chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not sure if related or an adverse reaction to COVID-19 vaccine:  Taking Rinvoq - immunosuppressant for Rheumatoid Arthritis:   dentist found lesion under tongue on 8/28/21; saw oral surgeon on 8/31/21 - removed lesion and sent to lab for biopsy; 9/4/21 - Urgent care Visit - diagnosis throat infection and otitis media infection:  antibiotic prescribed for 10 days.  Covid test:  negative; strep test: negative. Biopsy of lesion under tongue - results received 9/10/21 at oral surgeon's office. Biopsy diagnosis - Submucosal Inclusion Cyst, Benign.
Soreness @ site of inject, starting approx 2 days post vax; arm is still sore; prior to receiving the vax pt's arm was exposed to air condition;
Information has been received from a pharmacist referring to a 34 years old unpregnant female patient. There were no pertinent medical history or drug reaction/allergies of the patient. On 21-SEP-2015 the patient received her first dose of VARIVAX (Merck) (dose, lot# and expiration date were not reported) subcutaneously. There was no concomitant medication. After receiving the VARIVAX (Merck) the patient experienced a varicella like rash on unspecified areas of her body on an unspecified date in 2015. The patient visited her unspecified physician on an unspecified date in 2015 who diagnosed the patient with chickenpox. The patient was not prescribed any treatment for the rash. The outcome of the event was reported as recovering. The causality was not reported. Additional information is not expected as there is no consent to contact any healthcare professional.
Kidney infection; Arthritis; hand was not working as well; not walking well; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501323-00.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown) and on 02Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KIDNEY INFECTION (medically significant), outcome "recovered"; ARTHRITIS (non-serious), outcome "unknown"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "hand was not working as well"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "not walking well". The action taken for upadacitinib was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "kidney infection", "arthritis", "hand was not working as well" and "not walking well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) arthritis was probable, for kidney infection, upper extremity dysfunction, walking difficulty was not reported.  Clinical course: it was reported that on unknown dates, the patient experienced COVID-19 vaccination stirred up arthritis, kidney infection, hand was not working as well and not walking well and RINVOQ was not working very well, and causality was not provided. On an unknown date, kidney infection resolved. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. The patient had taken COVID-19 vaccination side effects. COVID-19 shot stirred up her arthritis so the physician told her she should not have taken it. She had a kidney infection and stopped RINVOQ for two weeks and resumed. It was unknown if she was enrolled in a COVID-19 vaccine trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Seriousness criteria other medically significant (OMIC). Initial report received on 7/17/06 from a physician. A 32 year old female pat whose past medical history included the current pregnancy, and one previous pregnancy that was a normal full term delivery, and allergy to sulfa drugs had received an IM dose of Adacel, lot number C2492BA, in the left deltoid, and a dose of Tubersol 5TU, lot number C2214AB, on 7/14/06 as a pre employment requirement. The route and site of administration of the Tubersol was not reported. The date of the pts last menstrual period was on 7/18/06, and her expected date of delivery is 3/25/07. At the time of this report, the pt was taking prenatal vitamins and was seeing her primary care physician. The pt had not established an OBGYN physician to follow her pregnancy care. Per the reporter, the pt had no experienced any adverse events since the Adacel and Tubersol administration on 7/14/2006. Follow up information received on 9/21/06. Per the reporter, the pt did not have any illnesses at the time of the vaccination on 7/14/06. The Tubersol 5 TU was administered Intra dermally on 7/14/06. The site of administration was not reported. Follow up information received on 11/20/06. The pt received the Tubersol 5 TU vaccine in the left forearm. On 9/3/06, 51 day post immunization, the pt experienced a spontaneous abortion at less than 20 weeks gestation. An ultrasound performed that day, showed a non viable pregnancy and a suction D and C was performed. The recovery status of the pt is unk.
