chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". Therapeutic measure, PAXLOVID was taken as a result of drug ineffective, covid-19, from 05Sep2022 to 10Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
It was my second shot.  It is two days later and the injection area now covered by a 2-3inch diameter red swollen rash.  It looks like a red circular patch.  Warm to the touch.
Rash, swelling and warmth upon touch at injection location spreading to approx 2-3 inches in diameter.  Did not appear until approx 7-10 days after injection. Lasting approx 1-1.5 weeks.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: COVID ARM
This spontaneous report was received from a medical assistant referring to a 13 month old male patient. The patient had no medical history, concurrent conditions nor concomitant therapies. On 15-NOV-2018, the patient was vaccinated with a dose of ZOSTAVAX (dose was not provided) per subcutaneous route lot # N025570; instead of the scheduled VARIVAX (for varicella vaccination) because ZOSTAVAX was mistakenly placed in the VARIVAX container. No adverse effect was reported.
Focal seizures began 9/4, prolonged w/u at hospital, diagnosed with encephalitis thought to be autoimmune. Still hospitalized. NMDA Encephalitis.
Initial soreness at site of injection on first day, continued for several days and gradually faded. On Day 5 (Saturday), onset of itching, redness, rash, inflammation at injection site and extending throughout the outside of shoulder. Has become worse over the past several days. Has not resolved, No treatment to date.  In addition on Day 5, I began to experience lethargy, throat soreness, overall fatigue, body ache, and mild fever. These symptoms persisted for approximately three days and are now lessening.
Bone pain; Vivid dreams; vaccination related malaise; Night sweat; Vaccination  site erythema; Vaccination site swelling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat) and VACCINATION SITE ERYTHEMA (Vaccination  site erythema) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia). At the time of the report, BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia) 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. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information received
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L027070, expiration date: 30-APR-2017; dose was not provided) orally. The vaccine was exposed to temperature of 32 degrees Fahrenheit for 4 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reported received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse referring to an unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patient's were vaccinated with an approximately 6 doses of improperly stored VARIVAX, lot # M023380, expiration date of 11-MAY-2018 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 7 hours and 41 minutes: 1.9 grades Centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA010953.
Extreme headache (migraine) lasting 48 hours Extreme fatigue lasting 48 hours
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Dec2020 (Lot number: EL0142) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible. No further information is expected.
A week after the vaccine I had break through bleeding which lasted for 3 months. I visited my Dr. who rx'd a stronger birth control.
Per the ED Physician documentation and report from family, patient had been experiencing some chest pain for the last week to week and a half  with SVT before presenting to the emergency department. patient had a holter monitor study earlier in the week that results were pending.  1/23/21- patient arrives to the ED via ambulance with complaints of sharp chest pain, palpitations and heart rate in 150's. Patients troponin level then elevated and it was determined patient was having a NSTEMI.  1/24/21- patient had recurrent episodes of SVT and family decided patient would benefit from further cardiac workup so she was transferred to a higher level of care. Unknown if patient has discharge from the facility we transferred her to.  This patient is felt to be of significance since she is 1/3 patients currently in our facility who developed cardiac/blood issues post vaccination from the same pharmacy with the same lot number vaccine. VAERS reports were put in for all three to determine if further investigation is needed.
Very heavy periods; Early periods; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8736) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and mango allergy. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA 24 HOUR) and fluticasone propionate (FLONASE) (OTC- over the counter), all for an unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient period was clockwork and getting periods every 25-26 days and she tracked it. The patient was on the medications before the vaccine and had her period regularly. On 03Apr2021, the patient experienced period came three days early and it was very heavy. The clinical outcome of the events of experienced period came three days early and very heavy periods was Not recovered.  No follow-up attempts are needed. No further information is expected.
With in hours I had a fever of 100.7, every muscle and joint hurt, horrible headache, extreme nausea, no appetite. Arm was hot, swollen and bruised. This lasted about 36 hours and then subsided and nasal congestion started.
