chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/21/2009 Dad noticed a red spot on patient Left upper thigh that was getting larger and stating to blister in middle. Patient no seemed to be bothered by it able to put weight on legs.  Dad denied any possible burn. No treatment reassurance and monitor discuss symptoms of skin infection or any problems with standing to call ASAP. 12/10/2009 Mom reported that spot resolved without any problems and patient doing better.
Pt. called complaining or localized swelling and redness around both vaccine sites. (PREVNAR 13 site worse than the ZOSTAVAX).
Fatigue, headache, sore arm (6"dia), backache, fever, lethargy, yes, I'm tired!
painful,  eraser sized lump appeared in neck; right side just below base of skull 2 inches from ear canal. Does not appear to be getting any larger. Still there today. Monitoring to see if it grows or moves.
Injection site reaction involving upper arm (left). Multiple blisters formed along with erythema from mid portion of arm to elbow. Edema noted as well. This was the site of varicella vaccine administration. Given cephalexin for cellulitis as treatment.
Shortness of breath, low oxygen level,  cough, fatigue, nausea, vomiting, diarrhea, body aches, headache, chills
Information has been received through the Merck pregnancy registry from a health professional concerning a 16 year old female who on 09-OCT-2007 was vaccinated with the first dose of GARDASIL (lot #not provided).  On an unknown date, "the patient received the second dose of GARDASIL (658554/0928U). * Concomitant suspect therapy included varicella virus vaccine live.  Per the reporter, the patient came back into the office because she was having a cough and cold, which turned out to be prenatal symptoms.  The physician did a pregnancy test on the patient which came back positive.  Per the reporter, the patient received the first dose of varicella virus on 06-DEC-2006.  The lot # for varicella virus vaccine live was 659692/1767U, unspecified which dose.  Additional information received from pregnancy questionnaire (31-MAR-2008):  The lot# for the first dose of GARDASIL was provided as 658094/0524U and the date of the second was listed as 06-FEB-2008.  Follow up information was received which reported that on 16-JUN-2008 the patient delivered a female infant.  The infant's weight was 12.3 (unit not reported), length was 23.25 inches.  The infant was normal, there were no congenital anomalies and no other complications or abnormalities.  Additional information is not expected.
Bloody nose 4:00 AM so I could drive and get my dialysis done. I was on for about and hour they decided to take me off and then I went around the building to the health partners urgent care and they ballooned my nose to stop the bleeding. They took an INR test and it was 11.5, so my son took me took the hospital. They gave me vitamin K as soon as I got in the ER and kept me in the hospital for three days.
None, Patient was given ZOSTAVAX instead of Varicella. According to MMWR, this will count as Varicella dose.
Headache Fever (101.3) with chills body aches/malaise nausea/decreased appetite site injection-arm pain
BP, which had been normal in the morning, prior to the vaccination, rose to 166/85 around 2 p.m,, then to 199/86 around 4 pm.I was light-headed, and had tingling sensation in my feet.
Patient was given first dose in error (because under the age of 18yo). CDC recommendations are to get the second dose per usual. Parents were informed after first dose and wanted her to have the second dose. Father accompanied her for the second dose.
The first two days I was just way too tired and couldn't do anything, headache, and arm was sore.
The day after receiving the third dose; The day after receiving the third dose of the vaccine, the patient's chronic post-partum inflammatory arthritis dissipated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Dec2021 13:00 (Lot number: FJ8757) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic post-partum inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9265, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 08:00, outcome "unknown", described as "The day after receiving the third dose"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 12Dec2021 08:00, outcome "unknown", described as "The day after receiving the third dose of the vaccine, the patient's chronic post-partum inflammatory arthritis dissipated". Therapeutic measures were not taken as a result of immunisation, therapeutic response unexpected. No follow-up attempts are possible. No further information is expected.
Swelling on left thigh and soreness. Swelling was 9cm in diameter.
