chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 54 year old male pt was treated with OncoTICE for bladder cancer recurrence. On 13Jul04 he received his first installation of OncoTICE. On the  morning of 14Jul04, the pt ate a small bowl of hot cereal and shortly after he experienced a headache and an upset stomach with heartburn.
incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th March 2021).   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: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-May-2023 The case was received from the patient via interactive digital media. The patient asked that he or she would have to start over on the two shot's or just need to get the second shot. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive the second shot of Shingrix, which led to incomplete course of  vaccination.
Child received vaccine on 3/21/17-Developed whole body rash 4d later.
Fever x 24 hrs on 11/19/01 with 15 pox widely scattered on body (back, abdomen, legs.
Heart palpitations that are currently active, 12 days and counting, and shortness of breath for 3 days.
Severe pain and locking up of shoulder where injection occurred.  Went to Urgent Care on morning of 10/22/2016 when pain during previous night was not responding to 400 MG of Ibuprofen at three hour intervals and range of shoulder joint motion completely restricted.  Began Treatment at noon on 10/22/2016:  800 MG Ibuprofen 3 times daily as needed; Butalbital-APAP-Caffeine 50-300-MG 2-3 times daily as needed. Symptom relief while using medicine.  Concern about continuing high doses.  Leaving on an international trip on 10/25/2016.
THERE IS NO ADVERSE EVENT BUT IT WAS ADMINISTRATION ERROR. THE PATIENT WAS GIVEN 0.5 ML OF COVID19 PFIZER VACCINE BOOSTER INSTEAD OF 0.5 ML OF COVID19 JANSSEN VACCINE BOOSTER AFTER THE INITIAL FIRST COVID19 JANSSEN VACCINE GIVEN ON 03/07/2021. THERE WERE NO REPORTED ADVERSE EVENTS  BASED ON FOLLOWING UP WITH THE PATIENT'S HUSBAND.
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended re-vaccination. Parent of child notified of situation on 12/8/22, declined re-vaccination at that time. Parent stated child did not feel well after vaccination and ran a fever.
Case number PHEH2016US026442, is an initial spontaneous report received from a pharmacist on 10 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620301) at a dose of 0.5 ml intramuscularly on 09 Oct 2016. The pharmacist stated that, 2 patients received FLUVIRIN multi dose vial (MDV) that had experienced a temperature excursion up to 16 C for up to 12 to 20 hours No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
Pt had a 5 cm swollen induration on right deltoid where vaccine was given. She described pain 6/10 on pain scale, itchiness, and the site was hot to the touch.
Roughly 20 to 30 minutes after the patient received the vaccine, the patient experienced nausea and vomiting. No other symptoms were reported.
9/22 rash, warmth and pain at injection site, lasting 3 days. 9/23 beginning of malaise, myalgia (not localized), lasting 10+ days. 9/23 loss of appetite, lasting 10 days. 9/25 abdominal cramping and frequent bowel movement without diarrhea, lasting 3 days. 9/27 onset of fever and chills, lasting 2 days. Max temperature 100 degrees. Slight feverish episodes for an additional 2 days. 9/29 onset of nighttime inflammation of joints of hands, wrists and feet lasting 4+ days. Inability to completely close fingers into a fist upon awakening, with improvement as the patient worked her hands. Steroids prescribed. 9/29 onset of mild to moderate morning headaches, lasting 4+ days.
At the time of vaccination I did not have side effects until 6 weeks later I noticed I had trouble breathing I noticed I was more tired and would easily get tired and sleepy. I usually had high energy and constantly doing things and its unlikely for me to fall asleep in the day but now I fall asleep as soon as I sit.  I now take 3 naps a day.
On 4/11/01, about 6 hours later, around 03:00, the child awakens crying, throws up, has a high fever of 101F(R). She also has a 3" lump that is bright red and hot at the injection site. The child ran a fever and was sick for 4 days despite around the clock Tylenol and ibuprofen.
