chrisvoncsefalvay/vaers-outcomes huggingface dataset:
creatinine went up for a little bit but then it came back to normal again; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single both for COVID-19 immunisation. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "recovered", described as "creatinine went up for a little bit but then it came back to normal again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was told to take the COVID-19 Pfizer shots so the patient took number 1 and number 2. The patient's nurse said the creatinine went up for a little bit but then it came back to normal again. It came back to where it was before the patient took the shot. The patient read in the article here that, the patient took a booster shot now (15Oct2021), it said it may go up 20 percent. The patient asked if it would come back again and if it was just temporary side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:  THEN PATIENT'S DAUGHTER CALLED A WEEK AFTER THE INJECTION AND SAID THAT PATIENT'S ARM IS SWOLLEN AND PAINFUL. ADVISED PATIENT TO DO WARM COMPRESS TO PROMOTE BLOOD CIRCULATION.PATINET ADVISED TO GO TO MD IF NOT RESOLVED
Pop out came out; 19percent had the lymph nodes in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm). At the time of the report, SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Rt anterior thigh w/ 6 x 6 cm redness & induration.Pt limping,fever 101 for 2 days.
patient still got covid; Initial information received on 19-Jan-2021 regarding an unsolicited valid serious case from non-healthcare professional.   This case involves patient (unknown demographics) who had covid (covid-19), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) 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 and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed covid (covid-19) (serious ) (Unknown latency), following the administration of INFLUENZA VACCINE. Covid-19 was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the event.  Information regarding the batch/lot number should be requested.; Sender's Comments: This case involves patient of unknown age who presented with covid-19, after vaccination with INFLUENZA VACCINE .Time to onset is unknown. Moreover, concomitant medication, family history, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Local swelling, axillary lymphadenopathy, hives around injection site per pt.
G61.0 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY 4/21/2023 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY
This non-serious initial spontaneous case, was received from a Pharmacist, on 20-Sep-2017, concerning a 23-year-old adult female patient. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number (as reported 178601), expiry date (April-2018): not reported). It was reported that FLUAD was suggested for 65 and over (explicitly coded to inappropriate age at vaccine administration). It was reported that, there was no adverse event after receiving the vaccine. The outcome of the event was not reported. The reporter assessed the event as non-serious. Follow up received on 22-Sep-2017: It was reported that, there was no adverse event after receiving the vaccine. The narrative was amended accordingly.
left shoulder and neck stiffness and pain with movement since first vaccine worsened after second vaccine denies any trauma, illness or increase activity
Pimply rash on neck and trunk; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 23Jun2021 at 16:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, sulfonamide allergy and COVID-19. Concomitant medications included aciclovir sodium (ACYCLOVIR) and losartan potassium (LOSARTIN). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jun2021, the patient experienced pimply rash on neck and trunk. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event pimply rash on neck and trunk was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse refers to herself a 51 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced hypersensitivity (hives, swelling, runny nose, sneezing, hard time breathing). The outcome of hypersensitivity was unknown. The reporter considered hypersensitivity to be related to PNEUMOVAX 23.
Developed severe vertigo 2 days after vaccination with HPV and MCV.  Diagnosed with presumed labyrinthitis, given a course of prednisone without significant improvement.  Saw ENT, referred for MRI (see below).
Active cold sore; Feeling sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age (Age: 59, Unit: unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose tomorrow, 09Jan2021 but was asking if she can take the second dose because is feeling sick and has active cold sore since an unspecified date. She would like to know if there is any recommendation on if she should wait to get the second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
12-14hrs later - sore arms, fever, chills, and body aches lasted for 4-5 days, and Monday I was still tired.  Sep/Oct 2021, I first noticed when I was exercising, my heart was racing and that was not normal and now its daily and it could stress and now I do low impact exercise and my heart is racing almost weekly and when I bent to pick something up. My heart was racing. I saw my doctor on November 17, 2021 and was referred to Cardiologist on November 24, 2021. Got heart monitor.
I developed a sore throat about 10-11 days after the vaccine. I have no idea if it's related, but given that I always wore a mask and no one else in my family got it, I think it could have been. It lasted for 2 days.   Please note that it was a mild sore throat; I missed work only to be sure I wouldn't expose anyone to COVID in case that's what the symptoms were from.
Significant swelling of upper left arm and pain.  Treated with ice and naproxen.
Diagnosed with Bells Palsy on 5/1/21, two days after second dose was administered.
Acute muscle and joint pain that extended for about 4 days. I had a itchy rash on my left arm and it when over my shoulder down my back. They was the same side of my injection site. I got referred to a dermatologist. She prescribe a steroid cream.
Patient is a 74y.o. male who came to the ER with shortness of breath. He had been diagnosed with COVID-19 earlier in the week. He was treated with monoclonal antibody therapy. He continued to have dyspnea and developed hypoxia so he came into the ER. Patient was treated with Decadron and Remdesivir.
