chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid test result=Positive / covid test date=Jan2022; covid test result=Positive / covid test date=Jan2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Jun2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and intramuscular, administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hepatitis b, for Immunization; Flu, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  Additional information: The patient was not received any other vaccine in four weeks. The patient was not had Covid prior to vaccination. The patient had no known allergies. The patient tested for Covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events DRUG INEFFECTVE, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE HYPOXIA 1/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
VACCINE GIVEN AFTER BEING AT ROOM TEMPERATURE FOR MORE THAN 3 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced vaccine given after being at room temperature for more than 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given after being at room temperature for more than 3 hours was not reported. This report was non-serious. This case is a duplicate of 20210541234. This case, from the same reporter is linked to 20210540338.
Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- especially after the 2nd dose- Then, she started having increase heart palpitations and chest pressure. Eventually noted ischemic changes with purplish discoloration face, hands and feet. At this time it became great effort to walk due to lack of air- SOB was severe. She was taken to ER at hospital where she was admitted with possible PE, MI or heart failure. After few days no improvement was achieved and patient trans ported to another Hospital to receive more advance care but she was pronounced death in the morning of 5-11-21. The death certificate heart failure as immediate cause of death, preceded by PE and pulmonary hypertension.
Severe arm pain all the way down (same arm as injection) lasted one day, severe pain on bottom of the feet kept me awake all night, confusion, nausea, loss of appetite, muscle aches all over my body 2 days, slight head ache, fatigued, My aunt had a hard time waking me up. She shook me and called my name. I fell into a deep deep sleep. Slight chest pain lasted 1 or 2 minutes. If symptoms continued I would have called the Dr. All symptoms subsided.
A week after getting the shot the left side of my body went numb/tingling.  My left foot felt like I was stepping in a puddle of water.  Left facial check went numb, left side of my neck hurt, left eye went blurry, left ear pain and sore throat. Went to ER to rule out a stroke. They did blood work, CT scan and EKG. Since then I have seen a neuorolgist, ENT, Cardiologist and my primary doctor. I have had multiple MRI's and blood wrok done. I still am having chest pains, sore throat, ear pain, tingling in my left arm, and blurred vision.
Technician admin vaccine. Mild vasovagal response after 3rd vaccine. Patient reported feeling nauseous, became pale, and hot. Patient was sitting in chair and no LOC. Pharmacist called over to assist in management. Patient provided water. Patient had color return immediately, was still feeling hot. Patient was fanned to help cool and bp was taken. BP 101/78 pulse 61. Patient provided a KitKat. Patient symptoms resolved and felt better; wanted to go outside with husband to get fresh air. We requested patient to wait in area, but patient insisted with husband that they would just like to get fresh air outside and will let us know if they have any other issues. Patient was pleasant with us and husband was also very comforting for wife.
After Flu vaccine administration on 10/5/2023, the employee developed redness and swelling at the injection site as well as pain in the arm.  Approximately a week later, she started experiencing numbness and tingling in her hand.
Experience tingling, then numbness in my hand then it went to my face which was a hardness and tingling or needles & pins in my lip, it was on the left side, the same side as the injection and started to subside after an hour and a half  to 2 hours, defined a strange wierd feeling which I still very slightly feel.
Extreme dizziness; Heart racing; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 04May2021 at 12:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, asthma, high blood pressure, thoracic outlet syndrome and carpal tunnel.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) and experienced allergy to flu vaccine; ethinylestradiol; etonogestrel (NUVARING) and experienced drug allergy. On 04May2021 at 13:00, the patient experienced extreme dizziness, heart racing and diarrhea. The dizziness had not stopped. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme dizziness, heart racing and diarrhea was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sunday, 21February 2021 and was just a little tired; Woke up at 5:25 a.m. three days after 1st vaccine on Saturday, 20 February 2021 and was extremely dizzy; Unable to walk; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 17Feb2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure since age 49 year 2003. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril/ hydrochlorothiazide (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and alive vitamin supp (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient woke at 05:25 and On 20Feb2021 at 05:30, three days after first vaccine on Saturday and was extremely dizzy and unable to walk. The patient went back to back and slept from 11:00 to 17:05. Drank some water, ate a little food and went back to bed.  Up at 19:15 for a few minutes and went back to bed until around 6:15 AM Sunday, 21Feb2021 and was just a little tired, but was not dizzy anymore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events extremely dizzy and unable to walk and just a little tired was recovered on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
No adverse affect at time of injection.  2 hours later, began to have problems.  Saturday April 10, fatigue, dizzy, finally able to eat, still not feeling well, exhausted and weak
This patient is one of a cluster of 15 patients that had an injection site reaction characterized by erythema, pruritus & nodule at the injection site. Lasted 14 hrs to 1 week. No treatment given.
