chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to hospital ED on 3/11 with signs and symptoms of DKA and Dehydration.  Per chart review was seen by PCP on 3/5 and had lab work done and showed elevated glucose and was started on metformin.  Was recently diagnosed with diabetes, fatigue, insomnia and loss of appetite which patient stated started after second COVID-19 vaccine dose on 2/2/21.  Patient stated none of these symptoms or diabetes prior to COVID-19 vaccinations.  Per medical record review, no mention of diabetes although lab work did reveal mildly elevated glucose in 2017 (though unsure if was fasting or not) and no mention of diabetes diagnosis in following medical records.  Patient treated for DKA and discharged on 3/14.
Began with stomach cramps followed by one bout of loose stool/diarrhea. At approximately 2:00AM vomiting began with a sore throat. She vomited four times about one hour apart with the sore throat dissipating after the third or fourth time. Very mild diarrhea occurred during vomiting. After each bout of vomiting she said her stomach felt relieved. She also complained of fatigue. There has been no vomiting, sore throat or diarrhea since approximately 7:00AM 1/26/2018. She says she is feeling quite well, is eating a mild diet and drinking water with no adverse side effects.
6 month to 4 year multidose vial, not mixed with required diluent. Bacteriostatic 0.9% Sodium Chloride, used by mistake.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Patient in post vaccination area reports feeling; dry mouth, difficulty swallowing , and tingling on the left side of her face. 11 minutes (1331) after vaccination (1320) She has PMH- Anxiety, Hypertension, Thyroid problems, Tachycardia.  Pt is AOx4, resp even, skin p/w/d, speaks in clear complete sentences. She is able to swallow her own secretions, no drooling noted. VS#1 98%, 64, 110/72, 17 (1337) VS#2 98%, 61, 112/78, 17 (1410) Denies any symptoms, states her symptoms have subsided. Pt appears in NAD, ambulates with a strong and even gait. Pt states, "I wasn't sure if this was a reaction or my anxiety" Educated regarding s/s of an allergic reaction and when to seek medication attention.
Information has been received from a physician via a field employee referring to patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unspecified time, the patients received the first dose of GARDASIL or GARDASIL 9 (lot number, dose, and route not provided), and had not received second dose of any HPV product or had received second dose of any HPV product at an unspecified time one year after first dose (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Diagnosed with cancer; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with cancer) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 NEOPLASM MALIGNANT (Diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Diagnosed with cancer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEOPLASM MALIGNANT (Diagnosed with cancer) to be not related.    No concomitant medication was reported.  Reporter stated that the patient previously received 1st, 2nd and 1st booster dose of Moderna COVID-19 Vaccine, and he was recently diagnosed with cancer. Patient needs to start chemotherapy next week from date of report.  Company comment:This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious (important medical event) event of Neoplasm malignant, unspecified days after receiving the booster dose of COVID -19 vaccination with mRNA-1273 vaccine. The patient reported that he previously received first and second doses and then the first booster dose of mRNA-1273. He was recently diagnosed with cancer and had to start chemotherapy. His HCP mentioned that cancer was not caused by vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious (important medical event) event of Neoplasm malignant, unspecified days after receiving the booster dose of COVID -19 vaccination with mRNA-1273 vaccine. The patient reported that he previously received first and second doses and then the first booster dose of mRNA-1273. He was recently diagnosed with cancer and had to start chemotherapy. His HCP mentioned that cancer was not caused by vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
ARM VERY SWOLLEN AND PAINFUL FOR MONTHS, MUSCLE IN ARM WEAK STILL HAVING PAIN IN RT. UPPER ARM.
Awoke with severe Vertigo, Dizziness, Nausea, Headache
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), HYDROCHLOROTHIAZIDE, IRBESARTAN (AVALIDE), ATENOLOL (TENORMIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.
devel erythma & hematoma over inject site rt deltoid; erythema measured approx 4 cm in diameter; afebrile also upper arm stiffiness; tx warm compress & rest body part;
anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
Grand mal seizure and upper body rash Emergency room treatment (4/12/2021 @ 9:30Pm) including IV saline and magnesium  CT scan results were normal Magnesium level  normal Follow-up with GP within 48 hours
Patient states that a few days after receiving the ADACEL she is experiencing a red, hot, hard lump at the injection site.
