chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to the clinic accompanied by mom to be vaccinated. It was determined the patient needed  a TDAP vaccine. After screening patient and ordering the TDAP in computer, I mistakening asked the vaccine  manager for a DTAP. I then input the vaccine information into computer under TDAP and administered the  vaccine to the patient in the left deltoid. The patient was then monitored in post vaccination for 15  minutes for any adverse reaction. No reactions were noted and the patient left the vaccine area with  mom. While doing a final count at the end of clinic it was discovered that I had given a DTAP instead of TDAP to the mentioned patient
Lightheaded, nausea, sore throat, lethargic. Sent to nurses office to call parent.
240 pm :Patient complaint of burning right ear and numbness in her mouth. Vitals T 97.3, P 74, R 16, BP 120/90.  315 pm: Symptoms subsided per patient. Patient discharged from clinic.
A few hours after the J&J shot, I started experiencing a strong under the skin itch/stabbing sensation, which was particularly bad at the injection site and around the injected arm. I then broke out in a fever and took a 4hr nap in the middle of the day (unusual) after a normal night's sleep. Over the course of the week, I developed a migrating cold that felt like, at first,  a standard cold, a sinus infection, and, then, laryngitis as it worked its way back and got more intense and then faded. This was accompanied by breathlessness (blood oxygen levels around 90% according to finger reader), fatigue and mental impairment (disorientation, hallucinations), as well as daily fevers met with 2-6hr naps.  Basically, it felt like I picked up a really bad cold in the 3hr-1week after I got the vaccine.   This is in line with how my body has responded to the flu shot and other vaccines. For example, I've receive three flu shots and each time came down with the flu or something exactly like it 12hr-2weeks later. Those are the only times I've had the flu or something like it.
This spontaneous report was received from a registered nurse concerning unspecified number of patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # not provided). The doses of VARIVAX (Merck) were exposed to -5.1C for 3 hours and 21 minutes. No adverse effects were reported. Additional information has been requested.
Chills and headache, fatigue.sore arm   . Relieved with Motrin late at night.   Then woke with chills, fatigue and headache in am.  Took Tylenol. Finally felt better by 2:30pm
Fever, headache, nauseous, diarrhea, body aches.  took 800mg ibuprofen for fever, headache and body aches.  symptoms lasted about 30 hours.
Fever onset several days after immunization. Vomiting and stomach pains same day as immunizations.
Vaccine used beyond expiration date - vaccine expired 12/31/21 and administered 1/3/22.
This case was reported by a nurse via sales rep and described the occurrence of elevated liver enzymes in a 18-year-old female patient who received BEXSERO for prophylaxis. On 27th July 2018, the patient received the 1st dose of BEXSERO. On 1st September 2018, 36 days after receiving BEXSERO, the patient experienced fever. On 5th September 2018, the patient experienced elevated liver enzymes (serious criteria hospitalization). On an unknown date, the outcome of the elevated liver enzymes and fever were unknown. The reporter considered the elevated liver enzymes and fever to be related to BEXSERO. Additional information was received as follows: On 1st September 2018, the patient's body temperature was recorded as 103 degree F. On 3rd September 2018, the patient's white blood cells count was 1.4 and platelet count was down to 82. On 5th September 2018, the patient's liver enzymes were checked and they were Alanine aminotransferase 306, Aspartate aminotransferase 549 and Blood alkaline phosphatase 167. On 5th September 2018, the patient's white blood cells count was 2. On 3rd September 2018, the patient was hospitalized and transferred to another hospital on 5th September 2018. The patient was given further IV's. The reporter believed the only difference was that the patient had gotten her dose of BEXSERO. The reporter believed this was an adverse event related to the 1st dose of BEXSERO and did not plan to give the patient the 2nd dose of BEXSERO. Labs results were since returned to normal. The reporter agreed to follow up from GlaxoSmithKline.