vomiting and diarrhea starting the evening after immunizations.  worsened the next evening with nonbloody liquid diarrhea several times each hour and nonbloody nonbilious emesis.  supportive care with Zofran and fluids.
2003-present, hearing loss, scoliosis, sinus,high blood pressure, tinittus, rhinitis, sleep disorder, headaches, muscles joint pain, muscles spasm, recurring skin lesions, fatigue, constipation, diarrhea, discogenic disease, blood in feces, chills, vision problems, PTSC, treatment in hospital. 3/3/09-records received-11/27/07-alcohol abuse, substance induced mood disorder, PTSD, insomnia, depressive symptoms. Chronic hypertension, persistent front headache associated with dizziness, lightheadness and diaphoresis. Fever, some photophobia and nausea. Possible blast trauma. Nightmares, hearing voices at night. Subjective tinnitus, acute sinusitis. Facet joint pain lumbar spine.  Follow-up: muscle aches, asthma, pre-diabetes, depression. I want to get better.
Dizziness, sluggish, nausea, feeling of not well on day after injection Since injection skin does not heal properly or in a timely manner and problems breathing more than before.
pt was given the flu vax on 4NOV94 on 15NOV started w/cough; 17NOV started w/fever; By 18NOV was in severe resp distress & was adm to hosp; dx viral pneumonia; cultures neg;
When I first got the shot,  my right hand tingled for a few minutes and then it went away.  My arm hurt for About a week after the vaccination my right arm (where I got the vaccination) started to itch.  I felt a slight bump- like a mosquito bite- where the shot happened.  The next day I had a slight rash.  Since then, there is a larger circle around the injection site and it has itched since then.  The rash is still there and it itches off and on- especially when my sleeves rub the wrong way on it.
Patient had passed out approximately 4:00am the morning after the vaccine and went to the emergency room. Medical staff did not necessarily link it to the vaccine as she has had multiple episodes of fainting due to her brain tumor.
After both vaccines I got a fever, body aches, nausea, a sore arm, and swollen lymph nodes. In March, 1 month after my vaccine, I began having debilitating chronic pain in both legs. Primarily nerve pain. I went to the hospital for this numerous times and saw countless doctors, but no one was able to figure it out. I was given medications to try and help with these symptoms. A year and a few months after, I woke up one morning unable to walk and was hospitalized for 5 days. Lesions were found in my brain and spine and I was sent home with a walker. I completed PT for months twice a week and eventually stepped down to a cane and then nothing. I was diagnosed with MS in September of 2022.
On 2/25/2004 mother brough her child in for immunizations. On 2/26/2003 mother brought the child back stating that his arm was swollen. She states that she noticed it last night; she was not sure of the time. Upon examination the right deltoid was noticeably red,swollen, and feverish. Mother states that the child has no other complaints other than a sore right arm. Mother was encouraged to give the child an inti-inflammatory (Motrin)to help reduce the swelling. Was also told that if the swelling became worse and she was concerned to visit the ER if after hours. Will contact mother in the am to see if there has been any improvement in the child's condition.
10-15 minutes after the vaccine was administered that patient c/o "feeling dizzy and eyes were swirling"  Some mild shortness of breath and patient was sweating.   Rapid response was called and responded. Pt was taking to Urgent care In facility for further evaluation.
Myalgia, Arthralgia, Diarrhea, hard area at site Narrative:
Patient presented to the ED on 4/4/21 and was admitted to another facility for intestinal obstruction. Patient presented to the ED on 5/6/21 and was admitted for hypotension due to hypovolemia.