10/2/23 Received vaccine in Right Arm 10/8/23 Onset of pain right knee(mostly lateral)  No injury noted 10/12/23 Onset of pain in right shoulder . No injury noted  Treated with Ice, Tylenol, Compression (of Knee) rest.  Pain still exists but seems to be abating.  Do not know of final outcome  * NOT ABLE TO ENTER MFR OF VACCINE: PFIZER ** NOT ABLE TO FILL IN ANYTHING ON CONTINUATION PAGE, E.G. SUPPLEMENT
My right arm was achy and I kept getting tingly off and on. The next day it went to the left arm and I thought I was having a heart attack. I went to my doctor after my knees started hurting and I called the nurse practitioner and she ordered an X-ray; then, a week later I went back to my doctor and he prescribed a CBB drops medication for me and then after that did not work, he prescribed some gabapentin. The medication helped a little bit but then when I went to bed last night, I couldn't get to sleep at all.
My arm was so sore I could hardly move it. I had horrible body aches, chills, a fever,  migraine, nausea, and loss of appetite.  Fever was so high it caused dehydration.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted and bumped his head on the counter after receiving flu vaccine. paramedics came and vitals were checked. Pt refused to go to hospital and had friend pick patient up from pharmacy.
2 IN BY 3 IN WELT AROUND INJECTION SITE, RIGHT DELTOID
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (dose and route were not reported), lot # M045207 and expiry date: 30-JUN-2019 for prophylaxis. The vaccine was exposed to temperature of 47 to 77 Fahrenheit for 510 minutes. There was a previous temperature excursion of 47 to 77 Fahrenheit for 6 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007239: US-009507513-1707USA007238: US-009507513-1707USA006714:
Shortness of breath, wheezing, coughing onset of asthma symptoms, bronchial spasms.
Patient was given the hib vaccine that was reconstituted with the wrong diluent. Vaccine will be repeated.
07/18/2003 pt behind on immunization due to recurrent OM. Received DTaP #2, IPV #2 left leg, Comax (Hep B #3/HIB #2) and Prevnar #1 in right leg. Child with 50 cent red wheal with IPV initially, but later that night whole left leg red, hot, swollen. Pt very upset, leg very painful to touch.
24 hours after administration, infant became inconsolable for over 12 hours. Evaluation in ED showed no other reason for irritability. Workup included a normal abdominal xray, non focal exam and normal corneal staining exam. The following day infant was still slightly lethargic but not crying inconsolably. On day 4 after immunization, infant returned to baseline.
Recurring skin boils; Dizzy; Injection site swelling; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Recurring skin boils), DIZZINESS (Dizzy), INJECTION SITE SWELLING (Injection site swelling), PYREXIA (Fever) and FATIGUE (Fatigue) 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 an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced FURUNCLE (Recurring skin boils), DIZZINESS (Dizzy), INJECTION SITE SWELLING (Injection site swelling), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, FURUNCLE (Recurring skin boils) and INJECTION SITE SWELLING (Injection site swelling) had not resolved, DIZZINESS (Dizzy) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira and Moderna Vaccine.  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.
Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of a dose of Varivax. Unspecified medical attention was sought. A product quality complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Bradycardia; foggy brain; He missed 9.5 months of work in 2021/ had to modify and had to change jobs due to still having some of the complications and was not able to physically perform at the same level; unable to even walk unassisted for a month and also in 2021; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 301458A), administered in the left arm for COVID-19 immunization. The patient had no relevant medical history and had no family medical history relevant to adverse events. There were no concomitant medications. Vaccination history included: BNT162b2 (first dose, via an unspecified route of administration (lot number: EJ1685 and expiry date: 31Mar2021) as DOSE 1, SINGLE), administration date: 28Dec2020, for COVID-19 immunization, reactions: "vertigo", "unable to even walk unassisted for a month and also in 2021."; BNT162b2 (second dose, via an unspecified route of administration, administered in the right upper arm (lot number: EN6201) as DOSE 2, 0.3mL SINGLE), administration date: 24Feb2021, for COVID-19 immunization, reactions: "cardiac related issues", "bradycardia", "foggy brain", "lightheadedness", "instability walking"; Flu vaccine (end of Sep2020), administration date: Sep2020, for Immunization. The following information was reported: GAIT INABILITY (medically significant) with onset 2021, outcome "unknown" described as "unable to even walk unassisted for a month and also in 2021"; BRADYCARDIA (medically significant), outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "recovering" described as "foggy brain"; PERFORMANCE STATUS DECREASED (non-serious) with onset 2021, outcome "unknown" described as "He missed 9.5 months of work in 2021/ had to modify and had to change jobs due to still having some of the complications and was not able to physically perform at the same level." The events "bradycardia", "unable to even walk unassisted for a month and also in 2021" and "foggy brain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: down in low 40s.   Additional information: Patient received his 3rd dose, a booster vaccine administered on 01Oct2021 and it is handwritten with no expiry date but says Pfizer 301458A for the lot. He does not have the dose or quantity as it is handwritten and was at (Facility Name withheld) and believes it was administered to his left upper arm but that is not documented on his card. He missed 9.5 months of work in 2021 and returned to not partial duty but returned for work on 15Sep2021 and worked from September 15th to April and had to modify and had to change jobs due to still having some of the complications and was not able to physically perform at the same level so had to change the role of his respiratory therapy career.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300168790 same patient and product; different dose number and events;
Headache, Fever, Diarrhea, NauseaVomitin,  Local symptoms: Pain-discomfort. General symptoms: Chills, fever, headaches, joint pains, muscle pains, nausea, diarrhea.   Narrative:
Small welt started out dime size and was warm, by 10PM rash spread to the size of an egg. The next morning a good portion of triceps and arm were inflamed. By the evening on May 1st the rash spread and was inflamed with shooting pains down my arm and swelling into my armpit.
