chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Patient has pain in his chest), GASTROINTESTINAL DISORDER (GI Issues), ABDOMINAL PAIN UPPER (A lot of stomach pain/has a lot of ongoing stomach pain), DECREASED APPETITE (Loss of appetite) and ILLNESS (The patient felt sick his first night after the shot) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Was Hospitalized in Jan 2022 for COVID-19 Infection) in January 2022. Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL, INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (LISPRO INSULIN) for an unknown indication. On 10-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced ILLNESS (The patient felt sick his first night after the shot) and PYREXIA (Fever the night of the shot). On an unknown date, the patient experienced CHEST PAIN (Patient has pain in his chest), GASTROINTESTINAL DISORDER (GI Issues), ABDOMINAL PAIN UPPER (A lot of stomach pain/has a lot of ongoing stomach pain), DECREASED APPETITE (Loss of appetite), IMPAIRED WORK ABILITY (The ongoing stomach ache is so bad that he cannot work) and PRODUCT ADMINISTRATION INTERRUPTED (Patient had so many side effects to the Moderna Covid-19 vaccine that he did not get his second dose in the Primary Series.). At the time of the report, CHEST PAIN (Patient has pain in his chest), GASTROINTESTINAL DISORDER (GI Issues), DECREASED APPETITE (Loss of appetite), ILLNESS (The patient felt sick his first night after the shot), PYREXIA (Fever the night of the shot) and PRODUCT ADMINISTRATION INTERRUPTED (Patient had so many side effects to the Moderna Covid-19 vaccine that he did not get his second dose in the Primary Series.) outcome was unknown and ABDOMINAL PAIN UPPER (A lot of stomach pain/has a lot of ongoing stomach pain) and IMPAIRED WORK ABILITY (The ongoing stomach ache is so bad that he cannot work) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: (Negative) Several Physicians test after test, all come back Negative. On an unknown date, SARS-CoV-2 test: (Positive) got infected with Covid-19 in late January 2022. mRNA-1273 (Spikevax) (Unknown) dosing was delayed on an unknown date. The patient got infected with Covid-19 in late January. It was reported that the patient saw their Physician about these side effects. The patient does not report a history of Pericarditis/Myocarditis and had not been diagnosed with Pericarditis or Myocarditis. The patient had so many side effects to the Moderna Covid-19 vaccine that they did not get the second dose in the Primary Series. Reportedly, the patient had seen several physicians test after test, and all come back negative. No treatment information was provided by the reporter. Reporter did not allow further contact.
MORNING AFTER 2ND DOSE AROUND 6AM  WAS LITTLE WEAK AND SLUGHISH AND AS THE DAY PROGRESSED AROUNF 830 AM I WAS IN EXTREME PAIN IN MUSCLES  AHES AND SHOOTING PAINS THROUGHOUT MY BODY AND FEELING VERY HEAVY TO THE POINT I COULD NO LONGER STAND UP. NO ENERGY AND SEVERE HEADACHE AND SORE ARM.
Five or six days after shot, itching then a red bulls eye appeared around the injection site 4" high and 2 1/2 inches wide around the injection site.  Warm to the touch and itchy.  Today is 10 days after injection and it's still there.
