chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 07Apr2021 at 13:30 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food or other products. 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 07Apr2021 at 20:00, the patient experienced severe diarrhea. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe diarrhea was not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Presents to the ED with C/O SOB, Cough, and Congestion for the last 3-4 days, exposed to COVID.Admitted for Acute Respiratory Distress with Hypoxia, Covid Pneumonia, Hypoxia, and SOB and Cough.  Tx W/ IV Decadron,Rocephin and azithromycin , Zinc,Vitamin-C, zinc, vitamin D3 replacement. Supplemental Oxygen. Remdesivir. D/C home /HHC
Patient received Tdap and MENACTRA and within 5 minutes had an episode where her eyes rolled back and she had 2-3 rhythmic GTC movements of upper extremities and stayed with her eyes rolled back x 5-10 seconds; patient afterward stated she felt shaky though did not appear post ictal.
In 1997, the pt "broke out all over with atypical chickenpox." At the time of this reporting, the outcome of the pt's symptoms was unknown. Additional information has been requested.
Septicemic, headaches, lymph nodes enlarged, in hospital 2 days with no medicines given.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 79 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
+ lightheaded and nausea, and then syncope followed by hypotension consistent with vasovagal response.
Earache; Vision abnormal; Headache; 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 EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache). At the time of the report, EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received. No new information was reported.
Metal taste and tingling along sides of tongue.  I can?t taste anything. Same response from dose1, never completely resolved .
This spontaneous report as received from a nurse practitioner refers to a 15 year old female patient. The patient's pertinent medical history included angioedema and the patient was allergic to thimerosal and presented with popular rashes for unspecified vaccines. On 04-JUN-2012, the patient was vaccinated with 0.5 ml VAQTA (lot# 1168AA and expiry date: 20-JUN-2014) intramuscular for prevention of hepatitis A. Concomitant therapies included EPIPEN. On 08-JUN-2012 the patient experienced rash around the injection site. The patient sought medical attention and was treated with BENADRYL. The outcome of the event was unknown. The relatedness of the event with the VAQTA was not reported. No product quality complaint (PQC) was reported for VAQTA. Additional information has been requested.
Felt flushed, or hot. Became Light Headed. Rested and hydrated.  Recovered
FEVER; SORES IN MOUTH; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number.  No concomitant medications were reported. On 10-MAR-2021, patient developed fatigue and sores in mouth. She had also developed a fever. She was hospitalized twice and she was given IV fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and sores in mouth, and the outcome of fever was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fatigue, sores in mouth and fever as possible.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210331424- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Sores In Mouth. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  20210331424-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fatigue, Fever. This event(s) is labeled and is therefore considered potentially related.
Flu like symptoms Body aches Arm soreness Tender to touch Left under arm swollen and radiating to left side of breast
GENERAL FATIGUE; ARM PAIN; SWELLING; REDNESS; TENDER TO TOUCH; CHILLS; BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, treatment medications included: diphenhydramine/paracetamol, and ibuprofen. On 10-APR-2021 22:00, the subject experienced chills. On 10-APR-2021 22:00, the subject experienced bad headache. On 11-APR-2021, the subject experienced tender to touch. On 11-APR-2021, the subject experienced general fatigue. On 11-APR-2021, the subject experienced arm pain. On 11-APR-2021, the subject experienced swelling. On 11-APR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, bad headache, general fatigue, arm pain, swelling, redness and tender to touch was not reported. This report was non-serious.
Approximately one hour after receiving the Moderna vaccine, I returned home. As I was walking into the house, I became dizzy and lightheaded. I braced myself against the wall so I wouldn't fall. My husband then walked me slowly to the nearest chair. After about 20 seconds, the dizzy spell stopped. However, while I was braced against the wall, I lost control of my right arm. It fell away from the wall and started flopping around uncontrollably. I had never had this happen before, but have had repeated dizzy spells since then with the same uncontrolled movements of my right arm. In fact, after receiving the Moderna booster shot on 9-1-21, I had a similar experience the next day. I was using a walker for stability as I was not feeling well, with body aches and a low fever. As I was walking with the walker, I had a dizzy spell come on, and lost control of my right arm which let go of the walker handle. As a result, I fell and hit my head on the floor. I did not lose consciousness.
pt recv vax 31OCT97 & & 31OCT97 pt exp lightheadedness & dizziness, numbness & heaviness in arm, a low grade fever 101 for approx 4 days & chills;
I woke with chest pain and shortness of breath on the morning of the 13th. I decided to call my doctor and they suggested I come in for an EKG (1/13). EKG showed strain to the right ventricle but not alarming amounts. My doctor ordered a D Dimer test (1/13) which was very high and I was admitted to the emergency room. I was given a CAT scan (1/13) and it was discovered I have several large blood clots in my lungs and was started on anticoagulation that evening.
