chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on the arm; Sore at the site of injection; Red at the site of injection; Itchiness at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE URTICARIA (Hives on the arm), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information received: Updated event outcome from not recovered to recovered for all reported events. Patient had declined further follow-up.
Phone call from patient on 12-11-09 at 2:50pm with complaints of itching and hive like rash on her back, arms, legs and abdomen x 4 to 5 weeks, patient states "it started 1 week or so after she had her H1N1 vaccine". Patient saw doctor and was given Rx for Benadryl and later give Rx for Methylprednisone. Patient claims rash still present.
Patient has not received her primary Moderna series and was given 0.5mL of Moderna Bivalent.
Case number PHEH2013US013854 is an initial spontaneous report received from a nurse on 24 Jun 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly with MenCYW liquid conjugate component of MENVEO (batch number: M120193), instead of being reconstituted with MenA component on 24 Jun 2013. No adverse event was reported following this drug administration error. No other information was available at the time of this report.
First, where the vaccine were administered which wasn't healing, it turned brown. A bruise appeared in her leg, everyday a bruise would come up especially in that area, then red dots appeared in her arms and tongue and a big purple black bruise on her palatal. It took us several days to figure out it was something that was not normal, therefore we took her to the ER in April 6th, 2015 around 3:00am. Her labs results came back with an alarming platelet count of 1k. Labs were repeated after more than 5 nurses tried to draw blood from different areas of her body because non of her veins worked. She was rushed in ambulance to a Hospital with Pediatric Hematology services. She was admitted in ICU and they administered Intravenousl Imuno Globulins. She had an adverse reaction to the treatment and her hemoglobin dropped.
10 hours post vax, the infant had an episode of pallor, limpness, and unresponsiveness for approximately 3 hours.
Myocardial infarction with cardiac arrest (V fib).  Rescusitated with CPR, defibrillation.  Angiocath done, LAD stented.
Information has been received from a nurse concerning her 12 year old son who on 19-JUL-2011 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) in his right arm. The patient was given 2 other vaccines at the same time. She had tetanus toxoid (manufacturer unknown) in his left arm, VARIVAX (Merck) in his left arm. The reporter stated that after getting GARDASIL, her son "fainted, and his left arm shot up as a tonic clonic movement while he was unconscious. After a couple minutes he recovered and was fine. The patient did not remember fainting. No treatment was given for adverse events. The patient sought unspecified medical attention. Follow up information has been received from the nurse (licensed practical nurse) concerning a 12 year old male with no illness at the time of vaccination (camp physical) who on 19-JUL-2011 was vaccinated with the first dose of GARDASIL (lot # not reported) into right arm. Secondary suspect therapy included VARIVAX (Merck) (lot # not reported, the second dose in his left arm). Concomitant therapy included DTaP (manufacturer unknown, in his left arm). The reporter stated that the patient had 3 immunizations that day-after GARDASIL and VARIVAX (Merck) were given (at same time by 2 nurses). On 19-JUL-2011 at 3:00 PM, the patient's left arm jerked upwards, the eyes rolled back and he fainted. He was sitting on exam table during injections. No injury was noted. There were some jerking movements (looked like a seizure). The patient came "back" in about 5-10 seconds. He was unaware of what happened, did not remember getting shots, wondered where he was and said it all went black. He was re-oriented. Cool wash cloth on head. He was given DTaP by staff. He was watched for 30 minutes and then went home. No further treatment was needed. The patient only complained of site pain at injection site for 2 days. He had not had the second injection yet. The patient did not seek medical attention. Additional information is not expected. This is an amended report. Another adverse event "some jerking movement (looked like a seizure)" was added into AE information screen and made it as an other important medical event.
Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She states he took ibuprofen at home . She states that on April 26,2021 pt's primary care physician - was contacted. She states that on April 28,2021 she heard back from him . She states hat on April 29,2021 he went to get lab work (WBC) that md ordered. she states that  pt was contacted on May 1,2021 by primary care physician to go to the ER . She states that he was admitted to hospital from May 1,2021- May 4,2021 and diagnosed with Leukemia (CML)
Patient began experiencing fevers of 99-100 degrees F the next evening, and the fever increased to 102 degrees F before bedtime. Thursday morning around 3am, the patient woke up and went to the kitchen to get water and passed out, hitting her head in the process. Ambulance was called and the patient was taken to the ED.
Patient complaining of intermittent extremity spasms on 12/12/22 to Hospital ER department. He states that it had been on going for 3 days.
rash; Enlargement of the lymph nodes on the same arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm). At the time of the report, RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Case crosslinked with MOD21-019884. Concomitant medications were not provided. Treatment information was not reported.
Face became blotchy 1hr p/vax, eyes puffy, 3 day diarrhea & queasiness, 1.5hrs p/vax;
Chest pain and shortness of breath for 4 hours 2 days after time of vaccine injection. Ongoing bouts of chest discomfort and shortness of breath going on 2 days since.
This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold. Concurrent medical conditions included allergy (unspecified). In March 2019, the patient received SHINGRIX. In March 2019, 12 hrs after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out and unresponsive to stimuli were recovered/resolved and the outcome of the vomiting was unknown.  It was unknown if the reporter considered the passed out, unresponsive to stimuli and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 2 weeks before the date of reporting. The patient passed out which was described as non-responsive for 30 to 40 seconds. After becoming responsive, she vomited. The reporter did not consent to follow up.
found dead/ sudden death; This is a spontaneous report from a contactable physician. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was found dead with her dog by her side on Thursday night just days after she took the second dose of the Pfizer COVID-19 vaccine. The reporter noted, "Covid-19 has turned all of our lives upside down in a way that we never imagined, and now it's safe to say that we won't even be able to say goodbye to our daughter." The (Name) mother also blamed the vaccine for the sudden death of her "healthy" daughter. While a post-mortem was expected to be held to learn more about her death, some of the family members believed she simply suffered a heart attack, while her mother was connecting her sudden death to the vaccine. The patient died in Apr2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information in this report precludes a full assessment of the case; therefore a possible contributory role of the Pfizer suspect product BNT162B2 to the reported Death cannot be completely excluded. Information on relevant medical history, concomitant medications, and post-mortem result would be needed for a thorough medical evaluation of the patient's sudden death.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found dead/ sudden death
Patient is not yet 18 years old. Patient was given Moderna vaccine by mistake for Covid 3rd (Booster dose). Patient did request the Moderna vaccine specifically but pharmacy did not catch that she was not yet 18 and should have received pfizer vaccine.
minor soreness at the injection site of her left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.). At the time of the report, VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
major muscle weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Mar2021 08:40 (Lot number: EN6201) as dose 2 , single for covid-19 immunisation. Relevant medical history included: "Urothelial carcinoma", start date: Jul2020 (ongoing); "Last Chemo treatment", start date: 12Jan2021 (ongoing), notes: Began immunotherapy; 23Feb2021, 09Mar2021, 23Mar2021; "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Heart" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for cardiac disorder (ongoing); ZETIA taken for blood cholesterol (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol (ongoing); NORVASC taken for blood pressure abnormal (ongoing); ASPIRIN taken for cardiac disorder (ongoing); FERROUS SULFATE. Vaccination history included: Bnt162b2 (Dose 1, Single dose, Time: 08:30 am, Lot-EN9581, Site and Route- Left arm, Intramuscular), administration date: 22Feb2021, for Covid-19 Immunisation, reaction(s): "rash". The following information was reported: MUSCLE FATIGUE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "major muscle weakness". The event "major muscle weakness" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle fatigue.  Additional information: The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. the patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient taking any medications prior to the event being reported as yes.  No follow-up attempts are possible. No further information is expected.
Sore arm right after Next day (7/11), I felt weak and tired. Very fatigued. Similar to how I felt when I first had covid 5 months ago.
He got his vaccine, the first day he was fine, the next day he left work early as he was feeling really sick.  He started noticing a red rash underneath his skin, circled it to see it's growth and the redness grew for about 3 days.  About the 4th or 5th day the redness stopped growing but the welt got larger.  At one point it looked infected as it had a yellowish scab, and now it looks like somebody put out a cigarette on him.  The area is red and the area is peeling off.  It kind of looked like a monkey pox pustule, but is not sure if it's a pustule or not.  He did not have any rashes all over his body or anywhere, just the area where the vaccine was given.  He still has the welt that is very visible on his arm, feels like it is going down somewhat but the redness still has not gone down.    He did not seek medical attention as it was not life threatening.
