chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DURING COVID VACCINATION CLINIC, DIVISION 1 EMPLOYEE ASSISTING WITH POST-VACCINE OBSERVATION REPORTED TO PHARMACIST THAT A PATIENT WAS FEELING LIGHTHEADED. SHE IDENTIFIED PATIENT WHO WAS DISTRESSED AND APPEARED UNSTEADY. THE PATIENT REPORTED THAT THEY HAD TUNNEL VISION AND FELT VERY LIGHTHEADED. PHARMACIST ASKED THE PATIENT TO REMAIN SEATED AND TRY TO TAKE SEVERAL DEEP BREATHS WHILE THE PHARMACIST HELD THE PATIENT'S LEFT SHOULDER TO ENSURE HE WOULD NOT FALL IF SYNCOPE OCCURRED. THE PATIENT HAD FLUTTERING EYELIDS AND APPEARED IAPHORETIC AT FIRST, BUT AFTER SEVERAL MINUTES RECOVERED SOMEWHAT. THE PATIENT REPORTED THAT HE HAD RARELY HAD SIMILAR EPISODES IN THE PAST DURING SOME MEDICAL PROCEDURES, BUT NEVER ASSOCIATED WITH A VACCINATION. PHARMACY TECHNICIAN HAD A D1 EMPLOYEE RADIO FOR A CODE WHITE AS SHE CONTACTED 911 ON HER CELLULAR PHONE. PARAMEDICS ARRIVED AND ASSESSED THE PATIENT'S HEART RATE, SEATED BLOOD PRESSURE. AND STANDING BLOOD PRESSURE. THE PATIENT REPORTED FEELING SLIGHTLY LIGHTHEADED WHEN FIRST STANDING, BUT MUCH IMPROVED OVERALL. THE PARAMEDICS INDICATED THAT THERE DID NOT SEEM TO BE A MEDICAL EMERGENCY BY THIS POINT AND EXPRESSED CONCERN THAT THE PATIENT MAY BE DEHYDRATED BUT THE PATIENT REFUTED THIS POSSIBILITY. HE ALSO STATED THAT HE HAD NOT RECENTLY OVEREXERTED HIMSELF AND HAD EATEN LUNCH EARLIER THAT AFTERNOON. PHARMACIST PROVIDED THE PATIENT WITH GATORADE AND ICE TO IMPROVE BLOOD SUGAR, ELECTROLYTE, AND HYDRATION STATUS AND THE PARAMEDICS DEPARTED. THE PATIENT REMAINED FOR APPROXIMATELY 30 MINUTES UNTIL HE WAS FEELING CLOSE TO BASELINE AND FELT COMFORTABLE LEAVING.
Received expired dose for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Weakness, decreased level of consciousness. At 11:15 AM, did not feel like going on the bus, said he felt tired. Gave him juice, water, crackers and was able to keep down. No nausea or vomiting. Pulse normal; ambulating well. At 12:00 noon, weaker. Went on bus to hospital. Pulse still normal range. Pt observed for 2 hours and 35 minutes in ER.
04/04/2022 I had a reoccurrence of bladder cancer discovered during a routine check in with my oncologist. Cystoscopy discovered and a biopsy was taken. This was being monitored and being checked on every 6mo for any new issues. 04/09/2022 A Urine sample was taken. 04/19/2022 Surgery to remove tumor. Chemotherapy: mitomycin.
On August 29, 2021 I started to get a pain in my naval region around 7:00pm at night. The following day, August 30, 2021 the naval pain was so bad I was bent in half. I was also very nauseas, had no real appetite and was constipated. On Tuesday, August 31, 2021 I woke up and the pain had moved to my lower right abdomen. It hurt to lift my right leg up to go up the stairs and when trying to sit down in a chair I was in a lot of pain and was leaning to the left to take the pain off of my right side. I went to the ER that morning at 10:00am and had a temperature around 99 degrees Fahrenheit. After an ultra sound and CT Scan, it was determined that I had appendicitis. At 9:15pm that evening (August 31, 2021), I had an emergency appendectomy. It has been about a month since the surgery and I no longer have any pain in my lower right abdomen. Recovery has been going well and the incisions are healing well.