throat was a little closed; Diarrhea; trouble clearing her throat, her throat was a little closed; coughing; rash towards the left side of the neck; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL DISCOMFORT (trouble clearing her throat, her throat was a little closed), COUGH (coughing), DIARRHOEA (Diarrhea) and OROPHARYNGEAL DISCOMFORT (throat was a little closed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 12-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (trouble clearing her throat, her throat was a little closed), COUGH (coughing), RASH (rash towards the left side of the neck) and HEADACHE (headache). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 14-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat was a little closed). At the time of the report, PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL DISCOMFORT (trouble clearing her throat, her throat was a little closed), COUGH (coughing), DIARRHOEA (Diarrhea), OROPHARYNGEAL DISCOMFORT (throat was a little closed), RASH (rash towards the left side of the neck) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Astesex when needed (reflux), No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-may-2021 and contains No new information
Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swollen, numbness, stiffness. Nerve pain on right arm, left hand joint pain at 8d
SWELLING OF TOUNGE, HIGH HEART RATE, BLURRED VISION, RINGING IN EARS, METAL TAISTE IN MOUTH, RED RASH ON HEAD AND CHEST.  WAS TREATED AT THE EMERGENCY ROOM AND RELEASED.
24 hours later, broke out in rash on back, arms, fingers and toes, They appeared to looks like raised fluid filled bumps.  3 days later, the bumps burst and turned into larger ulcerations.  I have photos I am happy to share.
I had fatigue, joint aches and pains, feverish, chills, felt like I had the flu coming on. I decided to use a home COVID-19 test that did come back positive. I called my doctor to discuss my symptoms and positive test, I chose to not take the antiviral and go with CDC guidelines and quarantine. The worst part was the lower back pain when I had coughing and sneezing but once that eased up withing five days.
Potential AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Potential AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Potential AE). At the time of the report, ADVERSE DRUG REACTION (Potential AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. No treatment information was provided.   Reporter did not allow further contact
symptoms of lyme disease after taking the covid vaccines. Not sure if it was from the vaccines but had been in remission for 6 years.
Side effects only lasted for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects only lasted for two days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects only lasted for two days). At the time of the report, VACCINATION COMPLICATION (side effects only lasted for two days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
I experienced a breakthrough case of COVID-19 with tiredness, fever, chills, body aches for the first couple of days. Then I developed a cough and runny nose, loss of smell/taste and trouble sleeping.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA304535. This case involves a 10 years old female patient who was received expired dose of IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect RABIES (HDC) VACCINE lot M15651M via intramuscular route, expiry date- 24-October-2018 in Left arm. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
heart rate is usually normal at 58 - 60, but right now it is 85; stuffy nose; dizziness; really tired; fever of 101.5F; weird metallic taste in her mouth; Tender Injection Site; Swollen Injection Site; Red rash on the injection site (5" X 3"); Hot to the touch Injection Site; A Little Sore Injection Site,arm is very sore; A little Red Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore), INJECTION SITE ERYTHEMA (A little Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE RASH (Red rash on the injection site (5" X 3")) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site). On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")) and INJECTION SITE WARMTH (Hot to the touch Injection Site). On 15-Feb-2021, the patient experienced PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired). On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is usually normal at 58 - 60, but right now it is 85). On 20-Jan-2021, INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")), INJECTION SITE WARMTH (Hot to the touch Injection Site), PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
8/3/21 PMH of diabetes mellitus, type II;  presents for cough and SOB after exposure and positive covid test at urgent care
Pulmonary Embolism in lower left lung treated with Elaquis and increased statin
Pt was given Tdap and MCV on 7-22-14. Seen in office on 7-24-14 due to erythema, warmth and mild pain to both injection sites. From Tdap site, erythema is extending down arm to elbow, not hard, weeping or pus seen. Pt has been applying warm compresses. Told to continue this practice.
nothing for 2 days then onset rash and itching on fingers Between joints- worse every day spreading to wrists and more like hives. then spread to MCP joints. Both knees red but not hives. small petechiae on anterior lower legs, thighs and upper arms. a few erythematous areas on chest wall , ears red and itchy. no respiratory problems , no headache or joint aches at all. lasted for 1 week did not respond to topical creams . resolved spontaneously on day 7
Information has been received from a 74 year old female with no known medical history and drug allergies, who two weeks ago was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included XANAX. For the past 2-3 days her back had been very itchy but she cannot determine if there was a rash present. No laboratories studies were performed. The patient did nit seek medical attention. At the time of this report the patient had not recovered. Additional information is not expected.