First two shots were Moderna; Booster shot was Pfizer  This happened way after the vaccine was given, 2-3 weeks after. I noticed my heart rate sped up and then it went into atrial flutter. I went to see the nurse practitioner and it was confirmed atrial flutter. My heart rate was 105. I felt very weak and tired. My legs were really weak. No headache. That was basically it and I was tired because the heart rate was going too fast. They upped the rythmol from 150 to 225mg every 8 hours as needed and that helped. She checked my thyroid and that was normal. We did magnesium  and it was a little high but its always been that way between 0.2-0.4 for a couple months now . I had a blood panel and that was abnormal but everything else was normal, because of renal failure. We just increased rythmol and that seemed to do the trick. The outcome was helpful because I?m back to my old self but I have the increased medication.   Follow up ECG 10/27/2021 Follow up with NP 11/30/2021  Received flu shot 10/6/2021
COVID Vaccine Breakthrough Case  J&J Dose 6/22/21 (203A21A) COVID Positive 12/28/21  12/28/21: Patient is a 37-year-old male with past medical history of diabetes, anxiety, smoking.  He presented on 12/28/2021 with chief complaint of nausea and vomiting. His symptoms started yesterday.  He states that he forgot to take his insulin and ate poorly over the Christmas holiday. His sugars therefore became very high and he started feeling sick.  He currently feels that he is back to his baseline health after receiving fluids and insulin in the ED.  This is not the 1st time that he has been hospitalized with elevated sugars.  He states that he was diagnosed with diabetes last year and has needed insulin since the time of his diagnosis.  He does not know how much insulin he takes at home.   He denies ever taking oral medications for his diabetes.  He does not take any medications otherwise.  He is unaware of any other past medical history.  He denies any illicit drug use.  He had a surgery on his left wrist in the past but otherwise denies surgical history.  Family history is noncontributory.   In the emergency department, his vital signs were in to bed.  Lab work was notable for glucose 941. Other notable findings include anion gap of 17, lactic acid of 3.2, and presence of ketones in urine.  He was diagnosed with DKA. He received LR, Zofran, and insulin drip.  He was admitted for further management.  12/29/21: Received call from nursing the patient was agitated.  He wanted to leave AMA as he "had things to do." When I got to the room, his insulin drip had already been discontinued as he was getting ready to leave.  His GlucoStabilizer was reviewed and he was administered 10 units of Lantus prior to discharge so that at least he would have some long-acting coverage throughout the day. The patient had no idea how much insulin he takes at home regularly.  Patient was also notified that he was COVID-19 positive.  We discussed quarantine you for 10 days.  We discussed returning to care if he develops shortness of breath.  I did not spend much time trying to convince him to stay as he was punching the wall due to lack of patience and wanting to leave.
Same Day: Severe Chills, Extreme Fatigue, Left Arm Soreness And Tender, Fever Next Day: Chills, Fatigue, Left Arm Soreness And Tender, Headache
After immunization of flu and pneumonia into the left arm. Patient states the vaccine was mixed in the syringe. 3 hours after injection left arm started to swell from elbow to shoulder. # days later swelling has radiated down below the elbow. Complains of redness, soreness, pain swelling, hotness. Has applied ice to site.
pounding headache; chills; high fever; She also got vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
HISTORY OF PRESENT ILLNESS:     60yo M PMhx extensive as below including but not limited to paraplegia secondary to fall years ago, former tobacco dependence states quit "years ago" on 3L oxygen 24hrs a day, neurogenic bladder with chronic indwelling catheter presents for fever Tm 102 per EMS and tachycardia per EMS. Given 500mL NS PTA ED by EMS. Chronic indwelling foley catheter in place. Associated symptoms are cough, dry non productive. No CP, abd pain, pain in extremities reported. Allergy to Amoxicillin.
This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The patients current condition include prophylaxis. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 9 patients experienced disability (from an unspecified adverse event), 8 patients died, 124 patients did not recover (from an unspecified adverse event), 16 patients had adverse event which was life threatening, 354 patients had to visit emergency room (from an unspecified adverse event), 65 patients were hospitalized, 5 patients extended the hospital stay (from an unspecified adverse event), 80 patients experienced serious adverse events (from an unspecified medically significant adverse event), 1169 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)","adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. This is one of the multiple reports from the same reporter.
Fever up to 101.8, runny nose, cough, covid headache, loss of taste and smell, tinnitus, eye socket pain, boxy aches, bone pain in femurs, nausea, diarrhea  - the exact same symptoms I had when I had covid in December, and most had continued off and on for three months.
pt recvd vax 11JAN96 & devel t103 on 12JAN96 w/red rash across chest which resolved on 13JAN96;c/o lt sided h/a w/soreness of lt arm;
felt like flu; joints ached; woke in the middle of night aching; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like flu), ARTHRALGIA (joints ached), MYALGIA (woke in the middle of night aching) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like flu), ARTHRALGIA (joints ached), MYALGIA (woke in the middle of night aching) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (felt like flu), ARTHRALGIA (joints ached), MYALGIA (woke in the middle of night aching) and CHILLS (Chills) was resolving.          Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   This case was linked to MOD-2021-031434 (Patient Link).
