chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Mobility decreased/could hardly get out of bed; Injection site pain/soreness at the injection site with Humira; This is a solicited report based on information received by Pfizer from a company (MFR no.: 21K-163-4117449-00). A contactable 82-year-old female consumer (patient) reported for herself that:  Solicited report by a consumer of an 82 year old female with events of non-serious had second dose of covid vaccine, it triggered rheumatoid  Arthritis and could hardly get out of bed and soreness at the injection site with Humira (adalimumab). There was no reported medical history. On an unknown date in 2021, the patient experienced soreness at the injection site. In 2021, the patient had second dose of covid vaccine, it triggered  Rheumatoid arthritis and could hardly get out of bed. Pfizer biontech covid-19  Vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 30Jan2021, patient received 1st dose  COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. On 20Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. The patient's past medications include:Prednisone for unknown indication.  Causality for humira(adalimumab): The reporter's causality for the event(s) of had second dose of covid vaccine, it triggered rheumatoid Arthritis and could hardly get out of bed onset in 2021 and had second dose of covid vaccine, it triggered Rheumatoid arthritis and could hardly get out of bed onset in 2021 with humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of soreness at the injection site with humira (adalimumab) was a reasonable possibility. The reporter's assessment of the causal relationship of the events with 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. No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported events of Rheumatoid arthritis flare up and Mobility decreased cannot be completely excluded. However, the reported event of Injection site pain/soreness at the injection site with Humira was consider as unrelated to vaccine and more plausibly explained by concomitant HUMIRA. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
his heart is skipping a beat; having hard time to breath; his heart rate is little bit high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date 27Sep2021 04:00 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Meningococcal vaccine (No, may be a month ago, it's been over a month. It was like, for cancer, for pelvic cancer. I don't know what they call for his age, right before they go to the middle school. They have the meningitis one and they offered that one for like pubic cancer or pelvic cancer."), administration date: Aug2021, for Pelvic cancer. The following information was reported: EXTRASYSTOLES (non-serious) with onset 27Sep2021, outcome "unknown", described as "his heart is skipping a beat"; DYSPNOEA (non-serious) with onset 27Sep2021, outcome "unknown", described as "having hard time to breath"; HEART RATE INCREASED (non-serious) with onset 27Sep2021, outcome "unknown", described as "his heart rate is little bit high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of extrasystoles, dyspnoea, heart rate increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
medical assistant gave an expired Trumenba given on 3/2/2023 it expired on 2/28/23
1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm, muscle aches entire body, extreme fatigue, body feels really heavy (like being pulled down), chest feels thick (like full of cotton), headache, alot of nausea,  taste and smell are muted (still have both but not as intense as normal).  My doctor thinks I was an undiagnosed covid case, early on in the pandemic (had been exposed unknowingly to someone who had traveled 3mths overseas at the pandemic outbreak, the tests they ran came up unknown but all my symptoms were what would turn out to be covid symptoms including complete loss of taste and smell.
dry heaves; lost voice; This spontaneous case was reported by a non-health professional and describes the occurrence of RETCHING (dry heaves) and APHONIA (lost voice) in a 61-year-old male patient who received mRNA-1273 (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RETCHING (dry heaves) and APHONIA (lost voice). At the time of the report, RETCHING (dry heaves) outcome was unknown and APHONIA (lost voice) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.
Pt recv vax on 1/14/99; 20 min post vax pt exp tingling & numbness of left head & left arm/ shoulder, numb little finger, small red blotches on arms & chest; tx=Benadryl
Deltoid area swelled immediately upon giving injection with hives at injection site immediately. Pt given Benadryl and Motrin examined by MD. Pt stayed 30 min for observation, signs lessened and pt Ok'd' home.
Patient passed out about 10-15 minutes after being injected with 0.5ml of Fluvirin. 911 was called and EM. personnel took her to Hospital.
3 DAYS FOLLOWING THE  2ND SHOT , I FELT SEVERE PAIN  BELOW THE RIBCAGE WHICH LASTED ABOUT 15 MINUTES. THE  PAIN (THOUGH NOT AS SEVERE )MOVED DOWN INTO THE BELLY AREA.  I BEGAN TO FEEL NAUSEOUS AND BEGAN TO PASS GAS. THIS LASTED  ABOUT 30 MINUTES. THEN I SEEMED TO INSTANTLY FEEL FINE AND STILL DO 24 HOURS LATER.
Pt. received FLUZONE IM on 10/8/13 at 7:10 PM. Pt. contacted pharmacy at 11:30 AM on 10/9/13 stating she was experiencing inflamed, red, rash on left upper arm. Pt. states experiencing burning sensation after admin.
