chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dermatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history included: "History CA of bladder", start date: 31Aug2020 (ongoing), notes: Treatment Vit BCG Immunotherapy; "Anxiety" (ongoing); "Depression" (ongoing). Concomitant medication(s) included: BUSPIRONE oral taken for anxiety (ongoing); ESCITALOPRAM oral taken for depression (ongoing); LORAZEPAM oral taken for depression (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical site of injection: Left arm; Lot number: EL9264), administration date: 07Feb2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Anatomical site of injection: Left arm; Lot number: EN6203), administration date: 27Feb2021, for COVID-19 immunisation. The following information was reported: DERMATITIS (non-serious) with onset 25Mar2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient age at time of vaccination: 68-69 (years). Biopsy of lip and L buccal cheek resulted in dermatitis, could be due to drug reaction. Vaccination facility type for 1st dose 2nd dose 3rd/Booster was Hospital.
Started my menstrual Cycle 10 days earlier than normal. I did this with my first two doses of pfizer too.
@ MN pt started running 104 fever in spite of having been given APAP; pt would cry 15-20 mins @ a time; woke frequently during noc difficult to console; did not see MD & was nl next day;
From telephone contact received at AP on 10/18/2002, it was reported that a 45 year old male patient received TD ADS ADULT (Lot # U0522AA) on 09/20/2002.  Approximately eight hours later, the patient developed soreness at the injection site, fever, "knots" in his arm and general body aches.  These symptoms lasted for two days and the patient missed work.  Reportedly, these adverse events have fully resolved.
Chief Complaint Patient presents with ? Breathing Problem     "she has been having problems breathing everytime she walks"  ? Edema     bilateral legs      HPI 73-year-old female history of CHF, COPD, atrial fibrillation presents with shortness of breath. Symptoms progressively worsening for the past 6 weeks. Patient states symptoms are worse when she attempts to ambulate. Patient sees a pulmonologist and is on albuterol inhalers which she states have not improved her breathing. Patient is not on any oxygen at baseline. Patient denies any fevers, chills, chest pain. Patient is compliant with all her home medications. No noted increase in leg swelling.   Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for congestion, ear pain and sore throat.   Eyes: Negative for photophobia and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria, flank pain and hematuria.  Musculoskeletal: Negative for arthralgias, back pain and myalgias.  Skin: Negative for pallor and rash.  Neurological: Negative for dizziness, syncope, light-headedness and headaches.  Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious.   ? COVID-19 02/10/2022 ? Acute on chronic diastolic CHF (congestive heart failure) 02/10/2022 ? Atrial fibrillation with RVR 05/05/2021 ? Acute kidney injury superimposed on CKD 06/03/2019 ? Essential hypertension 05/02/2019
Patient requested Varicella injection.  Dr. ordered Varicella injection. Writer gave patient Shringrix injection instead of Varicella injection in error.  After error was discovered, writer discussed with Dr. and patient was contacted by writer and advised of error. Patient stated, " I understand. It's ok. I work in the medical field and I know mistakes will be made. I am ok. My arms are a little sore from the injections but other than that, I'm fine. I will come in on Monday to get my Varicella because I need it for school. Writer apologized to patient for the error. Writer also reported error to immediate supervisor.
I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
About 5mins after receiving vaccine, team member starting vomiting. Continued vomiting and 7min after vaccine states her lips are tingling and throat scratchy. She was in ER triage by 1127.
little fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (little fatigued) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced FATIGUE (little fatigued). At the time of the report, FATIGUE (little fatigued) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received dose 1 of Moderna intramuscularly on 16-Jan-2021 with lot number 011J20A on left arm, dose 2 of Moderna on 13-Feb-2021 with lot number 031M20A on left arm, dose 3 as first booster of Moderna on 20-Aug-2021 with lot number 052E11A on left arm and dose 4 as second booster of Moderna on 21-Mar-2022 with lot number as 046L21A on right arm.  Treatment medications were not provided.   This case was linked to MOD-2023-713924 (Patient Link).
young lady got the first vaccine last week who was under age; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (young lady got the first vaccine last week who was under age) in a 16-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (young lady got the first vaccine last week who was under age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (young lady got the first vaccine last week who was under age) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided.
pt feeling dizzy & lightheaded;aching all over & feeling as if is going to pass out;
This spontaneous report was received from a certified medical assistant and refers to a 4-day-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 13-MAR-2017, the patient was mistakenly given a dose of ROTATEQ orally, lot# reported as M042172, expiration date 08-JUN-2018 (dose was not provided). The vaccine was intended for a different patient in a different exam room. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
1st Shot - swollen lymph nodes , achy muscles, edema/ fluid in joints, sore muscles , sore arm pits and sore breasts for 5 days.  2nd Shot- same symptoms as above for a day. 5 days after shot, got itchy, burning, sore blotches all over the body (legs, chest, neck and armpits) also had runny nose with clear discharge and a sore throat. Went to an urgent care center because wouldn?t get into physician soon enough. Doctor prescribed hydroxyzine and prednisone and told me it was allergic reaction.