After the 1st shot on 10-21-21, apart from the expected fatigue,  body aches and severe headache, I woke at midnight with my heart pounding in my chest, which continued on and off through the night.  The next day, there was so much pressure in my head that it was hard to bend down to tie my shoes. I saw my doctor the following day and my vital signs were normal. I felt intermittent sharp pains in my heart, as well as occasional pounding of the heart during the night in my heart. 10 days after the 1st shot, I resumed my normal cardiovascular exercise ( spin bike 3 times per week) but felt exhausted afterward. I also felt exhaustion and a pounding heartbeat when I climbed a flight of stairs. After the 2nd shot on 11-17-21, I felt intermittent sharp pains in my heart, as well as occasional pounding of the heart during the night. Two weeks after the second shot, I resumed cardiovascular exercise ( spin bike 3 times per week) but felt exhausted for several days afterward. I also felt exhaustion and a pounding heartbeat when I climbed a flight of stairs. Dr diagnosed myocarditis on 12-13-21.
On 6/22/00, the pt had an ultrasound. The reason for the test was 'dates, spotty, and Varivax'. The result of the ultrasound was a non viable fetus. On 6/23/00, at approximately 10 weeks gestation, the pt had a miscarriage and was hospitalized. She was treated the same day with a D & C. The reporter indicated that the pt's experience was an other medical event. It was noted that the pt did not have any concurrent medical conditions or develop any infections/illnesses during pregnancy.
Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 doses) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-335300 (Patient Link).
Minor discomfort in same spot after first dose, but no swelling, only last one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:00 (Lot number: ER2613) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Minor discomfort in same spot after first dose, but no swelling, only last one day". Therapeutic measures were not taken as a result of discomfort.  Additional information: It was reported that Swelling and slight pain in left armpit after second dose (started two days later, worse on third day). Minor discomfort in same spot after first dose, but no swelling, only last one day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
pain redness swelling at injection site, began course of Doxycycline, antibiotic, symptoms are begining to resolve
36 hours post injection, rash, itching started, 48 hours post injection, full body hives with itching, denied dyspnea, dysphagia, shortness of breath, respiratory problems. No relief with Benadryl PO, given Medrol dose pack with decreased symptoms.
Sore arm for four days and 24 hours of fever ranging  from 99.8 to 100.8
Burning feeling on upper arms and face; Nausea; Vomiting; Chills; Exhaustion; itchy on upper arms and face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 04May2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 09:15, the patient experienced nausea, vomiting, chills, itchy/burning feeling on upper arms and face, exhaustion. The clinical outcomes of nausea, vomiting, chills, itchy/burning feeling on upper arms and face, exhaustion were recovering.   No follow-up attempts are needed. No further information is expected.
Redness, swelling, and hot to touch on (L) deltoid area-extending toward elbow 85 x 85 mm.
The evening after the vaccine, around 5pm, my right arm was hot and red. It was painful to the touch. I developed welts with red bumps. I used a cold pack to see if that would help. That did not help. I initially consulted with the nurse on call, who advised me to go to urgent care. At urgent care, I was referred to the PCP. I consulted with my PCP and was prescribed a steroid Hydrocortisone cream. The cream did help to resolve the itching. It took about 5 days for the rash to resolve.
Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder) in a 62-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder). At the time of the report, VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter  The anatomical location of vaccine was shoulder   This case was linked to MOD-2021-354390 (Patient Link).
Within 17 days of receiving a booster shot, my dad had a heart attack and died.
PATIENT WAS GIVEN A VACCINE THAT WAS OUTSIDE OF THE ALLOWABLE TIMEFRAME OF A RECONSTIUTED VACCINES. WHICH MAY HAVE AFFECTED THE EFFICACY. PATIETN WAS INFORMED , INCEDNT REPORTS WERE SUBMITTED. PATIENT VOICED UNDERSTANDING.  WOULD LIKE TO HOLD OFF A BIT ON REDOING VACCINE DUE TO SCHEDULE CONFLICT, WILL INFORM OFFICE WHEN ABLE TO SCHEDULE.
