chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic to the flu shot; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves adult patient who was allergic to the flu shot (Allergy to vaccine), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic to the flu shot (Allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient was not taking any chances on the COVID (corona virus disease) vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No relevant laboratory tests were reported.  It was not reported if the patient received any corrective treatment.  The outcome of the event was unknown at the time of reporting.  There will be no information available on batch numbers.
Fever and flu-like symptoms after second dose. Later on I developed chest pain and racing heartbeat/heart palpitations that lasted for at least a few days to a week. These symptoms have mostly subsided, but minor and occasional chest pain is still persisting.
Pt developed an injection site (right deltoid) reaction characterized by redness and swelling. 4 - 5 cm diameter and appeared whelped up. Area is not sore but itches badly.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-DEC-2015, the patient received the first dose of VAQTA 25/0.5 intramuscularly and the second dose was inadvertently given too soon on 20-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
PT HAS SWELLING, AND STIFFNESS IN THE AREA WHERE THE TRUMENBA VACCINE WAS GIVEN WHICH WAS IN THE RIGHT DELTOID AREA. THE AREA FEELS HOT WITH ABOUT A 6X7 CENTIMETER OF REDNESS IN THE AREA. THE PATIENT ALSO EXPLAINED THAT IT'S PAINFUL FOR HER TO MOVE THE RIGHT SHOULDER COMPLETELY.
Immediately felt tongue swelling. Moderate to Severe body chills, temporal and frontal headaches for 4 days, severe body aches, moderate nausea for 72 hrs, and severe arm soreness. Hives at the injection arm two weeks later.
Information has been received from a 67 year old female consumer with breast cancer and ovarian cancer and a history of shingles who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included "a tetanus vaccine" (detail not specified). Two weeks after receiving the PNEUMOVAX 23 and the tetanus vaccination, the patient developed shingles. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. No further information is available.
Information has been received from a registered nurse concerning a 10 year old male, with no medical history and no known drug reactions/allergies reported, who on 25-MAR-1997 was vaccinated with only one dose of Varivax. There was no concomitant medication. The nurse reported a breakthrough of chickenpox in child vaccinated on 25-MAR-1997. The original vaccination was not in this office and notes did not indicate a lot #, dose, route of administration. On 29-MAY-2006 the patient contacted the doctor for rash on torso, face, extremities of less than 25 lesions. The physician diagnosed as breakthrough chickenpox. No fever noted and patient left the office not in distress, but will be followed. No product quality complaint was involved. Additional information has been requested
Hospitalization 10/17-10/21 for dyspnea, COVID 19. Treated with dexamethasone.
Fever started at 8pm around 99.5F and then around 1:30am fever went to 101.5F, took 2 advils and fever went down in the 99s. Fever didnt break until after 4 pm next day after 2 advils were taken.  Feeling tired/weak since had the shot.
Approximately 2 weeks post vax the pt developed one fluid filled lesion on his nose and six fluid filled lesions on his back.  Based on the description the pts pediatrician diagnosed the pt with chickenpox over the phone. It was reported that the pt was also irritable and afebrile.  Additional information has been requested.
As soon as injection given, little lump starts to appear, became more puffy in about 6 hrs.  2 days after, whole arm was sore and even more swollen.  By 10/25/19 arm that turned  black and bruised now becomes yellow.  No other symptoms.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003698 expiration date: 31-OCT-2019 and lot # N003700 expiration date: 01-NOV-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that the incorrect product storage had a time frame of 16 hours at 31°F or colder (21.7 °F). This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005611:
It occurred on November 26 around 2AM. Another guardian was taking care of her at this time. She vomited and had a very high fever. She had a febrile seizure. She was taken to the hospital and I met with her at the hospital. She was given an IV with TYLENOL. When she was in the hospital, she was monitored and made sure she didn't have any seizures. She was given a dose of MOTRIN to lower the fever even more. There were many tests done to see what caused the seizure and did a urine sample for a possible UTI. She ended up recovering that morning and was released from the emergency room around 11AM. The doctors concluded that she had rhinovirus but no uterine issues. It was mentioned that a seizure could happen again from a fever or another virus, but we are unsure if it will happen again.
