chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health worker referring to a number of unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose, strength and route unknown, lot #: L021215, expiry date: 10-JUN-2017 or lot #: L011085, expiry date: 01-APR-2017). There was no concomitant therapy reported. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Currently, developed 3 blood clots in right arm 4 days after receiving the vaccination.   First was noticed on the morning of April 6, the second in the evening of April 6, and the third was noticed on the morning of April 7.  First one has appearance of cellulitis located on the forearm.  Doctor issued treatment for cellulitis on April 6.  Reddish/purple skin colored with grey edges in a circle.   Second clot is below the skin with slight bulge closer to the elbow than the first.  The third indication is in the upper arm above the elbow on inside of arm.  Appearance marked by 2 curved lines similar to varicose veins just below where the clot is bulging the skin.  No discoloration of the 2nd and 3rd indications of clot.
Collapsed; Shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Collapsed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (very mild asthma before.) and Anaphylaxis (Reportedly experienced anaphylaxis with certain drugs in the past. ). Concurrent medical conditions included Sulfonamide allergy, Bee sting hypersensitivity, Fruit allergy (Grapefruit) and Reaction to preservatives (preservatives like sodium nitrate or msg.).    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath). On 08-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collapsed) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Collapsed) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Difficulty swallowing; Swollen throat; difficulty breathing; light headed/dizzy; felt hot; flushed; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 31-years-old (Non- pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205, Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:00 (At the age of 31-years-old) as single for COVID-19 immunisation. No Medical history reported. The patient concomitant medication included metronidazole taken for an unspecified indication at an unspecified dose. Patient had no known allergies. Prior to 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 11Mar2021 10:30 (30 minutes after) the patient experienced Difficulty swallowing, Swollen throat, difficulty breathing, lightheaded, dizzy, felt hot and flushed. Patient visited Emergency room [department or urgent care] for the adverse events. Patient received treatment of Epipen and steroid shot for the adverse events. Sinc e the vaccination, the patient had not been tested for COVID-19.  The out-come of event was recovering.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable other HCP who reported for a patient. A patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) on 17Apr2021 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection,) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization. No prior cardiac past medical history. Medical history was not reported. Concomitant medications were not reported. On Patient received 2nd dose of Pfizer COVID-19 vaccine on 17Apr. That evening noticed SOB and chest tightness. Over the next 3 days went to ED with worsening CP. Found to have elevated troponins and EKG changes. CTPE negative. Symptoms improved with pain management, steroids, and colchicine. Cardiac MRI done on 23Apr that showed EF 52% and findings consistent with myocarditis and small pericardial effusion. Patient managed with ACE and colchicine. The clinical outcome of the events was unknown.   Information on lot/ batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect product second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) to reported events myocarditis and small pericardial effusion is possible. Case will be reassessed upon receipt of follow-up information.
Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is one of 3 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced shingles on an unknown date after the vaccine, with outcome of unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101473111 same reporter/drug/event, different patient;US-PFIZER INC-202101473797 same reporter/drug/event, different patient
On 8/29, the day after being given the second vaccination shot for COVID-19, Pfizer,  my heart rate was going between 120 and 130bpm and did so for about 2 hours - while I was at rest.  At that point, I tried to call Pharmacy, where I got the vaccine to find out what I needed to do.  I got an automated menu.  So I called Online and spoke with a nurse practitioner who  told me to go to the ER.  I also experienced some weird smells.  I smelled burnt rubber and my husband did not.   Once at the ER, I was immediately checked in - bp was 144/95 and hr was over 130.   I was given 5mg Lopressor via IV, which lowered my hr to around 98, then released.
Case completed initial 2 dose Pfizer series in April 2021, and received a booster in September 2021, then was hospitalized for and died of Covid in October 2021.  Summary of Important Events: 9/25 - Covid symptom onset 9/27 - Tested covid positive 10/3 - Seen at ER. Creatinine 1.73, Na 129.  Started on doxycycline 10/6 - Admitted Hospital with worsening Covid, Sa02 77%.  Creatinine 2.18, Na 128.  Start decadron, remdesivir 10/7 - Start baricitinib.  US negative for DVT. 10/13 - Oxygen requirements increase resulting in ICU transfer 10/20 - BLE DVT noted 10/25 - Cefepime for leukocytosis, possible pneumonia 10/27 - Considering transition to comfort care 10/28 - Deceased
Patient called stating she started getting chills and got a fever a few hours after receiving the vaccine. The next day she also had a fever ranging from 100-103.
