chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes in left arm pit and left jaw/neck area.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 13:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history, Name of Drug as Reported: no, Reaction: Allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 13:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "swollen lymph nodes in left arm pit and left jaw/neck area.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. patient was not diagnosed with covid-19 prior to vaccination. since the vaccination patient was not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt developed popular rash to anterior chest, posterior neck and behind ears bilaterally about 4 hours after the injection. She had no other symptoms.
Within 24 hours I had diarrhea with blood in my stool.   The blood in stool lasted for 48 hours.   The Diarrhea has persisted for 32 days.
Two centimeter erythemous induration of right arm at the vaccine site. Treated with alternate hot and cold to right arm.
Numbness/tingling in entire face; Numbness/tingling in entire face, tongue and legs.; Numbness/tingling in entire face, tongue and legs.; Tingling in entire face and legs; Numbness/tingling in entire face, tongue and legs.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm right on an unknown date in Apr2021 at 14:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine sodium (SYNTHROID), fexofenadine hydrochloride (ALLEGRA), chromium (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm right on an unknown date in Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 16:00, the patient experienced numbness/tingling in entire face, tongue and legs. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events numbness/tingling in entire face, tongue and legs were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received MMR #2 (pt is active duty marine and does not have childhood immunization record) on 8/12/02 at approx. 14:00. Pt noted redness, swelling 8/13/02 after waking up. Area of swelling and redness at injection site 2 1/2" x 3 1/2" on 8/14/02. Medical visit 8/14/02. Advised ice application to site, Tylenol prn pain.
Administered this lot to their patients after the lot expired on of 10-9-2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered this lot to their patients after the lot expired on of 10-9-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this lot to their patients after the lot expired on of 10-9-2021). In 2021, EXPIRED PRODUCT ADMINISTERED (Administered this lot to their patients after the lot expired on of 10-9-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As reported they administered mentioned Lot to their patients after the lot expired on of 09 Oct 2021.  The vaccine administration date for each patient range from  11 Oct 2021 to 14 Nov 2021.  No concomitant medications were mentioned. No treatment details were reported.
Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 13Jan2021 10:30 AM at a single dose for COVID vaccine. Medical history was not reported. The patient had no known allergies. Concomitant medication included lisinopril (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID vaccine. The patient experienced chills and fever on unspecified dates. Treatment for the events included Tylenol. The patient did not have COVID prior vaccination. He did not have COVID tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
swollen gums; bad taste in her mouth; This is a spontaneous report from a contactable consumer or other non-health professional (patient) received from a Pfizer sponsored Marketing program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 17May2021 as a 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunisation. It was reported that, patient experienced swollen gums later that night and a bad taste in her mouth after the patient received the second dose of the Pfizer covid vaccine. Patient went to the dentist and was going to have some sort of periodontal work done. The patient been given an anti-inflammatory medication, but she had not taken it yet. Stated that, she did not know whether it was a side effect or not. The patient was going to have a deep cleaning done on her teeth. Patient questioned was this part of the vaccine and had anyone else reported this reaction. The reporter seriousness for the events was unspecified. The report was related to a study or program. The outcome of the events was unknown.  Information about Lot/Batch number are requested.
Large R axillary node swollen painful x 2 weeks w pain and pain returned two months later until now.  It interfered w mammogram and needed diagnostic and now follow up in 6 months w ultrasound
pt recv vax 3NOV97 & 5NOV97 pt exp a local erythema about two inches below the inj site;approx 4 inches in diameter;also devel pain & swelling @ the inj site w/a temp of 99.6;
None noted. Child was inadvertently administered DTap instead of TDap. Unable to verify responsible party by phone. Sent letter to known address.
There is a Disruption in menstrual cycle. Still experiencing it. Another thing I had was eczema on the bottom half of my body. I've had the eczema on my face but never anywhere below. It got really bad on my butt, legs and creeping up to my torso. I did go to a dermatologist. I heard later on that it could be a side effect from the vaccine. The eczema lasted for about a month to 2 months after the 2nd dose.
