chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; completely covered in hives; eyes were swollen; red eyes; lips were swollen three times the size; eczema; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), URTICARIA (completely covered in hives), EYE SWELLING (eyes were swollen), OCULAR HYPERAEMIA (red eyes) and LIP SWELLING (lips were swollen three times the size) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu), URTICARIA (completely covered in hives), EYE SWELLING (eyes were swollen), OCULAR HYPERAEMIA (red eyes), LIP SWELLING (lips were swollen three times the size) and ECZEMA (eczema). At the time of the report, INFLUENZA (Flu), URTICARIA (completely covered in hives), EYE SWELLING (eyes were swollen), OCULAR HYPERAEMIA (red eyes), LIP SWELLING (lips were swollen three times the size) and ECZEMA (eczema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment taken was cortisone cream and anti-histamine
Broke out in a rash around TD area and entire body yesterday at 6:00pm came in our office 11:30 AM 6/8/11. Td site 34x20 mm BENADRYL 25mg 1-6hrs for 7 days.
Provider d/c note:  "59yr old female with a history of T1DM, GERD, COPD, Hypothyroidism, who was brought here after she was found unconscious at home. Initially thought to suffer from pump failure but later it was discovered that her pump's battery died and she had actually ignored 2 warnings about line obstruction and low battery. It is plausible that she had suffered covid encephalopathy and due to the confusion was not able to manage her insulin pump and so it powered down causing her to go into DKA and coma. She was initially managed in ICU and is now stable on the floors. I agree with the students assessment and plan including: DKA - Resolved Rhabdomyolysis - improved with IV fluid hydration. Encourage continued hydration T1DM - Patient is confident she is capable of managing her insulin pump. She was managed here with basal and prandial insulin. Plan is to go home and set up her pump. Home care ordered to check on her tomorrow to make sure her insulin is set up with her pump. She has an appointment with endocrinology on Sept 1st. COVID - no sign of respiratory distress. No indication for covid directed therapy. Continue with supportive care. Superficial Blisters on back and right butt cheek, blister on head - local wound care   Elevate LFT's - unclear etiology, may be due to shock liver from dehydration. Hepatitis panel ordered - PCP to follow up. Plan is for repeat CMP on Monday and patient to follow up with PCP and consider liver imaging outpatient as indicated."
pt to ED with altered mental state x 2-3days; went into respiratory failure and stop shock; intubated with mechanical ventilation; pt's COVID test was positive; condition deteriorated; per death certificate pt died in the hosp; AHRF due to COVID, septic shock, AKI.
Pt fell from his chair while waiting at the waiting area after the Covid vaccination. Pt said he hadn't eated all day. He did not hit his head and he tried to get up on his own but I supported him to his chair. We called EMS as precaution. They checked his BP, sugar level and EKG. He refused to go with EMS and went home on his own.
platelet count dropped to 0; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PLATELET COUNT DECREASED (medically significant), outcome "unknown", described as "platelet count dropped to 0". The patient underwent the following laboratory tests and procedures: platelet count: dropped to 0. Therapeutic measures were taken as a result of platelet count decreased with I have had infusions twice a week , been on promacta and now EN Plate.  Clinical course: About a week after my first covid shot My platelet count dropped to 0. I have been treated for ITP ever since. I have had infusions twice a week , been on promacta and now EN Plate. So far nothing seems to help. If you have any information that could help I would appreciate it  The lot number for bnt162b2 was not provided and will be requested during follow up.
'CoVid Arm' -- well-defined rash around and below injection site (not circular, but actually more of a straight line down and along the bottom margin of the rash). SLIGHT itching, but barely noticeable.