some dementia; Rash on his legs and back that his dermatologist diagnosed as Pityriasis Rosea; significant swelling in his ankles; anxiety; This is a spontaneous report from a contactable consumer (patient) via a sales repsentative. An 81-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included heart disease and significant allergic reactions to many different things. The patient has had significant heart disease for years and is currently under the care of a cardiologist. The patient also has significant allergic reactions to many different things over the course of his 81 years. Concomitant medications included unspecified medications for heart disease. The patient is on many different medication for heart disease. Following two doses of the Pfizer vaccine: the patient has been experiencing for many months a rash on his legs and back that his dermatologist diagnosed as Pityriasis Rosea. The patient was also experiencing significant swelling in his ankles. The patient's family believes that there is some dementia and anxiety being experienced by the patient. He has been treated recently with steroids for the rash that he is experiencing without much improvement. Outcome of the event Pityriasis Rosea was not recovered, while outcome of other events was unknown.   Information on the Batch/lot number has been requested.
Patient with generalized seizure (stiffening of arms & legs). Lasted several minutes than patient asleep. Exam back to baseline later that evening. Concern re not visually tracking. Then on 7/2/2012 generalized prolonged seizures resulting in ICU admission, persistent poor visual tracking.
VERY MILD SORENESS AT INJECTION SITE; AT APPROXIMATELY 40-42 HOURS POST INJECTION, RAPID IDEATION, THOUGHTS UNCONTROLLED. PATIENT BEGAN PACING HIS HOME AND WORKPLACE. THIS COMPLETELY UNPRECEDENTED RACING OF THOUGHTS WAS CHARACTERIZED AS A "BRAINSTORM", AND SEEMED TO EBB AND FLOW FROM VERY FAST AND CHAOTIC THOUGHTS TO A FEELING OF RETURN TOWARD NORMALCY, IN CYCLES OF ABOUT 4 TO 6 HOURS LENGTH, AND CONTINUING INTO THE NIGHT, WITH NORMAL SLEEP IMPOSSIBLE. SLEEP WOULD BE FITFUL IN LESS THAN TWO HOUR STRETCHES. THE INTENSITY OF THE EPISODE SLOWLY BUILT OVER A PERIOD OF 10 DAYS. PATIENT'S WIFE, A REGISTERED NURSE, TOOK BLOOD PRESSURE, PULSE OX, AND TEMPERATURE ON SEVERAL OCCASIONS WHEN PATIENT REPORTED DIFFICULTY BREATHING, AND FEELING HOT. RESULTS WERE ALWAYS WITHIN NORMAL RANGE, WITH PULSE SLIGHTLY LOWER THAN NORMAL (56--NORMAL IS USUALLY BETWEEN 60-70). THERE WAS NO PAIN, NO HEADACHE, NO NOTICEABLE IRRITATION OR SWELLING OF THE INJECTION SITE. IT WAS POSSIBLE TO DRIVE, TO OPERATE THE COMPUTER, DUE TO THE FRIGHTENING AND UNUSUAL SITUATION, THE PATIENT DID NOT CONSUME COFFEE, OR ALCOHOL, AND REDUCED INTAKE OF FOOD DUE TO LACK OF HUNGER. THERE WAS NO NOTION OF ANY CONNECTION BETWEEN THE EXTREME MENTAL STATE AND THE PREVNAR INJECTION. ON JULY 24, PATIENT HAD AN APPOINTMENT WITH A PULMONOLOGIST AND TOLD HIM OF DISTRESS, SHORT TERM MEMORY LOSS, DIFFICULTY SLEEPING, AND FEELING OF DIFFICULTY BREATHING. THE PULMONOLOGIST REASSURED PATIENT THAT HIS BREATHING WAS FINE, HIS LUNGS WERE CLEAR, AND HIS OXYGENATION WAS EXCELLENT. BETWEEN JULY 24 AND 31, SYMPTOMS INCREASED DRAMATICALLY, AND PATIENT SAW A NEUROLOGIST AND SPOKE OF THOUGHTS ABOUT SUICIDE. ON AUG 1, THE PATIENT FELT A STRONG INCREASE OF A VIBRATION IN THE HEAD, SAW A STRANGE HALLUCINATION. THE NEXT DAY Aug 2, the problem rapidly subsided and the next day all muscles ached with a feeling of the flu. The following day the patient felt normal.
