chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection).; Tight chest/chest pain; Tight chest/chest pain; Tiredness; Pain at injection site on arm; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 16Apr2021 at 14:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) for an unknown indication on an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, within first hour of vaccination, the patient experienced pain at injection site on arm. On 18Apr2021 at 08:00, the patient experienced sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient underwent pixel lab Covid-19 test  test via nasal swab and the result was negative. The clinical outcome of the event pain at injection site on arm was resolved on 18Apr2021, after duration of 2 days, events sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain was resolved on 23Apr2021, after the duration of 5 days, while that of tiredness was resolved on an unknown date in Apr2021 (also reported as after duration of about 7 days).  No follow-up attempts are needed. No further information is expected.
Resident received Flu vaccination and Moderna Bivalent shot. On 9/25/2022  she was observed to have left sided droop, slurred sppech and unusual behavior (left faucet on, TV so loud).
Headache, fever, chills, hot, nausea, body aches, very tired, no appetite, missed work Monday-Wednesday. Still not completely better, but better than it was.
Twenty to thirTy miNutes After AdMINIstrATion, patient Reported dizziness, lightheadedness, ANd Nausea, blood pressure was measured by pharmacist As 185/90, 193/91, PARAMedics Arrived and it was 194/95. PATIeNt declined transport to ER. Will f/u with MD.
A "knot" formed at injection site quickly but was not bothersome until day 7. It itched tremendously and after being scratched it had an irregular welt like a mosquito bite.  This went down with benadryl cream. Shortly after the knot was much larger and it was hot to the touch.  18hrs the knot was much larger, probably 2in in diameter, red, and hot to the touch. 4hrs post 25mg of oral benadryl and 400mg of ibuprofen the spot was about 3.75in total diameter with a "target shape". A 1in red spot then a dull ring, then an exterior red ring about 1in thick. Still has heat but the "knot" decreased in size and hardness
still sleepy; I am still tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (still sleepy) and FATIGUE (I am still tired) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced SOMNOLENCE (still sleepy) and FATIGUE (I am still tired). At the time of the report, SOMNOLENCE (still sleepy) and FATIGUE (I am still tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment or concomitant Medication were reported
Information has been received from a health professional concerning a 15 year old female who was vaccinated IM with the first dose of GARDASIL (lot# not reported). Subsequently the patient started convulsing and fainted after administration. The patient recovered from her convulsions and from having fainted. After internal review, convulsion was considered to be an other important medical event. Additional information has been requested.
Felt hot all over; Flushed; Dizziness; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Felt hot all over), FLUSHING (Flushed), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced BURNING SENSATION (Felt hot all over), FLUSHING (Flushed), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, BURNING SENSATION (Felt hot all over), FLUSHING (Flushed), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        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.
KINRIX vaccine was administered to an 8 month old patient, when PEDIARIX was intended.
Headache, tingling all over body, nausea, vision (dots) weak, loss of energy, really tired, everything just seems diffrent and weird he says.
Booster given 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) 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 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has not been diagnosed or tested for COVID-19. Booster given 12 hrs  after puncture of via,specifically 4 days later.  No concomitant medication  were reported. No Treatment information was provided.   This case was linked to MOD-2021-416295 (Patient Link).
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 55 years old male patient who had chronic fatigue syndrome, fibromyalgia, muscle aches, injection site pain, acid reflux and diarrhea, while he received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2018, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, dose in series and route was not reported) in the right arm. On an unknown date, following the vaccination the patient experienced fatigue, fibromyalgia, muscle ache, injection site pain, acid reflux and diarrhea. (Other relevant tests included IgGs are low). Final diagnosis was diarrhea, acid reflux, injection site pain, muscle aches, fibromyalgia and chronic fatigue syndrome. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
C/o hands itching - bilateral about 4 hrs after vaccine then raised bumps came up w/itching - continues w/ bumps but improving.
Approximately 1 month after vaccine began having noticeable discomfort along lower side of left rib cage. Rash began appearing around April 30th and began to blister on May 3rd.  Diagnosed with Shingles on May 4th, prescribed valtrex.  Blistering finished by May 10th, discomfort around rib cage continued for another week. Area continues to heal/improve.
