chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had difficulties thinking clearly; Flu like symptoms; Feel lots of anxiety and frustration; Feel lots of anxiety and frustration; Feel aggressive; Irritability; Had issues breathing with my lungs; Felt like my heart beat was a little bit off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 13Apr2021 17:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunization. The patient had history of depression and allergies with prednisone and penicillin. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication and therapy dates and serum allergy shots. The patient had no other vaccine in four weeks. On 13Apr2021 21:00,  the patient had flu like symptoms. He also started to feel lots of anxiety and frustration. He felt aggressive and had difficulties thinking clearly. He became confrontational with his partner and ended up jumping out of the moving vehicle, at a slow speed. He did have a long day, but he felt like irritability was a big factor. He also had issues breathing with his lungs and felt like his heartbeat was a little bit off. He did not have COVID-19 prior to vaccination and not tested post vaccination. The patient did not receive any treatment for the events and recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Patient presented at the pharmacy on Saturday at approximately 12:30PM complaining that the night before, his arm left was swollen as well as his chest on the same side and had has some difficulty breathing. He said at that moment his breathing was better but he was still swollen. Patient was give two 25mg oral diphenhydramine caps and sat on the bench in front of the pharmacy until his wife was done shopping and then left with her. I called patient at 5:00PM Saturday. He said his breathing was better but he was still swollen. I advised him to seek medical attention if the swelling did not go down.
1. local injection site reaction for 10 days after vaccine (walnut sized knot, warmth, some redness, soreness) 2. chills, fatigue, low grade fever for 48 hours post vaccine 3. extreme fatigue, mental confusion and forgetfulness, neuropathy in hands and now feet, blurry and double vision starting 48 hours after vaccine and still on-going 4. anxiety, panic, and hallucinations during hospitalization for 24 hours, resolved now
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: Called 911 and parametics arrive within minutes. Upon arrival, paramedics examined patient and results were normal. Parametics offered to take patient to hospital, but patient refused. Patient stated that he had a fear of needles. He stated that he suffers from chronic migraines. Patient called a friend to pick him up from the pharmacy. Patient rested for 20 minutes, left the pharmacy feeling better and back to normal.
FEVER, RASH, HEADACHE, NAUSEAS, VOMITING, DIAHRREA, BODY PAIN.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who experienced excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes, while he received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPOL lot N1G41, expiry date- 28-Jul-2019 via intramuscular route in the left deltoid. It was a case of potential medication error due to incorrect product storage. (Other relevant tests included No lab data.) Final diagnosis was excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes. An unknown corrective treatment was received. The patient outcome is reported as Not Applicable for excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes.
Continued psoriasis outbreak; Red dots from plaque over most of my body; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 47-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8730) via an unspecified route of administration in the right arm on 27Mar2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing, psoriasis from 2001, irritable bowel syndrome (IBS) from an unknown date and unknown if ongoing, Barret's from an unknown date and unknown if ongoing, and spondylitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included tofacitinib citrate (XELJANZ) from an unknown date for psoriasis; esomeprazole magnesium (NEXIUM) from an unknown date for an unknown indication; alprazolam (XANAX) from an unknown date for an unknown indication; colecalciferol (VITAMIN D) from an unknown date for an unknown indication; and vortioxetine hydrobromide (TRINTELLIX) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EN6202) in the right arm on 06Mar2021 at 16:30 (at the age of 47-years-old) for COVID-19 immunisation. The patient reported that on 03Apr2021 they experienced continued psoriasis outbreak. They reported having red dots from plaque over most of their body starting about a week after their second dose. They continued to get worse even after resuming their tofacitinib citrate treatment. The patient reported it was very unusual as they had never had that much red spotting since their diagnosis 20 years ago. The patient was treated with acetylsalicylic acid (ASPIRIN) daily. The clinical outcomes of continued psoriasis outbreak and red dots from plaque over most of their body were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Within 5 minutes of administration the patient got short of breath, chest tightness, shakiness and compaints it was hard to breathe. A few minutes later she compained of severe lower back pain like she "could feel the medicine in her kidneys".
Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.