Suspected vaccination failure/Received shingles vaccine 3 times, have shingles; Have shingles; Received shingles vaccine 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was currently 63 years old. The patient had received shingles vaccine 3 times and had shingles. The patient asked that he/she could tried the vaccine again. Additional supportive information: The patient received shingles vaccine 3 times, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PATIENT CAME IN THE PHARMACY TODAY TO SHOW RED, SWOLLEN, INFLAMED, HOT TO TOUCH AREA ABOUT 2.5 INCHES WIDE.  SHE COMPLAINED THAT THIS HAPPENED AFTER SHE GOT HER FLUAD VACCINE ON 11/1/23.  THE SITE OF REDNESS WAS ABOUT 4 INCHES BELOW THE ACTUAL SITE OF VACCINATION.  SHE COMPLAINS THAT SHE CAN'T FEEL ANYTHING IN THAT AREA
small localized rash around injection site. small lesions noted. afebrile. Mom instructed to keep child awayn from unimmunized individuals until lesions are crusted over.
Pt recvd 3rd dose of vax 2DEC92 & w/in 1/2 hr of vax pt devel extreme h/a, dizziness & nausea; No further details were provided;
Rash on left arm, same as injection site.  Starts approximately where injected and travels down to inside of elbow. At the time of reporting, no itching or burning as of yet.
intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
Pt was seen for a regular physical exam on the 23rd February 2010 during which time GARDASIL was administered. Later it was found that she was pregnant and her EDC is 8/15/2010.
Mom noticed redness and swelling at site of Varivax injection before pt went to school on 3/1/11. While at school mom received a phone call from the school nurse that it was worse. School nurse applied Benadryl spray. On 3/2/11 swelling and redness was worse 3" by 5" area advised to give Benadryl by mouth per Dr. Improvment was noticed by 3/3/11.
Fever; Allergy to vaccine; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches) 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 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 PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 97-102 (High) 97-102 per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A 14-year-old female received her COVID vaccine.  After about 5 minutes of sitting in the chair for her 15 minute observation, her mom said she felt nauseous and like she was going to pass out.  She was laid her back in the chair.  The patient's mother went to get orange juice.   She was pale and her eyes were rolling back in her head.  She did pass out for a few seconds, and I checked the patient's pulse and blood pressure.  BP 139/58, pulse 53.  By that point she was coming back around.  After she sat for several minutes and had orange juice and water, she was feeling much better.
Soreness for 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023018213   Additional Information: GSK Receipt Date: 06-Feb-2023: Reporter's Comment:  This case was self reported by the patient. The patient received first dose of Shingrix on right arm. The patient experienced soreness for 2 days, but did not clarify which dose this was referring to. The reporter did not consent to follow up. This case had been linked with US2023018213 same patient.; Sender's Comments:  US-GSK-US2023018213:Same reporter
On January 23 2022  got a wave of high frequency sound  that is piercing and constant. Became anxious, slightly nauseated. At first I thought it was something in my home but was unsuccessful in finding any source in my home that would turn off this high frequency constant buzzing noise.  With no remedy to this affliction a few days later  my husband also became afflicted with this high frequency buzzing that is constant and only changes in severity of how loud. Being an RN of 48 years I contacted a local ENT.
Tired; Ache all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Ache all over body".  Additional information: Reporter stated, so, I got the new booster what is it called, the Pfizer (Clarified as Pfizer COVID-19 vaccine). I got the new one and I was just wondering, so my son's been so tired. Was that normal. It says on there tiredness. When probed to clarify the concern: Reporter stated, we both get the same one (Pfizer COVID-19 Vaccine), I am having different symptoms than him. Just want to make sure we are okay with this. Reporter was informed about the role of Pfizer Drug Safety and Medical Information Department for the concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reported 1/4/17. Soreness in left arm the day after vaccine. Patient still reports throbbing pain when lifts arm up or lays on it. Had X-ray-shows nothing per pt.
