chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful lymph node swelling in my left underarm; painful lymph node swelling in my left underarm; pain was radiating yesterday into my left breast as well, causing tenderness too; pain was radiating yesterday into my left breast as well, causing tenderness too; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 16:45 (Lot number: FJ1611) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Peanut allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 03Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 24Apr2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 02Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 16:45, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 04Dec2021 17:00, outcome "not recovered" and all described as "painful lymph node swelling in my left underarm"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 04Dec2021 17:00, outcome "not recovered" and all described as "pain was radiating yesterday into my left breast as well, causing tenderness too". The events "painful lymph node swelling in my left underarm", "painful lymph node swelling in my left underarm", "pain was radiating yesterday into my left breast as well, causing tenderness too" and "pain was radiating yesterday into my left breast as well, causing tenderness too" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain. Therapeutic measures were not taken as a result of breast pain, breast tenderness.  Additional information: The patient was taking advil and icing the underarm area since Saturday 04Dec2021. It was Monday 06Dec2021 and there was still pain. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient had received prescription birth control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 Prior to vaccination and since the vaccination, had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
SWELLING OF LEFT SIDE OF FACE. PT SAW HER PRIMARY DOCTOR AND HE PRESCRIBED ANTIVIRALS PER PT
about 6-7hrs p/vax pt had high fever & convuls;t104.5,sz x 1hr-intubation w/sequelae lung collapsed;sent by helicopter to hosp;lung sequelae
bad headache; fatigue/tiredness; chills like the flu; Flu like chills; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced headache, fatigue, chills and influenza-like symptoms. On an unknown date, the outcome of the headache, fatigue, chills and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, fatigue, chills and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had all the side effects listed above namely bad headache fatigue tiredness and chills like the flu.  That pretty much went away.
Case previously recorded as MA2009-4548. Initial case received from a nurse, on 18 NOV 2009. A 10-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. NA09-008426.
Patient came too early for 2nd Moderna shot.  Patient had 1st shot on 5/24/21.  We gave 2nd shot on 6/4/21.  Pharmacist talked to patient on the same day and advised patient to go to ER if does not feel good.
4/10/21, Swollen/ sore lymph nodes left arm pit.  4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing  4/15/21, Swollen/ sore lymph nodes right arm pit.
Dizzy, weak, body aches, fever of 102.1, chills, sweating, nausea, vomiting
Caller stated her daughter getting a little rash and as days went by the rash started getting big. Rash has spread to both arms and is very itchy
Temp reaching 103.4 Headache Nausea Vomiting  Muscle aches Joint pain Cough
Fell; Dizzy; Broke her Wrist (After First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell), DIZZINESS (Dizzy) and WRIST FRACTURE (Broke her Wrist (After First Vaccine)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disease, unspecified.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FALL (Fell), DIZZINESS (Dizzy) and WRIST FRACTURE (Broke her Wrist (After First Vaccine)). At the time of the report, FALL (Fell), DIZZINESS (Dizzy) and WRIST FRACTURE (Broke her Wrist (After First Vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
p/vax pt c/o significant pain in lt arm, neck & thigh;no fever;recommended urgent care visit;pt recovered w/o incident;pt awakened pain free 9/22/99;
Pt devel a delayed urticarial rxn following vax w/Hep B vax; No further details were provided;
Rash; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain) and VACCINATION SITE RASH (Rash) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain). On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE PAIN (Pain) and VACCINATION SITE RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
CHILLS, EXTREME TIREDNESS, HIGHER BP, HEADACHE, FOGGY.
Reporting system indicates adolescent received a pediatric dose for first immunization.  CDC card also shows pediatric dose.  Contacted family (with interpreter) and will follow CDC guidelines to not repeat dose but to assure adolescent/adult dose at second shot in series.  Family will be provided with written documentation at second shot clinic in English and native language.
Sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient's arm was sore for  24 to 36 hours, after receiving the first dose of the Shingrix vaccine. Unable to obtain additional details. The permission to follow up was denied. The outcome of soreness was reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequelae.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously (strength, dose and site of administration were not reported) (lot # N026075, expiration date: 20-SEP-2019) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine was exposed to a temperature excursion between 6 and 14 degrees Fahrenheit (10.2 degrees Fahrenheit) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
throat pain; Hard to swallow; food feels like it goes to sinus cavity; late for second dose and will not be getting it; dizziness; headache; ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) and NASAL DISCOMFORT (food feels like it goes to sinus cavity) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced EAR PAIN (ear pain), DIZZINESS (dizziness) and HEADACHE (headache). On 26-May-2021, the patient experienced INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow) and NASAL DISCOMFORT (food feels like it goes to sinus cavity). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 26-May-2021, INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) had resolved. At the time of the report, EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), NASAL DISCOMFORT (food feels like it goes to sinus cavity), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Rheumatoid arthritis flare up; 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-163-4458098-00.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1160837) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was dosage not changed.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. 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.
temperature excursion and products were determined to be not suitable to use with no reported adverse event; another physician used the products and administered them to patients post excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA391393, 2022SA390948, 2022SA392234, 2022SA392303 and 2022SA392531.  This case involves a 10 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after temperature excursion and products were determined to be not suitable to use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller states she previously reported a temperature excursion (product storage error) and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller states that on 19-Sep-2022 another physician used the INFLUENZA QUADRIVAL A-B VACCINE and administered them to patients post excursion 0.5 ml dose once of suspect  (lot UT7695JA, exp date: 30-Jun-2023) via intramuscular route in the left thigh for Immunization (poor quality product administered).  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 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.