Initial information was received on 13-Oct-2021 regarding an unsolicited valid, social media, non-serious case received from a Consumer.  This case involves a patient (unknown age and unknown gender) who covid (covid-19) and flu (influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious covid (covid-19) and flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Did it 4 ten yrs. Got flu Quit 5 yrs. Ago & no flu Got Covid & got good Antibodies".  It is unknown if the patient experienced any additional symptoms/events  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of events was unknown.  There will be no information available on batch number for this case.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (Lot@ K009473, Expiry:03-JAN-2016), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
Inconsolable crying x 2 days, temp 101 x 2 days. Swollen, red area on left thigh apprx. 7cm.
Child passed a mucous mass rectally 6 hrs after vaccination then suffered diarrhea for one weeks and loose stools for two + weeks. Still experiencing loose stools.
Patient received Bexsero vaccine that expired on 7/31/2022 on 8/1/2022. Patient was notified and plan to return for a new dose.
COVID PFIZER - PT CALLED AND COMPLAINED REGARDING SHARP ACHY PAIN IN  LEFT THIGH AND ASKED IF THAT'S NORMAL AFTER THE COVID SHOT. SHE RECEIVED HER SECOND PFIZER COVID SHOT YESTERDAY. SHE SAID IT'S NOT SWOLLEN, NOT WARM, IRRITATED, NO OTHER SIGNS OF BLOOD CLOT. SHE SAID TAKING TYLENOL HELPS. ADVICED TO LOOK OUT FOR ANY SIGNS OF BLOOD CLOT AND CONTINUE TAKING TYLENOL AND ALSO SEND MSG TO HER DR. IF SYMTOMS GET WORSE OR NOT BETTER, TO GO SEE DR ASAP.
This spontaneous report was received from a physician and a medical assistant referring to a 66 year old non-pregnant female patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 21-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular route in the arm, for prophylaxis; lot # N020501, expiration date: 03-MAR-2019 (previously reported as NO23651 with expiration date in May 2019). Lot number NO23651 was an invalid lot number for pneumococcal vaccine, polyvalent (23-valent). On 22-NOV-2017, the patient experienced red-ringed rash with fever at the injection site as reported by the physician. On the same date, the patient experienced swelling, warmth and pain, as reported by the medical assistant. The patient sought medical attention and the physician advised the patient to take an unspecified dose of the over-the-counter antihistamine ZYRTEC as treatment (it was unknown if the patient took the treatment), on the other hand, the medical assistant reported that no prescription drug treatment was required for the experience. No product quality complaint was involved. The outcome of injection site rash and pyrexia was unknown. The injection site erythema, swelling and erythema went away on 26-NOV-2017. The warmth and pain went away on 29-NOV-2017. The causality assessment between the PNEUMOVAX 23 and the aforementioned adverse events was not reported. The physician reported a similar adverse event for another patient who received PNEUMOVAX 23 with the same lot and expiration date.
PATIENT CALLED THE CLINIC ON 10/29/21 AT APPROXIMATELY 11:26 AM AND STATED THAT SHE WAS EXPERIENCING PRESSURE UNDER RIGHT ARM AFTER FLU VACCINE RECEIVED ON 10/27/21. SHE STATED THAT SHE ALSO WAS EXPERIENCING SORENESS THAT WAS EXTENDING INTO HER RIGHT CHEST/BREAST AREA.  I PHONED THE PATIENT SAME DAY (10/29) AT APPROXIMATELY 2:47 PM TO GATHER MORE INFORMATION FOR VAERS REPORT. THE PATIENT STATED THAT SHE PHONED HER PHYSICIAN BUT WAS UNABLE TO GET ANYONE BECAUSE THEY LEFT FOR THE DAY. SHE STATED THAT THE OFFICE CLOSES EARLY ON FRIDAYS.
Headache, stiff neck, flu-like symptoms, cellulitis left arm.  Flu-like 24 hours after injection with sore arm then approximately 8-9 days later headaches, stiff neck and then on day 10 red, hot, swollen site on left arm approximately 2 inches below injection site and intense flu-like symptoms that have been ongoing for 3 days at the time of this reporting and still ongoing.  Sought medical care at an urgent care center today.  Said they haven't been given guidance on how to treat.  Told to use cold compress to arm, if fear of blood clot in arm to go to ER and to take Tylenol.
Pt developed an extensive rash on back & now spreading to his sides & axcillary areas
SICKNESS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious.