chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes in left axils of left arm.; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9269) via an unspecified route of administration on 06Feb2021 at 17:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included helicobacter pylori (HP) infection under control with meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 27Feb2021 at 17:15, the patient experienced swollen lymph nodes in the left axils of the left arm and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in the left axils of the left arm and tiredness were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Injection site - swollen size of softball has a knot and itchy - told her to use cold compress and take BENADRYL.
Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Headaches; brain fog; stumbling over words; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 14:00 (Lot number: ER8730) at the age of 40 years as dose 1, single and administered in arm right, administration date 13Apr2021 15:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), TREMOR (non-serious) all with onset 24Mar2021, outcome "not recovered" and all described as "Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips"; HEADACHE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Headaches"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "brain fog"; DYSPHEMIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stumbling over words". The events "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "headaches", "brain fog" and "stumbling over words" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia oral, paraesthesia, tremor, headache, feeling abnormal, dysphemia.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Patient did not received other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
Swelling 3 x 3 cm, redness at inject site (DTaP).
Had fever of 103 degrees F with bilirubinuria and acute elevated ALT/AST from 9 & 10 respectively to 96 & 45 then decreasing again after fever broke. No local site reaction noted.
Chills, shaking, high fever, nausea, body aches, severe fatigue, pain at injection site, redness and swelling at injection site....injection site and about 5 inches around it was hard and hot.
Pt reported to have 2 small seizures at approximately 6:20 P.M. Pt reported to be recovered per conversation 12/28/2021 at 4:30 p.m.
Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 24-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
36 hrs post injection; site became swollen (approx. 4" diameter), red, warm. s/s remain same 15 hrs post initial s/s.  (reaction: Atarax)
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 14-Oct-2019, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient mentioned having a reaction like a flare up post her second booster dose. Felt the same way post her second vaccine as well, hence was not too concerned when it occurred again after first booster and second booster.  Reporter causality for event to Rinvoq was no reasonable possibility.  Company comment: This spontaneous case concerns a 65-year-old female patient, with relevant medical history of Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred on an unspecified date (same month of vaccination) after receiving the 2nd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-568026, MOD-2022-568033 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with relevant medical history of Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred on an unspecified date (same month of vaccination) after receiving the 2nd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.
L upper arm swelling around injection siteApply cold compress to area and take Benadryl
PAtient with a history of vision abnormalities reported blurry vision after vax administration. Patient sat for 30min, reported minimal or no improvement and refused to present to ED
Potassium level came back high; LDL came back high; HDL came back high; Total cholesterol came back high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, DILTIAZEM, APIXABAN (ELIQUIS), LEVOTHYROXINE and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high). At the time of the report, BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12 Jul 2021 contains non significant information
I am 27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was date. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant) had resolved.        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.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Case number PHEH2014US022452 is an initial spontaneous report received from a nurse on 05 Nov 2014. This report refers to a female patient of an unspecified age. Her past medical history included a life threatening reaction to cephalosporins. On an unspecified date, she was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, the last season. One day after the vaccination, she noticed redness and swelling at the injection site. It was not painful and was a hive over the injection site which was very localized. She also had itching at the injection site. She was treated with a mycin antibiotic as she was advised not to receive penicillins and carbapenem. She completely recovered from the events on an unspecified date. The seriousness and causality of the events was not reported.
The primary reporter is Nurse. She is reporting that a patient received an expired VARIVAX (1279Z, 09/30/2012) on 10/18/2012. No adverse event reported. No further information is available.
sick with all three doses; lethargic after dose 1; fever not above a 100°F after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with all three doses), LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100°F after dose 1) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100°F after dose 1). On an unknown date, the patient experienced ILLNESS (sick with all three doses). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Fever, at an unspecified dose and frequency. On 10-Jan-2021, LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100°F after dose 1) had resolved. At the time of the report, ILLNESS (sick with all three doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-335764, MOD-2021-335775 (Patient Link).
Patient was given Td toxoid 0.5cc SQ instead of PPD as ordered. Immediate pain at site and coolness of right arm. 24 hours later developed 2cm of erythema/ induration with increase pain and inability to F/E wrist. Continued monitoring at future visit until resolved.
Rapid, fast rising heart rate Twice in about an hour and a half time period Second time went from resting heart rate about 70 to 180 in just a couple minutes No activity when it had happened. Was lying down trying to sleep
Doses given after temperature excursion; Doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Doses given after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Doses given after temperature excursion). On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (Doses given after temperature excursion) had resolved. On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Excursion in freezer for 20 minutes happened on 28 Nov 2021.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
At first, itchy small red raised spot to right of injection site. Thought it was an insect bite.  Later on, warm red slightly raised area about 1 1/2 in. wide by 2 1/2 in. long. Somewhat tender to the touch. The area stayed warm and got a bit larger, turning to splotchy red over the next several days. Applied benadryl, which helped some with the itch. At this time, it is still slightly visible, but seems to be fading away.
PATIENT CAME INTO THE OFFICE ON 05/28/08 PRESENTING WITH A RASH, WHICH THE DOCTOR DIAGNIOSED AS CHICKENPOX.
Pentacel expired on 12/7/2022 and was given today 12/8/2022 with no adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-helath care professional.  This case involves a patient of unknown demographics who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which expired on 12/7/2022 and was given today 12/8/2022 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Aug-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE(Suspension for injection)(expiry date: 12-Jul-2022)(unknown lot number and strength) via unknown route in unknown administration site for Prophylactic Vaccination(Immunisation). Information regarding batch number details has been requested.  On 12-Aug-2022 the patient had a non-serious event pentacel expired on 12/7/2022 and was given today 12/8/2022 with no adverse event (expired product administered)(latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  Outcome was Unknown for the event pentacel expired on 12/7/2022 and was given today 12/8/2022 with no adverse 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 guidelines. 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.