patient became flushed, felt like something sitting on her chest, respirations and blood pressure were elevated @ 180/138 @ time of evaluation. pt stated she could breath (was rapid and shallow) and could swallow. stated lips and mouth did not feel tingling or swollen. administered 25mg diphenhydramine po and called EMS.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 14-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sore injection site; Sore neck; sore pelvic lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, expiry date: unknown) via an unspecified route of administration in arm left on 28Feb2021 at 09:30 (age at vaccination: 65-years-old) as dose 2, single for covid-19 immunization. The patient medical history included penicillin allergy from unknown date. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested positive for COVID-19 since the vaccination. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiry date: unknown) via an unspecified route of administration in Arm Left on 7Feb2021 at 09:30 (age at vaccination: 65-years-old) as dose 1, single for covid-19 immunization. On 28Feb2021 at 10:00, the patient experienced sore injection site, sore neck (back of neck) and sore pelvic lymph nodes. Case was assessed as non-serious. Patient did not get any treatment for the adverse event. The outcome of events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
1. Patient given DTaP instead of Tdap 2. Patient had a vasovagal response immediately after injection
Breast red and with hives after 1st dose; Sore arm, tired and headache after 1st dose; Arm sore and with rash after 1st dose; Sore arm, tired and headache after 1st dose; Low grade fever after 1st dose; Sore arm, tired and headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Breast red and with hives after 1st dose), PAIN IN EXTREMITY (Sore arm, tired and headache after 1st dose), RASH (Arm sore and with rash after 1st dose), FATIGUE (Sore arm, tired and headache after 1st dose) and PYREXIA (Low grade fever after 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy and Breast cancer.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Breast red and with hives after 1st dose), PAIN IN EXTREMITY (Sore arm, tired and headache after 1st dose), RASH (Arm sore and with rash after 1st dose), FATIGUE (Sore arm, tired and headache after 1st dose), PYREXIA (Low grade fever after 1st dose) and HEADACHE (Sore arm, tired and headache after 1st dose). The patient was treated with Radiotherapy for Urticaria. At the time of the report, URTICARIA (Breast red and with hives after 1st dose) had resolved and PAIN IN EXTREMITY (Sore arm, tired and headache after 1st dose), RASH (Arm sore and with rash after 1st dose), FATIGUE (Sore arm, tired and headache after 1st dose), PYREXIA (Low grade fever after 1st dose) and HEADACHE (Sore arm, tired and headache after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were cream for hives.
Started vomiting & having diarrhea @ 130; turned white, lips turned purple, eyes did not roll back in head, took pt to clinic was seen immediately; MD state pulse ok; HR ok, no temp; DPH given;
Rheumatoid arthritis flare up; Flu; General body pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for Rheumatoid arthritis.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INFLUENZA (Flu) and PAIN (General body pain). On 11-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), INFLUENZA (Flu) and PAIN (General body pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information mentioned.  Patient took the first dose of vaccine on 10MAR2021. Experienced flu, rheumatoid arthritis flare up and general body pain. Recovered on 11MAR2021.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns a 68 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), on the same day of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had influenza and pain. The event resolved. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623561 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), on the same day of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had influenza and pain. The event resolved. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
DVT; This is a spontaneous report from a contactable physician (patient). This 60-year-old male patient received 2nd dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek4176) at single dose via an unknown route in left arm on 18Jan2021 for Covid-19 immunization. Medical history included factor 5 leiden and prior DVT. Patient did not have Covid prior vaccination. Patient had no known allergies. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) on 26Dec2020 for Covid-19 immunisation. On 08Mar2021, patient experienced DVT which resulted in doctor or other healthcare professional office/clinic visit. Treatment included blood thinner. Outcome of the event was unknown. Patient did not have Covid tested post vaccination.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely associated with the patient's underlying medical condition and was unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
He really wasn't feeling well; Nausea; Getting dizzy when turning from one side to the other in bed; Vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0182) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 17May2021, outcome "unknown", described as "Getting dizzy when turning from one side to the other in bed"; VOMITING (non-serious) with onset 17May2021, outcome "unknown", described as "Vomited"; MALAISE (non-serious), outcome "unknown", described as "He really wasn't feeling well"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information included: Caller reported that when he woke up on 17May2021, he was getting dizzy when he turned from one side to the other. Caller reported that he vomited twice the morning of 17May2021.Caller wants to know if these symptoms are common Caller is mostly concerned about the dizziness since he has a history of Vertigo. Caller states he will be going to the Emergency Room.  Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist and described the occurrence of bursa injury in a 31-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On the morning of 7 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) that was mistakenly administered into the bursa and in the top of the shoulder rather than intramuscularly.  On 7 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced bursa injury and intramuscular formulation administered by other route.  The subject required medical attention at the doctors office and was treated with a Medrol dose pack (Medrol Pak) and ibuprofen.  At the time of reporting the events were unresolved.  The pharmacist considered the events were possibly related to vaccination with Fluarix. Follow-up received on 25 January 2008 via the pharmacist. He reported that on 08 November 2007, the subject experienced a partial tear and inflammation of the rotator cuff tendon from the misplacement of the injection and secondary axillary lymphadenopathy. He also confirmed that on 08 November 2007, the subject experienced a bursa injury and intramuscular formulation administered by another route. He noted that the MRI indicated administration likely occurred into the infraspinatus tendon/bursa and local inflammation of tendon along with partial tear likely at injection site. The subject was treated with a MEDROL 4 mg dosepack and referred to physical therapy. He noted that the partial tear and inflammation of the rotation cuff tendon and bursa injury improved and he considered that these events were not related to the use of FLUARIX. He reported that the secondary axillary lymphadenopathy resolved on 07 January 2008 and he considered that it was possibly related on the use of FLUARIX. He considered that the events were not serious. The reporter indicated that the events could have been associated with the erroneous administration based on the result of the MRI.