Itchiness at injection site; hives at injection site; red at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE and CEFALEXIN (KEFLEX [CEFALEXIN]) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rash from her mid back to her navel.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash from her mid back to her navel.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 RASH (rash from her mid back to her navel.). At the time of the report, RASH (rash from her mid back to her navel.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Erythematous papules on upper arms and chest itching.  Treatment: Prednisone 40mg on AM x 2 days-tapering down for total of 8 days.
pt states that she developed a ear ache in her left ear that lasted 2 days.  A week after getting the vax her right arm was itchy, red, swollen at and below the injection site that lasted four days.  She used ice pack which seemed to help.  About 2 weeks later she had body aches and pain within her back, pelvis, shoulders, legs, and head.  She had a pulsating pain that starts in the base of her neck and goes up the left side of her neck into her ear and then quits and starts again.
Starting Sept 1, I had discomfort in the sternum, burning in the esophagus and dryness in the nose and throat.  On Sept 4, went to urgent care facility for those issues.  They performed an EKG (referred me to hospital for followup), chest xray and COVID-19 test.  They prescribed antibiotics.  On Sept 4, went to the Hospital ER for EKG and further cardiac testing which was negative.  (I am following up with my cardiologist next week.)  On Sept 7, went back to the ER for pain through ribs and bodyaches and fever.  They performed a chest xray and COVID-19 test.  Prescribed tylenol and motrin for fever and pain.   On Sept 13, followed up with my primary care doctor on these visits and sent me for bloodwork for COVID.  I still have discomfort in the sternum, dry throat, runny nose, headache and bodyaches on occasion.  I am taking motrin for pain.
11 day after treatment I came down with Shingles. Throbbing pain wrapping around the left side of my torso first, then began getting little shocks and stings throughout the area, on the second morning I woke up with a rash coving the area.
Received Moderna vaccines on 8/20, 9/18/21 COVID-19 positive by PCR on  1/9/22 admitted to hospital 1/9-1/11/22 d/t syncope, sinus bradycardia, found to be COVID positive on admission.
Information has been received from a physician concerning a female who was a caregiver to a patient who on 09-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 657767/0740U).  It was reported that while the patient was assisting an elderly patient who was receiving the vaccine.  At some point during the administration of the vaccine the caregiver believed that her eyes were exposed to a splash of the vaccine.  The caregiver was advised to rinse her eye with water.  On 10-JUL-2007 the caregiver experienced soreness in the affected eye.  The patient went to the emergency room and it was determined that she had a slight infection in the affected eye.  Unspecified medical attention was undertaken.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information received 4/16/08 indicated that the reporter had "no recall of any known reaction" following vaccination with zoster vaccine live (Oka/Merck). No further information is expected.  This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a physician concerning a female who was a caregiver to a patient who on 09-JUL-2007 was vaccinated with a dose of ZOSTAVAX (lot # 657767/0740U).  It was reported that while the patient was assisting an elderly patient who was receiving vaccine.  At some point during the administration of the vaccine the caregiver believed that her eyes were exposed to a splash of the vaccine.  The caregiver was advised to rinse her eye with water.  On 10-JUL-2007 the caregiver experienced soreness in the affected eye.  The patient went to the emergency room and it was determined that she had a slight infection in the affected eye.  Unspecified medical attention was undertaken.  A product quality complaint was not involved.  No further information is expected.
more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm; I couldn't use or lift my arm hurting; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram every four hours. At the time of the report, PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) had not resolved.        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.   No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 16-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002944: US-009507513-2104USA002984: US-009507513-2104USA002970: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002983: US-009507513-2104USA002982: US-009507513-2104USA002981: US-009507513-2104USA002963: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
After rest and water, pt bp decreased, still not normotensive. Pt felt like her dizziness was subsiding until we stood her up. BP increased. Pt sat back down, given more water, pb and cracker and lozenge.  11:21--pt reports lightheadedness is mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp reported.  Pt feels well overall otherwise.
pt recv vax 22JUN98 & 23JUN98 pt devel flu-like sx & redness inj site & swelling inj site;pt was not treated for the event;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 09:42, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Patient  had recived  Moderna booster dose  in our pharmacy on 11/19/2021. Pt called back on 11/22/201 morning to inform us that she has allergic reaction from vaccine. Rash started on 11/21/2021 on her arms and legs and spread to stomach on 11/22/2021.  She is taking Benadryl and its helping with itch.
Not a cough, but I feel like I want to cough; this had been going on for several hours, at least 6. Brief chest pain, probably heart. Lasted a few minutes, happened maybe 11 hours after the shot.
Swelling, pain at injection site, large red raised area at injection site that is hot to the touch, fever. I am already on tramadol, took 600 mg ibuprofen which had no effect on pain. Applied ice in 20 min intervals, though touching with wrapped ice bag hurts as does any touching, not sure it helped at all.
