chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore, swollen submandibular lymph nodes left side; Sore, swollen submandibular lymph nodes left side; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left deltoid (Lot number: EK9231, Expiration Date: Apr2021) at the age of 63 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 01Dec1979 (ongoing); "Type I Diabetes", start date: 26Oct2010 (ongoing); "Sulfa, Erythromycin, Penicillin allergy" (unspecified if ongoing); "raynauds" (unspecified if ongoing); "Shingles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EH9899)), administration date: 16Dec2020, when the patient was 63 years old, for COVID-19 immunisation, reaction(s): "Aches", "Mild nausea", "Chills", "Fever up to 100.8 for 6-8 hours", "Headache", "Fatigue". The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "Sore, swollen submandibular lymph nodes left side". Additional information: The events resolved within 2-3 days (as reported).  No follow-up attempts are possible. No further information is expected.
Was diagnosed with Covid-19; Was diagnosed with Covid-19; sick; This is a spontaneous report from a contactable pharmacist via medical information team. This pharmacist reported for a female patient.  A female patient of unknown age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date in Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller stated that the patient got sick and was diagnosed with Covid-19 on Mar2021. The caller was asking on how to proceed with second dose. The caller was asking whether the second dose can be given earlier than 3 weeks. The patient laboratory data Covid-19 was positive in mar2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid !9. 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, Committees, and Investigators, as appropriate.
This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On 01-OCT-2015 the patient was vaccinated with a dose of GARDASIL (lot#, strength, dose, dose# and route unknown). On 30-OCT-2015 the patient was confirmed to be pregnant via a urine screening (exposure during pregnancy). The last menstrual period (LMP) was on 10-SEP-2015 and estimated due date (EDD) was on 16-JUN-2016. The pregnancy outcome was pending. Additional information has been requested.
21 days between 1st and 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose). On 12-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Concomitant medications were not reported.
3 year old Pt was given pediatric dose of Pfizer Covid-19 injection of 0.2mL/10mcg instead of 0.2mL/3mcg. Follow up completed with Pt's parents 3 days later who state that the Pt has no side effects besides some localized swelling at the injection site. Pt is well and acting normally.
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    Patient registry ID was reported as 6561778  No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Caller thought she had allergies two days before 16May2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "slightly elevated blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure increased. Vaccination history included: BNT162b2 (Dose number: 1), administration date: 01Apr2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 14May2021, outcome "unknown", described as "Caller thought she had allergies two days before 16May2021". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:She is a very healthy 70 years old and fully vaccinated with Pfizer. She is only on one pill for slightly elevated blood pressure and it is a small dose. Caller clarified that she is fully vaccinated with Pfizer Covid vaccine. She has had 4 shots total. She did have her two boosters. Pfizer Covid vaccine: caller unable to provide lot number for any of her Pfizer Covid vaccines as they are not on her card. First dose given on 01Apr2021. Second dose given on 04May2021. First booster given on 24Nov2021. Second booster given on 18Apr2022. All Pfizer Covid vaccines were given at (withheld). Caller thought she had allergies two days before 16May2021. Caller clarified that the self test kit was a test for Covid. She had positive Covid test on 16May2022, but had all the symptoms two days earlier.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1. 05/14/21: Physiological shock, about 30 minutes, immediately after injection - 2nd vacc. 2. 05/15/21: Unusual fatigue similar to the flu, entire day. Pain at injection site.    (05/16/21, no symptoms) 3. 05/17/21: Low blood pressure, about 8 hours. BP, 70/45 to 85/50. Rapid pulse, 90-99. Felt heart pounding in chest, weakness, fatigue, and dizziness so used home blood pressure measuring device to determine rate multiple times.. But no shortness of breath.  Note, felt shock shortly after the vaccination. Although I waited the required 15 minutes at the cliniic, because I was in shock and alone, was unable to report it to anyone. Would have been good if a clinician had checked up on me. Had a ride to take me home.
