chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 week male with a history of premature birth and hospitalisation in NICU for 1 month who on 25-JAN-2007 was vaccinated with a PO dose of ROTATEQ. Concomitant therapy included SYNAGIS on 25-JAN-2007 and 22-FEB-2007. Concomitant vaccination administered that day included an IM dose of PEDVAXHIB, (manufacturer unknown), an IM dose of PREVNAR and IM dose of PEDIARIX. On 04-Mar-2007 the patient developed vomiting and diarrhea and was admitted to the hospital due to his young age. He was diagnosed with gastroenteritis and recovered in three days, which was described by the physician as typical for viral gastroenteritis. The physician also noted the patient's gastroenteritis was not related to vaccination with Rotateq. the patient's viral gastroenteritis was considered to be an other important event. Additional information has been requested.
now has atrial fibrillation; patient was having a heart attack/an active heart attack; dripping sweat; couldn't breath; pressure on their chest/ elephant was sitting on their chest; arm soreness/ felt like my arm was broken; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack) and ATRIAL FIBRILLATION (now has atrial fibrillation) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concomitant products included TAMSULOSIN, TESTOSTERONE, SERTRALINE, LISINOPRIL, GLYCERYL TRINITRATE (NITROGLYCERIN), AMIODARONE, ISOSORBIDE MONONITRATE, CARVEDILOL, ROSUVASTATIN, RIVAROXABAN (XARELTO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.  On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness/ felt like my arm was broken). On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack) (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (dripping sweat), DYSPNOEA (couldn't breath) and CHEST DISCOMFORT (pressure on their chest/ elephant was sitting on their chest). On an unknown date, the patient experienced ATRIAL FIBRILLATION (now has atrial fibrillation) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack), ATRIAL FIBRILLATION (now has atrial fibrillation), HYPERHIDROSIS (dripping sweat), DYSPNOEA (couldn't breath), CHEST DISCOMFORT (pressure on their chest/ elephant was sitting on their chest) and PAIN IN EXTREMITY (arm soreness/ felt like my arm was broken) outcome was unknown.  Treatment medications were not reported. The reporter states that the patient after receiving the second dose experienced arm soreness. On 13 March 2021 patient started dripping sweat, said couldn't breathe, and felt pressure on the chest. The test confirms that patient was having a heart attack. On 15 March 2021 the patient went to different hospital and they ran test and confirming that the patient is having active heart attack. The patient went to the Cath lab and was at the hospital for 4 days. The patient now had atrial fibrillation and the patient never took anything on their own to help treat the symptoms experienced.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286915 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Memory loss, tingling in the fingertips, vaginal bleeding, loss of coordination, loss of mobility, loss of vision, loss in the cognitive system.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX (batch number ZY3X4, expiry date 25th April 2020) for prophylaxis. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced normal soreness. This case has been linked with case US2018GSK180113 (reported by the same reporter for the same patient with different dose).
Reaction from flu shot.  Deep muscle aches from shoulders down to elbows that are constant.  Bone pain down arms, shoulder bone and across back. Muscle weakness in arms when trying to lift objects that have any weight at all and very painful to lift arms above head.  This is the same reactions I had when I tried to take Fosamax and Boniva. Body does not tolerate bisphosphonates in these drugs. They discovered my intolerance to these medications because after the same reactions to both and then stopping the drugs, pain and aches went away slowly after about 3 weeks. Talked to pharmacist at local drug store and ask if he was aware if there was a possibility of bisphosphonates being in this years flu shot and he said not to his knowledge. Have taken flu shots for the past 15 years and have had no reactions! It has now been 4 weeks since my flu shot and I am still in pain!!!!!!
