chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced pain and swelling at the injection site. I had difficulty raising my arm, and the pain and swelling spread to my entire arm and shoulder area. I also had a migraine level headache, dizziness almost to the point of vertigo, nausea, and suppressed appetite. I was unable to do my normal activities and had to miss work for the entire weekend. I am still experiencing lightheadedness and dizziness.
Pain, redness, and swelling at the injection site Tiredness Headache Shivering Upset stomach  Symptoms lasted for 3 days and dissipated over time
Myalgia, NauseaVomiting, Tachycardia,   MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS,  SHORTNESS OF BREATH, MILD SCRATCHY/TIGHTENING OF THE  THROAD, MILD SWELLING OF THE TONGUE, MODERATE FACIAL PAIN  ALONG CHEEKBONES/JAWLINE/UPPER JAW, INJECTION SITE PAIN,  SWOLLEN GLANDS   Narrative:    Other Relevant History:
kidney was removed on the left side;  Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Elderly (65+ Years) Current age: 68 Gender: Male Patient occupation: None of the above Dose received: More than 3  Most recent dose details Product=COVID 19,  Brand=Pfizer, Brand unknown=False, Lot unknown reason=Not available/provided to reporter at the time of report completion Lot unknown=True, Administration date=12Apr2022, Administration time=10:00AM Dose number=4, Vaccine location=Right arm  Previous dose details: Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion Prev dose administration date=12Apr2022, Prev dose administration time=10:00AM, Prev dose dose number=4, Prev dose vaccine location=Right arm  Facility type vaccine: Pharmacy or Drug Store If other vaccine in fourweeks: No Other medications in twoweeks: None Adverse Event:  I had an appointment on August 25, 2022 at 10:40 AM with Dr. to do an update on my right kidney into look where the kidney was removed on the left side  Adverse event start date: 25Aug2022 Adverse event start time: 10:45 AM AE resulted in: [Doctor or other healthcare professional office/clinic visit] If patient recovered: Recovered If treatment AE: Yes AE treatment: To check right kidney If covid prior vaccination: No If covid tested post vaccination: Yes  Covid test post vaccination: Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Had two tests done wrapped it in the other one, Covid test date=19Aug2022, Covid test result=Negative Known allergies: None Other medical history: None  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER: 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER: 2, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE NUMBER: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: NEPHRECTOMY (medically significant), outcome "recovered", described as "kidney was removed on the left side". The event "kidney was removed on the left side" required physician office visit. The patient underwent the following laboratory tests and procedures: Severe acute respiratory syndrome: (19Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nephrectomy. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient contacted the pharmacy the next day complaining of fever and vomiting starting around 11 the night that she received the vaccines. She stated that here vomiting had subsided, but she was directed to contact her primary care provider to seek treatment for this.
Severe swelling of left arm, all the way down slightly below the elbow and redness wrapped almost completely around to the front on my arm on both sides.  Extremely hot to the touch,   Extreme chills  approximately 12 hours after getting the shot for roughly 12 hours. Slight headache and aches in my joints, knees , ankles, fingers, etc.   this was during the second day and subsided by the evening.  Swelling, redness, and hot to the touch lasted numerous days and got worse for two days but subsided significantly after taking Benadryl but redness and slight heat remained for approximately 5 days.
Headache, Myalgia, CHILLS; FATIGUE; NASAL CONGESTION Narrative:
accidentally received an adult dose of Engerix-B instead of a pediatric dose; accidentally received an adult dose of Engerix-B instead of a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 18-year-old female patient who received HBV (Engerix B pediatric) (batch number XS27B) for prophylaxis.   On 28-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 28-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: accidentally received an adult dose of Engerix-B instead of a pediatric dose) and adult use of a child product (Verbatim: accidentally received an adult dose of Engerix-B instead of a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jun-2023 The nurse wished to know how to proceed. Information about vaccines, event and patients were collected. The vaccine administration facility was the same as primary reporter. The call escalated to second line. The reporter consented to follow-up. A patient accidentally received an adult dose of Engerix-B instead of a pediatric dose, which led to underdose and adult use of a child product.