3/23 , admitted 3 days after covid vaccine with chest pain. Patient with history of hypertension, hyperlipidemia, CKD stage III, right-sided sciatica, bilateral carotid stenosis, and prostate cancer.  Based on the presenting signs and symptoms as well as the available laboratory data, it appears most likely that the patient has acute chest pain with concern for stable angina. Patient was previously having chest pain and had an abnormal stress test on 3/18 showing anterior wall ischemia.  Patient was scheduled for a cardiac catheterization on 3/25. Patient underwent cardiac cath and had DES to proximal LAD, patient will be starting on aspirin, Plavix, Lipitor 80, will continue bisoprolol and hold losartan/HCTZ for now.  Patient will have Renal function lab with his cardiologist office in 2 days.
pt recv vax 24JUL97 & mom returned w/child states about 2PM pt woke up w/face & lips swollen;rt arm where DTAP given reddened, sl swollen & hot to touch;upper lip grossly swollen, lower lip sl swollen;angioedema;t100;
Given 5-11 Pfizer Covid 2nd dose of monovalent. Patient is 4 years and 6 months, should have received 6mo-4years Pfizer Covid monovalent. Monitored after vaccination, no reactions
This non serious case was received on 11 March 2009 from VAERS (reference number 249423) via a search of the QSCAN database. A 43 year old female patient received FLUZONE SV '2005-'2006 USP (lot number reported as 49281037615) on 13 December 2005 at 10:40 AM. Thirty minutes later the patient developed fatigue. At approximately 3:30 PM the patient developed a fever, muscle aches, headache, cough, chest congestion and a sore throat. At 8 PM the patient's left eye became very red, itchy, and swollen. The patient treated the fever with Tylenol and the eye symptoms with ELESTAT. The patient recovered. List of Documents held by sender: None.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Other medication in 2weeks was unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pimple on the arm where she had the shot, weird and hurt so bad; Terrible headaches; Achy from head to toe; Eye hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy from head to toe), EYE PAIN (Eye hurt), VACCINATION SITE MACULE (Pimple on the arm where she had the shot, weird and hurt so bad) and HEADACHE (Terrible headaches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (Achy from head to toe), EYE PAIN (Eye hurt) and HEADACHE (Terrible headaches). On 19-Apr-2021, the patient experienced VACCINATION SITE MACULE (Pimple on the arm where she had the shot, weird and hurt so bad). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy from head to toe), EYE PAIN (Eye hurt), VACCINATION SITE MACULE (Pimple on the arm where she had the shot, weird and hurt so bad) and HEADACHE (Terrible headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
11-24-2014 - 12:25 PM - client in clinic with her mother. Client hands and trunk of body shedding skin, very dry and skin from hands peeling off. Mom reports noticing the problem on 11-23-14. I visualized flaking of skin on palms and trunk area. No rash present.
Vaccine vial stored in fridge for longer than recommended period, potentially stored up to 28 days . No adverse reaction, no illness
Information has been received from a RN concerning a 69 yr old white female who on 17Apr06, was vaccinated IM with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Several hours post vaccination, the pt developed pain at the injection site. The pt's arm was very sore to the point of having trouble lifting the arm. The pt might have also developed redness and swelling at the injection site. The pt was treated with a triamcinolone acetonide (Kenalog) injection to get relief. Subsequently, the pt recovered in 4 to 5 days. The pt's injection site pain, redness and swelling were considered other medical events by the reporter (OMIC). No additional information is expected.
