, which continued for about 12 hours. Dizziness and faintness lasted about 24 hours.