terrible headache; body fatigue which kept me awake all night; kept me awake all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 14:30 (Lot number: EN6200) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "terrible headache"; FATIGUE (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "body fatigue which kept me awake all night"; POOR QUALITY SLEEP (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "kept me awake all night". The events "terrible headache", "body fatigue which kept me awake all night" and "kept me awake all night" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, fatigue, poor quality sleep. Additional information: However, it was also reported that the patient experienced the events five hours after the vaccination (probably discrepant). Treatment with Ibuprofen was taken as a result of the events. It was reported that the headaches were still there, and the patient was still feeling tired every day. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Reddened,  tender, warm, raised abscess to injection site approx 4in diameter
Arm is not quite twice the size of his other arm but it is very inflamed; very red; Arm is not quite twice the size of his other arm but it is very inflamed; very red; Back of upper arm is red; This is a spontaneous report from a contactable Nurse who reported for a male patient (Brother-in-Law). A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , intramuscular on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.On an unspecified date the patient reported "his arm was not quite twice the size of his other arm but it was very inflamed" and it was very red and back of upper arm was red. Events were non serious with outcome of unknown.  The nurse was wondering will he have to repeat that injection intra-muscularly for it to be effective. Information on the batch number has been requested.
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and Menveo at an unknown dose. On an unknown date, unknown after receiving Bexsero and Menveo, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero and Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that there was the patient that received both Menveo and Bexsero on the same day. The patient went to the emergency room and same to the physician's office twice with flu like symptoms, but these symptoms resolved and the patient was fine.
I woke up with a fever with about 100 and clogged sinus. Just had that for about 3 days.
14APR96 felt warm @ 1PM but okay;took bath 7PM & couldn't get self out of tub, became ashen in color w/blueness from nose to chin & hands & feet;began tremble, gasped for air & began retching as though trying to throw up;t103;rash;groggy
Mild pain in spleen, starting 24 hours after injection, lasting 8 hours.
No other adverse events or product quality complaints reported.; a temperature excursion on PEDVAX HIB, the product was administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.         On 30-APR-2021, a temperature excursion occurred on haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). On 14-MAY-2021, the patient was administered with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, strength, route and anatomical location were not reported, lot # T020615, expiration date 13-MAR-2023) for prophylaxis (product storage error). The vaccine administered experienced a temperature excursion of 47.51 degree Fahrenheit (F), with time frame 15 minutes. There was previous temperature excursion. A digital data logger was involved. No signs or symptoms were reported. No other adverse events or product quality complaints were reported.
Headache sx within an hour after injection.  Then few hours later, shaking chills, high fevers (102 plus), headache, fatigue, nausea This lasted up to 48 hours. FYI, had covid (mild sx) in January 2021. Wanted to get the vaccine to be protected for the variants.  Did have antibody testing and was positive before the vaccine.
either going into congestive heart failure or acute renal failure; either going into congestive heart failure or acute renal failure; Gained weight; difficulty breathing; significant swelling of feet and lower extremities; continuing large diureses; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek1283), via an unspecified route of administration in left arm on 06Jan2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, psoriatic arthritis, hereditary pressure point neuropathy, Sulfa allergy, latex allergy, and penicillin allergy. Concomitant medications included omeprazole (PRILOSEC); trazodone hydrochloride (TRAZODON) and ASA. The patient previously took NEURONTIN and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek2730), via an unspecified route of administration in right arm on an unspecified date in Dec2020 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient experienced either going into congestive heart failure or acute renal failure, gained weight, difficulty breathing, significant swelling of feet and lower extremities and continuing large diuresis on 19Jan2021. It was reported that starting 4 days after inoculation, patient was either going into congestive heart failure or acute renal failure. From symptoms it was probably congestive heart failure. Gained weight despite fluid restriction and Lasix, difficulty breathing and significant swelling of feet and lower extremities. Starting just before two weeks after onset of symptoms, patient experienced a continuing large diuresis and felt much better but have not returned to base line. Patient was treated with Lasix and fluid restriction. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved with sequel.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Imms of Hep A and HPV given at 830 AM. Patient waited 20 minutes and left to return to school . Called at 1015 AM that tongue was numb, (L) side hurt, was dizzy. Brought back to clinic - observed with VS q 15 mins x 1 1/2 hours. All symptoms except numb tongue resolved.
