chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burst blood vessel in my right eye.; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 3248), via an unspecified route of administration in the right arm on 02Mar2021 at 13:45 (at the age of 53-years-old) and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 3248), via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Prior to vaccination, the patient did not test positive for COVID-19. Concomitant medications included atorvastatin, multivitamins, ibuprofen (ADVIL), paracetamol (TYLENOL), melatonin (MELATON). There were no other vaccinations within 4 weeks of the COVID-19 vaccine. On an unspecified date (Mar2021), about 2 weeks after each dose, the patient experienced a burst blood vessel in the right eye. The clinical course was follows: About 2 weeks after each dose, the patient noticed a burst blood vessel in the right eye. He did not associate it with the vaccine after dose 1. It went away within 3-4 days. But it happened again approximately 2 weeks after the second dose, on 07Apr2021. Again, the patient initially did not associate it given the time lag. But today, the patient started wondering and so reported it as a precaution. There was no pain or irritation in the eye but just a red splotch on the eyeball. The patient had never had a burst blood vessel in the eye before. There was no treatment received for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the event was resolving.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 9/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pain to right upper arm started shortly after vaccine was administered.  Progressively worsening pain and swelling to right upper arm and right shoulder since onset.  Reports reduced range of motion to right arm due to pain.
While the nurse was pushing down on syringe plunger, fluid started to exit out of hub. Nurse immediately retracted needle from patient's arm.  Fluid was noted on patient's arm, clothing and 0.2 ml was noted left in syringe.  Pt's arm had no redness, bleeding or swelling. Patient was aware of the incident.
No adverse event; Lot number 030g22b expired 5/9/23. vaccine given 5/12/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (I cant lift my arm over my head), VACCINATION SITE WARMTH (Its hot to the touch), VACCINATION SITE SWELLING (Injection site swelling) and MYALGIA (Muscle ache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (I cant lift my arm over my head), VACCINATION SITE WARMTH (Its hot to the touch), VACCINATION SITE SWELLING (Injection site swelling), MYALGIA (Muscle ache), VACCINATION SITE PAIN (Injection site pain/ severe pain/ Burning/Can't touch the injection site/ It hurts to bad) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Severe diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (I cant lift my arm over my head), VACCINATION SITE SWELLING (Injection site swelling), MYALGIA (Muscle ache), VACCINATION SITE PAIN (Injection site pain/ severe pain/ Burning/Can't touch the injection site/ It hurts to bad) and HEADACHE (Headache) had not resolved and VACCINATION SITE WARMTH (Its hot to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medications details were provided. No Treatment Medications details were provided.
- Extreme fatigue, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful joints/most noticeable in arms, elbows, ankles, hips, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful muscles in fully body, starting one hour after shot for 48 hours, sleep/rest/Aleve - Dizziness and weakness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Lightheadedness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Swelling of arms and hands, starting one hour after shot for 48 hours, sleep/rest/Aleve - Headache, starting one hour after shot for 24 hours, sleep/rest/Aleve - Decreased mental clarity/slow to process information and speak, starting one hour after shot for 24 hours, sleep/rest/Aleve
Non-serious case received from a health care professional on 20 October 2009.  A 45-year-old male patient developed malaise and intermittent fevers (as high as 103 degrees Fahrenheit), four days after he had received a third dose of IMOVAX (lot number B0661) on 09 October 2009.  The first two doses of IMOVAX were given on 10 September 2009 and 17 September 2009.  The events required a visit to the doctor's office; treatment was not reported.  At the time of the report, patient outcome was 'not recovered'.  Follow-up information received on 19 November 2009 from a healthcare professional.  The patient had not been exposed to rabies.  The first three doses of IMOVAX Rabies had each been administered intramuscularly in the right deltoid.  The reporter confirmed that the malaise and intermittent fevers started on 13 October 2009.  Corrective treatment was TYLENOL for fever.  No additional information was available at the time of reporting.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: 10 minutes after vaccine administered, patient reported feeling dizzy and that her heart was racing. VSS at the time. Patient placed in supine position. After 10 minutes, stated she felt better, drank some water and gatorade. She left in stable ambulatory condition with her husband after 30 minutes of monitoring. VSS throughout.
The day after I had a bad headache and my body was aching.  Three days after my upper body developed a red raised rash.  A week later the rash is still here.
About 12:00 pm the day after vaccination, a small reddened area appeared on the left wrist which was about the size of a quarter along with a small dime sized raised area that looked like a hive in the middle of reddened area.  Also reported inflammation of right side of upper lip.  Patient describes that it looks as if he had botox injections.  Swelling in lip and hive on wrist has slowly improved.  On 8/5/21 states he awoke with a swollen eye on his left side.  Says that it was so swollen in the morning that his eye was closed shut.  Says that today he also noticed that although the lip swelling has improved, he has some swelling in his left cheek in close proximity to his lip.
