chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their first dose of Comirnaty on 13NOV2021 and got the 2nd dose 6 days ago, 19NOV2021 with them as well; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: KF5127) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 13Nov2021, when the patient was 6 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "received their first dose of Comirnaty on 13NOV2021 and got the 2nd dose 6 days ago, 19NOV2021 with them as well"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Fatigue".  Additional information: Reporter stated they have 2 patients, a 5-year-old female patient and a 7-year old male patient who received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021 with them as well. Reporter asked if the patients are considered fully vaccinated or do they need to administer a booster dose for them. Two patients received the first dose of Pfizer COVID vaccine on 13Nov2021 and was given the second dose on 19Nov2021; got the second dose from school by accident 6 days after first dose. When probed for the side effects: Reporter stated the female patient had fever and for the male he had fatigue. That's what the parent told me they don't give me too much information.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101638690 same reporter/product/event, different patients.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with COMVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), after the vaccines were exposed to temperatures from outside of recommended condition. No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/27/2021.
In 10/92, the pt received her 1st dose of Engerix-B. Subsequently, she developed a rash, fever and vomiting. The reporter indicated that no additional doses of Engerix-B were "ever given". As of 10/4/01, the outcome of the events was unknown.
Pt had episode of transient global amnesia on Monday January 10, 2022. He is concerned that Covid booster may have caused it.
lung capacity decreased to 30%; This spontaneous report was received from a pharmacist, concerning a currently 45-year-old female patient. The patient's concurrent conditions included amyotrophic lateral sclerosis (ALS). No information was provided regarding the patient's medical history, concomitant medications or previous drug allergies.  On an unspecified date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (vaccination scheme, dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient's lung capacity was decreased to 30% (total lung capacity decreased).   At the time of the report, the patient had not recovered from total lung capacity decreased. The causal relationship between the event and the suspect therapy was not provided.
Swelling/inflammation/stiffness of the shoulder and upper arm. Pt experiencing residual stiffness as of 9/19. Advised pt to apply cool pack, take a dose of anti-inflammatory, and stretch arm and shoulder as tolerated.
Fever of 100.5 treated with acetaminophen for 1 full day. Loss of appetite. Muscle pain.
I woke and I felt exhausted - like I would have to resign from work that day - that's how exhausted I was. At 6:00 pm, I felt like I had energy. And from then on - I felt like my body had been reset - like I had more energy. (Until the second dose of the vaccine.)
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 29-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Some twinge of discomfort first 1-2 days after shot. One week after injection. Red raised, itching from site to elbow , hot tender- no other symptoms. Woke up pt with itching. Pt does not really any recent injection but has had before.
Severe pain to (L) upper arm surrounding site of vaccine admin. swollen and very tender on exam.
G62.9 NEUROPATHY 2/7/2021 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY    ALTERED MENTAL STATUS, UNSPECIFIED I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/7/2021 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY    ALTERED MENTAL STATUS, UNSPECIFIED
I got the shot on a Friday night at 5pm. I experience the arm pain in my left arm through out the top of my arm , by the end of  that night. By Saturday evening most of the pain was gone from that site. Late Saturday night I started noticing some pain in the arm pit on the left arm, didn't think much about it. By Sunday mid morning the pain was just getting more severe. Started to pay close attention to the side effects of the vaccine to realize that I most likely had swollen lymph nodes. The pain continued through the following Wednesday, when the pain started to not be as bad. I still to this day have some pain in the lymph nodes. I have contacted my doctor and was told to just monitor the site to make sure nothing is worse. That these reactions are common. I also have some soreness in my upper arm under where the shot was given, that I'm not sure if it is from the shot or the muscle compensating from the soreness of the swollen lymph nodes.
Eyes started burning (Not sure if vaccine related); Eyes started itching (Not sure if vaccine related); Vision fades sometimes (Not sure if vaccine related); This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)). At the time of the report, EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) outcome was unknown.            Patient stated that for the above mentioned events if she blinks, it gets back to normal. Patient didn't saw her doctor since June2021 and in June her vision was healthy. Her blood sugar had been normal after vaccination and it did not fluctuate. No concomitant medications were mentioned. No treatment details were reported.
Two and half weeks after receiving the vaccine I woke up in the middle of the night sweating, with intense vertigo, could not walk without holding on to the walls, passed out.
RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE.  THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN
p/vax pt exp a measles type rash on trunk & scalp;pt had n fever;
Feeling unwell. "Burning" head to toe, shakes, near syncope, sweats, tiredness, dizziness, lightheaded. Onset of symptoms less than 1 hour.  Patient denied symptoms of chest pain, (L) arm pain, or SOB. Patient sent by EMS to local emergency department.
Pruritis, shaking, nausea, tachycardia, rash to arms, chest and back.
received a dose that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number B223P, expiry date June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. In the week of the reporting, the patient received a dose of Fluarix QIV that expired June 2021 which led to expired vaccine used. The reporter consented to follow up. Healthcare professional was agreeable to recontact but asked to follow up via email since she serviced several locations.  No further information was available while on call regarding the patient or specific date of vaccination.
missed second vaccine dose (more than 3 months since first shot); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second vaccine dose (more than 3 months since first shot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.
Thyroid swelled up large, especially on my right side. Tenderness and sore on lower edge of the swelling especially. I feel like it set me back ten years in my healing if my thyroid. It kept swelling fir about half an hour then didn?t even start to reside u til about two hours after the injection. It has slowly been going down and still is slightly swollen. I am in hopes it will continue to improve over time. Did not get second dose of the vaccine and will most likely not get any boosters either.
Severe allergic reaction 10 days after 3rd Moderna shot. Hives all over body and now have dermatographia up to this day. Was given steroid shot and prescribed prednisone, famotidine, Dexamethasone and triamcinolone acetonide 0.1 % topical cream during a month's period. Eventually was told to take over the counter antihistamines as needed.