Within 14 minutes of 03/06/2021 before I left I became dizzy and light headed. After that another symptom was for 2 weeks i had my right Achilles tendon would hurt when I would bend it significantly. It stopped just prior to the second dose. I developed a lethargy. The light headiness continued for the two week.  It would come and go. The second dose I had felt pressure in my head almost immediately. I had fevers up to 101 degrees for multiple days but not consecutively. I had discomfort/inflammation in my left arm first and then a couple of days later I had it in my right armpit. It evolved into a constant fatigue.  I also had muscle aches. I could function but had to force myself to do anything. I also had "brain fog" I had a dry cough as well. I then developed heart "loud beating" not a palpitation. I had shortness of breath. Occasional head aches as well but not significant.
Slight nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Slight nose bleed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Syndrome Guillain-Barre in 1986 and COVID-19 in 2020. Concomitant products included SIMVASTATIN, LISINOPRIL and HYDROCHLOROTHIAZIDE for Product used for unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 21-Apr-2021, the patient experienced EPISTAXIS (Slight nose bleed). At the time of the report, EPISTAXIS (Slight nose bleed) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 (other-other): NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment. treatment medications were not reported    Reporter did not allow further contact
MA failed to see documentation on new hire chart that gave dates of the Tdap (5/20/08) and Hep B #2 vaccinations (6/23/08).  The MA gave the new hire a Tdap and a Twinrix on 7/14/08.  The new hire complained of pain to the Tdap site - (I'm still having pain to my arm.") There was minimal swelling and no redness noted, however, the new hire is a person of color, so there may have been slight redness that I was unable to discern.
Cried for 3 hours last evening (02/15/00), 9:00PM-12:00AM. Unstable gait today - resolved by afternoon, no fever.
Redness at cite, cellulitis present. Treated with Augmentin for 10 days. Symptomatic treatment. Is to return if symptoms worsen.
swelling is increasing; injection site is hot to touch; redness; hard lump to injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling is increasing), VACCINATION SITE NODULE (hard lump to injection site), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE NODULE (hard lump to injection site). On 22-Mar-2021, the patient experienced SWELLING (swelling is increasing), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, SWELLING (swelling is increasing), VACCINATION SITE NODULE (hard lump to injection site), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
swelling; discomfort; breaking out of her skin; breaking out of her skin/skin break out from her shoulder to her hips; lymph node under her arm swelled like there is a large orange on her armpit.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ISOPROPANOL, TANNIC ACID (IVY DRY) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.) outcome was unknown.            No Concomitant Medication was provided.   This case was linked to MOD-2021-068579 (Patient Link).
Itching at the site of the vaccine injection; tingling/itching sensation on lips; tingling/itching sensation on lips; Tightness in chest; difficulty breathing; All over body soreness pain in legs and feet; Sore and itchy throat; dry mouth; Runny nose; sneezing; headache; Very tired and sore slept for 16+ hours; Sore and itchy throat; All over body soreness pain in legs and feet; All over body soreness pain in legs and feet; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 19-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FW0162), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 AM (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included asthma (had to administer Pro-Air Asthma medication multiple times) from an unknown date and unknown if ongoing. Patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 14Apr2021 at 13:30 (01:30 PM), the patient experienced itching at the site of the vaccine injection, tingling/itching sensation on lips, tightness in chest, difficulty breathing, all over body soreness pain in legs and feet, sore and itchy throat, dry mouth, runny nose, sneezing, headache, very tired and sore slept for 16+ hours. Adverse event: Itching at the site of the vaccine injection and tingling/itching sensation on lips. Tightness in chest and difficulty breathing. Had to administer Pro-Air Asthma medication multiple times. All over body soreness pain in legs and feet. Sore and itchy throat, very dry mouth. Runny nose, sneezing, may have caused headache. Very tired and sore slept for 16+ hours. The patient received treatment for the events tightness in chest, difficulty breathing. Outcome of the events was recovering.  Follow-Up (PRD/SRD 18Aug2021): Follow-up attempts are completed. No further information is expected.
