chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood sugars; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugars) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 prophylaxis. Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension, Non-smoker, Alcohol use and Abstains from recreational drugs. Concomitant products included AMLODIPINE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter and SELEXIPAG (Oral) 1600 microgram twice a day. On 01-Jun-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugars) (seriousness criterion hospitalization). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to BLOOD GLUCOSE INCREASED. At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugars) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose: high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLOOD GLUCOSE INCREASED (High blood sugars) to be related.    Company comment: This is a spontaneous case concerning a 76-year-old male patient with primary pulmonary hypertension, who experienced the serious unexpected event blood glucose increased, on an unknown date after receiving an unspecified dose of mRNA-1273. Patient was hospitalized for 3 days due to event. Clinical course, diagnostic tests and treatment details were not provided. Selexipag was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report. 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. The patient had no known allergies. No treatment medication were reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 76-year-old male patient with primary pulmonary hypertension, who experienced the serious unexpected event blood glucose increased, on an unknown date after receiving an unspecified dose of mRNA-1273. Patient was hospitalized for 3 days due to event. Clinical course, diagnostic tests and treatment details were not provided. Selexipag was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
More than 7 months from the first shot and had not received the second shot; Weakness in the left shoulder; Thorn ligament left shoulder; Left rotator cuff muscles atrophy; Not able to raise the left arm; Pain on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (Weakness in the left shoulder), LIGAMENT RUPTURE (Thorn ligament left shoulder), MUSCLE ATROPHY (Left rotator cuff muscles atrophy), INJECTED LIMB MOBILITY DECREASED (Not able to raise the left arm) and VACCINATION SITE PAIN (Pain on the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurologic disorder NOS (Nerve problems in the neck).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2020, the patient experienced MUSCULAR WEAKNESS (Weakness in the left shoulder), LIGAMENT RUPTURE (Thorn ligament left shoulder), MUSCLE ATROPHY (Left rotator cuff muscles atrophy), INJECTED LIMB MOBILITY DECREASED (Not able to raise the left arm) and VACCINATION SITE PAIN (Pain on the injection site). On 23-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 7 months from the first shot and had not received the second shot). On 23-Jan-2021, VACCINATION SITE PAIN (Pain on the injection site) had resolved. On 24-Jan-2021, INJECTED LIMB MOBILITY DECREASED (Not able to raise the left arm) had resolved. On 23-Aug-2021, PRODUCT DOSE OMISSION ISSUE (More than 7 months from the first shot and had not received the second shot) had resolved. At the time of the report, MUSCULAR WEAKNESS (Weakness in the left shoulder) had not resolved and LIGAMENT RUPTURE (Thorn ligament left shoulder) and MUSCLE ATROPHY (Left rotator cuff muscles atrophy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, Magnetic resonance imaging: abnormal (abnormal) MRI of the neck and shoulder revealed torn ligament and left rotator cuff muscle atrophy. On 24-Dec-2020, X-ray: abnormal (abnormal) X-ray of the neck and shoulder revealed torn ligament and left rotator cuff muscle atrophy.     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 medications were provided.  Treatment information was not provided.  As of 23-Aug-2021, patient had full range of motion in the affected arm. but he still has a weak shoulder
(2nd) day after injection arm was sore  (6th) day after injection  Left arm swollen.  Very Red and warm at touch.  Tightness and tender at touch. (All upper arm).  Ice pack and Tylenol was used for treatment.
Headache started at top of head and then moved all over, pressure on head,behind ears, forehead Thought pain was from high blood pressure but that is under control and pain continued. Had a MR I which showed nothing wrong, prednisone pack, doubled up on nortriptiline,am now on butalbital,accetamophen,caffeine Nothing has taken it away although doesn?t cement to jump around head like it did
Client received Hepatitis A vaccine 1ML on 12/13/2022, then another Hepatitis A 1ML on 1/24/2023 in left deltoid. After receiving injection, it was noted by provider that 2nd injection had been given too soon.  Provider states client was advised of vaccine error. Client was instructed he will need another Hepatitis A vaccine in six months. Client denied any signs and symptoms of adverse reactions. Client will need to return to clinic for dose 2 on 7/24/2023 or after that date.
Within 1 hr of vaccine intense itching at site mild itching over body, pain at site, swelling of left arm from elbow up to shoulder, cellulitis at site redness, heat, pain, itching, 2x2 patch at site s/s lasted 3 days, each day decreasing in intensity.
pt recv vax & lab eval revealed neg surface antigen, negative surface antibody & core antibody pos; the nurse reported 4 pts;
Urticaria on 1/16/16, after MMR-V, flu, DTaP-IPV on 1/11/16. C/O paresthesias in lower extremities in 1/18-19 without weakness. Had urticaria after MMR 12/23/12 (vaccine in 12/19). Did not have DTaP, IPV, flu, VARIVAX at that visit.