Total weakness.  Could not get out of bed without being lifted.  After getting up was able to walk with assistance. No appetite or thirst. Could not stay awake.  Slept most of a 36 hour period.  No treatment given.  After that was tired for another 2 days but able to maintain a schedule.
aseptic meningitis; varicella-zoster virus (VZV); .  This report has been received from the authors in a published article, tittle as stated above concerning a 31-year-old male patient. The patient's medical history included two dermatomal varicella-zoster virus (chickenpox) infection episodes in the past, first during childhood and second at 29 years. There were no other complications, and the recovery was uneventful. The patient has been healthy and took no medications.   On an unknown date in 2020 (reported as the prior week), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, as part of his workplace requirement.  On an unknown date in 2020, the patient presented to the emergency room (ER) with an acute headache for 5 days in the summer of 2020. The headache was localized frontally. The pain was described as sharp and non-pulsating in nature and 10/10 in intensity. It worsened gradually and was associated with nausea and one episode of nonbilious, non-bloody vomiting. He took over-the-counter Nonsteroidal anti-inflammatory drugs (NSAIDs) for the headaches with no improvement. The patient was admitted to a hospital. On physical examination, he appeared uncomfortable and complained of a persistent frontal headache. Vitals were within normal limits, and physical examination was unremarkable without any dermatomal rash. Signs of meningeal irritation were negative. COVID-19 PCR and COVID-19 antibody testing were negative. CT head and CT angiogram head and neck were unremarkable. Lumbar puncture was performed, which showed elevated proteins (86 mg/dL) and mononuclear cells with a lymphocytic predominance (96%) on initial studies suggestive of viral meningitis. The patient received acyclovir and ceftriaxone. The patient reported an improvement of his symptoms on hospital day 2 with an appropriate pain control regimen. The patient was tested for human immunodeficiency virus (HIV), with results of negative. Cerebrospinal fluid (CSF) PCR studies were positive for varicella zoster virus (VZV) PCR (6800 copies/mL) and negative for Herpes Simplex Virus 1 and 2. Diagnosis of aseptic meningitis secondary to VZV was made. VZV IgG came back positive. Intravenous acyclovir with appropriate hydration was continued. The patient's headache resolved gradually, and he was discharged home (hospital day 4) on oral acyclovir for 10 days. The patient was followed up after discharge and was doing well with complete resolution of symptoms on an unknown date.  The reporter considered the event of aseptic meningitis secondary to VZV to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  Upon internal review, the event of meningitis aseptic was considered to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.
Weakness, extreme fatigue, unable to walk or breathe, pulse at 226, Clinic unable to secure blood pressure reading, nausea.
starting getting dizzy about 1230-1PM; then 15-20 mins later became nauseated & started vomiting; Instructed to contact MD;
during noc p/vax pt had low grade fever, strong high pitched cry for 2 hrs, & legs turned blue from hips to knee; appetite next day & few days afterward dec from 6-9 6 ox bottles to 3 bottles daily; better 11AUG less cranky;
Felt really bad for a few days; Chills; Fatigue; Severe pain; Back pain; Couldn't get out the bed; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed), FEELING ABNORMAL (Felt really bad for a few days), PAIN (Severe pain) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included TRAMADOL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain). On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain) had not resolved and FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            Reporter did not allow further contact
This spontaneous report as received from a healthcare professional via a company representative refers to an approximately 62 year old of unknown gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 08-OCT-2013, the patient was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Concomitant medication was not reported. The reporter stated that the ZOSTAVAX had been improperly stored in the refrigerator for an unspecified time. No adverse effect reported. Additional information has been requested.
COMPLETELY NUMB LIPS; This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAY-2021, the subject experienced completely numb lips. The action taken with covid-19 was not applicable. The patient had not recovered from completely numb lips. This report was non-serious.
The first couple of days i just felt soreness in my arm but after three days until the seventh day I was in so much pain that I couldn't move a lot and took 2 acetaminophen pills three times a day and barely eased the pain. On the seventh day I felt my focus and concentration not clear. Day 8 is when I started feeling good and fully functional
had Covid; had Covid; This is a spontaneous report from a Regulatory Authority. A non-contactable consumer reported that a male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she knew a gentleman in withheld who, along with his wife, had Covid. He got the Pfizer vaccine and now needs quadruple bypass. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rapid heartbeat; difficult to breath; chest tightness; felt high, couldn't focus, out of it; chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt high, couldn't focus, out of it), CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (difficult to breath) and CHILLS (chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (sore arm). On 05-Feb-2021, the patient experienced FEELING ABNORMAL (felt high, couldn't focus, out of it). On 20-Feb-2021, the patient experienced CHEST DISCOMFORT (chest tightness) and DYSPNOEA (difficult to breath). On 23-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat). On 06-Feb-2021, CHILLS (chills) and VACCINATION SITE PAIN (sore arm) had resolved. On 14-Feb-2021, FEELING ABNORMAL (felt high, couldn't focus, out of it) had resolved. On 23-Feb-2021, HEART RATE INCREASED (rapid heartbeat) had resolved. At the time of the report, CHEST DISCOMFORT (chest tightness) and DYSPNOEA (difficult to breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not Provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow Up was received on 29-apr-2021 contains updated contact  address of the reporter
The vaccine had expired in 05/25/2021 and was administered on 05/27/2021.
