chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serious fatigue; pain; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "serious fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain"; VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen"; CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "The left side of her chest, stomach and back are paining". The events "serious fatigue", "pain", "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen" and "the left side of her chest, stomach and back are paining" required physician office visit. Therapeutic measures were taken as a result of fatigue, vaccination site pain, vaccination site erythema, vaccination site swelling, chest pain, abdominal pain upper, back pain.  Additional information: patient reported that after vaccination she had a lot of severe fatigue for a few weeks but the beginning ahead pain, redness around the injection site and site was swollen but then she had pain in left side of chest, stomach and in left side of her back and she stated that the injection site is still pink after over a month. The doctor advised her to take ibuprofen and also cortisone (Advil). She used ibuprofen and cortisone cream for over a week .  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Received call from client's wife + she stated he received imms. on Tuesday + by Tuesday night left knee was swollen and painful, also had temp. of 99.6. Denies any recent fall or ever having problem with knee prior to this. Wife states he has been taking OTC pain meds and placing ice on knee. He has no temp today wife plans to call MD today.
Breakthrough case admission after 2 vaccines Moderna 12/24/20 lot# 026L20A;  Moderna 1/19/21 lot# 012L20A
Patient receives a booster dose after the corresponding date.  The last dose of Pfizer-BioNtech vaccine with lot FJ5683 was on 04/14/2022 and the booster dose was due in August 2022 and she received it on 06/07/2022 (two months earlier).
Developed salty taste in mouth 4 hours after getting vaccine. Persisted for a week.
Case number PHHY2012US051914 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with trivalent inactivated influenza vaccine (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051910). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born. The baby was found to have autism on an unspecified date. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
About 10 minutes after vaccination, patient began to experience heightened anxiety with no other symptoms.  Evaluated by a paramedic on staff and symptoms quickly resolved.
This spontaneous report as received from a registered nurse refers to a 43 year old female patient. In July 2005, "8 years ago", the patient was vaccinated with a first and second dose of VARIVAX (Merck) (route and lot # not reported) and on an unspecified date, received a third dose of VARIVAX (Merck) (route and lot # not reported). The nurse reported that on an unknown date, after the first 2 vaccinations, varicella titers were drawn and were negative. An unspecified amount of time after the third dose of VARIVAX (Merck) titers were drawn again and found to be negative. The outcome of varicella titers were negative was reported as not recovered/not resolved. Additional information has been requested.
Redness, bump, heat at site, numbness, tingling, pain from site down arm into fingers, weakness, racing heart from first and second vaccine, unable to use arm as she could before vaccine and is left handed, causing sleep issues due to the pain, numbness, tingling.  Mentally causing problems and is ongoing.
Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken to medical area, BP 180/100s, HR 90, Temp normal. Exam normal except for hand tremors.  Minimal liquid and no food intake in last 24 hours. POC glucose 96 a minute or two after eating crackers. Given more food and water.  Initial symptoms improved but continued hand tremors and persistent hypertension to high 170s/high90s for over 1 hour, HR 70s. One BP 160s/90s HR 60 but then back to BP systolic 170s. Transferred patient to local emergency room for further evaluation. Patient reported that he was discharged from ED after several hours that evening.
MODERNA COVID-19 Vaccine EUA  Patient received first dose of Moderna COVID vaccine on 1/20/2021, presented to Emergency Department on 1/29/2021 with complaints of left-sided chest pain below her breast, with an onset 1/26/2021. In ED diagnosed with Pulmonary Emboli in lower branches of left lung, and a urinary tract infection. Pulmonary Embolism diagnosed with CTA of Chest. Patient treated with Apixiban 10 mg BID with anticipated duration of therapy for at least 6 months.  Patient subsequently received second dose of Moderna COVID vaccine on 2/26/2021
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown age who was vaccinated with a dose of vaccine FLUZONE QUADRIVALENT prior 2 days of sixth months birthday, lot number, Expiration date, dose, route and site of administration not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient reports multiple epsiodes of diarrhea and nausea without vomiting starting at 0300 on 6/9/2021.  Denies any blood in stool or abdominal pain.  No relief with Pepto or vinger.