Pt broke out in hives the night of receiving the vaccine then continue to have symptoms for over 12 days following the injection
Headache; Joint pain; Muscle pain; Diarrhea; High fever (103.2); Chills; Pain in armpits; Pain in armpits and groin; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0175) via an unspecified route of administration in the left arm on 28Apr2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021 at 21:00, the patient experienced headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin. On same day, the patient underwent body temperature test and the result was 103.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, joint pain, muscle pain, diarrhea, high fever (103.2), chills, pain in armpits and groin was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
3 inches circle at the injection site; hard; swollen; red; sore; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). On 29-Mar-2021, the patient experienced INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, INJECTION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Information has been received from a patient's mother concerning an 18 year old female with no allergies who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL. Concomitant therapy included YASMIN. Then within a short time after the first dose the patient's arm felt heavy, her face became pale, her body went limp and her arms and legs were flailing. This only happened for a couple of seconds and then she came to and her color in her face came back. The patient stayed at the office for ten more minutes and was given water and sugar since she had an empty stomach and was then fine to leave. No labs and diagnostic tests were performed. The patient slept the rest of the day, and was fine. No further information is available.
Went in to get 3rd dose, was given a half dose (0.25mls); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)). At the time of the report, ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
VARlVAX was improperly stored and administered; This spontaneous report was received from other health professional referring to a 1-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021824, expiration date 25-JUN-2022 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).    The vaccine was stored in a temperature of 16.1 degree Fahrenheit (°F) for 1 hour and 45 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Knot on my arm; Knot is up the base of the neck, and shoulder; Knot is up the base of the neck, and shoulder; Lips are a little bit numb; Arm is really kind of still a little bit uncomfortable; Shoulder is puffed up on the right side where she got the injection; Bottom of her face feels odd; hurts down to her elbow; A spontaneous report was received from a consumer concerning a female patient who experienced a knot on my arm: vaccination site mass, knot that has moved up from her shoulder to her neck: musculoskeletal discomfort, lips are a little bit numb: hypoaesthesia oral, arm is really kind of still a little bit uncomfortable: limb discomfort, shoulder is puffed up on the right side where she got the injection: injection site swelling, bottom of her face feels odd: facial discomfort, and she hurts down to her elbow: injection site pain.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date in Dec 2020, approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On an unknown day in Dec-2020 the patient developed a knot on her arm, a knot that has moved up from her shoulder to her neck, her lips were a little bit numb, her arm was uncomfortable, her shoulder was puffed up on the right side where she got the injection, the bottom of her face felt odd, and she hurt down to her elbow.  The events were treated with Tylenol, however she still had pain.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS unexpected vaccination site mass, musculoskeletal discomfort, limb discomfort, facial discomfort, hypoaesthesia oral and NS expected injection site swelling, injection site pain.  Event onset about 1 week after first dose mRNA-1273. Treated with Tylenol. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recvd 3 doses of Engerix-B 6MAY91, 6JUN91, & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Dizzy 2 days and still going on.head ache couple hours .body aches 6to 8 hrs. Fever 2 to 3 hours.
Wide, red, itchy spot at the site of the injection.  Lasted about three days.
Pt received 1st dose of anthrax vaccine on 6/11/08 and reported to the ER on the morning of 6/15/08. She was complaining of itching and red bumbs all her body. States she had wheezing and shortness of breath the morning after the injection and the rash is getting worse. Treated with benedryl and ordered to follow up with her primary care clinic.
Fatigue, chest pains, unbalanced, soreness at injection site, constant stomach pains.
This spontaneous report was received from a medical assistant and refers to a 70 years old female patient with hypertension, osteopenia and allergies to: sulfa, amide-type anesthetics, sumatriptan and egg derived. The patient's historical conditions were not reported. The patient's concomitant therapies included: albuterol, alprazolam, aspirin, vitamin D, ubidecarenone (COQlO), cyanocobalamin (VITAMIN Bl2), estradiol, fexofenadine hydrochloride (ALLEGRA), nebivolol hydrochloride (BYSTOLIC), olmesartan medoxomil (BENICAR) and pitavastatin calcium (LIVALO).    On 16-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 by intramuscular route (lot number: R009163 and expiration date 06-JAN-2020) as prevention of pneumococcal disease. On an unknown date in August 2018, following the vaccination, the patient experienced injection site swelling, which was treated with ice and heat . Then, on an unknown date in August 2018 (reported as "within 48 hours"), the patient recovered of injection site swelling. No laboratory diagnoses were performed. Additionally, it was reported that the patient called the physician (details were not provided). The causal assessment between the events and therapy with PNEUMOVAX 23 was not provided. This case is linked to another case reported by the same reporter.; Sender's Comments: US-009507513-1808USA009735:
Patient received 0.5ml of Moderna for booster instead of 0.25ml. No adverse reactions noted on date of administration
I broke out, only on my face, with very large, red and hot welts. Nothing that I put on it would calm it down and no allergy medicine (like Benadryl) would calm it down. It lasted like that for about a week. The second week, the welts went down, but the marks were still visible. It took about a month for all of the welts and marks to go away.
Swollen lymph nodes under my left arm causing fungal infection. Fever and body aches for a day and a half. Severe fatigue.