chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She is postmenopausal 3-4 years/had her menstrual cycle from 15Jul2021-30Jul2021; It was heavy with clots; This is a spontaneous report from a contactable physician. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient had no COVID-19 prior to vaccination. The patient's medical history included postmenopausal (3-4 years). Concomitant medications were not reported. The patient received the first vaccine on 14Jul2021, and she had her menstrual cycle from 15Jul2021-30Jul2021. It was heavy with clots. She is postmenopausal 3-4 years. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included patient was sent for Ultrasound to r/o other cause of post-menopausal bleeding. It was unknown if the patient has been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Jul2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Postmenopausal bleeding and Heavy periods. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received 2nd dose 2/18/2021 had fever that day, the next day, on the 20th it started at about 5:00pm then at about 6:00 pm I had severe left chest pains that soon went to the left shoulder. Emergency services was called and I was first taken to nearby hospital and they transferred me to a different Hospital. I had pericardial effusion was put on Lasix and Potassium. Tests done was a heart MRI, heart cathertization, lung CT scan, echocardiogram, EKG. Arteries were open and not clogged, it was determined that I did not have a heart attack. I've never had high blood pressure or any other heart related conditions. I was released after 5 days feeling well
Patient developed pain, swelling, decreased ROM right arm and temperature of 102F following immunization.
Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 03Mar2021 at the age of 45-year-old female as a single dose for COVID-19 vaccination. The patient's medical history, concomitant medications and allergies to medications, food and other products were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The facility where the most recent COVID-19 vaccine administered was other. On 12Mar2021, the patient experienced rash in neck area. The rash resembles red spots with itching and burning sensation. It started as small patch and is spreading even on the fourth day of the rash start. The treatment received for the events were unknown. The clinical outcome of events were unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of PNEUMOVAX 23 (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA001475, 1403USA002926, 1403USA002927 and 1403USA002928 via same reporter link. Additional information has been requested.
arm started to hurt; When the analgesic muscle rubs and tylenol wears off, it hurts just as bad as before; The pain mainly radiates from the injection site up to the shoulder.; from the injection site up to her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to hurt), PAIN (When the analgesic muscle rubs and tylenol wears off, it hurts just as bad as before), ARTHRALGIA (The pain mainly radiates from the injection site up to the shoulder.) and VACCINATION SITE PAIN (from the injection site up to her shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE and APIXABAN (ELIQUIS) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt), PAIN (When the analgesic muscle rubs and tylenol wears off, it hurts just as bad as before), ARTHRALGIA (The pain mainly radiates from the injection site up to the shoulder.) and VACCINATION SITE PAIN (from the injection site up to her shoulder). At the time of the report, PAIN IN EXTREMITY (arm started to hurt), PAIN (When the analgesic muscle rubs and tylenol wears off, it hurts just as bad as before), ARTHRALGIA (The pain mainly radiates from the injection site up to the shoulder.) and VACCINATION SITE PAIN (from the injection site up to her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication provided were muscle rub (analgesic) and Tylenol.
Approximately 12 hours after receiving his second COVID vaccination, patient began experiencing stomach aches & headaches.   The next day he began coughing and it hasn't let up yet.  Sputum is beige/blood-tinged.  Afebrile.  Scattered rhonchi heard upon auscultation.  Offered azithromycin and ipratropium-albuterol nebulizers for sinobronchitis.
Chest pain/centralized ache on right side of chest. Short and sporadic aches. Aches spreading up to chin, periodic chin numbness. Pain spreading to right arm, down arm to right fingertips - numbing of fingertips. All lasting a few seconds to minutes. no regularity.
Gave Tdap vaccine and about 3-5 mins later patient was talking/laughing with sister,  when sister said I don't think she is ok. Patient started feeling light headed, confused with some shivers and fainted.  Immediately called rapid response code- Dr. and RN for assistance. Pillow was placed as well as a cold compress on forehead. RN performed vital signs and waited for patient to gain force to transfer to wheelchair. Transferred patient to treatment room and pt lay in bed and rested. Patient complained about nausea and slight headache. She was under observation for about 20-30mins approx. Dr. ordered Zofran for nausea and was then released by Dr., all vital signs were stable.  Patient stated she was feeling better.
palpitations; left arm had been hurting; chest tightness; after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue). At the time of the report, PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported couple days after receiving the vaccine things were stressful at work and he started to experience palpitations, his left arm had been hurting, he had chest tightness, and fatigue. This has continued until today, and he doesn't feel like he can do as much as he could before.   Patient did not receive the 2nd dose because of the possible correlation. He has not taken any medications or treatments for his symptoms, but has been trying to rest. He has never been diagnosed with covid-19, myocarditis, or pericarditis previously.   This case was linked to MOD-2021-404469 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Non significant follow up received contain other patients events.
No additional AEs reported; Patient received MMR II intramuscularly; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-AUG-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter intramuscular route (Incorrect route of product administration) lot number T016352 rHA expiration date 12-MAY-2022, administered for immunisation.  Caller didn't know what dose number was for the patient, but states that the patien was caccinated in the past and statred a new job where he had titers that were "barely low" for Varicella and MMR, so the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) but the pharmacy did not have Varicella vaccine.
Pain in Left arm, heart start  was twitching often. diarrhea, dizzness
The next day after having the vaccine I felt a pain on my arm and I could not lift my arm for about 2-3 weeks. It was swollen and very painful that I could not move my arm to do my daily activities. I went to the doctor and she said that it was nothing serious and she did not do any tests but she gave me some exercises to do at home and I still have some pain but not as bad as in the beginning. She gave me some medications for the pain and swelling.