It started with general fatigue then it got worst and limited my daily activity. I spoke to my primary and they asked me to wait awhile to observe the symptoms. The doctor thought that it could be something from being quarantined for so long. I couldn't walk at the time I was very exhausted at the time. I stood up to one point and felt like I was going to collapse. My daughter then suggested that I go and see a cardiologist in regards to my symptoms. Early September, I was seen by my cardiologist and she did a EKG, Eco, and a full Cardiogram. The results came back I was told that I had a weak heart. After 90 days or so I was given another EKG so check if my heart returned back to normal and they stated that it went up from a 15 percent to about 30 percent. As a result of that I was advised that I am a candidate for a pacemaker defibrillator. It will be implanted as of Friday March 25th.
cyst on kidney; cyst on pancreas; Hepatitis B; Jaundice; Cyst on liver; started getting ill; 2nd dose not administered within vaccine schedule window; MRI Abnormal; Ultrasound abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice) and CYST (Cyst on liver) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stomach discomfort (Starting back in August 2020 she didn't feel good, had stomach issues off and on.) since August 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RENAL CYST (cyst on kidney) (seriousness criterion hospitalization), PANCREATIC CYST (cyst on pancreas) (seriousness criterion hospitalization), HEPATITIS B (Hepatitis B) (seriousness criterion hospitalization), JAUNDICE (Jaundice) (seriousness criterion hospitalization), CYST (Cyst on liver) (seriousness criterion hospitalization), MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal). On an unknown date, the patient experienced ILLNESS (started getting ill) and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window). The patient was hospitalized from 05-Feb-2021 to 08-Feb-2021 due to CYST, HEPATITIS B, JAUNDICE, PANCREATIC CYST and RENAL CYST. On 05-Feb-2021, MAGNETIC RESONANCE IMAGING ABNORMAL (MRI Abnormal) and ULTRASOUND SCAN ABNORMAL (Ultrasound abnormal) outcome was unknown. At the time of the report, RENAL CYST (cyst on kidney), PANCREATIC CYST (cyst on pancreas), HEPATITIS B (Hepatitis B), JAUNDICE (Jaundice), CYST (Cyst on liver) and ILLNESS (started getting ill) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (2nd dose not administered within vaccine schedule window) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Hepatitis B: positive Positive. On 05-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver.. On 05-Feb-2021, Ultrasound scan: abnormal (abnormal) Identified a cyst on her pancreas, cyst on her kidney and cyst on her liver..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.   No concomitant medications were reported. Treatment medications were not provided by the reporter Patient did not received second dose and it has been months after the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: NNI only asking for FU On 26-Jul-2021: NNI only asking for FU
no adverse event; improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 27-JUN-2022, the patient was vaccinated with improperly stored vaccines of hepatitis A vaccine, inactivated (VAQTA) (lot #U033212; expiration date: 07-NOV-2022; strength, dose and route of administration were not provided), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W00774 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 04-SEP-2023; strength, dose and route of administration were not provided), both administered for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).
BLOOD CLOT ON INSIDE RIGHT ANKLE; COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (diclofenac), and other pre-existing medical conditions included: The patient had no illness at the time of vaccination. The patient had no past history of similar events. The patient had no Adverse event after any previous vaccination(s). The patient had no Pre-existing acute illness 30 days prior to vaccination. The patient had no History of hospitalization in last 30 days. The patient had no Family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination and was not currently breast-feeding. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number was not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 77 years old. Concomitant medication included Listerine mouthwash. On an unspecified date, the patient experienced covid-19 symptoms for 24 hours after the vaccine. On an unspecified date, the patient experienced blood clot on inside right ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 symptoms, and the outcome of blood clot on inside right ankle was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220915331.; Sender's Comments: V0: 20220954311- covid-19 vaccine ad26.cov2.s- blood clot on inside right ankle. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt describes 1 week post vaccination waking up with left sided neck pain extending to arm as well as left side swollen gland neck.
