chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light blue ring at the injection site; she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size; she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel; she removed the bandage over the injection site there was a red spot in the middle area; area is about the size of a nickle, it is a hard knot and puffy; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female who experienced light blue ring at the injection site (vaccination site discoloration) and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema), area is about the size of a nickle, it is a hard knot and puffy (vaccination site induration) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient experienced a non-serious light blue ring at the injection site (vaccination site discoloration) and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema) and area is about the size of a nickle, it is a hard knot and puffy (vaccination site induration)(Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was light blue ring at the injection site and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size.   It was not reported if the patient received a corrective treatment.  The patient outcome was not recovered from the area was puffy like a pillow, hard knot size of nickel.  The patient outcome was not reported for other events.  Information on the batch number was requested.
Approx 2 weeks after receiving the 2nd Pfizer vaccine I developed severe headaches, bouts of being clammy and vertigo.  Still experiencing the effects but slowly subsiding.
HIVES, RASH ON VACCINATION ARM, ANAPHALXIS, DIZZINESS
Coughing; Low energy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    Concomitant products included PREGABALIN (PREP C) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MULTIVITAMINS [VITAMINS NOS] (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever). At the time of the report, COUGH (Coughing), ASTHENIA (Low energy) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided The action taken with the drug was Not applicable.
no adverse effects reported; 9 month old patient was administered an adult dose of vaqta; This spontaneous report was received from a health professional (Registered nurse) refers to a 9 month old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-MAY-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dosage information and route of administration were unknown) of lot # R024007 with an expiry date of 12-OCT-2019 for prophylaxis (product administered to patient of inappropriate age). No adverse effects were not reported. The outcome of product administered to patient of inappropriate age was unknown. No product quality complaint reported.
Low grade fever, chills, minor nausea, fatigue, night sweats, injection site pain, pain in armpit of injected arm   Took Tylenol and ibuprofen  Day one after shot was more severe but has lasted for two days now
11:05 PT received 2nd dose of MODERNA (037B21A) COVID vaccination  11:15 PT's wife stated that she noticed his speech started to slur and then he fainted and notified medical personnel on site 11:16 Dr. made first contact with PT, and had him recline in his seat.  PT was administered an ice pack to his forehead.   11:18 Vitals were obtained:             02: 97%            HR: 76 11:20 Blood pressure was  hard to obtain so ambulance was called 11:28 Ambulance arrived.  PT denies any history of low BP.  States that the tunnel vision has subsided and feels much better. 11:32 First BP 102/70 11:36 2nd BP 103/62, PT was advised of lower BP by EMS crew.  PT denied transport to hospital and signed off care.   11:40 EMS cleared scene.
Initial report received from the patient's grandfather, who is a healthcare professional on 13 October 2008. A 16-year-old male patient received a typhoid vaccine; a meningococcal vaccine; a Tdap vaccine; and a Hep A vaccine (trade names, manufacturers, lot numbers, route/site of administration not reported) on 30 June 2008, prior to leaving for a trip. On 07 July 2008, treatment with ARALEN (manufacturer Sanofi-Syntholabo) was initiated (reason not indicated). An unspecified amount of time later, the patient experienced headaches, dizziness, tiredness, and he felt withdrawn, had difficulty getting organized and was disoriented. On 12 August 2008, he felt depressed and slept a lot. The patient was diagnosed with major depression and was treated with LEXAPRO, TYLENOL PM and RISPERDAL. The patient was in a psychiatric facility for eight days and was reported to be agitated and excited. Patient outcome was not reported. Documents held by sender: case notes.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.11. Concomitant products were not provided. On 03 Apr 2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30 Mar 2021, vial was moved to clinic on 03 Apr 2021. 20 vials were sent to clinic. Vaccine BUD date was 29 Apr 2021. On 31 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
The first dose had arm pain; the second dose was given on 02/11/2021, cause 5 hours high fever; stay on the bed until the fever was gone; I took another day to completely recover to normal
Next day about same time of vaccination, runny nose for about three hours then gone. Feeling almost normal. Almost no pain on the harm. The day after at about ten PM feeling really tired, cold chills, Went to bed and couldn't sleep almost all night. Hot chicken veg soup helped. Couldn't never get rid of really bad headache, sore neck, extreme fatigue, foggy mind.  A few scattered and small red spots on skin. Not getting bigger nor smaller. Occasional chills but no fever 36.2 C to 37.2 C max at one point. Tingling skin and occasional numbness on hands and fingers. At one point today the hands turned white and tingly then back to normal. About 15 minutes earlier I took to baby aspirins with plenty of water. It worked on the headache but it may have been responsible for the whyte cold and tingly hands. The skin on the forearms also turned almost violet and then back to normal within about ten minutes. How long are these side effects supposed to last? I haven't been able to work. We are on day four.