On Jan 8, i received the first Moderna vaccine. Then i received the second dose on Feb 5.  After the first dose I experienced diarrhea which did not worsen after the second dose On feb 6 after the second dose I had a fever of 100.  My usual temperature is around 97.  I also got a rash on my back waist, breasts  area under my breasts ander my arm pits.  This rash lasted for 2 days.  After the rash went away the itching continued to today 2-12.  I took childrens claritin last night to help with itching which interfers with sleep.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 15:00 as dose 3 (booster), single (Lot number: Ff4554) at the age of 60 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 at 10:00 as dose 1, single (Lot number: 1805022), in left arm and on 23Oct2021 at 09:00 as dose 2, single (Lot number: 1822809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper coagulation" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) received in 2 weeks of vaccination, which included: LYRICA, start date: 01Apr2022, stop date: 25May2022; VIMPAT, start date: 01Apr2022, stop date: 25May2022; ELIQUIS, start date: 01Apr2022, stop date: 25May2022. No known allergies were reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022 at 20:00, outcome "recovered with sequelae" (13May2022) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Rebound of covid symptoms and positive test 5 days after paxlovid treatment ended.
Face on right side became very flush along with neck and chest.  I asked if this was normal, they then proceeded to take my heart rate and bp.  Heart rate down to 41/bp was 169/95 - heart was not functioning normally.  I sent to ER to be checked out since i had had a tripple bypass in 2018.  They did ekg at site and at hospital.  Dr said i was ok but potassium was low they gave me four tablets and then i left.  Later in the day, i has an extremely severe headache, nausiated, muscles and bones over entire body ached.  On Saturday 3/6 worsened i called the on call doctor.  He stated was normal but did treat me for the severe cough and head cold i had along with the reaction to shot.  Lasted thru Sunday evening.
Three days after my first vaccine, my ears started to ring. After my second vaccine, that night, the ringing got so much worse.  It got so much louder and fuller sounding. Now it?s almost impossible to ignore.  It has made it hard to focus, hard to sleep, I get more headaches, I get confused more, and I have a harder to grasping  concepts, sometimes.  It gets so unbearable at times and it is often louder than my air conditioner unit.   I feel anxious more than ever because the sound itself is unnerving. I try to convince myself that it is a nice sound.
White blood cells went up greatly; Blood clots in his legs; oxygen went down/oxygen levels went down; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included he had Leukemia and was on treatment. The patient's concomitant medications were not reported. The patient took first dose bnt162b2 for COVID-19 immunization. Caller says that her father got his second COVID vaccine from Pfizer. He wound up in the hospital 3 days later. His white blood cells went up greatly and he has blood clots in his legs. They do not know what is happening. They are very worried about him. He is getting a bone marrow test today (08Feb2021). His oxygen went down yesterday (07Feb2021) and is now on oxygen. She is freaking out about it. She really thinks it has to do with vaccine. It was asked if there was any information on other people with Leukemia getting the vaccine. If what research there was on this. They need all the help and information they can get. Every minute counts as everything getting worse. He is now on oxygen as his oxygen levels went down. He is getting worse every hour. The patient underwent lab tests and procedures which included oxygen saturation: his oxygen went down yesterday/oxygen levels went down on 07Feb2021, white blood cell count: his white blood cells went up greatly on an unknown date, biopsy bone marrow: unknown results on 08Feb2021. Reporter seriousness for White blood cells went and Blood clots in his legs up greatly was hospitalization. Therapeutic measures were taken as a result of oxygen went down. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Information has been received from a nurse practitioner (N.P.) concerning a 49 year old female with hypothyroidism and gastroesophageal reflux disease who on 2-MAR-2009 was inadvertently vaccinated IM with a 0.5 ml first dose of GARDASIL (lot # not reported) due to human error. It was reported that the patient was supposed to received a tetanus toxoid vaccination. There was no product confusion involved. Concomitant therapy included omeprazole (MSD), SYNTHROID and vitamins (unspecified). On 3-MAR-2009 the patient experienced pain and swelling in armpit after the vaccination. The patient sought medical attention at the practice. No lab test performed. As of 9-MAR-2009 the patient was recovering. Additional information has been requested,
Patient reported swelling in her arm where the vaccination was given that spread up her shoulder and into her neck. She also said that it felt warm to the touch even after 2 weeks had passed. The pharmacist on duty told her to take benadryl and apply an ice pack in 15 minute increments. The next morning (today) we followed up with the patient and she said she still had the swelling and pain. We called her physician's office for her to schedule an appointment and we are waiting to hear back from them.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. On an unspecified date in 2016, the patient was vaccinated with an expired dose of VARIVAX (lot number K011801, expiry date 21-AUG-2016, subcutaneous, dose not reported). The reporter stated that the patient did not report any adverse effects or any other issues following the administration of this VARIVAX. Additional information has been requested.
Day 9 after taking 1st shot of Moderna for COVID-19:  This morning I noticed that the injection site was red, 1/2 dollar-sized, circular rash.  It was slightly warm to the touch.  I took a photograph and sent this to my PCP office.  I was advised to take 25 mg of benadryll, ibuprofen as needed, ice the area, and it was recommended to not take the second shot
itchy pink rash and swelling within 1-2 days, then a clear left facial nerve palsy on the evening of 11/12, 5 days after the injection.  Significant improvement by the next morning.  Continues with a very subtle residual