Low grade temp 1 day after shots. Fever elevated to 103.8 axillary. Rash (head to toe) days later. Ear infection (bilat.) day 5-6 post IZ.
increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).; This spontaneous case was reported by a nurse and describes the occurrence of FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 022M20A and 042L20A) for COVID-19 vaccination.     Patient allergies included: None; nothing severe. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient not had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high (1.5 years ago (No change)) and Coronary artery disease (1.5 years ago (No change)). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.   On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).). At the time of the report, FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Fibrin D dimer: 1.69 (High) 1.69. In February 2022, Fibrin D dimer: 1.35 (High) 1.35. In March 2022, Fibrin D dimer: 1.38 (High) 1.38. In April 2022, Fibrin D dimer: 0.88 (High) 0.88.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) to be related.    On 01-Dec-2021, the patient received a first booster dose (Lot: 027H21B) of Moderna vaccine.  Reporter stated that her hematologist stated there may be a connection to the elevated D-Dimer lab value and the Moderna vaccine. She reported the Moderna vaccine may have increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).  No treatment medication was reported.   This case was linked to MOD-2022-568897 (Patient Link).
A male patient reported that his "bladder began to shrink" after being treated with OncoTICE approximately 3 years ago.
Patient returned to ER for possible allergic reaction and "trouble breathing" swollen glands. Per ER pt given epinephrine x one, Solumedrol and Pepcid. Discharged on Decadron/clindamycin and Benadryl Also dx w/possible throat infection
inflammmed retina/Optic nerve inflammation; color vision problems; Light sensitivity; vision dim; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity), VISUAL IMPAIRMENT (vision dim) and EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Polycythemia vera since August 2000 and Thyroid nodule. Concomitant products included THYROID for Thyroid nodule, LEVOTHYROXINE SODIUM (SYNTHROID) from 1993 to an unknown date and FAMOTIDINE from January 2021 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity) and VISUAL IMPAIRMENT (vision dim). On 13-Mar-2021, the patient experienced EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation). At the time of the report, DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity) and VISUAL IMPAIRMENT (vision dim) outcome was unknown and EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation) had not resolved.            Patient being treated with steroids for 3 weeks. Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-081612 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Email and ADR received, added patient demographics, concomitant drugs, past medical history, allergies, additional AE , start date and outcome of an event updated from unknown to not recovered.; Sender's Comments:  MOD-2021-081612:first dose case
This medically confirmed spontaneous report (initial receipt 23-Oct-2014) concerns a 62-year old male patient. The reporter was not aware of any past medical history of arm/shoulder injury. On 08-Oct-2014, the patient received AFLURIA (batch number T57606) in the left arm at 0.5 ml annually via intramuscular route for the prevention of influenza. This was the first time that the patient received AFLURIA or any flu vaccine. Two days after vaccination, the patient experienced pain and swelling in his right arm (opposite arm that received injection). The patient was constant and could be felt from his elbow to shoulder blade. The patient received tramadol 50 mg three times daily for pain, which did not help. The outcome was reported as not yet recovered.
Pt devel t105; Seen in ER 29MAY91- tx @ ER given oral antipyretic;
Initial and follow-up information has been received from the Merck Pregnancy Registry via a 23 year old female who was vaccinated on an unspecified date with a dose of Gardasil when she was a month pregnant. Subsequently, the patient gave birth to an infant with a cleft palate. At the time of the report the patient had recovered. The infant's outcome is unknown. Additional information has been requested.
during pap appt, patient received varicella vaccine.  patient had recently been seen 10/22 for employee PE/forms/titers. varicella immunity low; patient was to receive vaccine and was aware of this since 11/4/21. at pap visit, nurse went in before provider. when provider went in, patient confirmed LMP was 8/22/2021. pt concerned of "spotting" in sept/oct. due to this info provided at that moment-provider ordered IH-HCG which turned out to be positive. per provider, patient also expressed that she had 2 positive urine pregnancy tests at home. this was not disclosed to either MA or RN who assisted pt before pcp went in.
Days 1-3 - fatigue, lightheadedness, shoulder pain. Day 7: redness, mild swelling, mild tenderness at injection site (no infection)
Headache, shortness of breath, difficulty breathing, fatigue from 6/12-6/18.  Pulmonary embolism diagnosis on 6/18
Felt Very sick; cough; tested positive for Covid-19 after 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination). At the time of the report, ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment Medicines include Cough Medications (no specific details)  to help up with cough.   This case was linked to MOD21-056951 (E2B Linked Report).; Sender's Comments:  MOD21-056951:Crosslinked Patient with Wife case
Forehead acne breakout for 72 hours.; Sore deltoid (location of injection); This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. The patient did not have any allergies to food, medications, or other products. The patient's past drugs were not reported. 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 patient's concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) for an unknown indication since an unknown date. On 12Apr2021 at 04:00, the patient experienced sore deltoid (location of injection) and forehead acne breakout. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event forehead acne breakout for 72 hours was resolved on 15Apr2021 and that of the event sore deltoid (location of injection) was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician, concerning a 65 year old female patient with hypertension, hypercholesterolaemia and hypothyroidism, who on 29-OCT-2007 was vaccinated SQ in the right upper arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 658555/09364U). Concomitant therapy included ZETIA, TOPROL XL TABLETS, and SYNTHROID. On 29-OCT-2007, a few hours after administration of the vaccine, the patient developed a "golf ball sized" area of warmth and irritation at the injection site. She called the office, and was prescribed BENADRYL and cold compresses. The patient subsequently recovered (duration not specified). This is one of three reports from the same source. Additional information has been requested.