The morning after the second Covid 19 shot I woke up with soar joints, fatique,. dizzy.  Throughout the day chills, then hot, no energy.
ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT OPEN ANGLE GLAUCOMA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT OPEN ANGLE GLAUCOMA ACUTE PULMONARY EMBOLISM 12/1/2022 BILAT PLEURAL EFFUSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 BILAT PLEURAL EFFUSION ACUTE PULMONARY EMBOLISM 12/1/2022 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY
She developed a welt, two inches in diameter that started the day of the injection.  The area was raised, hard, warm to touch, and painful.  The symptoms last one to two weeks
A report was received from a health care professional on 10/23/2003 concerning 6 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine from 10/13/2003 until approximately 10/23/2003. It was unknown if there were any adverse events associated with the inadvertent administrations. There was insufficient information to determine the reporter's causality assessment. Update 1, 2/13/04: A follow up report was received from a health care professional indicating that 2 vaccinees under 4 years of age inadvertently received Fluvirin. The reporter was unaware of any adverse events at the time of reporting. No follow up pending, all information received.
blood clot in his brain; Patient collapsed on the floor at night 2 days after receiving 2nd dose; brain was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN DEATH (brain was dead), CEREBRAL THROMBOSIS (blood clot in his brain) and LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021B21A and 001821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) (seriousness criterion hospitalization prolonged). On 30-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in his brain) (seriousness criteria death and hospitalization prolonged). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, X-ray: blood clot (Positive) x-rays revealed blood clot in his brain.         No concomitant medications were reported.  After the 2nd dose, On 29Mar2021, at night, he collapsed on the floor and was taken at the hospital on same night by ambulance. So he was hospitalized on 30Mar2021 and upon doing tests and x-rays, they found blood clot in his brain. He stayed in hospital through out and transferred to hospice center on 06Apr2021 where he passed away on 08Apr2021. His brain was dead and never recovered from the clot.  Unknown treatment medications were given at the hospital.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Depression; Increasingly severe menstrual pain; Irregularity in period; Increased PMS type symptoms; Fatigue; Mood changes; It has significantly impacted functionality.; This is a spontaneous report from a contactable other HCP (patient). This 43-year-old no pregnant female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 25Jan2021 (Batch/Lot Number: en5318) (vaccinated at the same age) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hx thyroid cancer, allergies to Mango and ginger. Patient was not diagnosed with COVID-19 prior to vaccination. Patient intramuscular received first dose of bnt162b2 on 07Jan2021 with Lot number ej1685. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); loratadine (CLARITIN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 6 months after the vaccine, patient have noticed increasingly severe menstrual pain, irregularity in period, and increased PMS type symptoms including fatigue, mood changes, depression. It has significantly impacted functionality. The events received medication treatment and result in Physician office/clinic visit. The outcome of events was not recovered. Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.
3 days after 2nd dose of Pfizer vaccine  started with high-grade fevers with chills and rigors at night with associated rash neck and under arms,  continued to have fevers for several weeks. diagnosed w/ mono on 9/5/21, completed prednisone, prescribed gabapentin on 9/19/21 for HA, + sob w/ exertion. Presented to ED on 9/20/21 and had low platelet, low white blood cell count.  He reportedly has an enlarged spleen.  His LFTs were elevated.  Hospitalized in October (10/21/21-11/7/21) with fever of unknown origin. Found to have Pancytopenia and suspected hemophagocytic lymphohistiocytosis (HLH).Diagnosed with adult onset Stills disease (AOSD) with MAS in November 2021.   In December he started taking ivermectin, cyprohepadine, glutathione injections and multiple other supplements in attempt to detox COVID vaccine. Patient presented to ED 12/14/21  after outpatient labs drawn yesterday showed significant agranulocytosis WBC 1.6 and thrombocytopenia platelet 22. He continues to have daily fever related to AOSD. He was re-admitted and confirmed diagnosis of refractory HLH via bone marrow biopsy on 1/10/21. HLH complicated by cytopenias, polymicrobial infections resulting in multi-organ failure. Patient discharged with home hospice on 1/27/22 and died on 1/28/22.  His family believes his disease was directly linked to COVID-19 vaccination.