My uvula became swollen (60%) and obstructed my airway. I was unable to swallow and I started to expectorate. It started as a clear liquid then became a thick mucus. I went to the emergency room and they started to immediately treatment me for anaphylactic shock. Once I was stable enough I was transferred to the ICU ward and stayed there for two days.  Since my last stay in the hospital until now my results have come back and I have found that I have alpha gal syndrome.
Systemic: Hypotension-Mild, Systemic: blood clots in lungs, decreased O2 levels and severe asthma attacks-Moderate. Additional Details: patient's daughter came to pharmacy to tell us MD instructed her to tell us to report patient had adverse effect from COVID-19 vaccine. Blood clots in lungs, hypotension, decreased oxygen levels, and severe asthma attacks. Patient was hospitalized on August 30th and has not recovered.
Injection site was red a firm; Red welt in the arm; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Red welt in the arm), PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE ERYTHEMA (Injection site was red a firm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced URTICARIA (Red welt in the arm) and PAIN IN EXTREMITY (Pain in the arm). On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red a firm). At the time of the report, URTICARIA (Red welt in the arm), PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE ERYTHEMA (Injection site was red a firm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced welt calmed down. After a week symptom reappeared and the injection site was red a firm. Then the redness was expanded.  patient take Antiallergic for treatment   Concomitant product use was not provided by the reporter.  Treatment for the event included antiallergic.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the known safety profile of the vaccine.
patient was seated when received vaccine.  she was led to main waiting area to wait for observation.  about 5 to 10 min after the shot patient was seated and began to pass out.  she came to after a few min and put into lying down position with feet up.  appearance was  and clammy skin.  911 was called.  her blood pressure was normal.  heart rate normal.   911 call- based on my answers to their questions they decided to come to the pharmacy.   patient stated that she did not have much to eat and that she has passed out from a nose piercing in the past.  her color came back by the time she left.  ems checked her out.  she signed a form stating that she did not want taken to hospital.
This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Hives broke out over body (torso, buttocks, legs, arms) and spread quickly. I consulted facility and they referred me to my primary physician. Unable to get appointment before I had to leave on out-of-town trip.  The rash remained for a week and grew worse with time.  Itching was severe. Finally, I experienced some hives on my the 7th day.  Treatmetnt: I took Benadryl every 12 hours to control the itching.   As the itching increased, I applied Fluocinoide Cream USP. 0.05% (a cream I had on hand for psoriasis). Benadryl + Fluocinonide may the rash tolerable.  The rash became bright red, then started to fade by 02/28/2010.  A couple of days later, the rash was gone. When I returned home, I visited my primary physician. He asked meto report the incident.  I tried to submit this earlier, but had difficulty checking over my answers.  Please disregard if this is a repeat.
Tenderness and swelling  in axillary region of the same arm of the injection site. Potential inflammation of axillary lymph nodes.
Pt devel fever 101-102, vomit, nose bleed, irritable;
swollen gland, sore throat, onset 18AUG; t103 18AUG & 19AUG; 20AUG t101, tongue chalky white, nausea onset 18AUG, no appetite; (no vomiting);
From initial information received on Oct 11 2004 from a health care professional regarding an adverse event, it was reported that a five year old male patient received a fourth dose of IPOL, lot number X0772, administered subcutaneously in the left arm, a fifth dose of Tripedia, lot number U1258CA, administered intra muscularly in the left deltoid, and a Tubersol 5 TU skin test, lot number C1707AA, administered intradermally in the left forearm on Sept 14 2004. Two days later, on Sept 16 2004, the patients mother called to report the patient had a red, sore arm at the injection site. The exact site was not specified. Motrin, heat and ice were prescribed. On Oct 11 2004, the patient was seen at the doctors office. His left arm was still sore with scattered red and warm areas. It is unknown if the patient recovered from this event. From additional information received on Nov 15 2004 from a health care professional, it was reported that the patient had no illness at the time of vaccination. reportedly, he was vaccinated as a private doctors office and the vaccine was purchased with private funds. Through a telephone conversation with the patients mother on Nov 8 2004, the mother reported that the patient seems normal recovered. It was also reported that the mother called the doctors office on Sept 16 2004 to inform him of the reaction.