This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles on the right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. The patient's past medical history included shingles. Concurrent medical conditions included thyroid disorder (NOS), blood pressure management and cholesterol. Concomitant products included vitamins (NOS) for an unknown indication. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced herpes zoster (shingles on the right arm). At the time of the report, herpes zoster (shingles on the right arm): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Other concomitant medications included thyroid medication, cholesterol medication and blood pressure medicine. The patient did not receive any treatment medication.
Felt tired for a day; Started having like pins and needles; A little bit numb in arms and in hands and fingers and in both arms; Feeling like neuropathy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 07Mar2021 (Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I was supposed to call, because I had the Pfizer vaccine last Sunday, a week ago yesterday. And I felt tired for a day like that, a little bit (unspecified date). But on Friday, a few days later, I started having like pins and needles feeling like neuropathy like a little bit numb in my arms and in my hands and my fingers and in both arms. And when I spoke to someone about, I wanted to change my second appointment, they said that I should call. I spoke to a doctor there and doctor said that I should call you guys. And that's people are tracked. I want the people's track in. I want to know if this is a typical thing, like I'm not seeing it written anywhere and I did have this reaction once through another vaccine (Unspecified vaccine). I am just checking on it because I don't know what that is with me. I'm nervous not to get the second one." The patient felt tired for a day on an unspecified date, feeling like neuropathy, started having like pins and needles, a little bit numb in arms and in hands and fingers and in both arms all on 12Mar2021. The outcome of the events was unknown. The event "feeling like neuropathy" was considered as serious (medically significant).  Information about Batch/Lot number has been requested.
Flu symptoms: stuffy nose, sinus draining, low- grade fever, sweating/chills, extreme fatigue, muscle and joint aches.
1)  Severe Headaches 2)   On and Off Fevers 3)  Severe abdominal pain for a week (while experiencing what felt like a UTI) thick discharge daily for 7 days ..  4)   Have not had a cycle in over a year, severe bleeding for 9 days  5)  large clots in blood coming from the body 5 to 6 days 6)  felt like a 3-day miscarriage  7)   Today, 6/7/21 Still have bleeding and extreme fatigue
prolonged joint pain; prolonged muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain). At the time of the report, ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
Patient does have chronically positive COVID-19.  He has remained asymptomatic throughout this hospital stay.  ED to Hosp-Admission Discharged  5/17/2021 - 5/22/2021 (5 days) Hospital  MD Last attending ? Treatment team Stable angina Principal problem
Rheumatoid arthritis flare up; had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib).; Lack of drug effect; having swelling and pain, flare ups.; having swelling and pain, flare ups.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4336601-00 (Agency).  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib)."; THERAPEUTIC PRODUCT EFFECT DELAYED (non-serious), outcome "unknown", described as "Lack of drug effect"; SWELLING (non-serious), PAIN (non-serious), outcome "unknown" and all described as "having swelling and pain, flare ups.". The action taken for upadacitinib was dosage permanently withdrawn.  The reporter considered "rheumatoid arthritis flare up" related to bnt162b2.  Clinical course: The patient stopped Rinvoq because he was having swelling and pain, flare ups. Around the COVID-19 vaccinations, he was having worse flare ups.   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 currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 year old patient. On 09-MAY-2017 and 13-JUN-2017 the patient was vaccinated with the first dose and the second dose of PROQUAD (lot # M043307, Expiration date: 24-APR-2018, rHA) for prophylaxis respectively. No adverse effects were reported. No product quality complaint (PQC) was involved.
