chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHE WAS STILL IN BED; USES A WALKER TO GET AROUND; BLOTCHY SKIN/VITILIGO; DARKENING OF SKIN/DISCOLORATION OF SKIN; SKIN STARTED TANNING; COUGHED UP BLOOD CLOT; FELT SOMETHING TICKLING; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 240 pounds, and height was 60 inches. The patient's concurrent conditions included: alcohol non user, non smoker, penicillin allergy, erythromycin allergy, sulfa allergy, hypertension, fungus flare up, and pain, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam for drug used for unknown indication, melatonin for drug used for unknown indication, paracetamol for drug used for unknown indication, tizanidine for drug used for unknown indication, vitamins nos for drug used for unknown indication, ketoconazole for fungal infection, enalapril for hypertension, furosemide for hypertension, and tramadol for pain.  On MAR-2021, the patient experienced coughed up blood clot. On MAR-2021, the patient experienced felt something tickling. On MAY-2021, the patient experienced blotchy skin/vitiligo. On MAY-2021, the patient experienced darkening of skin/discoloration of skin. On MAY-2021, the patient experienced skin started tanning. On an unspecified date, the patient experienced she was still in bed, and uses a walker to get around. Laboratory data (dates unspecified) included: ACTH stimulation test (NR: not provided) Unknown, Antibody test (NR: not provided) Unknown, and Liver function test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from darkening of skin/discoloration of skin, skin started tanning, blotchy skin/vitiligo, and she was still in bed, and the outcome of coughed up blood clot, felt something tickling and uses a walker to get around was not reported. This report was non-serious.
He got his vaccine and also got his high dose flu and pneumonia vaccine at the same time.  He had no reaction except feeling warmth like stream down his arm.  He went to work afterwards and stayed until 10:00 PM and had no issues.  He woke up the next morning, the arm was aching like normal, was fatigued, in pain with his neck and head, which he thought was a sinus problem.  He had some itching as well.  Then other things started happening, he felt like there was electricity coming of them, tingling.  He also felt like he had an ice pick stuck in the middle of his head between his eyes, and had difficulty swallowing, feeling like esophagus is tight, tightness in chest.  Is shaking all of the time, he is unsteady and stumbled and broke his foot.  He is also having pain in his joints, heavy leg syndrome, vision problems, had cataracts removed and now has worse vision than he ever had before.  He suffers now from depression and anxiety since getting the vaccine.  He now sees a psychiatrist and a neurologist.  He was then diagnosed with possible TMJ problems, went to doctor, had a CAT scan and cone scan, and did not see problems with his jaw other than bruxism.  He also has some other problems happening, and his neurologist said he did not have TMJ.  His neurologist believes his problems could be related to the vaccine as he did not have those problems prior.  He now takes Zoloft, Xanax, Divaleroex-ER 250 mg 2 every night at bedtime to sleep. She wants to some type of new therapy to help him, but there are a lot of side effects and will FU with her to see what the next step could be.    He has now not worked since 10/25/2021, and he was slowly phased out of his position and having his title/computer and other company property changed.   He is now on a leave of absence after being on short term disability.  He does not see any improvement and is trying to get on disability due to this condition.  He has worked for the company for 18 years.   He was on short term disability, now on leave of absence and trying to get on permanent disability.    He continues to have pain in his head, temples, and other parts of his body.  Was put on medications by the doctor, students and they gave him muscle relaxers and anti-inflammatories which did help some.   He has internal shaking all over his body, vibration like sensation all the time.   His hands also shake if he tries to hold something.  It is hard for him to do anything.  His vision also seems to be worsening.    He is now struggling and cannot work due to his current condition.
Entire body itching, no hives or rash; This is a spontaneous report from a contactable consumer (patient). As 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 29Mar2021 at 11:00 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 30Mar2021 at 12:00 the patient experienced entire body itching, no hives or rash. The patient did not receive any treatment for the event. The outcome of entire body itching was not recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mom reports that once he received the injections he stopped talking and went back to jabbering.  The patient developed shingles in August from the injections then the speech delay occured.  Patient was given acyclovir and keflex. He was then sent to first steps which reported that 18 mo level for self help, social and fine motor skills, 17 mo for gross motor, 16 mo for cognitive skills, 13 mo for language skills.
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Medium
Severe throat tightness that lasted for 12 hours before resolving. Follow up appointment scheduled with primary care physician to address before second dose.