Patient came into pharmacy requesting a COVID vaccine. Patient told pharmacy staff this was her first dose. Patient was asked again before receiving the vaccine if  she was here for  her first pfizer  vaccine; at every checkpoint she stated yes. Patient was given the pfizer vaccine and later it was discovered that this was her fourth pfizer shot when entering it into the immunization registry.
half of upper lip swelled; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:30 (Batch/lot number: EN6205), at age 74 years old, as dose 1, single, for COVID-19 immunisation. The patient has no medical history and concomitant medications. The patient reported that he took the initial COVID-19 shot on 03Mar2021 at 9:30 AM and after he went home, he ate a bowl of jambalaya and half of his upper lip swelled. The patient wanted to know if this could be due to the vaccine. He stated that he has never had an allergic reaction to anything in his life and from where he lives, they eat a lot of different foods. The patient put something cold on his lip which prevented it from swelling any bigger, but it was still swollen. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Ischemic colitis; symptoms 3 weeks after 2nd dose: sudden abdominal pain, bloody diarrhea,  passing blood clots instead of stool;  had blood work & CT at the ER, saw gastroenterologist and had colonoscopy 5 days later. Colonoscopy confirmed ischemic colitis.  No symptoms prior to this. No GI history.
On 3/1/2021, received second dose at 3:15pm and at 3:45pm driving home from work I developed chest pains and went to urgent care. I got there by 5:30pm and they ran an EKG; results were normal. On 3/2/2021, I left work at 2:30pm feeling ill and when I got home by 3:30pm I had flu symptoms. Symptoms were body aches, headache, fever, chills, nausea. This lasted for 24 hours. When I woke up on 3/4/2021, I was just tired with chest pains. I went to work and on my way home at 3:45pm shortness of breath started with increased chest pains. I went to urgent care and they told me to head to the ER. I got to the ER by 6pm. They ran blood work, EKG and Chest X-ray; results all normal. I followed up with PCP. I was out of work from 3/5/2021 to 3/12/2021. PCP thought I might have COVID. Took PCP test on 3/9 and results were negative. I was able to return to work on 3/15/2020 but still had shortness of breath and chest pains as well as feeling exhausted all the time. Due to no change, PCP provided me with script for Echocardiogram, Exercise Stress Test, inhaler as needed and to see Pulmologist.  Waiting on insurance company to approve echocardiogram and pulmologist appointment is 3/29/2021. It has been challenging to complete daily living activities like washing dishes, showering, climbing 20 stairs to my apartment, laundry, walking to the postal mailbox, etc. I get easily tired and winded. Prior to 3/1, I was healthy and exercising 3x's a week, walking 4 miles and hiked with no issues for the past year ranging 3.5-7 miles with incline.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 14:15 as dose 3 (booster), single (Lot number: GH9703) at the age of 70 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 included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: If vaccine received: Yes, Other medication in 2 weeks: Yes. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 02Feb2023, Treatment stop date: 06Feb2023, Lot number=NDC: 00069-1085-30, Indication: Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician and a healthcare worker (certified medical assistant) referring to a currently 5 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unspecified date the patient was vaccinated with a dose of M-M-R II injection (unspecified lot and expiration date, Albumin status, dose, frequency and route were not provided). The patient had no concomitant medication. On an unspecified date, the patient was diagnosed with persistent autoimmune thrombocytopenia after an unspecified amount of time following the M-M-R II administration. Healthcare worker reported that the mother of the patient recalled that bruising started about a week after M-M-R II administration. On an unspecified date, the patient had an unspecified lab work done at the pediatrician office. The outcome of persistent autoimmune thrombocytopenia was unknown. Upon internal review, the event persistent autoimmune thrombocytopenia was considered to be medically significant. Additional information has been requested.
myasthenia gravis crisis; Initial information received on 15-Feb-2023 regarding an unsolicited valid  serious case received from a pharmacist.  This case involves a 18 years old and unknown gender patient who had myasthenia gravis crisis after receiving vaccine Influenza Vaccine (Quadrivalent).  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date (Last September), the patient received an unknown dose of suspect influenza vaccine (quadrivalent) (strength, formulation, produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient developed a serious event of myasthenia gravis crisis (latency: unknown) following the administration of influenza vaccine (quadrivalent). Patient refuses mRNA COVID booster.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown  Seriousness criteria: Medically significant.; Sender's Comments: Sanofi company comment dated 21-Feb-2023: This case involves a 18 years old and unknown gender patient who had myasthenia gravis crisis after receiving vaccine Influenza Vaccine (Quadrivalent). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, concurrent condition, medical history, past vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
1/18/03 to ER. Seen and dx cellulitis and needle injury. Rx for Diflucan 250mg x 7d bid. 1/19/03 to ER. Mom states temp was 99.8 left upper arm swollen and hot to touch, didn't see doctor at that time. Left hospital and went to medical center. Didn't remember doctor's name dx was same. 1/21/03 seen by Dr. Encouraged to continue medication given in ER. States child is getting better. Mom instructed to apply warm compresses q 4 hrs x 30 mins. No fever since 1/19/03. 1/21/03 child also seen in health dept to assess arm ? swelling seen upper arm down to approx 2 inches above elbow also slightly hot in area.