Headache; Pain in arm; Fatigue; Nervous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and NERVOUSNESS (Nervous) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CITRATE FREE. On an unknown date, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and NERVOUSNESS (Nervous). At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) had resolved and NERVOUSNESS (Nervous) outcome was unknown. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication information provided No concomitant medication information provided It was unknown if patient was enrolled in a COVID-19 Vaccine Trial
This spontaneous report as received from a registered nurse refers to a 12 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03-03-2014 was exposed to an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
17 year old received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, it was reported that a 17-year-old received the first dose of the vaccine. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported  The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Information has been received from a consumer, for the Pregnancy Registry for Gardasil, concerning her 16 year old daughter who on 04-OCT-2007 was vaccinated with a first dose of Gardasil (lot number not provided).  Concomitant therapy included DEPO-PROVERA.  On 04-OCT-2007, after the first dose, the patient's mother reported that the patient felt like she was going to faint and developed a rash on her arms and hands.  Subsequently, the patient recovered (date not specified) from feeling faint and rash on her arms and hands.  Sometime in December 2007, the patient was vaccinated with a second dose of Gardasil (lot number not provided).  The patient's mother reported that the patient is now "approximately 23 and a half weeks" pregnant (estimated LMP is 13-Sep-2007).  On 27-Feb-2007 the patient had an ultrasound performed, which was negative for fetal anomaly.  Unspecified medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008. Follow up information received on 23-Jan-2009 from the physician's office. The reporter stated that the patient delivered a healthy normal baby girl, vaginally, weighing 6 lb .5 oz on 15-Jun-2008. The patient/mother developed a "fever" (Temp. not specified) after the delivery, but it resolved and the patient was discharged at the regular time, her stay was extended. The baby was fine". Additional information is not expected.
Severe onset of symptoms; felt like when 911 called and ended up in hospital with COVID-19 from 6/1 to 6/23 .  Almost totally immobile with pain; headache, back and leg pain; neck stiff; fingers stiff; muscle aches and hip soreness; weakness in legs; nausea; trembling; chills; inability to tolerate food or drink; temperature went up from 97.6 [normal] to 101.3 [any temp from 99.9 up I am seriously ill]; high temp lasted two days; normal at 97.8  on third day
Pt reported experiencing difficulty lifting her left arm since receiving the vax. The arm is in a lot of pain.
It started with body weakness; feverish; progressed to chills and high fever; moderate to severe body aches. And headaches severe sinus congestion. These lasted for about one week. I did Augmentin (I'm a dentist). I took Mucinex and Vitamin C, Zinc, and Levothyroxine and Theraflu. These helped my symptoms. I got skin rashes towards end of first week of the symptoms and they still haven't gone away. They are on my hand back part of the palm. It's itchy and raised. And I have them on my lower legs, as well. I have recovered from flu like symptoms but not from skin rashes.
After second dose, individual became weaker and needed to use of cane to walk around. Became progressively weaker over course of a few weeks, then on May 14th had chest pressure, nausea, and dizziness. This continued, Wednesday May 19th complained of trouble breathing, shortness of breath, but felt better Friday, May 21st, until Saturday May 22nd at 6:00 AM individual complained of more severe chest pressure. Taken to hospital, determined heart attack and kidney failure.
Sniffles; A cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold). At the time of the report, RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) outcome was unknown.        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.   No concomitant medications were provided. Treatment medications were unknown.    Reporter did not allow further contact
Pt recvd 2nd Engerix-B vax on 22SEP92 & parents noted inc fussiness; 23SEP92 temp was elevated to 101.9 R, pt was fussy & irritable; Reporting MD doubts that sx were due to Engerix-B; feels that they were more likely due to viral infect;
very small pockets of liquid (maybe 4); This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8732, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 30Mar2021 16:00 (at the age of 45-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medications were not reported. The patient has no known allergies. The patient has no other medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced very small pockets of liquid (maybe 4) on an unspecified date. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.
