chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was sore for about one day. I did not receive any treatment. I also experienced COVID-19 around 11/21/2022. I really had a bad cold, symptoms lasting about one week I tested positive for two weeks. I tested positive for COVID-19 on 11/26/2022. I also got sick twice again and it felt a lot worse in end of February 2023 and April 2023. I tested for COVID-19 and it was negative in these months. On 02/27/2023 I lost my voice about two weeks and had a terrible couch, chills, fever, nausea and also gastrointestinal issues ever since getting COVID-19. I took prednisone for 5 days which helped a lot but one month later I got sick again and it took 2-3 weeks for my symptoms to go away.
Itching really bad; Warm at injection site; Knot at injection site/ knot has gotten bigger; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger) and PRURITUS (Itching really bad) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm at injection site) and INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger). On 10-Mar-2021, the patient experienced PRURITUS (Itching really bad). At the time of the report, INJECTION SITE WARMTH (Warm at injection site) and PRURITUS (Itching really bad) outcome was unknown and INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medications. The patient stated that the next day it was warm at injection site and had a knot. The patient also stated that on 10-Mar-2021, it was itching really and on the day of reporting her knot had gotten bigger. No treatment information was provided.
Unprovoked submassive DVT/PE -- patient w/ 6 months of unintentional weight loss, malaise worse over last 2 weeks-- reportedly up to date with age-appropriate cancer screenings-- no recent immobility / surgery / trauma/ or prolonged travel -- no known family history of blood clots -- had one episode of what sounds like phlebitis in the remote past, details unclear
Local rx w/redness and swelling at site of MMRV vaccine. Pt given ice and Benadryl 2.5 ml. Monitored in office for 30 mins with improvement.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-DEC-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
mom called & stated pt lt arm is swollen, red, hot & painful to touch & has a red streak running downward from where vax given;
Within 15 minutes of getting  Covid19 Pfizer Vaccine my tongue went numb. Detecting hot and cold was difficult. This lasted about 14 hours. The other things I am experiencing is a metalic taste in my mouth and my whole right arm is tingling (Pin pricks) like I slept on it and the blood is rushing back in. These 2 symptoms are still ongoing.
I am tracking my menstrual cycle very closely because I am trying to get pregnant. I got my period quite a bit earlier than expected. I got the vaccine on April 9th and got my period on April 12th. According to my period tracker (OVIA) that I've been using since December, I was supposed to get my period on April 23rd. The period also lasted 5.5 days, when I usually average 3-4 days.
muscle and joint aches with most pain in areas where I was already sore from arthritis before vaccination
Caller added with the first dose everything was fine, she had a little fatigue, but all fine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 09:30 (Lot number: EN6203) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (ongoing), notes: Verbatim: Endometriosis. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Caller added with the first dose everything was fine, she had a little fatigue, but all fine".  No follow-up attempts are possible. No further information is expected.
Swelling like a baseball @8hrs Tounge & Throat swelling @ 24 hrs Loss of voice @ 48 hrs- still have problems periodically -was seen by doctor and treated with antihistamine and steroid
10/19/07 received Flu shot in left hip. Woke up 10/20/07 with painful swelling in hands and all joints below neck. Progressively worsened, could not bend knees or ankles. Saw physician Monday 10/22/07. Labs drawn. Referred to Rheumatologist conts. with Sporadic stiffness and pain
This spontaneous report was received from an office manager referring to an unknown 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 patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # M025193, expiration date 21-MAR-2019, (dose number, route and anatomical location of administration were unknown). The temperature of excursion was 51 F for 30 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician via field representative referring to a female patient of unknown age. The physician stated that this was a new patient whose previous physician had retired, and therefore the physician was not familiar with the patient's medical history. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot# were unknown) for prevention of shingles. On an unknown date the patient developed shingles under her left arm, and it spread to her chest. The patient saw the physician for medical attention and was treated with unspecified pain medication. The outcome of the event was reported as recovering/resolving. The causality was not reported. Additional information is not expected as the reporter didn't like to be contacted.