Moderna Dose 1 4/24/2021 (002C21A) Moderna Dose 2 5/22/21 (022B21A) COVID Positive 1/2/22 COVID Positive 1/6/22 COVID Positive 1/10/22  1/2/22: The patient is a 92-year-old pleasant lady who has past medical history significant for dementia and diabetes. She lives at home with a granddaughter.  She was brought to the emergency room today with fall.  She was found by family on the floor at 2:00 a.m. today morning. Ambulance was called and she was brought to the emergency room.   The patient is not sure exactly what happened.  She is not sure how she fell or how she lost consciousness.  She has small abrasion on her scalp posteriorly.  She has some head back neck and hip pain for which CT scan of the head, cervical spine, lumbar spine and pelvis was done that showed left superior inferior pubic rami sacral fractures. She required two doses of IV fentanyl in the emergency room.  She also about Tdap and Zofran.  When they try to walk her though significant pain and was heart by family that she cannot go back.  On-call orthopedics was contacted who recommended weight-bearing as tolerated and outpatient follow-up if needed.   She also had COVID-19 positive though she does not have too many respiratory symptoms.  She is however not very reliable.  Her labs did show glucose of 223 ALT AST of 80 and 92 and hemoglobin 10.7.  She was subsequently admitted for pain control and deconditioning as she could not ambulate well due to her pain.  The patient states she has some lower back pain but could not give me details.  She denies any complaints to me but she is not reliable.  1/10/22: 92yr old female patient with history of Chronic anemia, dementia, DM-2,HTN, Dyslipidemia, osteoporosis, chronic back pain due to thoracic vertebral fractures, GERD was admitted on 1/2/2022 with complaints of having fallen at home.  Patient was noted to have sustained left superior and inferior pubic rami and sacral fractures.  Patient was admitted to the hospital for adequate pain control and therapy.  She also was noted to be positive for COVID-19 infection.  Patient was placed in isolation.  Orthopedic consultation was obtained from the emergency room and patient was advised to follow up as an outpatient.  Patient continued to work well with physical therapy during the course of hospital stay.  Patient was slowly weaned off of the oxygen and her pain was well controlled.  She completed a course of treatment with dexamethasone which increased her blood sugars during the course of hospital stay.  The Foley catheter was removed.  Patient will complete 1 dose of Levaquin which was prescribed in the hospital on 1/12/2022.  Patient has history of chronic microcytic anemia being followed as an outpatient by Hematology/Oncology.  Patient received 1 unit of PRBC transfusion during the course of hospital stay.  Patient's insulin was adjusted for the blood sugars.  Patient remained stable for discharge to the skilled nursing facility.  Patient's son was updated of the discharge planning.  All questions were answered.
Subjective Fever that started 11 hours post Vaccine administration which continued for the next 12 hours. Ibuprofen and Tylenol as directed by package for fever. Left sided axillary lymphadenopathy began 36 hours post administration.  Muscle spasms in deltoid of injection site that started 36 hours post administration.
First couple of days I had a fever of 102 F, all of my muscles aches, swollen limph noides, hot and cold all around felt crappy it seemed to get worse each day.  On the 3rd day I became shakey, and cold to the point that I was not in controll, then I had sharp pains in my chest and could not breath.  I was rushed to the emergency room thinking I may have been having a heart attack.  After may proceedures at the hopsital and about 7 hours they determined that my symptoms must have been related to my hep A/B vaccination
Both legs swollen, left worse than right. Left thight swollen twice the size as the other leg. Right leg had silver dollar sized swollen area. Hot to touch, red area that covered his whole thigh and itching.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: 5 mins after giving the vaccine, patient felt lightheaded, dizzy, about to faint, looked paled. BP 82/49, pulse=45. pt drank some water & apple juice. after 15 mins took BP 113/74, pulse 59. advised pt to take ibuprofen, rest, and drink water. Follow up with pt the next day 10/30/21, she stated at home she felt disoriented at one point and took advil for soreness. today feel better
It looks like the patient received a 3rd dose of Moderna. 1st dose listed - 12/30/20. 2nd dose listed - 1/27/21. 3rd dose given 4/13/21.