chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received first shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were reported. No Treatment informations were reported.
Patient after immunization felt dizzy and nauseated. start sweeting and fingers became stiff. She said I didn't have breakfast and recently worked a lot of shifts. After measuring her blood pressure and giving some candy and water she felt better and sat for half an hour to make sure she is fine before leaving.
Pt given MMR/Varicella in Left thigh. Pt developed rash on site of vaccine administration one week later. She also has a few papules scattered on her upper extremities and legs. Mom noticed "bump" on thigh developed a cluster of similar papules that were itchy. Redness also developed around the area. Pt had no fever. Pt came to office 8/1/14. Pt given keflex and acyclovir.
Steep rise in blood pressure previously controlled by medication.  Not able to control with increased dosage of meds.
fever; Slight pink 4" circle at injection site near shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder) and PYREXIA (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and :044A214) for COVID-19 vaccination.     The patient's past medical history included No adverse event and No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder). On 13-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062497 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062497:Dose 1
I received , my booster show at 12:00 noon Tuesday the 2nd of November  With in an hour I was very sleepy and went to bed.  . The next morning I had a  fever of 101, the chills and every muscle in my body heart. I called in sick at work. I didn't take and pills. I had a fever for about 5 hours. could not get out of bed. I slept  tell next morning the 4th of Nov. Thursday.  Felt ok but my hands were completely numb and cold  from 8:00 am tell 1:00pm  now I am fine
On 04/20/2021 a couple of hours post vaccine, 09:30 AM, I started spotting with my cycle. It had only been 15 days since my last cycle. I had a headache and my arm was sore from the injection site. During the night, everything was worse--body aches, headaches, chills, very tired and fatigue and I could not go to work the next day. My legs felt like anchors were attached to them. My congestion returned and my cycle was heavier than normal. At 03:30 PM, I took a Tylenol, It did not work. On the morning of 04/21/2021, I took more Tylenol. On 04/23/2021 I called Family Care because my arm felt the same, I had SOB, I had to use the Albuterol. I did not go to the Urgent Care because I was staining my clothes because of my heavy cycle.  On 05/02/2021- my stomach started hurting like menstrual cramps. My fingers and toes started tingling and that's when I went to the ER. And my friend who took me to the ER told me I felt cold. It was 70 degrees outside and I was very cold.  My heartrate  was 130. My temperature shot up to 104.3. I hardly ever get a fever. I never had a fever when I had COVID. While I was at the ER they learned I had a blood clot in my gonadal vein  and they also learned I had sepsis. They could not determine were the sepsis came from. I did not have an open would or any of that. I was  in the hospital from 05/02/2021- 05/07/2021.
temperature of 101; achiness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101), MYALGIA (achiness) and LETHARGY (lethargy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ROSUVASTATIN, LEVOTHYROXINE, Ziopan, LOSARTAN, ZINC, FISH OIL, TESTOSTERONE, POLYCARBOPHIL CALCIUM (FIBER), Relieve eye drops, COLECALCIFEROL (VIT D [COLECALCIFEROL]), UBIDECARENONE (Q10) and ASCORBIC ACID (VIT C) for an unknown indication.    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 PYREXIA (temperature of 101), MYALGIA (achiness) and LETHARGY (lethargy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In March 2021, PYREXIA (temperature of 101) had resolved. At the time of the report, MYALGIA (achiness) and LETHARGY (lethargy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 (High) 101F.     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.
And less than a day be sick; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a patient (consumer or non-health care professional) via social media.  This case is linked to case 2020SA300462. (same report media)  This case involves patient with unknown demographics who experience sick for less than a day (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose  dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for less than a day (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from illness.  There will be no information available on the batch number for this case.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about January 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Fever for 5 days, cold like symptoms, on 3/12/2011, developed extreme swelling of left salivary gland and fever, liklihood case of mumps from live vaccine
The first one was like burning sensation.; vaccines hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were recovered/resolved.   It was unknown if the reporter considered the burning sensation and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR081833   Additional Information: GSK receipt date: 18-May-22 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had received a dose of shingles vaccine and hurts like hell. The first one was like burning sensation. Additional Supportive Information: Follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR081833.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081833:same patient, 2nd dose
About 10 days after the vaccination my oxygen started dropping and not coming back up as it should. I had to call 911 and was taken into the emergency room. They did some blood work and ended up finding a blood disorder. The doctor asked if I had a blood transfusion, and I hadn't within the past two years, and he didn't know why I had the disorder. Because of the oxygen issue I was admitted to the hospital for 10 days. They gave me antibiotics and were treating it like pneumonia even though that was not the diagnosis. They needed to have me on high wind flow oxygen to assist my oxygen intake. I was in the hospital for almost two weeks and then they transferred me to a rehab for 2 weeks. I was having trouble swallowing. My pulmonary fibrosis started to get worse during this time. I was scheduled to have physical therapy, occupational therapy and speech therapy. This seemed to help. I am now on a chemotherapy pill due to the blood disorder.