Headache and low grade fever (99.5F) beginning 18 hours after administration. Non-responsive to labeled dose of NSAIDS.
T104.7  6 1/2hr, local rxn, vomiting, Seen by MD;
Seizures - 4/14/09, diarrhea, diaper rash - rash - face, scrotum bruised w/infection.  7/13/09 Hospital DC summary received DOS 4/15/09 to 4/22/09. Assessment: Bilateral Frontotemporal Hemorrhage, Bilateral Retinal Hemorrhage, Suspected Child Abuse or Neglect. Patient's parent noticed shaking of the right upper and lowr extemity. Seizures. Swelling of left testicle. Frenulum tearing. Diaper rash.  7/13/09 Hospital records received DOS 3/22/09 to 5/29/09. Additional information abstracted: Assessment: Observation for Abuse / Neglect, Intracranial Hemorrhage, Umbilical Hernia. Mother of patient requests help in getting infant to latch onto breast. Evaluate for tonic-clonic seizures, patient went limp, somnolent. Several witnessed episodes of seizure-like activity. Tonic-clonic movements of RUE, face, right leg. Anterior fontanelle bulging. Anemia.
Day after her shot pt woke up with intense pain in the arm; "I could hardly move my arm". Pain mostly over the deltoid. Entire arm felt like a deep ache down to the fingers and up into her neck. General ill feeling, some nausea, no energy, no vomiting, no fever or chills, no hives or itching, stayed in bed all day. Today she's less ill than yesterday but still has a deep ache in the arm and it's going into her L side. She did not receive any routine vaccinations in childhood. At about age 10 she did get some type of tetanus shot; not known whether it was a Td or DTap, because she lived in an old house and her parents were concerned. She had not had any tetanus shots since that time.
pt recv vax 1986 & pt exp fever & tenderness around the inj site;
Significant soreness at the injection site (right shoulder) to the point of making it difficult to raise my right arm (started around 10AM and became worse until about 8PM). Chills at 12:30AM.
Syncope within 30 minutes of injection, she has never experienced syncope episode before but was unconscious following passing out for several minutes. This led to her hitting her head on a glass window, counter top and floor resulting in concussion. Seen in Emergency Room of Medical Center immediately following fall.
Fatigue, extreme muscle aches, dizziness, no energy, swollen lymph node under left armpit.
The day following the shot, I was extremely tired in the afternoon, took a 4 hour nap and then went to bed at the normal time, still tired. Woke up the next morning with no symptoms.
Bivalent vaccines have undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and may have; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Sep-2022 at 4:32 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions).    No concomitant product reported by the reporter.  Patient received vaccine in deltoid.It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient.Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The patient had previous doses intramuscularly and the location was reported as deltoid.  No treatment medication reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:Master case
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted soon after giving the vaccine, fell face forward and hit his head and had laceration on his forehead, was sent to the ER for further management.
The morning after vaccines pt awoke with a 2 1/4" red, circular, raised area at site where varicella was given SQ (L) arm. Site was warm tot ouch and itched. Physician examined and prescribed Ceftin. Mother reporter fever that evening of 102-103. Pt awoke 9/13 with a 2nd "spot" below 1st one and taken to an ER. Diagnosed as burn from ice applied directly to skin. Topical ointment prescribed at ER. Pt referred to Burn Center for assessment.
This case was reported by a healthcare professional and described the occurrence of abdominal pain in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 30 December 2011 the subject received a dose of ENGERIX B (20 mcg/ml, unknown) as the 2nd or 3rd dose in the series. That evening on 30 December 2011, within hours of vaccination with ENGERIX B, the subject experienced abdominal pain, fever and nausea. At the time of reporting the events were resolved. The healthcare professional reported a second adult with same events following ENGERIX B vaccination (see case ID A0960623A for further details).
Pt had 8cm wide and 5cm long red square patch with sm knot at injection site, warm to touch. No generalized rash.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002795: US-009507513-1701USA010824.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little achy) and POLLAKIURIA (Frequent urination) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Little achy) and POLLAKIURIA (Frequent urination). At the time of the report, PAIN (Little achy) and POLLAKIURIA (Frequent urination) outcome was unknown. Treatment information not provided. List of concomitant medication were not given.