Patient had seizure with eye deviation; taken to hospital ED. Treated with Ativan. Had respiratory depression requiring intubation and ICU stay. She also required Presiois for hypotension. Evaluated for septic shock in ICU also.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
paresthesia of the left arm, tachycardia, fatigue and confusion. Patient was discharged from urgent care/ER day of. Advised to rest and call pharmacy with any questions or concerns.  Patient states she has recovered, just feeling tired after discharge which is a normal side effect of receiving the vaccine.
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 14-AUG-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # N022583, expiry date: 20-JUN-2020) (dose, frequency and route were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint was involved.
MMRV and Varicella were administered on the same day and were given IM instead of SQ.  Parent was asked to bring the child back to the clinic for a follow-up visit as a precautionary measure.  Parent was called by NP after follow-up appointment was missed.  Parent stated that child "felt warm" the first night after immunizations, but was fine the next day.  Parent reported that child is eating normally and playing today and has no other symptoms.
Redness, swelling-hard and warm to touch . Left upper thigh 8"x5" (redness). Seen at hospital. DX: cellulitis. RX: BACTRIM.
This case was reported by a consumer via call center representative and described the occurrence of got the flu in a unk patient who received Influenza vaccine. Concurrent medical conditions included ill-defined disorder (unknown). Concomitant products included medication unknown (Unknown). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced got the flu and possible vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the got the flu and possible vaccination failure were unknown. It was unknown if the reporter considered the got the flu and possible vaccination failure to be related to Influenza vaccine. Additional details: Patient's initials, date of birth, sex were unknown. Date of onset of adverse event was unknown. The field representative stated at the soccer game someone mentioned, to another person their relative got the flu, after having a flu shot. The field representative was near the two people having this conversation. Reporter's phone number was unknown. This was 1 of the 2 reports received from the same report source.
just had a little arm pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable 80-years-old male consumer (patient) reported for self that patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just had a little arm pain (pain in extremity). The patient underwent lab tests and procedures which included antibody test: less than 50 on 4 antibody tests that both showed less than 50. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 05-NOV-2013, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Severe inflammation in legs. Seen in ER D-dimer high. No evidence of clot in leg which was where the main complaint of pain and swelling. Pain in both legs but right greater than left. Elevated blood pressure 153/61. Headache. Nausea with vomiting. Dizziness. Fatigue. Global joint pain > 24 hours after injection. Chest pain dominant left side.
Fever, fatigue, myalgia (for 24 hours)  Frequent premature ventricular contractions  (3-4 per minute) (peaked after 12-16 hours then subsided. Some residual still present but not as frequent) Headache (peaked around 12-16 hours) (still present with sneezing coughing or during chaining in head position (standing up or laying down)
No adverse event; patient received the 1st dose of the primary series on 29Nov2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on 15Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the 1st dose of the primary series on 29Nov2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on 15Dec2022) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose of the primary series and lot number: 939903) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient received the 1st dose of the primary series on 29Nov2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on 15Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received the 1st dose of the primary series on 29Nov2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on 15Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received the 1st dose of the primary series on 29Nov2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on 15Dec2022).    Concomitant medications details were not reported by the reporter. Patient received the 1st dose of the primary series on 29-Nov-2021 and accidentally she received one dose of Moderna COVID-19 Vaccine Bivalent booster instead of the 2nd dose of the primary series on  15-Dec-2022. Treatment details was not reported by the reporter.
sneezing, hoarseness, feels sluggish, no appetite and fatigued. Narrative:  Per nursing report: "took 2nd dose of Moderna on 3-11-21. States started sneezing last night [3/14] with hoarseness and states today [3/15] feels sluggish, no appetite and fatigued."  Other Relevant History:
Extreme headache, joint and muscle ache, swelling of left upper arm and  rash, nausea, chills, dizziness
This is a spontaneous report from a contactable consumer. A 71-years-old female patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 12:15 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension, gastroesophageal reflux disease, multiple allergies, arthritis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); omeprazole (OMEPRAZOLE). The patient experienced weakness in my right arm on 31Jan2021 with outcome of not recovered.