Rash on the neck. Associated symptoms include redness, mild warmth, itchiness, stinging, discharge, body ache, and tenderness.
Physical pain.  Child refusing to walk, crying, swelling.  Continued into the next morning and same symptoms at 7:00 AM on 1/29/2012.
DRESS syndrome; Presistant fever; Rash; Eosinophilia; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and subsequently developed Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.  The patient's medical history was not provided. Concomitant product use was not reported.     On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    After vaccine administration, the patient subsequently developed persistent fevers, rash, and new eosinophilia.  The reporter stated being concerned for possible DRESS related to the vaccine. The patient was urgently referred to dermatology for a skin biopsy. No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, DRESS, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age who experienced a serious unexpected event of eosinophilia and systemic symptoms (DRESS) syndrome, including persistent fevers, rash, and new eosinophilia. The event occurred with unknown latency after first dose of mRNA-1273 on 05 Jan 2021. No further information available. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
I received the flu vaccine and the shingles vaccine at the same time.  The shingles vaccine is named Zostavax (I believe).  I have redness, some swelling, itching, and soreness and the site of the shingles injection.  No treatment at present time.
Myalgia, Fever, Purpura, NauseaVomiting, Night sweats Narrative:
Developed Ileocolic Intussusception 4 days after 2nd dose of ROTATEQ requiring surgical intervention.
Narrative: 59yo male patient admitted to outside facility hospital on 11/12/21 with Chief complaint: Altered mental staus, Unresponsive, Shortness of breath. Pt remained inpatient with diagnosis of Uncontrolled type 2 diabetes mellitus with hypoglycemia and diabetic coma. Pt ventilator dependent and was transfered pt to facility for long term vent patients on 11/17/21. On 11/28/21 pt readmitted to same outside facility hospital with acute respiratory failure as well as ENCEPHALOPATHY. Pt died on 11/30/21at this facility. Pt had received covid vaccines on 3/20/21 & 4/17/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
This is a spontaneous report from a contactable consumer (parent). A 18-years-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that patient kept complaining his arm hurt but he is kind of a baby about shots but today he just showed the consumer that on his biceps it's like a big round red mark, doesn't look really like swollen but is obviously red maybe it is like 6 inches by 4 inches, like his whole biceps. Outcome of events was not reported.
Muscle in right leg up to hip and very red injection site area approximately 2" x 3"
Developed a headache the next morning upon waking up. move to a full "Migraine" by Tuesday the 23 when she sought treatment at Clinic. She was given IM Toradol and sent home with PO Toradol.  Is till having HA all the time.
Information has been received from a registered pharmacist concerning a female patient who on an unknown dates, was vaccinated with 2 complete series of RECOMBIVAX HB (dose, route and lot number not reported). On an unknown date, the patient reported that she had undetectable titer levels. The patient sought unspecified medical attention by contacted the pharmacist. At the time of the report the patient had not recovered. Follow up information was received from a doctor of pharmacy who reported that the vaccines were not given at that pharmacy. No further information is available.
This report describes the occurrence of an injection site reaction in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  On 04/04/2003, the subject received an injection of Pediarix, which is not indicated for use as the booster dose in DTPa immunization series.  "Almost immediately", the subject developed an injection site reaction characterized by swelling and a "knot the size of a tennis ball", which was "very hot" to the touch.  The subject was seen by her physician.  As of 04/10/2003, the swelling had "gone down some".
Breakthrough COVID-19 infection in fully vaccinated individual admitted to  hospital on 04/08/2021 with increased symptoms of combativeness and confustion
6/19/21 - 6/27/21:  fatigue, muscle and joint aches 6/25/21 - 6/27/21:  slight intermittent pain in upper left abdomen.  6/27/21:  very short chest pain 6/27/21 - 7/4/21:   swollen lymph node in left thigh  7/4/21:  sudden pain in center of upper abdomen that radiated to my back along with vomiting.  Diagnosed with acute pancreatitis with a blood lipase level greater than 30,000.  After testing and assessment, the  medical  team could not find a cause and advised me to report my case.
Extreme arm pain, unable to move arm without significant pain for 7 days, pain when arm at rest. At present time (1/29/21) I still have arm soreness that will last 24 hours after very light strain (e.g.  washing dishes, folding laundry, light yoga, etc.)