Fatigue. Pain at injection site. Chills, all starting approximately 10 hours following vaccination
Left deltoid, warm to touch, red, extremely swollen, hard to touch- treated after Keflex.
Injection sight swelling, small pimple sized pustules with inflamed surrounding capillaries. ?Rash? is not itchy and spreads from injection-site arm (left) across and down upper chest and breasts. Noted approximately 22 hours after second dose. No reaction to first dose, other than mild arm tenderness.
A fever began 12 hours after the injection. Four days later, I'm still having a fever ranging from 99 to 102.
10 weeks after 2nd dose, vaccination arm got sore and achy, tendonitis like pain.  Still lasting 2 weeks later until today.  It has immobilized my right arm where I got both shots.
Very sore arm at site for 5 days after ( painful) Stayed in bed for 2 days, headache, nausea, loss of appetite, general unwell feeling
Herpes Simplex virus that was in my right eye became very active casuing substantial pain, loss of vision and infection on the surface and below the surface.  My cornea transplant surgeon and I determine the covid booster activated the virus.  Months of treatment later and i still don't have the vision I had prior to the booster.
This case was reported by a physician and described a 74 year old male pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 2/4/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/23/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/27/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Breakthrough Case of COVID Nov 14, 2021.  Was in the hospital for 4 days Sunday - Thursday.  It took me a long time to get over the symptoms. Probably about 2 1/2 months to feel like myself again.
I did not have an adverse reaction to the vaccine. On 07/16/2022 I tested positive via a home test for COVID-19. I felt symptoms on 07/15/2022, I had a dry cough and flu like aching. I called my primary care doctor for advise. Stay isolated for five days and discussed a prescription if my symptoms got bad. At this time, I don't think my sense of smell is as good as it was before.
Case number PHEH2015US026593 is a spontaneous report initially received from a medical assistant on 16 Dec 2015. This report refers to a 65 year old male patient. Past medical history was none known. His vaccination history included administration of seasonal influenza vaccines (manufacturer and batch number: not reported) yearly. Previous vaccinations were well tolerated. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 151301) at 0.5 ml intramuscularly on 14 Dec 2015 at 16:15 hours. It was reported that given FLUVIRIN was stored above temperature range before administration. The case was assessed as non-serious. No adverse event reported following this administration error. Follow-up information received from a medical assistant on 23 Feb 2016: Time of vaccination, seriousness criteria and other clinically relevant information updated in the narrative.
Patient passed away on May 29th due to "Sudden Cardiac Death due to Cardiomegaly.
Developed a "cyst" on my left collar bone that gradually doubled in size and then shrunk to its original state. It is not painful and could have no connection to the vaccine; however, in the interest of scientific research, I felt it was important to report this information.
Patient received first dose of the Pfizer COVID-19 vaccine and was sitting in a chair in the waiting area with her husband and son standing next to her. After 5 minutes go by, she experiences syncope and her husband gets my attention. I grab an EpiPen and rush over and see that her body is hunched over, eyes open but patient is unresponsive for about 5 seconds. She then regains consciousness and is responsive and states that she feels dizzy and light headed. Her husband helps her get on the floor flat on her back with feet elevated. She immediately states she feels better. After about 15 minutes in this position, she sits back in the chair and her and her family remain in the waiting area for another 40 minutes for observation. She is also given water. Throughout the 40 minutes, her and her husband continuously let me know that she is feeling okay.   She leaves after observation stating she feels good enough to go home.
Information has been received from a physician concerning a 29 year old female with no pertinent medical history and no drug allergy who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. On 11-AUG-2009 after vaccination the patient has been experiencing fever and body aches. The patient had called the physician for medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Follow-up information received from a medical assistant who reported that the patient also experienced vomiting for 1-2 days and was prescribed with TYLENOL. The patient's outcome was unknown because the patient hadn't called back or followed up with the office. Additional information has been requested.
Five days post vax, the pt developed a fine, papular, red rash on facial area. By seven days post vax, the rash had generalized over entire body area. The pt had no fever, no vomiting and no diarrhea.
feel extremely fatigued with 101 fever; feel extremely fatigued with 101 fever; no appetite; head/body aches; head/body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0170) dose 1 via an unspecified route of administration in left arm on 28Apr2021 at 01:30 PM (at the age of 29-year-old) as single dose for COVID-19 immunisation in Hospital. Medical history included asthma, PCOS/ Polycystic ovarian syndrome, allergies to sulfa drugs, raw apples, covid-19 (prior vaccination). Concomitant medications were none. No other vaccine in four weeks. In 2021, 1st dose made her feel extremely fatigued with 101 fever, no appetite, & head/body aches. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
7/30/02 RIGHT OPTIC NERVE-ELEVATED,360 DEGREES SWOLLEN WITH TORTUOUS VESSELS & SMALL HEMORRHAGES;LEFT OPTIC NERVE FLAT,NORMAL;ALSO AFFERENT PUPILLARY DEFECT;MONITORED MONTHLY 1/27/03 PERSISTENT SWELLING,ONGOING INFLAMMATORY PROCESS;AFTER COURSE OF STEROIDS,STILL ELEVATED DISC,PER NEURO-OPTHALMOLOGIST, VULNERABLE TO VIRUS ATTACK AND/OR INFILTRATES, MAY EVENTUALLY HAVE LOSS OF VISUAL FIELD; CURRENTLY MONITERED EVERY THREE MONTHES.