Immediately following injection pain and tingling in my arm down to my hand that lasted for 7 days. Rash on left arm from shoulder to elbow, raised bump at injection site that was hot to the touch and itchy, lasted 7 days. Nauseous and couldn't eat for two days. Fever 101, for 36 hours. Fatigue for a week. Headache that continued from first vaccine and never went away and became very painful and still have them to date (mostly over my right eye and the base of my head on the right side, now have also progressed to my entire head and very painful). Nosebleeds for 3 days (from day 2 to 4). While I did not visit the doctor, I notified my doctor via the patient portal.
after about 5-6 hrs left side of my face became partially numb/feels like a hand is on my face/ Now been 4 days and still somewhat numb; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 03Feb2021 09:00 am at SINGLE DOSE for covid-19 immunisation.  Medical history included sjogren's syndrome, allergies to sulfa.  The patient's concomitant medications were not reported. It is reported on 03Feb2021 02:00 PM, about 5-6 hours after the vaccination, left side of patient face became partially numb. Everything functions fine but feels like a hand is on her face. Went to doctor who couldn't find anything else wrong and encouraged her to still get second shot. Now been 4 days and still somewhat numb, possible getting better but hard to tell. No treatment received for the events. Outcome of the event was not recovered. The patient is not pregnant. No covid prior vaccination. No covid tested post vaccination.
Vaccine MMR given 5/29/07 called 5/31/07 was  was seen at pulmonologist office. Felt was more than just local reaction large hot red area back of right arm fever 101, cold compresses Ibuprofen, Keflex
For a couple days right after the injection, my arm was sore. Then more than a week after, my arm got really red, swollen, hot, and itchy. It lasted for 3-4 days and then gradually eased up, the itching lasting the longest.
After completion of the second vaccination dose, patient developed back pain a few weeks later. Approximately 3 months after completion of second vaccination dose, patient developed idiopathic transverse myelitis which has resulted in permanent lower extremity paralysis.
She said her arm has been in pain since she recd the vaccine on 11/2/10 pain on her arm in between her elbow & shoulder. She also said she has been to her physical therapist & massage therapist.
shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA281960 and 2019SA282001 (same reporter).  This case involves a 70 years old male patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on 08-Oct-2019 (reported as this morning).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  Patient had no adverse reaction.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Onset infantile spasms w/in 1 wk of 3rd DTP; mom thinks may have had  1 the day pt got DPT but a/got it;
Superficial blood clot in the right upper arm 4 month after two shots of Pfizer
PATIENT STATES ARM WAS VERY PAINFUL FOR FIRST 1 - 2 DAYS, NOW STILL PAINFUL AND CAN'T RAISE ARM ABOVE WAIST ALMOST 4 WEEKS POST-DOSE
Seizure 8 days after vaccine. Three seizures. Hopefully no more. Too many vaccines required for children - chicken pox not deadly, HGP primarily 20 something males.  Need to split MMR. Pediatricians and drug companies were concerned about huge revenues than balance. Some vaccines good, but not so many.
hot; chilled; liver enzymes were elevated; iron levels very low; stomach pain; irritation in her throat; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of Pfizer's COVID vaccine on 25May2021. She began to have some stomach pain the next day and irritation in her throat (on 26May2021). About a week later on (Wednesday) 02Jun2021, she had very bad stomach pain. She was hot, then very chilled, and she went to her doctor the next day and to the ER the day after. She had some blood work done and ultrasound, and the imaging came back normal. But her liver enzymes were elevated and iron levels very low. Only the tests and the pain indicated that something was wrong. She was asking has anything like this been reported before and was it safe for her to receive the 2nd covid vaccine. The outcome of the events was unknown.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.