4x6 cm welt on right shoulder, severe headache, s/ muscle pains. Sxs began within 12 hours of the injection and abated 12 18 hours after they began. Welt persisted at 48 hours.
I waited approximately 15 min after injection, then checked out ( another approximately 5 min), walked to my car and started to drive home. About 40-45 minutes after injection I had a distinct sensation of swelling lips and a tightening of the throat. I stopped driving, drank some water in the car. Fortunately, this reaction did not progress and after a few minutes more began to dissipate. I drove the rest of the way home. Then a late afternoon nap. I will have Benadryl with me for the 2nd dose.
The night of receiving the 2nd dose of COVID vaccine I have fever, chills, severe back and abdominal pain, and fatigue that lasted 24 hours.  On the evening of 12/14 I started with severe abdominal pain and vomiting.  On the morning of of 12/15, I reported to a HCF ER, where it was determined I had appendicitis and I was transported to another HCF for an emergency appendectomy.
-Swelling of lips and face within 20 minutes of injection. Lasted approximately 4 hours. Over the counter Antihistamine was taken.  -Diarrhea approximately 45 minutes after injection. Lasted thirty minutes treated with water for hydration.  - Lethargic for three days after injection.  - Heightened insomnia for two nights.
C/O sever pain to left arm, loss of sleep times 4 days, taking mortin 800mg every 8 hours as needed for pain, continues to c/o pain to left arm.
pt recv vax 14JUN95 & notified by mom of rxn on 16JUN pt seen @ clinic 16JUN & found to have swollen-red-inc warmth to lt arm fr elbow to lt shoulder; noted some bruising type discoloration @ inj site; c/o inc itching & pain; had full ROM
Induration with mild erythema at the site of administration - Right lateral thigh. Induration measuring 3 x 4cm.
Information has been received from a Certified Medical Assistant (CMA) concerning a 64 year old patient of unknown gender. Relevant medical history and drug reactions were not provided. On 18-MAY-2015, instead of being administered with ZOSTAVAX vaccine, the patient was inadvertently administered with a dose of VARIVAX (Merck) dose (0.5 ml, subcutaneous, lot number: K003421, expire date: 06-MAR-2016). No adverse effect was reported. Additional information has been requested.
soreness at the injection site last; chills; fever; swelling of the tongue; swelling of the throat; headache; weakness; very sick for 4 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to shellfish (food allergy: shellfish), peanuts and different things and immune deficiency (low white blood cells), chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that the patient was expected to receive the 2nd dose on 01Mar2021. However, following the first dose, the patient had soreness at the injection site last, chills, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days on an unspecified date. It was reported that she was advised by her pharmacist to take Tylenol and Benadryl, every 4 hours to keep the fever down and to keep the tongue and throat from closing. Therapeutic measures were taken as a result of soreness at the injection site last, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days. Outcome of all events were unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
6/24/10 - developed fever. 6/25/10 - developed generalized pink papular rash. Resolution by 6/28/10.
Moderna COVID-19 Vaccine. Approximately 1 week after my first vaccine dose, the arm given the shot, became itchy, red, patchy (2x3 inch area), bumpy.  This is day two of that reaction with no change or improvement.
Soreness, swelling, headache, chills, fever, body aches,  joint pain, muscle pain, runny nose, fatigue, upper and middle back ache, chest pain, and dizziness.
Rash other than @ inject site, allergic event (hives), large rash on head & face 1 hr following immun; 10JUL91 had rash & swelling top lip & vomiting lasting 30 minutes;
Moderate-to-moderately severe axillary lymphatic swelling.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the right arm on 03Apr2021 (at the age of 22-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW8735) in the arm right on 24Apr2021 (at the age of 22-year-old) both as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021, the patient experienced moderate-to-moderately severe axillary lymphatic swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event moderate-to-moderately severe axillary lymphatic swelling was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Nightmares; Wakes up with palpitations; This is spontaneous report from a contactable consumer (patient herself) via a medical information team. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunization. It was reported that, caller received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 15Feb2021, since the second dose of the vaccine she's been experiencing nightmares and wakes up with palpitations on an unspecified date in 2021. She would like to know if anybody else has reported this symptoms. She also mentioned that a friend of her (male) acquired cancer after receiving the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.