At 10:00 AM the morning following vaccine administration, the patient began experiencing chills and lethargy. By 11:00 AM, temperature was 103. By 2:00 PM temperature was 104 and he had a headache and stomachache.
24APR91 from mom stating pt lt arm was sore, tender swollen for the last 2 days, splints lt upper arm against body & doesn't move it, redness from inject site down the arm;
I went to bed at 8:30pm with a temperature and fatigue. I was awoken at around 11:30, convulsing, chest tense unable to move or breath. After around 30 seconds, I regained the ability to move and breath.  Stayed in bed for several minutes, still convulsing. I eventually went up two flights of stairs, stumbling, unable to keep my balance. I went back to bed after a minute with the help of a family member. Several minutes later, I crawled back upstairs on all fours because I couldn't stand properly on my own. For around an hour, my torso tremored uncontrollably in bursts lasting around 45 seconds. My eye rolling tic was worse than it had ever been before in bursts lasting around 45 seconds. After an hour, the tremors became significantly less intense, and then I developed a sharp migraine. I went to back to bed to with the help of a family member since I still could not retain my balance on my own. The next day I had a fever and fatigue, but none of my symptoms as severe as the night prior.   Ever since then, I will get short bursts of uncontrollable tremors lasting from between 3-10 seconds long several times throughout the week. I will get a sharp tingling feeling in one of my lower leg/foot that last for around 3 minutes once or twice a week.
This 16 year old girl developed a Lipschultz ulcer within 24 hours of Pfizer COVID vaccine #3.
Date and time adverse event started:  05/06/21 1:00pm lethargy started, 05/07/21 6am chest pain started Date and time of vaccination: (list both if they received both shots):   NA      Brand and lot of vaccine:   Moderna   Route and body location of the vaccination(s):  IM DELTOID Left arm Adverse events experienced and are they still occurring now:   Chest pain through the middle in between breast where the bone is, does not feel pain laying flat on back or right side, but if stands or lays on left side feels it, sharp pain. What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these):   Took indigestion tablets to see if it was heart burn and took baby aspirin, and drank water Recommended to see doctor, cause is likley GI.
Narrative:  Patient received first booster on 2/17/22 and reported to his team provider at his visit on 3/3/22 that he developed cold sores around his mouth and inside his nose after receiving this vaccine. No such reaction reported for his first or second dose in the series. Unsure if patient has ever experienced cold sores before. Patient reported self treating with ketoconazole cream he had at home. Cold sores resolved.
Info has been received from a health professional concerning a 9 year old female who on 3/20/97 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was reported that on 1/18/05, the pt experienced chickenpox breakthrough described as a generalized, moderate generalized chickenpox rash, during a middle school outbreak, with 200 tiny blisters on her scalp and body. It was noted that the pt was afebrile. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
After receiving vaccine client states she feels lightheaded.  Vital signs obtained. BP 130/73, pulse 75, O2 sat 98%. Client states she is feeling better.  Client discharged home.  Client advised to call if symptoms return or worsen.
Vaccination site pain; Arm Soreness; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; adalimumab (HUMIRA) via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg, single for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced vaccination site pain. On an unknown date, the patient experienced arm soreness after PFIZER Vaccine. On an unknown date, arm soreness after PFIZER Vaccine and resolved. The outcome of events was recovered. The reporter's causality for the events of vaccination site pain and arm soreness with Humira (Adalimumab) was no reasonable possibility, with COVID-19 VACCINE was not reported.  Information on the lot/batch number has been requested.
1:15 pm Seasonal flu vaccine recipient rec'd vaccine. 1:20pm C/o itching and redness at site (right deltoid) and upper back area. 1:20pm BENADRYL 50 mg IM given per MD order. 1:40 pm itching and redness subsided.
Shingrix late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose between 12 or 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was pharmacist student. The reporter was looking for recommendation on timing for Shingrix late second dose.  No further details on this case were available during the call. The reporter personal information on Medical Information database was declined. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Big node on the injection site; I don't feel very well; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE NODULE (Big node on the injection site), MALAISE (I don't feel very well), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   Reporter did not allow further contact
One day after pneumovax given patient presented with fever fatigue and myalgia. The injection site was warm, indurated and erythematous. 4 days later improving