48 hours post vax, the pt developed swelling, hardness, warmth, and pain at injection site.
tired; groggy; under the weather/Feeling abnormal; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US136607 (Novartis).  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 19Oct2023, outcome "unknown", described as "groggy"; FATIGUE (non-serious) with onset 19Oct2023, outcome "unknown", described as "tired"; FEELING ABNORMAL (non-serious) with onset 19Oct2023, outcome "unknown", described as "under the weather/Feeling abnormal".  Additional information: Stated had Covid vaccine yesterday, today was under the weather, groggy, tired.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
PATIENT WAS SEEN  AT THE PHARMACY FOR HER FIRST DOSE OF SHINGRIX ON 3/30/22 CIRCA 2PM.  SHE STATED THAT SHE FELT FINE AFTER RECEIVINGTHE SHOT THAT DAY, HOWEVER, SHE NOTICE REDNESS ON HER LEFT ARM THE MORNING. SHE  ALSO COMPLAINED OF IRRITATION AND AND PAIN IN THE AREA AS WELL. SHE PRESENTED TO PHARMACY TODAY WITH THE AFFORMENTIONED SIGNS/ SYMPTOMS AND UPON FURTHER ASSESMENT, I DETERMINED SHE HAS HAD AN ALLERGIC REACTION TO THE VACCINE.  I ASKED  IF SHE HAD TAKEN ANYTHING TO RELIEVE THE THE PAIN OR ITCHINESS, BUT DENIES DOING THAT.  I ADVICED HER TO TAKE BENADRYL TO RELIEVE THE ITCHINESS, IBUPROFEN  TO RELIEVE THE INFLAMMATION WITH A COLD COMPRESS.
CAME SICK, UPPER RESPITORY WITHIN 2 WEEKS/ CRONIC RETURN WITH SINUS PAIN AND BACK PAIN. STARTED HAVING PROBLEMS WITH TEETH/ POSSIBLE BEGINNING OF ABCESSED. PLACED ON ANTIBIOTICS/FLONAISE LATER ORDERED XRAYS FOR BACK (NEG) PATIENT HAS RECEIVED ONLY TWO FLU VAC IN PAST 30 YEARS. FIRST WHILE IN MILITARY DURNING 1976 SWINE FLU PANDEMIC AND WAS ORDERED TO RECEIVE VACINE. AND ON 10/17/2006 DUE TO PATIENT HIGH RISK TYPE 1 (INSULIN DEPENDENT) AVIAN FLU PANICDEMIC CONCERNS FOR UPCOMING FLU SEASON.  5/22/07 Received hospital medical records which were test results:  3/30/07 myocardial perfusion scan was WNL & unchanged from 10/05; 5/3/07 CT of c-spine revealed mature interbody fusion C6-C7, degenerative changes & posterior longitudinal ligament ossification combined w/congenitally fairly narrow canal cause spinal stenosis C4-C5 through C6-C7; 5/3/07 CT of head was WNL;5/9/07 MRI t-spine was WNL.  06/08/2007 Received medical records from 2nd hospital which consisted of Endocrinology consult of 6/5/07 & operative report of C4-5 cervical diskectomy of 6/5/07.  Consult indicates patient had NIDDM for 12-14 years after a bout of pancreatitis & had been on insulin x 2 years w/erratic control & peripheral neuropathy.  Recent cardiac cath revealed small lesions w/30% proximal stenosis in obtuse marginal branch of the left circumflex artery & had an ejection fraction of 60%.   Patient is a smoker of 1 1/2 pks/day & is enrolled in smoking cessation course.  Had a recent URI.  6/12/07 Received PCP medical records which consisted only of lab reports which reveal high triglycerides & cholesterol.
Information has been received from a physician concerning his 16 year old granddaughter with no medical history and no drug allergies, who, on an unspecified date, was vaccinated with a third dose of GARDASIL. There was no concomitant medication. Subsequently, the patient experienced cervical lymphadenopathy of the left side and the area was tender. The patient was seen by the physician. A complete blood count was performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a female registered nurse with no known drug allergies and no pertinent medical history, who on 29-MAR-2007 was vaccinated with Gardasil (Lot #656051/0244U) vaccine.  There was no concomitant medication.  The nurse reported she noted a pea sized lump at the injection site a day or so post vaccination and that the area continues to be painful.  The nurse reported that she did seek medical attention.  As of 03-MAY-2007, the nurse was recovering.  Additional information has been requested.
side effects 10 days after the first  in a shot I'm right; Throwing up; 10 days later my son and husband have fevers; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects 10 days after the first in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects 10 days after the first  in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches). At the time of the report, VACCINATION COMPLICATION (side effects 10 days after the first  in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
ALS;weight loss;swallowing difficulties Narrative: Patient has a recent diagnosis of ALS. 2.5 months ago she felt that she was a neurologic baseline. She had the COVID vaccines (Moderna) on 1/31 and 2/27. She reports neurologic symptom onset after Moderna#1 and very rapid progression after Moderna #2. She denies F/C with vaccines and associates her symptoms temporally with the vaccines. She is awaiting diagnosis confirmation and has requested delaying PSG until later in April, but we can re-visit this if she prefers to do the study sooner. She also reports laryngospasm and we are initiating Q12 PPI to determine whether this improves her symptom.
irritable, whimpering weak cry; shaking-given APAP @ 2PM by mom-seen @ clinic;  red & swollen inject site; t102.3;