Information has been received from a licensed practical nurse (LPN) concerning a "staff member" 18 years or older who was vaccinated by injection with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported that "after the patient received the second dose, the patient had experienced burning and muscle tightness. The burning and muscle tightness lasted for about five minutes and then it went away. There was no redness or swelling. The nurse said that they used a different arm from the first injection of HPV rL1 6 11 16 18 VLP vaccine (yeast)". The nurse also reported this same experienced happened to other patients after their second dose. (WAES # 0710USA00703, 0710USA00703). Additional information has been requested.
Initial report received from a healthcare professional on 19 September 2014. A 90-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number U5017AA, expiry date 03 April 2015, dose number not reported) in left deltoid on 19 September 2014. The patient denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include lymph node removal of right arm (reason not specified) and multiple allergies but only statins listed. The patient's concomitant medications were not reported. On 19 September 2014, same day after vaccination, the patient developed swelling at the injection site. Within 30 minutes, the right side of her neck had red blotches and her face was flushed. The patient was taken to emergency room for evaluation and treatment. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Two weeks ago (approximately on 17-JUL-2013) the patient had a seizure after having left the physician's office, where she had received her first dose of GARDASIL (dose, route, lot# not reported). This patient was brought back to the physician's office for observation and appeared to be fully recovered. Action taken with GARDASIL was not provided. Upon internal review, the event was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
after 2 hours my right eye was completely shut.; 1 hr after my shot my right eye started to drop; sunburn feeling on my cheeks; my face and eye started to swell up; leg swollen; This is a spontaneous report from a contactable consumer reporting for herself, via Medical Information.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 11:00 (Batch/Lot Number: EL0-0162) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced 1 hr after my shot my right eye started to drop  on 28Apr2021 12:00 with outcome of unknown , after 2 hours my right eye was completely shut. on 28Apr2021 13:00 with outcome of unknown , sunburn feeling on my cheeks on 28Apr2021 with outcome of unknown , my face and eye started to swell up  on 28Apr2021 with outcome of unknown; all these events were considered serious because caused the patient to visit the ER. The patient also experienced  swollen legs on an unknown date with outcome of unknown. During ER stay, the patient was treated with IV unknown medications. The patient was monitored for a couple of hours and then discharged home with three days therapy.  Follow up information has been requested. Information about Lot number had already been received.
Lymphadenopathy: axillary- swollen and tender to touch- bilateral. Ipsilateral more significant than contra lateral.
reporter states pt recvd vax in lt arm, devel pain in lt arm/shoulder, couldn't move neck; went to PMD, tx w/ meds, improved w/ tx.
Donor had seizure/ convulsion in parking lot of facility 52 minutes after immunization was given. Donor other symptoms include warmth, sweating, loss of consciousness for 5 minutes, convulsions lasting 30-45 seconds after medical staff arrived. EMS was called and donor was transported.
Start of an infection or a reaction; Vaccination site is burning hot like hot iron that never goes away; Vaccination site was itching; The vaccination site is hard like leather; Site is red; Vaccination site is twice the size of 50c piece; Pounding headache; Pain on the arm- left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the arm- left arm), LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching) and VACCINATION SITE INDURATION (The vaccination site is hard like leather) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Swelling (Swelling the size of a large watermelon after bee sting), Swelling of tongue (Tongue swelling after bee sting) and Airway compromise (Airway was compromised due to bee sting). Concurrent medical conditions included Bee sting hypersensitivity (honey bees).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on the arm- left arm). On 09-Mar-2021, the patient experienced HEADACHE (Pounding headache). On 10-Mar-2021, the patient experienced LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red) and VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency. On 02-Mar-2021, PAIN IN EXTREMITY (Pain on the arm- left arm) had resolved. At the time of the report, LOCALISED INFECTION (Start of an infection or a reaction), VACCINATION SITE WARMTH (Vaccination site is burning hot like hot iron that never goes away), VACCINATION SITE PRURITUS (Vaccination site was itching), VACCINATION SITE INDURATION (The vaccination site is hard like leather), VACCINATION SITE ERYTHEMA (Site is red), VACCINATION SITE SWELLING (Vaccination site is twice the size of 50c piece) and HEADACHE (Pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  The patient reported an ER doctor told him to take diphenhydramine and contact his PCP because it could be the start of infection or reaction.