Moderna Covid-19 Vaccine EAU Pain when getting shot and after.  Have bump at injection site.  Headache, chills, low grade fever, lots violent vomiting caused blood vessels break on face and neck.
Lt deltoid area of vaccine MIN local reaction of about 1 inch around VACC site-has pooling reaction area under the vaccine site of redness about 6 inches diameter with raised red border - and itches per PT-very sensitive to touch-with some dermographism and probably related to the IM changes of the vaccine.  Still a local reaction and NOT an infection-no nodes or fever.
Local reaction in left deltoid, pain, hardness swelling 10cm x 12cm approximately 12 hours post vaccine.
2/16 vaccination Rash on arm of injection. Took antihistamine. Spoke with allergist and cardiologist; family hx of afib. Told me to take medication for palpitations but I chose not to because my BP tends to run low
No adverse effects; a patient may have been administered an improperly stored GARDASIL 9; This spontaneous report has been received from a registered nurse refers to an 11 years old patient whose gender was not provided. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported.     On 05-AUG-2019, the patient was administered an improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); dose as prophylaxis (number of dose in vaccination scheme), frequency, route and anatomical location of administration were not provided; (lot # 1614897, expiration date:  was reported as 10-JUL-2021, but upon internal validation has been determined as 20-SEP-2021); According to the reporter,  On 05-AUG-2019 the reported said  "a patient may have been administrated an improperly stored" (incorrect product storage); the vaccine was exposed to a temperature excursion below of  36 degress Fahrenheit (°F)/ 2 degress Celsius (°C) (-1.44 °C) for a timeframe of 35 minutes on that day, which was not recorded by a digital data logger. Previous temperature excursions and adverse effects were not reported.
pt recv vax & nurse checked w/dad on pt condition;pt coming out of bathroom, when asked if ok states ok but lifted shirt & showed nurse had bright, red, blotchy rash over entire upper body;no resp distress;VS WNL;c/o little itching;
A few weeks after COVID booster on 10/27/22, I started developing extreme leg weakness and fatigue, some shortness of breath while running and walking/climbing hills and stairs. Thought it was just side effects but symptoms persisted to the point I had to stop mid-run, legs were extremely weak, could barely move them. Got a full set of bloodwork done beginning of December 2022, diagnosed with severe iron deficiency - ferritin was 2. Started ferrous sulfate 375 mg every other day, mid-March 2023 had repeat blood work, labs improved. Will get repeat blood work done in June 2023.
Swollen feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 17:00 (Lot number: EW0162) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "benign prostatitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen feet".  Additional information: The patient had allergies with aspirin. The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included antihypertensive. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
On 26Sep2022 patient had developed a terrible ear ache which is still ongoing today; Patient had 102°F fever, she was fine by 25Sep2022; This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (On 26Sep2022 patient had developed a terrible ear ache which is still ongoing today) and PYREXIA (Patient had 102°F fever, she was fine by 25Sep2022) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-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. On 24-Sep-2022, the patient experienced PYREXIA (Patient had 102°F fever, she was fine by 25Sep2022). On 26-Sep-2022, the patient experienced EAR PAIN (On 26Sep2022 patient had developed a terrible ear ache which is still ongoing today). On 25-Sep-2022, PYREXIA (Patient had 102°F fever, she was fine by 25Sep2022) had resolved. At the time of the report, EAR PAIN (On 26Sep2022 patient had developed a terrible ear ache which is still ongoing today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2022, Body temperature: 102 Degree F.         It was reported that the patient earlier had taken Moderna vaccine. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-651161 (E2B Linked Report). This case was linked to MOD-2022-651168 (Patient Link).; Sender's Comments:  MOD-2022-651161:Husband's case, same reporter
Fever, chills, generalized body aches, headache, dizziness symptoms felt for 24 hrs. Symptoms relieved with ibuprofen 400mg every 6-8 hrs.
Patient said that he received 2 vaccinations on 10/27/16 and said his arm was sore afterwards and started to get better but is still sore.