Fever; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EN6198) at the age of 65 years as dose 1, single and intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches".  Additional information: No concomitant drugs, Patients medical history (including any illness at time of vaccination), Relevant tests noted. Specific relevant test for thromboembolic events with thrombocytopenia was found. Unspecified information provided as Adverse events with Onset date: 03Nov2021, Seriousness Criteria; Persistent/Significant disability/Incapacity, Important medical event, AE Outcome: Recovering, Treatment: No and Onset date: 01Nov2021, Seriousness Criteria: Important medical event, AE Outcome: Recovered, Treatment: No. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
MALAISE, EXTREME FATIGUE, JOINT/MUSCLE /WHOLE BODY ACHES, HEADACHE AND INJECTION SITE HAS SWELLING AND PAIN. PATIENT HAD NO FEVER BUT CAN'T SLEEP FIRST NIGHT HE HAD THE SHOT BECAUSE OF PAIN.
Pt states he rcvd vaccine on 1/8/00. 48 hours post vax pt experienced severe dry cough, progressing to fever, chills, spasmodic dry cough, burning in chest, heartburn.  Pt was out of work for 5 days. Presently has an intermittent dry cough and is afebrile.
pt had radiating pain from middle of left arm up to spine the first night following dose.  for the last 3 months, pt has reported having a coming and going pulsating pain around middle of left upper arm.  Pain is described to be more common in the morning upon wakening but distinctly different from her typical arthritis pain.  She has not seeked medical attention at this time
During annual physical exam, doctor's assistant administered pneumonia booster (original was 2001) to deltoid area (L) arm. Approximately 3 hours later & for 3 days, I experienced heat, redness, swelling on (L) arm.
Intense inflammed Reddish purple rash covering most of body. occurred  3-4 days after the second dose
Fever with chills that didn't come down easily even under the administration of Acetaminophen 500mg every 4 hours (strangely temperature was only 37 C), throbbing head ache, body ache, drowsiness and fatigue, loss of apetite, nausea, heartburn, constipation.
After vaccine on  2/25/2021 had standard chills, aching lasting 2 days.  2 days after vaccination started to develop pimples to chin (painful) and hot flashes which were intense but have since decreased in severity.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 07-JAN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J000444, expiration date: 11-APR-2014 (also reported as 10-APR-2014), 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
This nurse was called to the monitoring area to assist a patient that was passing out. Patient called out she felt dizzy at which time her eyes rolled back and she started to go limp. EMS was called immediately. Patient was assisted to the floor by multiple staff. Patient lost consciousness for 15-20 seconds. Patient regained consciousness spontaneously. Pupils were enlarged. BP 110/70, HR 65, Pulse ox 99%. Patient was s/p covid vaccine # 1 (Lot ER8727, exp. 7/31/21). Ice pack applied to patient's neck. Patient laid on floor and remained awake, alert, and oriented. Patient stated she felt better. She was sat upright and given water. Patient stated she has not had anything to eat or drink since last night. Patient was assisted to chair slowly. EMS arrived @ 12:24. Patient then had a second episode where she felt dizzy and started to pass out. She was again lowered to the floor. Patient was placed on a monitor by EMS, BP 74/44. EMS inserted IV line into her Left AC and started fluids. BS via fingerstick was 104. Patient was transported to ED without further incident.
SHINGLES; Information has been received regarding a case in litigation from a lawyer referring to a currently 65 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a hospital for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event shingles was unknown.
The pt experienced a fever of 101.6, 7 days post varicella vax with a 5 minute long generalized seizure. Seen in the
"Little" difficulty breathing, choking sensation 4 hours after administration. Fever and chills during the night. Slight fever day after then symptoms disappeared.
This spontaneous report as received from a pharmacist refers to an approximately 86 year old male patient with vaccination. On 27-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K000329, 0.65 ml, subcutaneous. Concomitant therapies included PREVACID, XANAX and prednisolone eye drops. Patient had a history of penicillin allergy. Couple of days later, on an unspecified date in the year 2014 the patient experienced excessive sweating in the buttock region. No treatment was given. On the same day of vaccination of 27-OCT-2014 the patient also begun treatment with prednisolone eye drops. No product quality complaint was involved. Patient didn't seek medical attention. The outcome of event was reported as not recovered. The reporter causality was not specified. Additional information has been requested.