COVID-19; COVID-19; terrific cough; higher fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 29Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "COVID-19"; PYREXIA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "higher fever"; COUGH (non-serious) with onset Oct2021, outcome "unknown", described as "terrific cough". Clinical course: the patient had typical symptoms he described as higher fever that lasted for about three days and then it broke. Then he had a terrific cough. The worst cough I have ever had even though he was vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient presented to ED with right sided numbness including arm, leg and body. Face not involved.  Over 14 days since J&J COVID vaccine. Patient admitted with  left thalamic stroke, neurologist involved, not believed to be related to vaccine. Started on aspirin 325 mg daily and Plavix. Still hospitalized.
WITHIN A FEW SECONDS AFTER RECIEVING THEIR VACCINE, THE CLINE T TURNED WHITE AND SAID SHE FELT HOT. AFTER SITTING IN THE CHAIR FOR A COUPLE MINUTES, THE CLIENT WAS HELPED TO THE FLOOR AND FEET ELEVATED. WITHIN A MINUTE THE CLIENT FELT BETTER AND WAS ABLE TO SIT. SHORTLY AFTER, THE CLIENT THEN WAS ABLE TO WALK. WET COMPRESS AND A FAN HELPED CLIENT COOL. NO OTHER ISSUES OR CONCERNS.
13 year old whom has not had all of their IPOL shots is able to get it patient is behind schedule and only received one dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00864486) and transmitted to Sanofi on 18-Nov-2021.  This case involves a 13-year-old female patient who did not have all their IPV (VERO) [IPOL] (lot number, expiry date not reported) shots was able to get it, was behind schedule and only received one dose via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (inappropriate schedule of product administration).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  It was reported "Medical Assistant calling to find out if a 13-year-old whom has not had all of their IPOL shots is able to get it. Caller stated patient is behind schedule and only received one dose. Caller stated patient only had one injection of IPOL initially."  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 the 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.  There will be no information available on batch number for this case.
severe back pain 3 weeks after second dose.  Nothing is alleviating my pain.  I cannot sit, sleep or walk without debilitating pain.  I Have been to Urgent Care and my primary doctor for help.  Muscle relaxers do nothing and it's been a full week of misery.
SORE ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient has no known drug allergies, patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 12-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20220210630.
pt recvd vax; devel GBS; md felt GBS related to hep B vax;
After about five minutes patient became pale and diaphoretic. Lasted about 20 minutes then patient left after signing an AMA. Patient with mother.
About 15 minutes after arm felt "tingly", injection sight pain,  site was swollen, hard and red.  Around 10-12 hours after I got body aches, lower back pain, felt  like I was coming down with something. By Monday night I came down with 101 fever then spiked up to 103 for 3 days then broke on Thursday. I called my Employee Health on Monday to inform them of my condition, they had me get tested for Covid on Tuesday morning (test came back negative). I then went to urgent care  on Wednesday due to my fever, they tested me for Strep and diagnosed me with Faringitis, treated with over the counter medication.  After Thursday morning my fever broke around 10am and started to feel better. Still have a little rash, sore throat but feeling better. If symptoms get worse I will go to the Dr.  or urgent care but am feeling better now.
his spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795.