Red, swollen, itchy knot under skin near site of injection approximately two inches in diameter. Lump continued to grow to more than one swollen subcutaneous, hot-to-the-touch knot throughout the next 29 hours. Once reaction grew to affect entire upper arm, medical attention was sought out. A shot of Benadryl and a shot of Rocephin were administered at approximately 1:30 PM by medical team.
pt recvd vax;c/o bilateral foot pain;tx w/ atb for poss cellulitis;did not improve & pt saw neurologist who dx autoimmune polyradicular relapsing neuropathy;
Rash. Erythema. Shoulder pain (L) deltoid per NP school nurse.
Swollen arms, was not able to move arm. Arm got infected. Had to be antibiotics for ten days (per patient on 11/16/15).
Positive for SARs-COV-2; Positive for SARs-COV-2; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, expiry date and lot number not reported), via an unspecified route of administration On an unknown date in Apr2021(reported as last Wednesday), as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021(reported as last Wednesday), patient received first dose and tested positive for SARs-COV-2. The event was considered serious (medically significant). It was reported that the patient had scheduled for second dose. The outcome of the event was unknown.  Information related to batch/Lot no. was requested.
Patient received Moderna 0.25 mL instead of Pfizer - no reported adverse effects reported
Swollen eyes and lips that lasted 36 hours. Went to the doctor and was given an IV of steroids and prescribed steroids to take for the next couple days and allergy medication.
Information has been received from a physician's assistant concerning a 67 year old white female with high blood pressure who on 04-OCT-2007 at 12:45 PM was vaccinated on left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant therapy included hydrochlorothiazide. There was no illness at the time of vaccination. On 06-OCT-2007 in morning the patient developed rash on her side torso. It was not specified whether the rash was shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from physician's assistant who stated that the patient had 6 small blister like lesions on abdomen that were itchy. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. No further information is expected.
red part got bigger; arm got itchy; burny; kind of red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (arm got itchy), VACCINATION SITE PAIN (burny), VACCINATION SITE ERYTHEMA (kind of red) and CONDITION AGGRAVATED (red part got bigger) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PRURITUS (arm got itchy), VACCINATION SITE PAIN (burny) and VACCINATION SITE ERYTHEMA (kind of red). On an unknown date, the patient experienced CONDITION AGGRAVATED (red part got bigger). At the time of the report, INJECTION SITE PRURITUS (arm got itchy) had resolved and VACCINATION SITE PAIN (burny), VACCINATION SITE ERYTHEMA (kind of red) and CONDITION AGGRAVATED (red part got bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Chills, shaking, headaches - went to hospital ER - ER MD feels unlikely vaccine reaction - was discharged same day from ER - was completely "fine" 24 h after incident.
One week after the injection, my arm started to itch and turned pink.  On Saturday  it was bright pink.  The yesterday it was bright pink, from the injection site down to my elbow,  and was warm and I had a swollen area just above the elbow on the inside of the arm.  Today it is still pink, but not as itchy.
Pt requested to be seen on an urgent basis for a "rash" that started two  days ago after his flu shot.  Pt. states he had a flu shot last week and after that he developed a rash all over his body. He says there is a big red blotch where he got the  shot. He says it is on his shoulders, neck and legs.
PFIZER-BIONTECH COVID-19 VACCINE EUA COUGHING, RUNNY NOSE, CONGESTION, BODY ACHES MILD HA & NAUSEA
Patient was 11 on July 25, 2007 when she went into the Pediatrician's office for a School Physical.  Patient received the first vaccine during the visit and received the second shot on or about October 22, 2007.  Patient began struggling with fatigue and general achiness about 2 weeks after the vaccine.  This progressed and became worse.  She had issues with fatigue and overall body pain, joint pain, headaches and stomachaches.  Patient was able to work through it part of the time but still missed a lot of school.   At the end of February, Patient had severe headaches, dizziness, stomach pain, and fatigue. Patient had virtually stopped eating.  She had lost 10 pounds in a matter of a month.  The diagnosis was "sinus infection."  The doctor prescribed an antibiotic.  Patient had an adverse reaction to the antibiotic and had to be prescribed a different one.   She was on Antibiotics for several weeks without any improvement.  In addition to the above noted symptoms reported to the doctors, patient  reported difficulty concentrating and severe leg pain and tingling down to her ankles.   We have enlisted the help of a Integrated Manual Therapist to get the toxins out of her body.  She has been in treatment since mid April and has been improving.  She is still having occasional severe headaches, stomach pain and fatigue.  Patient has begun eating again but has not gained any weight back (she has lost a total of 20 pounds).