DELTOID PAIN EVERY MORNING, PAINFUL TO LIFT OR ROTATE LEFT ARM (DELTOID/ROTATOR CUFF REGION), CAN NOT LIFT HEAVY OBJECTS WITH LEFT ARM, INFLAMMATION IN AIRWAY, ASTHMA SYMPTOMS/ASTHMA ATTACKS DAILY, SOB/TROUBLE BREATHING DAILY, EXERTIONAL DYSPNEA, DRY COUGHING IN FIRST WEEK, PRODUCTIVE COUGHING AFTER FIRST WEEK, SWOLLEN LYMPH NODES, SORE THROAT, THICK NASAL MUCOUS, COUGHING AND SOB MADE WORSE WHEN LYING DOWN, CHEST TIGHTNESS/PRESSURE, HEADACHES.
I was in a low disease state of SLE, 2 days after injection i had a severe flare of lupus requiring steroids; This is a spontaneous report from a contactable other Hcp (patient).  This 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 16Dec2020 13:30 at single dose in Arm left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included systemic lupus erythematosus (SLE) and in remission. No Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication received within 2 weeks of vaccination included hydroxychloroquine, topiramate (TROKENDI), prucalopride succinate (MOTEGRITY). The patient was in a low disease state of SLE, 2 days after injection and had a severe flare of lupus requiring steroids on 18Dec2020. The adverse event result in Doctor or other healthcare professional office/clinic visit. Steroids received as treatment. The outcome was recovering. The events were assessed as non-serious; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Systemic lupus erythematosus syndrome aggravated cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Redness of entire circumference of left upper arm, very taut.  Slightly raised erythema developed on neck and bilateral preauricular region of face.  Parents gave her Claritin.  24 hours later, when seen by phsyician, rash was resolving, but there was mild erythema on face and uppper arm and mild edema of upper arm present.
patient received a tenivac immunization that was later noted to have expired with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 years old male patient who received a -2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] immunization that was later noted to have expired with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2022, the patient received expired 0.5 ml, dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength: standard, formulation: unknown) (lot U6831AA, expiry date: 08-Oct-2022) via intramuscular route in the deltoid NOS (not otherwise specified) with no adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.; Sender's Comments:  US-SA-2022SA422490:
being out of mind for two weeks; A lot of pain and soreness in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of DAYDREAMING (being out of mind for two weeks) and PAIN IN EXTREMITY (A lot of pain and soreness in legs and feet) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1218) for COVID-19 vaccination.     Concurrent medical conditions included Hospice care. Concomitant products included LISINOPRIL, FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DAYDREAMING (being out of mind for two weeks) and PAIN IN EXTREMITY (A lot of pain and soreness in legs and feet). At the time of the report, DAYDREAMING (being out of mind for two weeks) and PAIN IN EXTREMITY (A lot of pain and soreness in legs and feet) outcome was unknown.            No treatment information was provided.
Information has been received from a physician concerning a 65 year old female with rheumatoid arthritis and drug hypersensitivity to iodine, "Prevacid" and "Prilose" who on 29-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot#658862/1415U).  Concomitant therapy included ZANTAC 75, MIACALCIN, CARAFATE, VALIUM, INDERAL, SOMA, vitamin D (unspecified), TUMS and VIVELLE.  On 29-JAN-2008 the patient developed diffuse joint pain within four hours of vaccination with Zostavax (Oka/Merck).  The joint pain was located at multiple sites and symptoms felt similar to an arthritis attack.  Currently, the patient was feeling 50% better from her initial symptoms.  It was reported that the patient received a 0.5ml dose of Zostavax (Oka/Merck) intramuscularly.  The physician stated that he will confirm the dosing and route of administration with the nurse.  Regarding medical attention the patient was seen 5-6 days after vaccination.  No product quality complaint.  Additional information has been requested. 02/17/2010 Follow up information was received by the physician indicating that the patient received the dose of dose ZOSTAVAX  subcutaneously (previously reported IM) on 29-JAN-2008 an 11:12am. The patient also experineced back pain and cold/clammy on an unknown date. The patient cam in for a MD visit and had the labs drawn. All labs were normal except chloride 100.9 MEQ/L (range 101-112) and creatinine 0.52 mg/dL (range 0.7-1.3). All o ther labs were WNL. No further information is expected.