Patient received first COVID vaccine on 4/08/2021, which was Moderna. Patient presented to vaccine clinic on 5/06/2021 for second dose. Patient received Pfizer (instead of Moderna) on 5/06/2021.
Infant did not have an adverse event, per Immunization Program Director Dept of Health recommended us to file a report. ERROR vaccine administration, Vaccine KINRIX (recommended for 4 year) administered to 6 month infant in error. Infant did not have any reaction, mom only reported fever last night.
foot swelled up intensely; this foot swelled up intensely with lots of pain.; pain shooting up in leg; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN,) via an unspecified route of administration on 05Apr2021 at 14:30 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included cadaver bone and a 3-titanium screw in the right foot from a surgery 6 years ago and the patient had a history of allergy to dairy. Concomitant medications included birth control from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:00, the patient experienced few hours after the vaccine foot swelled up intensely with lots of pain and had been swollen and painful ever since the injection with pain shooting up the leg. On 22Mar2021, the patient underwent COVID-19 (nasal swab) test and result was found to be negative. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events foot swelled up intensely with lots of pain and pain shooting in leg was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 04/04/2023. I contacted my doctor and got a prescription for Paxlovid. I stopped taking it as the taste was terrible and the diarrhea. I was just coming off knee surgery and could not take it. As of today, I have chest congestion and a cough.
Lower-than-authorized dose volume administered of the correct formulation (e.g., leaked out)
Pt came back to report she has has severe muscle aches and pains since has shot on 9-20-10. As of today, 2-28-11, she has not seen her PCP but reports her arm is "useless" now. Referred pt for evaluation/treatment.
Chilled, severe body pain, severe headache, severe joint pain, fever, vomit
Pain and swelling in arm pit, arm where vaccine was administered; Pain and swelling in arm pit, arm where vaccine was administered; Pain and swelling in arm pit, arm where vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 11:30 (Lot number: Unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "Shellfish" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LEXAPRO. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 27Sep2021, outcome "recovering" and all described as "Pain and swelling in arm pit, arm where vaccine was administered". Therapeutic measures were not taken as a result of axillary pain, swelling, vaccination site pain.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling at injection site, stiffness got better but now 6 week later patient thinks nerve may have been hit with injection, trouble lifting arm above shoulder, bruising.
This spontaneous report was received from a healthcare worker concerning patients of unknown age. On an unknown date, 25 doses of (Oka/Merck) VARIVAX injection (other details unspecified) which was improperly stored at 15.3F for 36 hours, vaccinated to an unspecified number of patients at physician's office. No concomitant therapy was reported. No adverse effects were reported. No product quality complaint (PQC) was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with (Oka/Merck) VARIVAX. Additional information has been requested.
Approximately 10 minutes after receiving vaccine, I felt something in my neck(left side/vaccine in left arm) within a few minutes, my chin, and jaw started feeling weird/tingly-I brought it to the receptionist's attention, and she got a nurse, next few minutes, my face on the left side; especially lips and right below felt tingly/numb(like local dental anesthetic). My speech was Ok, my BP was monitored and was  a little elevated, nurse thought I was a little anxious because of my symptoms, BP was checked again about 10 minutes later and it was normal, they listened to my lungs to-all seemed to be well, except for these changing sensations going up my face, and lip. I stayed for about 20 minutes more, and returned to my office. Throughout the day changing sensations/lip area-that evening, my family said my lower lip was  drooping slightly downward-it seemed a bit swollen as well.  I checked in with the Covid Vaccine Clinic Wed. 01/13/20 in the AM as asked, and let them know i was still having symptoms in my lips, and felt slightly swollen on the one side.   It is 1/13/2020 @ 8:45PM and my bottom lip still feels strange(fluttery/tinglingly-not quite numb in sensation/  my cheeks/chin have intermittent differences in sensation