Stingling for over 2 hours at the site of injection. The next day deltoid tenderness and axillary tenderness, pain on lifting the arm, tender swelling in the axillare are on side of the injection, that lasted for for the next day, but started to go away on day 3.  Also had vague headache and sore throat with dysphagia the next day after injection and feeling tired- all resolved on day 3.
6.5 days after vaccination with the MMR, (the child) developed repetitive vomiting & retching very similar to previous reactions to eggs, He had severe vomiting X 8 hrs then intermittent vomiting for 12 more hrs. He also developed a fever lasting 48 hrs. (the child tests 4+ to eggs via skin testing.
I tested positive for COVID-19 on 12/15/22. We had been testing because my husband had a surgery, and we were testing negative. I had a dentist appointment coming up and decided to test and tested negative at that time. After my dentist appointment, I had a scratchy throat. About 2 days later, I decided to test again and that is when I tested positive. I had scratchy throat, congestion, and cough. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID.
Headache, nausea, fever, chills, muscle aches, tired, feeling like I'm drunk
61 after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (61 after first vaccine) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (61 after first vaccine). On 07-Apr-2021, PRODUCT DOSE OMISSION ISSUE (61 after first vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information mentioned.
Stuttering per pt father requesting appt - offered appt Oct 18 at 8:30. Pt. father said he can't, offered appt Oct 19 then he requested appt on Saturday I made appt for Saturday at 9:00 - they were no show.
Patient reports headache, nausea and vomiting that started Saturday 2/27 and ending late afternoon on Sunday 2/28.  Denied symptoms today on 3/1.
error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.
That evening patient experienced hives and itching (most of which were on her bottom).  She took benadryl
Patient complains of stiffness in upper arm above the elbow extending up to shoulder starting the day after receiving the shot. She states she used an unspecified pain relief cream and a cold compress on the area.
I was positive for COVID-19 on 01MAR2023, I was feeling tired with a fever and cough. I was tested at the school I work at, I didn't see a doctor but I took over the counter medication like TYLENOL. I started feeling better about 10 days later.
Information has been received from a pharmacist concerning a 25 year old female employee of the hospital who was vaccinated with two doses of VARIVAX (Merck) and does not have immunity. The two doses were given 6 weeks apart. The patient contacted the nurse in employee health. No further information is available.
This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # J013277 and expiry date: 06-AUG-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Pt developed intussusception requiring surgical reduction. Also had symptoms of resolving virus + viral exanthem c/w parvovirus (fifth's disease) on the day of when vaccines given.   6/15/09 Received hospital medical records of 5/31-6/3/2009. FINAL DX: Intussusception, s/p laparotomy w/manual reduction & appendectomy Records reveal patient experienced bilious emesis & bloody stools x 1 day.  Surgical consult done.  To OR when BE failed to reduce.  Progressed well & d/c to home.
High Fever, Chills, Fatigue, Headache, Joint Pain, Muscle Pain at injection sight (could not move arm), Muscle pain and joint pain all over body as well. Extremely bad rash around injection sight on upper arm/shoulder area looked like a severe burn. Vomiting the next day along with all the same symptoms listed above.  Symptoms lasted through Saturday 7/2/2016 except fever and vomiting. Fever & vomiting stopped on Thursday 6/30/2016.
Bleeding; Itching; She has a rash all over her body; she has stress all over; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over). At the time of the report, HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test positive: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any allergies. Patient did not experienced a similar event on the past.  Patient did not had any acute or chronic illness at the time of the vaccination.  Patient was using unknown medication for Blood pressure and cholesterol. Patient states that her symptoms was ongoing.  Dermatologist prescribed her a cleansing cream for the shower.   This case was linked to MOD-2021-419456 (Patient Link).
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: on 23-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patient between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.