Post administration of PNV23 (PNEUMOVAX) pt. got red, pale, chest pain, SOB, wheezing. Dr. gave the pt 0.3mg AUVI-Q on lat. (R) thigh.
Patient stated that she has a rash on her chest and that the arm in which she received the vaccine is numb and has not improved since the beginning of symptoms.  I spoke with the patient last on 06/10/2019 and was informed of the incident.  I informed that patient that she should contact her PCP and see if they would like her to come in to their office for further investigation.
PAIN IN LEFT UPPER EXTREMITY, TAKING TYLENOL/ ICING AND TRYING TO MOVE ARM FREQUENTLY.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 4 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 152 hours, 31F (-0.555 Celsius degrees) for 120 hours and 33 F (0.555 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Brain felt tingly like I had a fever; mild generalized malaise, arm/injection site soreness.  Slept it off that night and was better the next day.
headache; This is a spontaneous report from a contactable consumer (Patient).   A 65-year old male consumer patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified headache the patient experienced. At the time of the reporting outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
typical flu (moderate weakness) inflammation of lungs/irritation (suspect COVID19 infection already present prior to vaccination date//contact via email)
The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder. 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 COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine) outcome was unknown.    Concomitant medication included an unknown heart medication. The patient is fully  vaccinated with the 2 shots of Moderna COVID-19 vaccines and had been 6 month. The patient is in mid 70s and the reporter think patient received shots on February or March. No treatment medication was provided. This case concerns a patient in mid 70s with reported medical history of Heart disorder who experienced non-serious unexpected event of special interest COVID-19. It was reported that the patient experienced COVID-19 approximately 6 months after the 2 shots of mRNA-1273. The rechallenge was not applicable as the event occurred following the second dose. It was reported that the patient experienced mild case of COVID-19, however, no further information regarding clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient in mid 70s with reported medical history of Heart disorder who experienced non-serious unexpected event of special interest COVID-19. It was reported that the patient experienced COVID-19 approximately 6 months after the 2 shots of mRNA-1273. The rechallenge was not applicable as the event occurred following the second dose. It was reported that the patient experienced mild case of COVID-19, however, no further information regarding clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Patient came in 2nd sick visit for cough and fever. 1st visit Dx w/croup. Before leaving flu vaccine was administered along w/the sick recheck visit. Patient went home and had a seizure. Dad brought him to ER and was put on seizure meds to help.
redness & induration @ site of inject, extending from shoulder to elbow; denies SOB, declines reexam by DM; rx w/DPH;
flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Chills Body aches Fatigue Site soreness Joint pain Intermittent headache Nightmares 3-4 times per night that are very realistic Brain fog
I was suddenly like I was going to die; Upper arm was big, bruised, and there is a lump; Upper arm was big, bruised, and there is a lump; It looks like hematoma like a node; that it was a hematoma; There was a Swelling wound; Was a little sore on upper left arm; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EL9266) at the age of 80 years, as single dose for covid-19 immunisation.  The patient medical history was not reported.   Concomitant medication included unspecified pill taken for years. The patient received first dose of bnt162b2 Lot: EL9625 on 26Jan2021 at the age of 80 years. The patient experienced suddenly like she was going to die on an unspecified date, was a little sore on upper left arm on 20Feb2021, upper arm was big, bruised, and there is a lump on Mar2021, it looks like hematoma like a node; that it was a hematoma on Mar2021, there was a swelling wound on Mar2021.  It was reported that the events occurred approximately 3 weeks after the 2nd dose, that upper arm was big, bruised, and there is a lump: it was traveling down a little bit closer to where her arm bends. Is getting yellow on top. Where her lump is, the blood is not. Stated it was falling down her arm. After cold compression it has gone down a little bit. Then the patient went for a visit and the nurse advised to put warm pack in every 3 hours. She took a picture of it. The doctor told her that it was a hematoma. It's not the whole arm it's just her whole upper arm, it will like 4-5 inches.  The event suddenly like she was going to die was serious as life threatening. Therapeutic measures taken as a result of the events little sore on upper left arm, upper arm was big, bruised, and there is a lump, it looks like hematoma like a node; there was a swelling wound included cold and warm compression. The outcome of the events was unknown.
After receiving the second dose of the Moderna vaccine in May I started what appeared to be my regular cycle mid June. My cycle ended normally, but 1.5 weeks later started again. I had another full menstrual cycle again, then stopped finally stopped bleeding 5 days later. Only to start again 2 weeks later. I had originally summed this up to possibly a weird PCOS or endometriosis symptom, but the bleeding has now been going on 4 months on and off full cycles every 1-2 weeks for 5-10 days of full bleeding that I realized this was not a PCOS or endometriosis symptom. As it started one month following my second dose of the Moderna vaccine.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative, and then from a contactable pharmacist. The physician reported the same event for 3 patients. This is the second of three reports. A female patient of unspecified age and ethnicity received PREVNAR 13 on unknown date, at 0.5 ml single, for immunization. Medical history and concomitant medications were not provided. On an unknown date she had swelling of the arm and gums swelled up (it was unknown if the patient received a treatment). Outcome of the events was unknown at the time of the report. Follow-up (18Apr2014): New information received from a contactable pharmacist includes: event "gums swelled up" added. Follow-up (22Apr2014): Follow-up attempts completed. No further information expected.