Headache Joint pain Back pain Eye pain Fever shaking chills Fatigue Tiredness After a week tiredness still present and moderate fatigue
Headache, body aches, nausea, fatigue 22hrs after first shot,  18 hours after second shot. Symptoms lasted about 12 hours for both
Burning pain, very extreme; Numbness in upper back, pectoral and under arm/ bad side effect; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced pain burning and numbness. On an unknown date, the outcome of the pain burning and numbness were unknown.   It was unknown if the reporter considered the pain burning and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The patient self-reported this case. The patient stated that he/she experienced extreme side effect after receiving Shingrix vaccine. The patient received dose of Shingrix vaccine and experienced burning pain and numbness in upper back, pectoral and under arm. The patient also stated that it had been 5 days since vaccination from the date of vaccination. The patient asked was there anything he/she should do for relief, the pain was extreme. Additional supportive information: The follow-up would not possible, as no contact, details were available.
received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter
Patient received first dose of Pfizer COVID-19 vaccine on 8/19. I do not know where he got the vaccine. The following day he was noted to have altered behavior and ultimately seizures. Additional testing discovered the presence of a venous sinus thrombosis. He also has thrombocytopenia though this is a chronic issue. The possibility of a vaccine induced immune thrombotic thrombocytopenia has been considered and thus we will need to file a VAERS report. I was told that this could be initiated through Agency.   There are atypical features that suggest that this might not be vaccine related (type of vaccination, age and gender patient, near immediate onset of symptoms, and alternative potential etiology for thrombosis (cirrhosis)). That being said, there is a temporal relationship between venous and thrombosis in COVID-19 vaccine, I think we do have to file a VAERS report.
received flu vaccine 10/22/08. Next day had eruption that spread to entire body, at first urticarial, then maculopapular, involving mouth and eyes, followed by extensive exfoliation, c/w stevens-johnson syndrome
AE: patient felt dizziness and  was lightheaded 1 minute after the dose administration.  Treatment: patient was offered water and rested for 30 minutes. water and rest helped resolve the symptoms. Outcome:  patient was discharged to POV/Home.
Pt noticed next day large localized rash, redness, swelling, induration and itching. Pt stated it was larger than a quarter size and by the time of appt it was the size of a quarter.
This spontaneous report as received from a health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date approximately in September 2014, reported as "the past week and a half", the patients were vaccinated with improperly stored PEDVAXHIB (route, dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 3-Aug-2022 Reporter's comment: The nurse reported that the patient (unknown patient) was administered an expired dose of Bexsero vaccine on the day of reporting. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Clinic does the vaccinations for all surrounding locations. Pt was from another location and arrived for an appointment. Pt was checked in and taken back for vaccine administration. Vaccine was given by an MA and age was not verified.
Patient states that after waiting for the 15 minutes of observation, within 30 to 40 minutes she had a seizure. Said it resolved and she did not seek medical attention but wanted to know if she should receive the second shot.
Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAY-2023, the patient received Havrix. On 08-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was 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: 8-May-2023 The reporter consented to follow-up via email. The patient received an expired dose of Havrix, which led to expired vaccine used.
Itching; Achy; Slight fever, 100 maybe; Hives from her wrist to her inner elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Achy), URTICARIA (Hives from her wrist to her inner elbow) and PYREXIA (Slight fever, 100 maybe) in a 56-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (Achy) and PYREXIA (Slight fever, 100 maybe). On an unknown date, the patient experienced PRURITUS (Itching) and URTICARIA (Hives from her wrist to her inner elbow). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 24 hour during the day and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) was resolving and PAIN (Achy), URTICARIA (Hives from her wrist to her inner elbow) and PYREXIA (Slight fever, 100 maybe) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Temp 102.3 degrees with blotchy red areas on upper chest & lower neck. Given 25mg BENADRYL po & 1 1/2 tsp TYLENOL.
14SEP pt recvd vax &  16SEP multiple episodes of rolling eyes back & whining for few seconds; otherwise alert & playful; 30SEP still episodes of eye rolling x 3 days; 10-1 abn EEG;
With in 5 minutes of administering H1N1 mist, pt had a nose bleed from rt nostril.  Stopped in 10 minutes after applying pressure to nose.