no adverse event; Subcutaneous vaccine administered intramuscularly (IM) in the right thigh; temperature excursion; This spontaneous report was received from a medical assistant concerning to a 13-month-old male patient. His medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in January 2023, several vaccines which included a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number W006412 (expiration date: 23-FEB-2024) went trough a temperature excursion (about 1 hour at -14 degrees Celsius to -10 degrees Celsius) (Product storage error) and on 22-FEB-2023, the patient was vaccinated at a private doctor's office with this dose, intramuscularly as prophylaxis (strength, was not provided) (Subcutaneous injection formulation administered by other route).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007733: US-009507513-2304USA007731: US-009507513-2304USA007759: US-009507513-2304USA007810: US-009507513-2304USA007822: US-009507513-2304USA007828: US-009507513-2304USA007837: US-009507513-2304USA007842: US-009507513-2304USA007844: US-009507513-2304USA007848: US-009507513-2304USA007857: US-009507513-2304USA007860: US-009507513-2304USA007866: US-009507513-2304USA007869: US-009507513-2304USA007881: US-009507513-2304USA007884: US-009507513-2304USA007886: US-009507513-2304USA007889: US-009507513-2304USA007891: US-009507513-2304USA007902: US-009507513-2304USA007907: US-009507513-2304USA007927: US-009507513-2304USA007942: US-009507513-2304USA007988: US-009507513-2304USA008013: US-009507513-2304USA008017:
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 9/28/21 and the second dose of Moderna COVID-19 Vaccine on 10/21/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
As of 4/11/18 I noticed a rash under my left breast, which looked like eczema, or ringworm. About a week later at PM I noticed several bumps on my abdomen. As each day went by there were new bumps forming on my lower back, arm pits, cervical neck area and groin. There was no itching or fever. Taking BENADRYL did help! So eventually I email my Dermatologist for advice. He requested pictures to be sent via email. Finally on 5/4/18 I was seen by derm. A biopsy was taken of a few of the bumps, which is pending. I was also told that I had something called Pityriasis Rosea, possibly caused by a virus in the HERPES 6 family the same virus that cause roseola in babies and cause the chicken pox virus. I am pretty much a healthy 61 year hold, recently divorced, but not sexually active for 6 years. I do not easily get colds, or even the flu! I am very concerned that the Zoster Vaccine may have triggered my break out, even though it's a year later. Ironically it is almost a year to date that I received the vaccine and had the break out. I thank you for your attention to this matter.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 11:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 11:34 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity of patient was reported. No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Acute gout in left big toe. Treated with Colchicine .6mg tablet (2/day for 3 days, then 1/day for 12 days). Severe pain lasted for 2 days with swelling in big toe and joint.
Myalgia SORENESS AT INJECTION SITE Narrative:  Other Relevant History:
Saturday-monday severe brain fog, Tuesday severe brain fog and moderate headache, Wednesday moderate brain fog with fever, chills and headache
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe
Shingles long after second shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles long after second shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced HERPES ZOSTER (Shingles long after second shot). The patient was treated with ACYCLOVIR [ACICLOVIR] for Antiviral treatment, at an unspecified dose and frequency and ACRIVASTINE (BENADRYL OTC) for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles long after second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-276555 (Patient Link).
This spontaneous report as received from a medical assistant refers to the 43 year old White male patient with (felt two weeks ago), neck painful and movement painful, Hodgkin's lymphoma, hypothyroid, tobacco use, GERD, vitamin d deficiency and no known allergies. The patient's medical history included sarcoidosis and leukopenia. It was reported that on 20-MAR-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 09-JUN-2014 at 16:00, was vaccinated with the second dose of RECOMBIVAX HB in his left arm (lot number J008505) (dose and route not reported). No adverse events were reported. This is one of several reports from the same patient (MARS# 1406USA006320). Additional information is not expected.
The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) 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. A571272B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients).    No concomitant medications were reported.  It was reported that 10 shots of TE vaccines were administered to patients. Highest temperature reached was 47.5 F  No treatment details were reported.   This case was linked to MOD-2023-718501 (Patient Link).
91 year old lady with hx dementia, HTN, HLP, PAFib, was brought INTO the hospital for worsening mental status, fatigue and body aches. In the ED she was found to be in atrial fibrillation RVR rate 120s, . She is afebrile but was hypoxic on room air 88%. Patient tested positive for covid. CTA positive for bilateral infiltrates r>L with bilat effusions and noted to have a small non occlusive embolus of subsegmental branch of right lower lobe with no right heart strain, and ascending aortic dilatation, no dissection, and CT head shows remote lacunar infarcts and age related small vessel changes. .
patient was light headed and blurred vision, this occurred almost immediately after the injection by, imz tech.  Immunization tech called for me, rph.  I took her BP AT 610PM, it was normal at 128/78 and immunization tech held an ice back on the back of her neck.  She recovered quickly and we waited with her for the remainder of her 15 minute wait.  Two people were with her.  We got a motorized cart for her.  She left after the 15 minutes and felt fine, stating no residual issues.
Redness/swelling of left upper arm at injection site noted 1 day after vaccine, already resolving on 5/15/08.
Death. SIDS death? Under coroner's investigation.  03/05/07-Autopsy report received:cause of death Sudden Infant Death Syndrome. Toxicology report received. None detected. Records copied and sent to FDA.