Chest pain; cough; was feeling very tired; Very weak; Left Arm hurts; Trouble Walking; Slept for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak), PAIN IN EXTREMITY (Left Arm hurts), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and CHEST PAIN (Chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced ASTHENIA (Very weak), PAIN IN EXTREMITY (Left Arm hurts), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (was feeling very tired). On an unknown date, the patient experienced CHEST PAIN (Chest pain) and COUGH (cough). At the time of the report, ASTHENIA (Very weak) was resolving and PAIN IN EXTREMITY (Left Arm hurts), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours), CHEST PAIN (Chest pain), COUGH (cough) and FATIGUE (was feeling very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         Patient was advised by the doctor to drink Diet Mountain Dew for the potassium in it for energy.   This case was linked to IN-MODERNATX, INC.-MOD-2021-064921 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: Followup information included updated contact info Dose Start date updated, added lab result  new event was added Events outcome was updated from unknown to  resolved except fatigue.; Sender's Comments:  IN-MODERNATX, INC.-MOD-2021-064921:Mother case
Information has been received from a licensed practical nurse concerning a 9 year old male with no medical history or allergies who on 05-MAY-2007 at 9:30 AM was vaccinated SC in the left arm with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot number 657002/0337U). There was no illness at the time of vaccination. On 05-MAY-1997 within 24 hours of the vaccination, the patient developed an injection site reaction. The patient was seen in the office on 07-May-2007 and the reaction was described as a sore and painful injection site with a 9X7 inches pustule in left arm with a central pustule at the injection site and a low grade fever. The patient was given a prescription for Augmentin 400 mg/5ml two teaspoons twice daily for 10 days. The patient was to be rechecked in the office 7-MAY-2007. The patient's status is recovering. No product quality complaint was involved. Additional information has been received from medical assistant who stated that on 06-MAY-2007 the patient vomited in the morning. On the day of vaccination 05-MAY-2007, the patient developed redness and soreness at vaccine site. The symptoms worsened and the patient was seen in office on 07-MAY-2007 with approximately 9X7 inch redness and induration and central pustule at injection site. There was no fever (99.5). The patient was experiencing some pain on left axilla. The patient was treated with Augmentin. At the time of report the patient had recovered.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The  Public Health District, per guidance from the  Department of Health (DH), Centers for Disease Control and Preventio (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
This case was reported by a nurse to a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoid and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
Patient received covid vaccine on 9/4/21 and later that day started with lip swelling which graduated into full facial angioedema, facial rash and itchy skin that continued to worsen over the next few days. Patient was seen in office on 9/8/21 and treated with Benadryl and cetirizine. Patient was seen again on 9/9/21 and was doing better. Status of patient was unable to be obtained after this.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-NOV-2012 11;00, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
she was blacked out for a good 30-40 seconds; drenched and very sweaty; extremely hot; nauseated; A spontaneous  report was received from a consumer concerning a 25-year-old, female patient who received Moderna's COVID-19 vaccine and experienced blacking out, nausea, feeling extremely hot and sweaty.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included desogestrel-ethinylestradiol for birth control.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 16 Jan 2021, one day after the vaccination, the patient was found in the bathroom unconscious. The patient reported feeling very nauseated, extremely hot and drenched with sweat prior to blacking out. The duration of the blackout was approximately 30 to 40 seconds. Patient states she was washing hands, about to plug something in and next thing she knows she is being rolled over by her husband.  Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, blacking out, nausea, feeling extremely hot and sweaty, was not provided.
Patient came over and advised me he felt like his throat was swelling and he was having a little difficulty swallowing. He was able to drink water which he thought helped.  He was given Benadryl 50 mg IM.  Symptoms resolved completely.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB strength 2.5/0.5 (unit unspecified) (lot #L018500, expiration date 13-APR-2017 and lot #J013394, expiration date 25-AUG-2016) (dose frequency: once) intramuscularly (dosing details and anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Felt well/fine after shot. Second day, felt lethargic with headache, skin ache, and general apathy.  Relatively minor symptoms, but enough to complain about.  Took two naps during day. Hope to feel better tomorrow.
a month after each shot, she would flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunisation.     Concurrent medical conditions included Irritable bowel syndrome.    In 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) on 19-Sep-2023 for Irritable bowel syndrome, at a dose of UNK (second dose). At the time of the report, IRRITABLE BOWEL SYNDROME (a month after each shot, she would flare up) outcome was unknown.            Patient past Moderna-covid 19 vaccine included COVID-19 vaccine on an unreported date in FEB-2021 and MAR-2021, and then summer and then winter 2022 with unknown batch lot number. The patient reported that the physician said lymphocytes were asked to generate antibodies and there was no wonder that's when the flare ups happened. The patient reported an irritable bowel syndrome flare up comes every 30 days after she stops the steroid. Patient reported that she started to flare 3 days before taking treatment medications.   This case was linked to MOD-2023-744592, MOD-2023-745439 (Patient Link).