Headache; upset stomach; Fatigue; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, fatigue and fever. On an unknown date, the outcome of the headache and fatigue were unknown and the outcome of the upset stomach was recovering/resolving and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache, upset stomach, fatigue and fever to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported. The patient received the second shot of Shingrix yesterday.  The patient had some of the listed side effects as Headache, upset stomach, fatigue and slight fever and wanted to knowhow long should the patient allow for them  to pass. Fever seemed to have passed and stomach was getting better.
1945 local induration rxn 5cm in diameter to rt thigh p/vax; same rxn to lt thigh p/vax; poss due to excessive kicking & jerking; applied cool compress to thighs; APAP given
Patient administrated booster of Varivax 4/17/07 in right outer thigh on 4/17/2007. On 4/18/2007, she experienced, itching, redness + induration 5cm size. I recommended ice, Motrin, Benadryl for this mild adverse.
Acute Demyelinating Axonal Neuropathy (similar to Guillain Barre), leading to diffuse weakness and respiratory failure.  Now has a tracheostomy, remains weak, and now is transferred to an LTAC.
Erythematous papular rash 4 cm in diameter. (L) deltoid appearing within 4 hours of GARDASIL injection.
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to  Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions).  Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
Pt with longstanding ITP (10 years duration).  Is seen by Hematologist.  Got 1st Moderna Covid vaccine 2/20/21 at Cancer Center.  After first dose had drop in platelets starting 2/22/21 and received 2 or 3 units of platelets as outpatient.  Platelet count according to patient was 5K.  After transfusions came up and was ok and was up to 100K or higher before second shot.  Got 2nd shot at same clinic on 3/20/21.  On 3/22/21 platelets were low and was admitted to Hospital on 3/22 and received 5 units of platelets.  Released 3/24/21 with platelet count of 21k.  Did have some mild petechia and mild headache but no sig other symptoms. no bleeding occured.
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 75-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 16-Feb-2022 at 4:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Feb-2022 at 4:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's  Census Ethnicity was reported .  No concomitant medication was reported by reporter.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No treatment medication was reported by reporter.
About 8 hours later of vaccine I had a  fever, chills, headache, body aches, & fatigue. The fever only lasted about 12 hours and for the rest of the symptoms I was completely fine after 48hours. For pregnancy my due date is 9/8/2021  I am 14 weeks currently. I had heart palpitations but everything else has been good with pregnancy..
Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previous seizures or seizure disorders.
During the covid clinic where 2 stores teamed up to help with the event, one dose of moderna vaccine was given to a minor.  Nothing happened to the patient.  Pharmacy found out after the fact.
Suspected vaccination failure; flare ups with pain in joints; Fatigue ; Shingles; This case was reported by a other health professional via other manufacturer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz Xr) for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis and joint pain.   On an unknown date, the patient received Shingrix at an unknown dose. In August 2017, the patient started Xeljanz Xr (oral) 11 mg once daily (11 mg daily). In December 2019, unknown after receiving Shingrix, the patient experienced arthralgia aggravated and fatigue. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Xeljanz Xr was continued with no change. On an unknown date, the outcome of the vaccination failure, arthralgia aggravated and fatigue were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, arthralgia aggravated and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Age at vaccination was not reported. However the patient was an adult at the time of vaccination. The patient reports some flare ups with pain in joints and fatigue since december, 2019 after start of therapy XELJANZ XR 8/2017. Reports shingles for 2 weeks in January or February 2020, after receiving Shingrix vaccination years ago. Agrees that generally it was been hard to cope with rheumatoid arthritis and sometimes feels discouraged, but not depressed, prior to and continuing unchanged since start of therapy. The case has been considered as suspected vaccination failure being full schedule was unknown. It was unknown if the reporter considered the shingles, arthralgia aggravated and fatigue to be related to Xeljanz Xr as well.