little soreness in his left arm and upper back/neck; little soreness in his left arm and upper back/neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Surgery" (not ongoing), notes: Heart Surgery 1.75 years ago, valve repair open heart surgery to repair 2 valves. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "little soreness in his left arm and upper back/neck".  Additional Information: It was reported that, the patient did not have anything at first, a week later the pain was in the arm and the back of the head/neck area on the left side. It lasted for another week to 10 days and then it was done. The reporter stated that he had heart surgery a year and a half ago, and the pain in the left arm was giving mixed signals as to whether it was from the vaccine or from heart, so he decided to take the second shot on the other side. The patient was pretty good with the pain and didn't take any Tylenol with the first shot and then it went away. The patient  did not take any additional vaccine on the same date of pfizer suspect. Patient received both doses of pfizer suspect vaccine. Adverse events did not result in emergency room visit or physician office visit. Prior vaccination information in 4 weeks was that the patient received only both the doses of pfizer vaccine. Family medical history related to adverse event was none. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Patient c/o redness, slight swelling, and itching at administration site, noted day after vaccination. Noted 9-27-12 - decreased swelling, redness, no itching at site (varicella).
Patient received Moderna yesterday morning on 6/9/21 on her right arm. She called this morning and said that by yesterday afternoon the area of injection was feeling really itchy. She said that she doesnt have hives or anything but that it is extremely itchy. I recommended that she try OTC treatments (icepacks, benadryl, etc). I told patient that if it progressively gets worse, or starts to show signs of infection then she should reach out to her doctor
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with a first and a second dose of VARIVAX (Merck) (lot # not specified). It was reported than on an unspecified date the patient developed chicken pox after receiving VARIVAX (Merck). At the time of reporting the patient's outcome was unknown. The patient was seen by her physician. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of two reports from the same source. Additional information has been requested.
MOC reports that child's left arm is swollen, red and tender to touch.  Child has vomited twice today.  Denies elevated temperature.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included LANSOPRAZOLE (PREVACID) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Arm became very sore and throbbed keeping the patient awake thru the night. Patient self treated with heat and TYLENOL and arm was still sore at 4 days post injection. Referred to doctor who prescribed steroid dose pak and antibiotic. It is notable that patient had cellulitis from injection in July as well.
he is very concerned; he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.; it hurts him to walk; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.), PAIN IN EXTREMITY (it hurts him to walk) and ANXIETY (he is very concerned) 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 12-Jul-2021, the patient experienced URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.) and PAIN IN EXTREMITY (it hurts him to walk). On an unknown date, the patient experienced ANXIETY (he is very concerned). At the time of the report, URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.), PAIN IN EXTREMITY (it hurts him to walk) and ANXIETY (he is very concerned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Moderna Covid-19 vaccine in March or May or 2021. Patient going to see 3rd dermatologist.   No concomitant medication listed.  No treatment information provide.
Pt was given a dose of the Pfizer/COVID-19 Vaccine, in place of a 2nd dose of the Moderna/COVID-19 Vaccine
injection site is sore; injection site is red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix vaccine on his right arm. The patient stated the injection site was red with a 4 inch circle and the injection site was sore. Till the time of reporting, the sore arm and redness did not resolved. Additional information were not provided by the patient. The patient did not consent to follow up.
Patient described pain that radiated from injection site to shoulder: as days passed, pain lessened and redness/itchiness appeared.
10/01/2021- 8:30 am. Sudden onset of ?burning? sensation of  skin over entire body, skin redness, not hot to touch.  Burning sensation lasted  20 minutes and then itching over entire body for another 25 min. Entire Initial episode  lasted 45 minutes and was relieved by 25 mg Benadryl.  10/4/2021 - 10:00 pm . Sudden onset of ?burning? sensation of skin over entire body, redness of skin, not hot to touch. Burning sensation lasted 15 minutes, entire body began itching which lasted another 20 minutes. Episode only relieved with 50 mg Benadryl.  10/6/2021-12:00 pm sudden onset of burning sensation and redness of skin for 15 minutes on head, face & torso with onset of itching on arms, & neck.  Subsided without Benadryl  within  20 minutes.
According to dad, pt became pale, weak & fainted; pt became nauseated p/was fully reacted;
Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 09-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002530 and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 42 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.