5 hours after she received the vaccine she started to have tingling in her toes, fingertips and lips. Those have stopped. She had a temperature of 102 at max about 16 hours post vaccine. She had a couple of minutes of floaters in her eyes and could not see about 24 hours post vaccine. She also has had a headache
oxygen levels were down to 88; Diagnosed with COVID-19; Second dose will be greater than day 36; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) and OXYGEN SATURATION DECREASED (oxygen levels were down to 88) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter. The patient's past medical history included TIA (7-8 years ago). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), METOPROLOL, AMLODIPINE, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID-19) (seriousness criterion hospitalization). On 15-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen levels were down to 88) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be greater than day 36). The patient was hospitalized from 15-Feb-2021 to sometime in March 2021 due to COVID-19 and OXYGEN SATURATION DECREASED. At the time of the report, COVID-19 (Diagnosed with COVID-19) and OXYGEN SATURATION DECREASED (oxygen levels were down to 88) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be greater than day 36) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Oxygen saturation: 88 (Low) 88 percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient doctor sent him to the emergency room on 15-Feb-2021 where the patient stayed on a ventilator for a month.  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 is unlikely or not applicable.; 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 is unlikely or not applicable.
people are having the same symptoms as me; 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 VACCINATION COMPLICATION (people are having the same symptoms as me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease.    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 VACCINATION COMPLICATION (people are having the same symptoms as me). At the time of the report, VACCINATION COMPLICATION (people are having the same symptoms as me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient felt that people with Meniere's disease should not receive the vaccine.
mentions that she only had a sore arm with the first dose; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Lot number: EN6201, Expiration Date: 30Jun2021) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Guillain Barre syndrome", start date: Feb2017 (unspecified if ongoing), notes: Additional Information for Other Conditions: IDIP which is chronic.; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "mentions that she only had a sore arm with the first dose".  Additional information: The family medical history relevant to AE was reported as none. The concomitant product included IVIG treatment, one infusion every four weeks. Stated that, the patient's last dose before the second dose of the vaccine was on 15Mar2021. Additional vaccines administered on same date of the Pfizer suspect was reported as none. AE(s) following prior vaccinations were reported as none. It was reported that, the caller was called about the covid vaccine. Stated that, the caller had an adverse reaction to it, she filled out a report with Pfizer via text message but was unsure whether it went through so she was called today (unspecified date) to file a report. Stated that, the caller has Guillain Barre syndrome CPID and she needed a round of the IVIG in the hospital. Stated that, this reaction kicked the caller's you-know-what. Stated that, the patient took covid vaccine in right upper arm because she works at an elementary school. The caller mentioned that, she only had a sore arm with the first dose of the vaccine. Relevant tests were reported as none.  No follow-up attempts are possible. No further information is expected.
Started feeling very chilled and could not get warmed up; upper left arm was very sore; temperature rose 2 degrees +/-; felt slightly nauseated.  This only lasted one day.
I contracted COVID in August after my 2nd dose. I had fatigue, headache and cough. This lasted a week or so. I was not bad. It was a little moderate. I have worse symptoms now. I continue with fatigue and headache. This cough is chronic and seem to have gotten worse. I am now using an inhaler. I also have crazy bouts of extreme fatigue so often I have to go lie down. This cough is seeming to be getting worse and acting long term. I have been using seasonal allergy medicine to combat this.
Delayed cutaneous hypersensitivity L arm.  Heat, Pain, Redness, Welt 5cm x 8cm.  Duration:  7 days. Applied ice packs and Benedryl cream topically.
Area underneath the injection site (about 4 inches long by 1 inch wide) became red, a little inflamed, and warm about 1 day after the injection.
FAINTING; DIZZINESS/LIGHTHEADEDNESS; This spontaneous report received from a pharmacist concerned multiple patients of unspecified age and gender (specific number of patients unknown, reported as handful/bunch of patients). The patients' weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose, start therapy date was not reported, 1 total, for prophylactic vaccination. The batch number was not reported and will not be requested because the pharmacist does not have the lot number of the vaccine used. No concomitant medications were reported.  On an unspecified date, the patients fainted and experienced lightheadedness/dizziness. It was reported that the patients experienced these side-effects not only during vaccination which were from the anxiety or stress of the injection itself but, also during the 15 minutes that the patients were kept for surveillance. The patients did not require any hospitalization or any additional medical care. They just got monitored by a nurse and some of them became better after drinking water and taking rest on the chair for 15 minutes or a bit longer than that. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and lightheadedness/dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420689-Covid-19 vaccine ad26.cov2.s-Fainting. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
R eye reactions redness, watery, irration, pain. -similiar reaction, in left eye-lighter reaction. -upper R eyelid was swollen. polydex-eyedrops, polydex ointment, cold compress 2 tylenol, benadryl 25 mgs. Some discomfort was able to sleep. ZADITOR-2 times day in eyes.
SOB, edema, dysphagia, hoarseness, wt. loss, diplopia.
Client complains of "aching" upper left arm from shoulder to elbow since vaccination was given on 5/28. No swelling, redness or warmth. Has been using Motrin as needed which has helped. Pain increases when left arm raised above head.