gout flare up and pain; Was in so much pain; Toes are all swelled up on the right side; had to help to stand up and put leg on couch, so he could lay down; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 65 year) as dose 2, single for COVID-19 immunisation. Medical history included gout. The patient had not been taking any medicine 2 weeks prior to the Covid 19 vaccine. No prior vaccinations within 4 weeks. Concomitant medication(s) included ongoing metformin (METFORMIN); ongoing atenolol (ATENOLOL) taken for blood pressure abnormal; ongoing lisinopril (LISINOPRIL) taken for blood pressure abnormal; ongoing atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal, all has been taking for years. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration on 03Mar2021 for COVID-19 immunisation. On 25Mar2021, Patient gout picked up tremendously right after the shot. Patient gout flare up, originally in one knee, the left, then went to the right and then to foot. Toes were all swelled up on the right side. Started the day after the second shot. Patient was in so much pain, had to help to stand up and put leg on couch, so he could lay down. Pain get better, but then worse. This week he has felt in his big toe but has now spread to other toes. Patient took gout medicine only after the flare up. Medication was Indomethacin and the dose was 50mg three times a day. Patient took on an as needed basis. Patient did not receive Emergency Room and Physician's office. The outcome of events Pain and Gout flare was not recovered while for rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Hives appearing two weeks later across all parts of body, legs, arms.  Treatment: Triamcinolone 0.1% cream, Cetirizine hydrochloride tablet 10mg
Pt with a history of asthma and anxiety started to c/o dizziness, tightness in the chest.  VS were as follows: 1750 HR 79, O2 sat 97% on RA, BP 109/62  - 50mg of Benadryl given 1755 HR 74, O2 sat 99% on RA, BP 110/67 1800 HR 76, O2 sat 99% on RA, BP  115/72.   At 1800  Patient reported that she was feeling much better, tightness in the chest had resolved and was not dizzy.  Through out she was able to hold a conversation, no wheezing, and no SOB noted.  Pt discharged home with father.  Spoke to father to call PCP to advise on second dose.
pt recv vax 1230PM;  630 temp elevated APAP given; 10PM to MD dx illness red throat; given meds; t104.4; pt vomiting;
4pm: extreme tiredness and achiness; have stayed in bed for 2.5 days. Intermittent vomiting although havent eaten since 12 noon 04/07/2021. Terribly weak with no appetite.
Reported that she had been having heart issues and she has been sleeping a lot more than normal and hasn't been eating. On Monday, the day after her Pfizer COVID vaccination,  she went into AFIB  had a fever of 102. Her heart rate varied between 42 and 108 and was going up and down from 9 pm Monday night  to 8 am the next day.   Her BP was very low for her at 99/59 and pulse to 42-46. At 7 am the morning of her report on 3/4/21, her BP was 99/58 at 8am 107/65 at 9 am 115/66. By noon BP was 136/67 w/ 46 pulse.  She has had persistent SOB and fatigue.
After receiving Quadracel and Varivax, this patient had an adverse reaction - rash and blistering skin - at the injection site.
Beginning at around 8 pm began feeling the onset of muscle spasms in my upper back.  Condition worsened through the night resulting in restricted range of motion in the neck.  Required using sick leave the following day in order to care for the neck/back and to receive treatment at the chiropractor.  Typically I attend the chiro only every 3 weeks for minor maintenance adjustments and hands on therapy. However, I had to go in for this extra appt 6 days after my previous appt and the only thing that we can think of that might have triggered this flare up was the flu shot.  In the past I have had flare ups with the onset of illness.  I have had no other symptoms of illness except for the back and neck issues except for minor soreness at the injection site.
swelling on flank/side boob; swollen armpit/swelling on flank/side boob; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. Concomitant medications included birth control, doxycycline (MANUFACTURER UNKNOWN) and ustekinumab (STELARA) all on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient previously took Amoxicillin and Sulfa antibiotics and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:15 the patient experienced swollen armpit. On 02Apr2021, armpit swelling continued and in addition experienced swelling on flank/side boob. 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 reported events. The clinical outcome of the events swollen armpit and breast swelling was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Monday afternoon - Wednesday morning fever and aches. Wednesday evening - large rash on injection site This is my second dose  The first dose I had a delayed rash on arm - rash appeared 1 week after the vaccine
Has all the symptoms the injection site pain; Hives; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; This is a spontaneous report from a Non-contactable consumer reported for daughter. A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient got her second shot of the COVID-19 Vaccine, Pfizer. She got the second shot today (05Jan2021) and she had basically all of the symptoms, the injection site pain, hives, headache, muscle pain, chills, joint pain, fever, nausea. Reporter was requested to visit the nearest emergency room or contact the HealthCare providers. Reporter asked if the patient could take Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
tonguetingling; burning sensation tongue; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 05Mar2021 at 11:30 AM (at the age of 67-years-old) for COVID-19 immunisation. The patient medical history included high blood pressure and the patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. The patient received unknown medication within 2 weeks of vaccination and the exact therapy dates were not provided. On 10Mar2021, the patient experienced tingling tongue, burning tongue and sore throat. Therapeutic measures were not taken for events experienced. The clinical outcome of the events tingling tongue, burning tongue and sore throat was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
(L) thigh area diffuse deep pink inflammation with central punctate spot. Red, swollen.
1. There were NO REPORTED ADVERSE EVENT.  2. Vaccine was administered at 6 days past the UPDATED EXPIRY of 08/23/21 though still within vaccine PACKAGE EXPIRY date of 08/31/21.  3. Only filing as a VACCINE ADMINISTRATION ERROR report
While traveling in car with mother her eyes rolled back, her back arched and head tilted back. Hands began to twitch and she then went limp in car. Mother drove her to hospital. She was treated with KEPPRA IV for seizure. Had another seizure since. Tested at neurologist office put on 24 hr monitor which still showed seizure activity.