This spontaneous report as received from a consumer refers to her son. Drug allergies, reactions or medical history were not reported. On an unknown date, when the patient was 15 months old he was vaccinated with a dose of M-M-R II (lot#, expiration date, route of administration and dose were not reported). Other suspect therapies included flu vaccine (manufacturer unknown) (lot#, expiration date, route of administration and dose were not reported) and VARIVAX (Merck) (lot#, expiration date, route of administration and dose were not reported), both received at the age of 15 months. No concomitant medications were reported. The reporter stated that on an unknown date, after immunization the patient experienced seizures, a fever for two months and was later diagnosed with autism. The outcome of seizures, fever for two months and autism was reported as not recovered. The relatedness between the events and suspect drugs was not reported. Upon internal review the seizures were considered to be medically significant. Additional information is not expected.
9:28 SITTING IN CHAIR IN POST VACCINE AREA, BECAME UNCONSCIOUS, SLUMPED FORWARD, CAUGHT BY RN PREVENTING HIM FROM FALLING.  WE TRANSFERRED HIM TO COT. LAID HIM DOWN WITH FEET ELEVATED COOL COMPRESS TO NECK. HE WAS DIAPHORETIC, COOL CLAMMY SKIN, PALE COLOR.   VS 88/60, P 37, O2 SAT 97% RESPIRATIONS SLOW BUT REGULAR, NO CHEST PAIN, NO SOB.   9:34 ALERT AND ORIENTED X3. TALKING, SKIN COOL CLAMMY BP 108/74, P 44 O2 SAT 95% 9:36 SITTING UP IN COT, ATE SOME GRANOLA, DRANK POWER AIDE, HAD NOT EATING ANY BREAKFAST, TALKATIVE. 9:40 BP 100/64, P 40MO2 SAT 97% 9:44 BP 108/72 P 42 RESPIRATIONS 18 9:48 AM CALLED 911 PER CLINIC MANAGER AND STAFF ON SITE DUE TO LOW HEART RATE.  9:49 BP SITTING 98/72 P 54 0 2 SAT 98 10:02 EMT ARRIVED, THEY ASSUMED CARE OF PATIENT AND BROUGHT TO AMBULANCE FOR EVALUATION. 10:20 RETURNED TO CLINIC AREA.   PER STAFF ON SITE PERSONNEL, PARTICIPANT REFUSED TO BE TAKEN TO HOSPITAL AGAINST RECOMMENDATIONS OF THE EMT STAFF.  THEY HAD RECOMMENDED HE GO TO BE EVALUATED AT HOSPITAL.  HE RESTED IN CHAIR IN POST VACCINE AREA, TALKING ON PHONE.   10:57 HE LEFT SITE WALKING UNACCOMPANIED.
Resident had received second covid-19 Moderna booster on 5/11/22;  Resident has frequent history of UTIs, had VRE in urine on 3/25/22 , resident was taking amikacin 250 mg IM twice a day from 5/16-5/21 for different UTI. Resident was seeming to improve, alert and oriented to person and place. On 5/31 around 10 pm resident began reporting nausea and not feeling well, on 6/1 resident had emesis x 2 prior to am meal, refused meds, was able to eat some jello. No abdomen distention, some tenderness noted to left upper quadrant, VS stable for resident 136/88-98-14-97.1-96% on 2 L via nasal cannula. Later in the afternoon resident began having brown coffee colored liquid emesis on clear liquid diet, labs performed and sent to hospital. Residents oxygen began to drop to 86% so increased oxygen to 3L, resident complaining of abdomen and chest pain and sent to emergency department via ambulance. Medical Center later called to inform staff that resident had passed away and had a  incarcerated hernia. Resident was a DNR.
Within a few hours I fell on the floor unable to move paralyzed from my chest down. I spent 1 wk in the hospital the rest of Nov in a skilled nursing home - Rehab
Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 31 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: ER8730), in right arm, on 16Apr2021 at 15:00 as dose 2, single (Lot number: EW0164), in right arm and on 24Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FG3527), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BUPROPIONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2023, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253737 same patient, different event, different dose;