Immediate severe headache (12/30/20).  Following day (12/31/20)  persisting headache, marked diarrhea, severe chills.  Went to local ER: HR 135, afebrile.  WBC 12.3 w/10.4 neuts.  Chem profile, EKG, UA, CXR all okay.  Better with IV's.  Advised not to have second dose.  Doing well now.
Lymph nodes were swollen; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a 15-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   The patient's past medical history included detoxification (detox from mercury).   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 7 shots and experienced lymph node swollen for 6 years. The reporter stated that, the patient's body was detox from mercury sent to her body. The reporter reported that, the patient had very bad reaction to vaccines all poison in it.
pregnant 40 year old patient was administered a dose of Arexvy; pregnant 40 year old patient was administered a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t3n4m, expiry date 05-MAR-2025) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: pregnant 40 year old patient was administered a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant 40 year old patient was administered a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacist reported that a pregnant 40 year old patient was administered a dose of Arexvy which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
THEY GOT  NO ANTOBODIES AFTER RECEIVING  THEIR COVID 19 VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple myeloma. The patient received daratumumab (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 2019 for multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced did not get antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with daratumumab was not reported. The outcome of did not get antibodies was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This 61-year-old female with a history of COPD, ASD repair and stroke comes to the ED for the complaint of a productive cough that started 1 week ago.  The cough was productive of a whitish phlegm.  The patient started taking prednisone after the onset of the cough.  However, she started experiencing a shortness of breath that gradually got worse.  Therefore, she decided to come to the ED.  She denies any fever, chills, nausea, vomiting, diaphoresis or chest pain.  She complains of a tightness in the chest.
"Flushing" feeling felt during monitoring period. Patient requested a Benadryl but then symptoms resolved with no intervention. Pulse- 99 BP 154/99 O2 - 98 R - 22
Higher than usual dose: given 1.2mL No signs/symptoms at time of reporting.
I have swollen in my  face and itchy; itchy; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 1315), via an unspecified route on 04Mar2021 at 01:30 (at the age of 59-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 02:45, the patient experienced swollen in my face and itchy. Patient did not receive treatment for events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Headache-Mild, Systemic: Gallbladder flare-Mild, Additional Details: gallbladder flare with associated nausea, pain, changes in stool; new onset join pain in R ankle and shoulder; 1 episode of hemiplegic migraine
INJECTION SITE SORENESS, NAUSEA, EYEBALLS HURT, TACHYCARDIA.
High temperature of 101 degrees for 2 days.  (Day 8 and 9 post administration).  Red macular/papular rash head to toe appeared AM-day 10 (post administration) with scalp and extremities and trunk and watery eyes.
This spontaneous report was received from a physician assistant referring to a 2 month old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 26-JUN-2018, the patient was vaccinated with a dose of ROTATEQ orally (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 26-JUN-2018, the patient vomited immediately after receiving the first dose of their ROTATEQ vaccination series . The physician assistant reported that the patient recovered completely with no treatment on an unknown date in 2018. No additional information was provided. The reporter did not assess a causal relationship between the aforementioned event and ROTATEQ.
Infant diagnosed with benign neonatal epilepsy age 3 wks Got 1st set of vaccines 11/19/04- Had temp to 102 degrees but no increased seizure activity. With 2nd set of vaccines developed prolonged seizure activity starting 10 hrs after vaccine 4-5 seizure 10-15 min Temp 102.5.
2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Information has been received from a 50 year old male patient with allergy to yeast and history of Hodgkin's lymphoma in 2006, fine now, who on 12-JUN-2009 was vaccinated with the first dose of RECOMBIVAX HB. There was no concomitant medication reported. It was reported that on 02-JUL-2009 the patient experienced a migraine. The patient received the second dose of RECOMBIVAX on 13-JUL-2009 despite continued migraine. It was reported that he still had a migraine " for the past 18 days, which had never gone away." The patient was treated with Imitrex 100 mg and on 19-JUL-2009 received an injection of Imitrex and was also started on Dexamethesone. There were no laboratory diagnostic test performed. He reported a history of migraines for approximately 30 years and noted that when drinking beer he experienced migraines. It was reported that he stopped drinking beer 10 years ago and he had not had a migraine in the past few years. It was reported that he had missed 16 hours of work since receiving the vaccine. The patient sought unspecified medical attention. The patient had not recovered at the time of the report.  Additional information had not been requested.
Pain in the arm muscles; cramping in muscle of hands that generated her great pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain). At the time of the report, MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st December 2019, batch number 7RK7K, expiry date 26th November 2021).   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 27th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received Shingrix second dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know if the patient should repeat schedule. The reporter consented to follow up.
Sinus issues (headache, neckache, plugged nose, runny nose, stomach upset
Moderna booster given to 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old) in a 14-year-old patient of an unknown gender 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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Patient presented to ED with 1 week history of fatigue, body aches, cough. Patient became so weak she called an ambulance to come to the ED. Patient is still receiving inpatient treatment.