Patient recived first vaccibne dose 3/16/2021 then second dose in the series on 46/2021. Bosster Pfizer dose 8/31/2021. Was treated in the ER with Enooxaprin and then transferd hospital. CT scan shows extensive bilateral pulmonary emboli including saddle embolus.  Diagnosis Plan:  1. Bilateral pulmonary embolism  2. Saddle pulmonary embolus
swollen & painful left axillary lymph node; swollen & painful left axillary lymph node; nausea; epigastric pain; extreme fatigue; chills; severe body ache; headache; mild fever; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration in left arm on 07Feb2021 at 11:45 (at the age of 46 years old) as single for covid-19 immunisation. Medical history included heart valve incompetence from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to morphine. Concomitant medications included metoprolol; pantoprazole; ergocalciferol (VIT D); triamcinolone acetonide (NASACORT); calcium; vitamins nos (MVI [VITAMINS NOS]). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 at 02:00 PM (at the age of 46 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Feb2021 at 20:00, patient experienced swollen and painful left axillary lymph node, nausea and epigastric pain, extreme fatigue, chills, severe body aches, headache, mild fever. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
pt recvd vax 16AUG93 & 22AUG93 pt devel enlarged lymph nodes in groin one quarter size on the lt & smaller on the right, enlarged lymph nodes behind neck & a sore throat; pt taken to MD bloodwork nl;
Aches, headache and tired within 24-96 hours of both batches.    Increased blood pressure hypertension (especially diastolic), insomnia, pulsating tinnitus,.  All within 2 weeks of vaccine from batch 030B21A.  Symptoms have improved but still present.
left arm all swollen and the pain & inflammation spread all the way to shoulder and neck area that pt cannot move. She was admitted to the hospital for treatment.
NAUSE DIZZINESS  sat 98  hr 83 bp -94/76
PATIENT received the covid vaccine on 12/28/2020.  He had two episodes of  nausea and vomiting at 2 pm and at 3:30 pm on 12/28/2020 (about 3 hours after vaccination).  Nausea and vomiting have resolved.  Has bodyaches today. Denies fever, chills, cough, sore throat or HA.
no additional adverse effects; one patient was administered improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4-year old-patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not provided.      On 30-MAR-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022917, expiration date 19-JAN-2021 (dose, frequency, route of administration were not reported), which was reconstituted with properly stored sterile diluent as prophylaxis.   The reporter stated that vaccine was stored at a temperature of -14.1 degrees Celsius, and the time frame was 26 minutes. There was no previous temperature excursion. No additional adverse effects were reported. No further information was provided.  This call was because of a "data logger".
On 20JAN92 pt exp weakness in legs, aching in muscles of calf, thigh, hips, arms, aching joints; difficulty walking, t99 oral; achiness continues today; MD dx rxn to MMR;
Itching on arm. Approximately 12 hours after injection experienced severe chills and uncontrollable shaking. Fatigue, headache and body aches. Lasting approximately 24 hours. No increase in body temperature.
Patient felt dizzy. He reported dizziness at 17:10. No pain, no headache , no medical diseases, no heart disease, no SOB. Patient drink water and went home
This patient Died at Hospital on 12/09/2015 of complications related to ACTA2.
Initial misuse report received from a healthcare professional on 06 January 2014. A female patient  (no other information provided) had received a dose of ADACEL instead of Hepatitis B vaccine on an unspecified date. No adverse event was reported. Documents held by sender: none.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an infant male subject who was vaccinated with ENGERIX B. On 7 August 2007 the subject received a birth dose of ENGERIX B (10 mcg, unknown, right thigh). On 9 August 2007, two days after vaccination with ENGERIX B, the subject tested positive for hepatitis B surface antigen negative mother. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
This spontaneous report as received from a pharmacist refers to 2 nurses of unknown age. On 28-DEC-2013 reported as two days ago, the patients were due a dose of RECOMBIVAX HB, injection, (strength, route, lot number and expiration date not provided). No adverse events were reported. Additional information has been requested.
SCRATCHY THROAT , FULL FEELING IN BACK OF THROAT ,  TREATED WITH BENADRYL.  OBSERVED AND RELEASED FROM CLININC
I suffered severe migraine to the point of severe pain unlike any migraine I have ever had, drooping of eye and pain in neck and blurry vision, Went to dr she said I have Bella palsy that could be due to vaccine
received first dose / in August of 2020 and has not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was patient's mother. Age at vaccination was not applicable for this report. Till the time of reporting patient did not received 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
After about 2 hours of receiving the vaccine, I had tightness in  my chest for about 4 hours on the day of the vaccine; and tightness in chest after 24 hours of vaccine for another 3-4 hours with low grade fever 99.8.
Duplicate vaccine, patient received 2 doses of Pfizer prior, 3/01/2021 and 3/22/2021