Two days after my 2nd injection I experienced a major Sweet's Syndrome skin outbreak.; The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions  on my neck, face & back.; The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions  on my neck, face & back.; rash on chest, left arm, with smaller lesions on my neck, face & back/have light rashes; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the right arm on 07Mar2021 at 14:45 (02:45 pm) at the age of 73-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at the facility. The patient did not receive other vaccines on the same date. The patient had no other vaccine in four weeks. The patient's medical history included myelodysplastic syndrome (MDS) and Sweet's Syndrome. Concomitant medications included amlodipine besilate (AMLODIPINE), lenalidomide (REVLIMID), prednisone, danazol, and clopidogrel bisulfate (PLAVIX); all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6201) on 14Mar2021 (as reported; pending clarification) at 02:45 pm at the left arm for COVID-19 Immunization. The patient also previously took levofloxacin (LEVAQUIN) and valaciclovir hydrochloride (VALTREX) and experienced allergies with both drugs. The patient reported that as a person with MDS and Sweet's Syndrome, he has had a history of experiencing major skin outbreaks but it has been under control for over a year with oral meds. Two days after his 2nd injection he experienced a major Sweet's Syndrome skin outbreak. Apparently, the vaccine reacted with his autoimmune system to trigger a reaction. The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions on his neck, face & back. Once the symptoms appeared, the outbreak followed its normal course of action. It took about 5 days to reach its apex; thereafter the symptoms began to slowly subside. He is now into day 9 and have light rashes. By day 12 he expects all traces of the rash to be completely gone. Patient's assessment: he was not allergic to the vaccine but the vaccine set off his immune system. If/when the rash took longer than the normal 6 days to reach its apex, he was prepared to significantly increase his Prednisone. The patient had no COVID prior to vaccination and post vaccination. The patient did not receive treatment for the events. The onset of events was on 09Mar2021 at 21:00 (09:00 pm) with outcome of recovering.
Patient was given MMR dose as pre-employment protocol for an immune screen that showed no immunity to measles.  Patient did not have documentation of any vaccines from childhood.  Employee stated sore throat, localized redness to injection site, swollen lymphnodes, and slight rash to face, back, neck, and chest on 5/20/08.  Patient reports no fever.  Stated slight muscle ache 2 days prior to rash apprearing (5/18/08).
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U002539, was verified to be a valid lot number with an expiration date reported and established as 24-JUL-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 13-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 59 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Pt recvd 2nd dose of vax on JUN92 next, day devel sore throat, achiness, flu-like sx, general malaise which persisted for one day; pt later recovered; No further details were provided;
Head pressure, tinnitus, vertigo/dizziness ongoing since 7 days after the shot. Now 3 months later, symptoms remain and hearing is diminishing in right side.
Slight fever, chills, body aches, tiredness; Slight fever, chills, body aches, tiredness; Slight fever, chills, body aches, tiredness; Slight fever, chills, body aches, tiredness; This is a spontaneous report received from contactable consumer (Patient). A 55-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247) via unspecified route of administration, administered in right arm on 23Feb2021 at 12:00 (age at the time of vaccination was 55 years old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247) via unspecified route of administration, administered in right arm on 02Feb2021 at 12:00 (age at the time of vaccination was 55 years old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. On 24Feb2021, Slight fever, chills, body aches and tiredness. Patient did not receive any treatment. On 24Feb2021, the patient underwent lab test and procedure which included Slight fever. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Jaw stiffness for 5 days Development of numerous mouth sores Fever for 1 day Frequent headaches for 5 days Back stiffness for 5 days
Syncope <5 min. after admin of vaccines. From a sitting position while assuming standing position, she fell to floor. Syncope duration <5 sec. First aid to bump on forehead (ice) & bacitracin to abrasions on ankle & knee. After 15 min. of observation and resolution of syncope was ambulatory and left the clinic with her mom.
Chills; headache; extreme body aches; joint pain; severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), MYALGIA (extreme body aches), ARTHRALGIA (joint pain) and FATIGUE (severe fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), MYALGIA (extreme body aches), ARTHRALGIA (joint pain) and FATIGUE (severe fatigue). At the time of the report, CHILLS (Chills), HEADACHE (headache), MYALGIA (extreme body aches), ARTHRALGIA (joint pain) and FATIGUE (severe fatigue) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.