Started with cough, took cough medicine, got chills fever was 101 degrees at least, tried to vomit - nothing came up.  I was told to take Tylenol if arm ached but not aspirin.  But with a fever I finally took aspirin and went to bed.  About 6 hour duration of misery.  Took night time cough medicine and slept fairly well during night. By morning I was weak but fever gone and almost back to normal. This is first time I have had a reaction to a flu shot except a sore arm.  I got the extra strength shot due to my age and COPD.  I get colds easily and they last usually 3 weeks.
A nurse practitioner reported the occurrence of fever in a 43 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject was originally from Turkey.  He stated that he had no relevant medical history, concurrent conditions, or concurrent medications.  However, the reporter was "not convinced that he answered medical history questions correctly."  On 01/21/03, the subject received his first injection of Engerix-B (Lot # ENG5285C6).  Approximately 6 hours post-immunization, he began to experience chills, fever, joint pain and back pain.  He was seen by the reporter on 01/23/03.  There were no warm or swollen joints.  Physical findings were consistent with sinusitis.  White blood cell count was 13,600 cells/cu mm.  A nasal swab culture was negative for influenza.  The reporter prescribed a 10 day course of clarithromycin.  The most recent information, received on 02/27/03, indicated that the events resolved on 01/23/03.  The reporter considered the events to be possibly related to Engerix-B administration or to possible sinusitis.  The Engerix-B immunization series was discontinued.
Patient received a bivalent booster vaccine on 03/15/2023 after receiving a bivalent booster vaccine on 09/21/22.
This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (some stomach discomfort), DYSPEPSIA (indigestion), ABDOMINAL PAIN UPPER (stomach was sore), PYREXIA (Fever) and VOMITING (threw up) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (cancer survivor Cancer in 2021) and COVID-19 (Had fever every day from 23-Dec-2022 until 04Jan-2023.) from 23-Dec-2022 to 04-Jan-2023. Previously administered products included for COVID-19 vaccination: Pfizer (First dose, LOT: EL1283) on 26-Feb-2021, Pfizer (Second dose, LOT: EN6208. patient slept unbelievably for long period of time) on 19-Mar-2021, Pfizer (fourth dose and LOT: FP7138) on 04-Aug-2022. Past adverse reactions to the above products included Adverse drug reaction with Pfizer; No adverse event with Pfizer; and Sleepiness with Pfizer.       DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Pyrexia: 98.4 and 100.         No concomitant medications were reported.  Patient received Moderna (third dose and LOT: 017F21A) on 26-Oct-2021.  Had fever the whole time, Could taste food but couldn't eat. Had fever every day from 23-Dec-2022 until 04Jan-2023. Had difficulty breathing in middle of night, had to use allergy medicine to be able to find relief breathing, including steam. Dad diarrhea and could only eat ice chips for a period time. Was miserable.Was extremely uncomfortable, difficulty with almost every symptom of Covid. Did have taste and smell but, did have something slight that she couldn't smell.  It was reported that patient had some issues with Moderna and the Pfizer vaccines. The Moderna gave patient the problem. Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine. It gave patient a lot of uncomfortability. Last night, patient had something to eat and, right after patient ate, had some stomach discomfort that continued into this morning. Patient came home from work  early. Oral thermometer showed temperature was 98.4 and with mercury thermometer it was 100. Patient either took the vaccine too early or, was having some other kind of stomach   issues over something patient ate.     It was reported that patient had shingles shot before this Moderna Booster. Would have been after 04-Aug-2022 and 20-Jan-2023. Patient had the first dose of the shingles shot despite the vaccines patient had extremely uncomfortable, difficulty with almost every symptom of Covid.
pt recv vax in lt thigh;mom stated pt rt leg & face became fiery red p/vax;returned to room pt  rt leg no longer red-face only fiery red;forehead hot to touch;
Lower aspect left deltoid swollen "size of baseball", bruise "size of baseball", onset 10/10/2003 AM. Increased pain with movement most acute pain 10/12/2003.  Decreased serum sickness 10/15/2003.  Bruise notable for intense color.
After receiving the vaccine, I had a sore arm for half a day. On 10/5/2022, I tested positive for COVID-19 with a home test. On 10/6/2022, I had a video visit with my doctor through the patient portal. I was prescribed PAXLOVID and five days later I tested negative for COVID-19. I never rebounded which I thought I would do.
Pt denies any adverse event with first shot. She is c/o left arm feeling like a "constant Charlie Horse", left leg feels like a "constant Charlie Horse", CP, dizziness, jaw feels rigid, left hand fingers tingle.
89 year old lady with hx HTN, HLP, hyperthyroidism, was sent here by PMD because she tested positive COVID by PCR today. She developed symptoms of fatigue, chills and dry cough 6 days ago. No fever or shortness of breath, no nausea or vomiting or any other complaints. She presented to ED and had a CTA of chest which shows' bilateral pneumonia but no PE. She was mildy hypoxic on room air, 90-0=93% and is 98% on nasal cannula. She is ambulating around room.