Swollen; red; itching; Hot; hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard) and INJECTION SITE ERYTHEMA (red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date after the first vaccination, the patient put lotion Hempz to the injection site, washed it off, then developed all events. Concomitant medications were not provided. Treatment information was not reported.; 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 cannot be excluded.
patient was standing to go to waiting area and fell backwards, hit floor very hard.  Called 911, took vital signs, ice to back of neck,  elevated legs/feet bilaterally. Patient conscious after approximately 30 seconds.  Was oriented to person, place and time
lt arm swollen from shoulder to wrist, arm itching; (fever 102, lethargic on 18APR98);
For her hours after vaccine administration, experienced 10 to 15 minutes of left lower quadrant visual field defect.  Was not associated with headache or other neurologic (sensory or motor) deficits. Patient with history of headaches and remote history of migraines but never migraine with aura. No personal or family history of cardiovascular disease or stroke.  Visual field defect resolved completely and has not been experienced sense.
Flu like symptoms followed by two episodes of fainting and convulsions requiring ambulance 15 hours after vaccine.
HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2022, the patient experienced headache, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, and fever. This report was non-serious.
Patient had 2 doses of Pfizer vaccine on 5/18/21 and 4/28/21, and was hospitalized on 1/22/22 for resp. failure due to COVID
patient has experience a progressive worsen rash all over the body, with non-itchy, but painful welts.  Patient has also been experiencing body temperature fluctuations since getting vaccination.  Primary care doctor has instructed patient to come see him if condition does not improve in 2 days
Painful swollen lymph node in the left armpit (same side as injection), visible about the size of a golf ball.  OTC pain medication (Motrin) helps as long as I continue to take.  Without the OTC, pain is constant, even at rest.  Also experience extreme fatigue for 3 days.  The lymph node swelling is ongoing as of today (4/18).
Well, I was experiencing pain with the first one and everything. But though that was still tolerable; 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 left, administration date 03May2021 (Lot number: EW0173) at the age of 41 years 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 (non-serious) with onset May2021, outcome "unknown", described as "Well, I was experiencing pain with the first one and everything. But though that was still tolerable". Therapeutic measures were not taken as a result of pain.  Follow-up attempts are completed. No further information is expected.
Pt with swollen, red and feverish arm to the outer 1/3 of subcutaneous tissue on (R) upper arm. Pt received Varicella (SQ) (R) arm 7-6- noticed elevation in swelling and erythema over past 3 days. Pt seen in office on 7/9 to r/o cellulitis.
Tinnitus; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A421A and 038A421A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Pollen allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced TINNITUS (Tinnitus) and HEADACHE (headache). At the time of the report, TINNITUS (Tinnitus) and HEADACHE (headache) outcome was unknown.            Concomitant medication also included unspecified spray for nose. Treatment medication was not reported.
fever x 24 hrs to 101-tmax 102.9; high shriek crying x 24 1-2 hrs duration; swelling lt thigh;
This spontaneous report was received from an epidemiologist and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck), lot number reported as 1024255, expiration date 01-JUL-2017, (dose, route and anatomical location were not reported). No adverse effects were reported. There was no concomitant medication reported. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received ENGERIX B adult (batch number AHBVC189AA, expiry date 23rd January 2015). On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: The office inadvertently administered a dose of ENGERIX-B to an adult that was expired.
PATIENT RECIEVED FIRST DOSE PFIZER AFTER RECEIVING MODERNA.  HEALTH RECORD INDICATES PATIENT RECEIVED FIRST AND SECOND DOSES OF MODERNA (2/15 & 3/12) HOWEVER PATIENT STATES THAT SHE ONLY RECIEVED ONE DOSE.  SHE MARKED "NO" WHEN ASKED IF SHE EVER RECEIVED A COVID19 VACCINE. SHE ALSO RESPONDED NO WHEN VERBALLY ASKED PRIOR TO VACCINE BEING ADMINSTERED.  I CALLED AND EMAILED THE PATIENT AND RECIEVED A TEXT RESPONSE.