Developed chest pain, severe shortness of breath during the night following the vaccine.  NO chest pains were reported for the previous 4 years prior to the vaccine.  Was rushed to the hospital. Several tests were completed.  Troponins were elevated but no EKG changes.   Not able to complete a cardiac Cath d/t pt being too weak.  Pt placed on hospice and sent back to facility.
6 days after injection, I developed a rash on my upper arm.  There was a knot at the injection site and the area is red and itching. The redness has been spreading down my arm.  It feels hot and still itches.   I have not sought treatment.  Still experiencing symptoms.
I woke up on April 23 (8 days after my vaccine) with a rash on my upper, inner legs. It was slightly raised and red in color. On the 24th I woke up to a little bit more of the rash. It spread to the front of my left leg. I also had a few spots on both hands on palms and on the back of my hands. I had very few spots on my feet, but my feet were extremely itchy.  Woke up on the 25th and nothing seemed to have changed. On the 26th as the day went on the spots got lighter. This continued another day or 2 until the rash was completely gone.  I was never seen by a professional.
diarrhea issues since 2 weeks after my first vaccination and it is still continuing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea issues since 2 weeks after my first vaccination and it is still continuing) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea issues since 2 weeks after my first vaccination and it is still continuing). At the time of the report, DIARRHOEA (diarrhea issues since 2 weeks after my first vaccination and it is still continuing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information and concomitant medications were not provided.   Reporter did not allow further contact
No AE reported at this time; temperature excursion on ROTATEQ; This spontaneous report has been received from a health care professional referring to a 4 months old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-MAY-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength and anatomical location were not provided; lot# 1741376 has been verified to be a valid lot number, expiration date reported as 06-MAR-2022), orally for prophylaxis (product storage error). The vaccine underwent temperature excursion at 48.2 Fahrenheit (F) for 15 minutes. The previous temperature excursion was at 46.2 F for 15 minutes. The digital data logger was involved in recording excursion details. At the time of report, there was no additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA000779: US-009507513-2106USA000757: US-009507513-2106USA000712: US-009507513-2106USA000591: US-009507513-2106USA000663: US-009507513-2106USA000689: US-009507513-2106USA000988:
Mild localized arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild localized arm soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (parents told me I had a penicillin reaction once AS A CHILD (8-9 years of age).    On 17-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild localized arm soreness at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Mild localized arm soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling of face/mouth. Rash and itchy all over body. lips are not as swollen as they were this am at 6:00am and Rash is still visible but not itchy, time I'm writing this is 12:33pm
arm slightly sore but not like the first vaccine; slightly tired for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days). At the time of the report, LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-053332 (Patient Link).
pt rcvd vax;  pt exp weakness; "difficulty opening"; aching & sore throat; cough, puffiness & general arthralgia;
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL;  continued observation for an additional half hour and c/o subsided; client released to home.
L upper arm developed 17 cm x 12 cm area of swelling erythema and warmth. No treatment.
There is a large rash that has formed on my arm at the injection site and is spreading down. It is also itching which I'm trying not to scratch. It is raised and a little pinkish.
Patient received Pfizer 0.5 mL 1st primary dose on 07/06/2022 and inadvertently received the 2nd Pfizer Primary dose 0.5 mL too early. Patient presented to the clinic on 07/08/2022 for a Pfizer 2nd primary dose.  Vaccinating nurse misread the date on the vaccination card as 07/06/2021, and administered the Pfizer 0.5 mL 2nd Primary dose. After viewing database, the vaccinator noticed that the 1st dose vaccine was actually administered on 07/06/2022. The patient confirmed that she had received the 1st dose on 07/06/2022, making the interval between the doses 2 days. The clinic followed CDC guidelines regarding vaccine errors. Patient was monitored for 15 min and released without any complaints and a steady gait. Patient was given V-safe flyer for reference.