Around 10:30pm I started shaking quite uncontrollably was extremely cold. Next day the same but could barely move my body hurt so bad. By Thurs I managed to get myself to urgent care and have been taking 800mg of Tylenol and 650mg ibuprofen with just a small improvement. I managed to shower yesterday but it wiped me out. My joints hurt, my back is in full spasm as it?s the weakest part of my body due to surgeries. My appetite is very low with food tasting like cardboard. There is no way I can drive from city to airport to work- I don?t have the strength. I don?t know what to do.
Every shot patient got. Ended up with the flu.; Initial information was received on 20-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an adult patient who experienced the flu (influenza), after he/she received INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient hasn't had a flu shot since 2001. Was manditory at job 14yrs. Every shot he/she got ended up with the flu. 19 years no flu and no shot.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.
Information has been received from a woman at a physician's office concerning a 4 year old white male with no allergies and no medical history who on 08/09/2000 was vaccinated in the right thigh with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/13/2004 the patient developed 2 spots on his neck and broke out overnight with 40-50 spots in his scalp.  There was no fever.  It was also noted that the patient was very sleepy.  The physician diagnosed the patient at home.  The patient was treated with diphenhydramine liquid, pramoxine hydrochloride, zinc acetate lotion and ibuprophen.  On 05/20/2004 the patient recovered.  No further information is expected.
Shoulder and arm pain, unable to move arm on night of 3/7/19, but getting better this morning (3/8/19).
I started off with a little hacking cough 2 days after my vaccine. It got to be extreme fatigue where I couldn't get out of bed. I was running fever. I went to the ER my oxygen level was low, but my blood pressure was high. They tested me for covid and told me that I have covid. I couldn't eat. I couldn't lift my head out of bed. I tried to drink things but couldn't. I basically laid in bed for almost 10 days. When my oxygen would dip, I would do deep breathing exercises. I kept having fevers throughout the covid. When the coughing and fever stopped, I started getting real bad fatigue. I would try to move, and my heart would start racing. I still have extreme fatigue and my heart races still. I would also get headaches. When I went back to see them on the 28th of May, I had to do an echo cardiogram. They are still trying to figure out what to do. I am so fatigued that I can't do normal day to day activities like cooking and cleaning.
FEELING FLUSHED, MILD FACIAL FLUSHING Narrative:  0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84 P101 99% RA R 18 0837: 50MG BENADRYL GIVEN IM, 0841: C/O DRY MOUTH, FEELING SHAKY 0834: 124/83 P 102 99.4 100% RA 0850: C/O DRY MOUTH, COLD 0840: 118/77 P:  104 100% RA 100% RA.... 0855: 118/84 P101 100% RA T 99.0 0905: TRANSPORTED BY EMT
Shortness of breath, body pain all over, heart palpations, vomiting, fever, diarreaha, shivers, headache, fatigue. 48 hours starting approx 12 hours after receiving dose.
Warm to touch.; Red hot circle around injection site; Low a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever). At the time of the report, VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received their second dose and developed a low fever in the morning and a red hot circle around injection site which was warm to touch.   Concomitant medication also included Globoside to treat diabetes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Admitted to facility for bilateral pulmonary embolism after bronchitis for 3 weeks
The following his last Anthrax vaccination, he has developed a periodic "wheal" type lesion. the lesion first appeared approximately two months following his fifth Anthrax vaccination. He indicated that this lesion is approximately 0.5 cm in size. It begins with a tingling and then starts itching. the lesion has occurred approximately 4-5 times. And appears on both arms at the injection site only. The lesion last for up to three days. There is no drainage, his arm is not sore or tender when this occurs. He denies any other sxs that occur when the lesion is present. He states, "it looks like a big kite." He has not taken any medication for this. VAERS report complete. Typhoid vaccination was also administered that day.
patient's arm went numb; pain; nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "patient's arm went numb"; PAIN (non-serious), outcome "unknown"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage".  Additional information: Co administration of flu and pneumonia vaccine, patient's arm went numb. Respondent described pain and nerve damage. He further indicated that there was a settlement between him and vaccine manufacturer (it sounds like he said SERVA).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fainting. It was sudden onset, I felt fine for 24h after the injection (and had no side effects to the first dose), then felt very suddenly dizzy and lightheaded, then passed out for a few seconds. After I came to, I was able to quickly catch my breath and recover with no additional episodes. Beyond this, I had a mild fever but no other serious adverse effects.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with PEDVAXHIB (Lot # not provided). It was reported that the patient made a "high pitched sound" after PEDVAXHIB was given. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient sought medical attention. Additional information has been requested.