Chief Complaint: Chest pain with shortness of breath x5 to 6 days positive for COVID Additional Medical History:  Patient presents to the emergency department complaint of worsening chest pain and shortness of breath over the last 5 to 6 days.  Patient has felt weak and unable to eat or drink her normal amount.  Patient tested positive for COVID at home on Tuesday, called primary care physician's office and was started on Paxlovid.  Patient states his symptoms are getting progressively worse.  Patient has decreased oral intake secondary to "metallic taste in my mouth".  Patient has had trouble sleeping the last 3 days.  Patient has taken the Paxlovid, did not take dose today because "I did not think I can handle it".  Patient has chest pain that she described as a pressure, located anterior chest wall, nonradiating, worse with exertion.  Patient has associated shortness of breath, rates discomfort 6 out of 10.  Patient has tried nitro without relief.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Lump after 1st shot on 9/26/22 .  Lump went away pretty quick after 2nd dose on 10/26/22.     a few weeks after I started having upper chest pain. Tried several OTC solutions to lessen as it felt digestive.  Doctor sent finally sent me to ER in mid December after high BO and low SP02 reading at office. ER was unable to determine any problems. Followed up with GI, PCP and Cardio docs an all report no problems. I have mentioned to all of them that I had this happen after the JYNNEOS vaccine 2nd dose.
Chest pain and shortness of breath persisted for 24 hours. No resolution from aspirin, ibuprofen, or albuterol. Went to emergency room.
NauseaVomiting Narrative:  vomiting within 15 min of dose and post dose snack, resolved in ER with ondansetron and apap
Severe headache lasting  over 12 hours the day following injection.  Subsequent headaches periodically for several months following.  Recent headaches becoming more frequent and lasting longer, sometimes several days or longer.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure. On an unspecified date, the patient did an Antibody test and the result came out to be Negative (suspected immunological vaccine failure) and as such she felt that she had no protection and was not leaving her house. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20211006267.; Sender's Comments: V0: 20211021245-covid-19 vaccine ad26.cov2.s- Suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Wheezing; Catching his breath; Arm sore; Triggered his migraine; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Triggered his migraine), WHEEZING (Wheezing), DYSPNOEA (Catching his breath) and VACCINATION SITE PAIN (Arm sore) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20.2A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Migraine, Allergy and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ALBUTEROL SULFATE for Asthma, GABAPENTIN and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MIGRAINE (Triggered his migraine) and VACCINATION SITE PAIN (Arm sore). On 07-Jan-2021, the patient experienced WHEEZING (Wheezing) and DYSPNOEA (Catching his breath). On 07-Jan-2021, MIGRAINE (Triggered his migraine) and VACCINATION SITE PAIN (Arm sore) had resolved. At the time of the report, WHEEZING (Wheezing) and DYSPNOEA (Catching his breath) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feeling well; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , via an unspecified route of administration on 13Jan2021 at a single dose as patient works in a Healthcare Facility, also under the recommendation of her physician (COVID-19 immunization). Medical history included cardiomyopathy and patient has pacemaker defibrillator. Concomitant medication included sotalol. The patient had the injection (patient described the product as Pfizer EL3246) yesterday, the first dose and about 2 o'clock this morning (14Jan2021) she woke up and have been having symptoms, the side effect symptoms, she had fever, the chills, the body ache, the nausea and just not feeling well at all.  The patient was still experiencing the events. The patient stated that  they are actually kind of getting worse, she was getting nauseated, her entire whole body aches, not feeling well at all, she had a fever, she just took temp of herself and she has a low grade fever. No treatment was administered for the events. The outcome of the events was not recovered.  Information on lot number has been requested.
Started with a painful fit and finally pushed out a bowel movement.  After that the fierce vomiting and painful squeals about every 30-45 minutes.  Pt could not keep anything down even for seconds after having them.  At around 9am I noticed a larger lump in her sunken stomach that felt very hard.  Was headed to hospital when pediatrician called and requested to go to his office instead of emergency room.  Saw him at 2 and the vomitting had continued until bile.  Saw the Pediatrician and he sent us to Childrens health care. There we had an x-ray and then an ultrasound to conclude it was intussusception.
p/vax both arms felt like knives going through them;flu vax site better next morning but still sore;pneumonia arm has large red, hot, swollen area about 4" diameter circular area;chills & h/a w/aching all over;