18July96 Pt recv 1 dose vax. 01Feb98 Pt devel shingles consisting of "rash lower back L4-L5 & down r leg to anterior aspect toward knee & extended from rash line to labia majora left side
pushing up on her arm that her arm was hurting; headache around her ears and on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead). At the time of the report, PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
My arm started aching at the site of the injection immediately after the injection.  Two days later, after exercising my arms with weights and doing push-ups I experienced severe dizziness and my arm began hurting again.  Now, three days later my arm is still tender.  I get flu shots every year, but have not had adverse affects like this time.
Within 48 hours of immunization began with hives on abdomen and legs.  Spread to face.  Responded to Benadryl but now 5 days out still flares when Benadryl wears off.  Chest clear, BS o.k.
hurt her hand; This is a spontaneous report from a non-contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the caller was offered to be connected with safety department but caller refused, (e-transmitted the AE) Anonymous 62-years-old female patient refused to provide name or any demographics. Stated that, few days ago she received her first dose of the Pfizer COVID vaccine. On an unspecified date, she hurt her hand and wanted to know whether she can take Advil for it. Stated that, how long they have to wait before they can take anti-inflammatory medication. Stated that, her next dose was due in 2.5 weeks. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
A week later I noticed a rash around the injection site. Red and large.. it was warmer to the touch, but didn?t bother me. No itch.. I see it?s referred to as covid arm
local rash that developed 9 days after vaccination  Rash to right deltoid where vaccine was injected
felt lousy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt lousy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt lousy). At the time of the report, FEELING ABNORMAL (felt lousy) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L048854, expiration date 31-AUG-2017 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Loss of taste; Loss of smell; she tested positive- 5/tested positive for COVID-19; This is a spontaneous report from a sponsored Program. A contactable female consumer (patient) reported that a 37-years-old female patient received bnt162b2 (BNT162B2; Batch/lot number: EL1284) first dose, intramuscular on 11Jan2021 between 9-9:30 a.m at SINGLE DOSE at Right upper arm for covid-19 immunisation.  The patient medical history was not reported. Prior Vaccinations (within 4 weeks) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None.  The patient's concomitant medications were not reported.  The patient experienced she tested positive- 5/tested positive for covid-19 on 18Jan2021 with outcome of unknown, loss of taste on 18Jan2021 02:00 with outcome of recovered on 23Jan2021, loss of smell on 18Jan2021 02:00 with outcome of recovered 23Jan2021.  The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 Rapid Test): positive on 18Jan2021, sars-cov-2 test (COVID-19 Test): inconclusive on 29Jan2021.  The action taken in response to the event(s) for bnt162b2 was not applicable. Caller was scheduled today for the 2nd dose of Pfizer vaccine. However, 2 weeks ago she tested positive- 5 days after the 1st dose of the vaccine. Today, she had no symptoms for over a week and she didn't know yet if she was still positive for COVID or not. Caller was asking if she can take the 2nd dose today or if she needed to wait for days/weeks before taking it. On 11Jan2021, the caller received her first dose of COVID-19. On 18Jan2021, the caller tested positive for COVID-19. She was symptom free after 5 days. She was scheduled to receive her second dose at 12:00pm today. She stated she has been getting conflicting information. She wanted to know can she receive the second vaccine? Since 23Jan2021, she has been symptom free. She mentioned she filled out a questionnaire online about and she did respond that she tested positive after receiving the first dose, but she never heard anything back. Caller stated she noticed probably around 2 am in the morning on 18Jan, she had that feeling in my throat where she was losing her sense of smell and taste. She woke up that morning around 8am, and these senses were completely gone. Caller stated it was the only symptom she had. She confirmed she had a COVID-19 Rapid test done on 18Jan2021. She actually went and got tested again on Friday, 29Jan2021, to see if she still had COVID. However, the person doing the test must not have done it right. The person only swabbed one nostril and the test came back inconclusive as of yesterday. The events not require a visit to Emergency Room and Physician Office.   No further information was provided or obtained.
The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Saturday two days after the second dose I had significant dizziness which might be considered vertigo. I am now six days past the second vaccine and continue to have dizziness.
-Itching, Swelling, Firmness, Soreness around 2 inch diameter around injection site -Drowsiness
swelling, redness, eventually blistering of left arm -> worsening over 24 hrs after 1st noted; eval in ED -> NSAID + elevation