ACCORDING TO MODERNA PAPERWORK, SEVERE REACTION OF FACIAL SWELLING AND LOWER LEG WEAKNESS OF BOTH LEGS.  LATER, AND TO TODAY, TINGLING OF SKIN, ARMS AND HEAD CONTINUES.  I SPOKE TO INSURANCE BENEFITS NURSELINE AND THEY ADVISED GOING TO ER.  WENT TO ER, WAS EVALUATED, BP: 186/90ISH AT ARRIVAL.  BACK TO NORMAL WHEN DISCHARGED.  GIVEN 3 PREDNISONE TABS AND 1 BENEDRYL.  GIVEN 6 DAY SCRIPT TO WEAN OFF PREDNISONE.
Delayed injection site (hypersensitivity) reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Delayed injection site (hypersensitivity) reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome (post-infectious IBS). Concurrent medical conditions included Penicillin allergy, Primary biliary cholangitis (Chronically elevated liver enzymes) since 06-Jan-2020 and Hypertension since 01-May-2009. Concomitant products included VALSARTAN from 05-May-2009 to an unknown date for Hypertension, AMITRIPTYLINE from 15-Aug-2018 to an unknown date for Irritable bowel syndrome, URSODIOL from 06-Jan-2020 to an unknown date for Primary biliary cholangitis, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for Supplementation therapy.   On 07-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HYPERSENSITIVITY (Delayed injection site (hypersensitivity) reaction). On 14-Mar-2021, VACCINATION SITE HYPERSENSITIVITY (Delayed injection site (hypersensitivity) reaction) had resolved.            As per the reporter, the reaction did not require any treatment.      Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No new information provided.
Client had received 1 dose of Moderna and then on 10/28/2021 he received 1 dose of Janssen. No other adverse reaction, client had only received 1 Moderna and had not completed primary vaccination series.
Stroke; Fast heart rate, elevated heart rate; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 49-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2G7K9, expiry date 12th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season .5 ml and Flulaval Tetra Pre-Filled Syringe Device. In October 2022, 3 weeks after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced heart rate increased (serious criteria clinically significant/intervention required). On 3rd December 2022, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the stroke and heart rate increased to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022191338   Additional Information: GSK Receipt Date: 21 DEC 2022 Reporter's comment: The reporter was the patient. The patient received a dose of Flulaval Quadrivalent. The patient stated that about three weeks later patient developed an elevated heart rate that was unresolved. The patient had fast heart rate from 2nd November 2022 and was ongoing till the time of reporting. The patient was in hospital for stroke. The reporter wanted to know if this was mRNA vaccine. Reporter consented to follow up.
Information has been received from a nurse practitioner (NP) concerning a 30 yr old female employee who in 1998 was vaccinated with a dose of varicella virus vaccine live (lot632510/0694E). On 20Jun05 a titer was taken and it did not show seroconversion. Unspecified medical attention was sought. It was reported that no symptoms were present. No product quality complaint was involved. Additional information has been requested.
Injection arm swollen below injection site.; Injection arm swollen behind injection site.; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO158), via an unspecified route of administration in the left arm on 03May2021 at 14:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included calcium carbonate; Colecalciferol (CALTRATE), acetylsalicylic acid (ASPIRIN) (low dose) and vitamin d nos (VITAMIN D). The patient previously received ampicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03May2021 at 23:00, nine hours after the vaccination, the patient reported that the injection arm was swollen behind and below injection site. The clinical outcome of the event injection arm swollen behind and below injection site was not resolved at the time of this report.   The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: Facility information updated. Treatment Received updated to NO for all AEs. "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative. Event verbatim added for past drug Ampicillin allergy.
six hours after the vaccination chills, low grade fever, just exhausted and that lasted  12hrs, migraine of 12 days after  the vaccination , took Excedrin and talk to the doctor and the Excedrin help resolve the headache. Due to the  drug on the market and off the market and by the time was she was able to talk to the doctor she was able to resolve it self she did not. Virtual appointment she was able to determine the state of the head ache and was able to give directive for next steps if the head ache worsen. got better and did not have to go the hospital.
Guardian (Uncle) called the Health Dept, stating his 12 year old niece began having a fever the same day. She received her vaccines at the Health Dept. At this time 12 year old is still having a fever (101 degrees). Recommended tylenol, fluids and contact her PCP as needed.
8/12 - Arm achey, (L) - injection site. 8/13 - pain down (L) leg and (L) knee joint pain (L) calf pain (no fever, CP, SOB, behavior changes). 8/14 - 1041 am - mom called with pts above symptoms, advised to go to PCP/call PCP and go to ER/call 911 with only chest pain or shortness of breath.
Fever, Chills, Fatigue, Headeache and extreme dizziness. Headache and dizziness lasted full 48 hours. Chills, fever and fatigue lasted 24 hours.
chocking sensation/coughing and wheezing Pt self administered her own epi pen EMS squad called and pt transported to local ER