Muscle spasm, twitching, abdominal pain (lower right, sides), urethral pain, incontinence
Blood clot in his leg; really bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in his leg) in a 5-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second 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. On an unknown date, the patient experienced THROMBOSIS (Blood clot in his leg) (seriousness criterion medically significant) and VACCINATION COMPLICATION (really bad side effects). At the time of the report, THROMBOSIS (Blood clot in his leg) and VACCINATION COMPLICATION (really bad side effects) had resolved.            No relevant concomitant medication information provided.  Caller said that friend got really bad side effects from the Moderna vaccine. It was after the second shot. He was over 50. Within a very short time (days to a week), friend got a blood clot in his leg. He went to the hospital and doctors believed it was due to the Moderna vaccine. Doctors gave him blood thinners for three months and nowhe was doing fine. Caller did not want to provide any additional personal information. Caller said that friend probably got the first shot in February/March.  Treatment medication include blood thinners for blood clot provided.  Company Comment: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt went to ER 1NOV97 w/rash-swollen lt arm face swollen & red;med given;return to ER 2NOV97 w/inc rash & facial swelling;1day went into chest;had to use machine many months;was sick about 1wk;
severe sore throat; tested for COVID and was positive; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (severe sore throat) and COVID-19 (tested for COVID and was positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (severe sore throat) and COVID-19 (tested for COVID and was positive). At the time of the report, OROPHARYNGEAL PAIN (severe sore throat) and COVID-19 (tested for COVID and was positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided     This case was linked; Sender's Comments: Crosslink
First covid shot was moderna.  Patient called a short time after pfizer shot that she was having some intermittent SOB and had to use an inhaler. Also stated she had some itching without a rash. At a 24 hr follow up symptoms had become milder and not resolved. Patient also has hx of asthma.
Per MD note (1/3/22) Patient presents for URI symptoms for about 2 weeks off and on. She reports headache and cough. She has mild SOB. She hasn't used her rescue inhaler the past week. She uses 2L of oxygen at night. No O2 use during the day.  She has taken Tylenol, Advil and Mucinex with mild improvement.   - 1) COVID-19 (ICD-10: U07.1) Your COVID-19 test was POSITIVE.  Discussed OTC medications. Prednisone for bronchitis- discussed potential side effects.    Based on the CDC criteria (updated 12/28/21), you should self-isolate until you meet all of the following: -At least 5 days have passed from when symptoms first appeared. -You must be fever free for at least 24 hours (without using an anti-fever medication such as acetaminophen, ibuprofen, naproxen, or aspirin). -Your respiratory symptoms must have significantly improved.   You should continue mask use when around others indoors, especially within the first 10 days of symptoms.   You do not need retesting and it is expected to be positive for weeks after you are no longer considered to be contagious.   If you are having any life-threatening symptoms such as severe shortness of breath, passing out, swelling in your legs, confusion, skin turning blue, new chest pain, or any other severe symptoms, please call 911 or go to the ER.
Patient  woke up the next morning after injection and had hives on her injection site arm. Patient also had sore throat and aches, which subsided later that day. Rash continued and spread to other arms, back and trunk. Patient was taking allergy medication to alleviate symptoms. She will talk to doctor before next immunization.
The immunizations were administered in the afternoon of 2/24/04 and the parents noticed that the child developed hives on her extremities and torso on 2/25/04 at approximately 5pm. At that time she was extremely upset and screamed for quite some time and was found to have a fever, also.  (The time frame was not discussed in detail.) She was taken to urgent care and was treated with Benadryl.  Hives reappeared on 2/26/04 at 10 a.m.  She will subsequently be seen by an allergist.
fever, ache, epigastric discomfort, moderately severe h/a, generalized fatigue almost immediately p/vax 5FEB94; also red palms w/sandy gritty tactile sensation beneath skin;
Vaccine was administered after published expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
On 10/24/01, the pt received an IM injection of Engerix-B. It was not known if she had received previous injections of Engerix-B. On 10/26/01, the pt called the nurse because she noticed swelling at her neck near the collar bone. The nurse stated the pt's neck was "a little puffy".
Narrative:  Symptoms:  & altered speech, numbness in left upper extremity Treatment:
I had COVID- 19; I wasn't sick but had minor symptoms but I did have to go to urgent care do to the Irritable bowel syndrome with diarrhea once; she saw the doctor he mentioned she also got Costochondritis which is an inflammation of the chest wall