See previous report.  Symptoms started about 5:30 PM the days of the vaccination with chills and lethargy and low grad temp.   They culminated 30 hrs. later with chills nd a T to 101.8.  and then subsided.  Symptoms were not as severe  as with the first vaccination. see previous report
I did not have an adverse reaction or event to the vaccine. I tested positive COVID-19 on 05/23. I took a home test for COVID-19. I started out with a head cold, no temperature, weak and tired. I contacted my primary care doctor via tele visit. They offered the prescription PAXLOVID but declined to take it. I was instructed that if I felt worse to go to the emergency room.
Had rash-generalized all over body, fever highest at 103 and vomiting-occurred 3 days after MMR immunization. Allergic. Secondary infection of staph infection had surgery.
pt recv vax & exp tenosynovitis, sought medical attention & was hosp for five days;pt recovered;
Today around 5:30pm, patient felt he started breathing hard, then felt lightheaded, then had tingling around cheeks, sides of trunk and arms, and then his hands became rigid. All adverse events happened around the same time per patient. Patient had difficulty moving fingers due to hand rigidity. After 10 minutes, all adverse events went away on their own and patient felt back to normal.  Patient refused to visit urgent care or emergency room. Instead patient made teledoc appointment for tomorrow and was counseled by doctor if any of the adverse events return that he should promptly visit ER. Patient left after feeling asymptomatic for 15 minutes.
Patient described a 24 hr of complete malaise requiring bed rest directly following vaccine administration. "Complete lack of energy".
Very hot, itchy rash appeared a week later... It appears to be growing? Seems like "covid arm" that I'm finding on the internet. Just wanted to report it in case that's helpful info for data purposes?
Patient received the HepB Adult dose instead of the HepB pediatric dose.  As of 5:20pm 6/12/2023 patient had not had any adverse effects according to patient's father.
She stated her arm swelled up and was discolored yellow and painful. She came in today and said she still had swelling at her elbow but the pain is gone now.
fever, shortness of breath worsens, hospital visit on 05/31/21 massive heart attack stent put in release 06/03/21 defidulator
After each of the COVID injections (Dose 1 and Dose 2) : She had a breakthrough period that lasted for a couple of hours. And then it stopped. For Dose 2, it started a few hours after the injection. Sept 10, 2021  - 4 pm - took her in to her well child visit and the doctor took a look at her throat because she had been coughing. They did a COVID test and had negative results. No treatment, had missed three days of school but the doctor said just to give her OTC cough medicine. She had the cough a good three days.
Initial solicited pregnancy report and SAE report received on 18 January 2017 from a health care professional participating in a study. This is a prospective pregnancy registry case. This case involves a 42-year-old female subject who had during pregnancy and had miscarriage during the study participation. The subject's medical history was not reported The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status was not reported. The father's age in years was not reported. The current pregnancy history was not reported. The information on subjects' previous pregnancy and maternal drug exposure were not reported. The information on subject's concomitant therapies was not reported. On 09 January 2017, 40 days after receiving a first intramuscular dose of Influenza Quadrival A-B Vaccine on 30 November 2016 (site of administration and batch number was not reported), the subject had miscarriage. The event appeared after visit was not reported. The subject's treatment for infertility was unknown. The subject had no other relevant non serious adverse event. According to the investigator the, the event of miscarriage was considered as other medically significant. The information on Lab data and prenatal testing were not reported. The subject's corrective treatment was not reported. The pregnancy outcome was reported as; the subject had miscarriage on 09 January 2017. At the time of the report, the subject did not recover from the event miscarriage. List of documents held by sender: none. Sender's Comments: A 42-year-old pregnant female subject received a dose of study vaccine (information regarding LMP, date of conception, EDD or USG findings were unknown). The subject had a miscarriage 5 weeks after receiving the study product. Based on limited available information, the sponsor assess the event as not related to study product or trial procedure.
redness and swelling on the area of vaccination (left arm) disappeared and then on the seventh day the swelling and redness returned covering a broader area