The patient had internal bleeding on 06/06/21 requiring blood transfusion at Hospital. Blood thinner stopped.  She then had a R leg blood clot on 06/20/21 at Hospital.  The patient experienced R leg edema on 08/31/21 at hospital.
Patient had pain and loss of motion in left arm. This was so severe that the patient went to the ED and was admitted overnight for observation.
Moderna Shot #1 - Fever / Chills  Headache Soreness at injection site (left Shoulder)
Missed my period for March and April. This is now May and I am having 2 periods.
Information has been received from a 45 year old female medical assistant with no pertinent medical history who on 18-OCT-2007 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On that same day, the patient developed injection site redness, warmth and swelling. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. In November 2007, "about 1 month later" the patient recovered. There was no product quality complaint. Additional information has been requested. 03/26/2008 Follow-up information indicated that a 45 year old female certified medical assistant with a history of shingles who on 18-OCT-2007 at 16:00 was vaccinated IM with the first dose of ZOSTAVAX (Oka/Merck) (lot# 658209/1085U) in the right arm. On 18-Oct-2007 (also reported as 21-OCT-2007) the patient developed injection site redness, warmth and swelling lasting five weeks. The patient did not seek medical attention but was noted to have had a yearly physical. It was also noted that on approximately 21-OCT-2007 the patient broke out in shingles lasting 2 & 1/2 months. Additional follow-up information indicated that the 45 year old female certified medical assitant with several GI problems and a history of shingles, zollinger-ellison syndrome followed by an unspecified surgery who on 18-OCT-2007 was vaccinated with the first dose of ZOSTAVAX (lot# 658209/1085U). There was no illness at the time of vaccination. Concomitant drug therapy included TOPROL XL tablets and nonsteroidal anti-inflammatory drug (unspecified). On 18-OCT-2007 the patient experienced injection site redness that lasted 6 weeks (also reported as 5 weeks) and broke out in shingles 3 days after vaccination. Subsequently, the patient recovered. Additional information has been requested.
Headache, Myalgia, left arm pain, tired, achy  Narrative:
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient, who had not received any other vaccinations. On 26-Sep-2012 the patient received AFLURIA PFS (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was reported to be 3 inches below the AFLURIA injection site, described as being 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Syncope, acute atrial fibrillation with rhr, cardiac dilatation, acute renal deterioration.  The illness began with sudden syncope accompanied by severe scalp laceration.  Cardiac irregularity, AV block, blood pressure instability,  and atrial fibrillation lasted 6 weeks.  Renal insufficiency slowly resolved over 7 months.  Cardiac ablation was discussed.    On 1/24/22 the patient had a second opinion and on 2/4/22 began receiving  Ivermectin therapy.  The cardiac symptoms resolved promptly and the creatinine fell from 1.29 at start of therapy to 1.1 (former normal) within a month.
The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 15-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 15-Apr-2022) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 15-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 15-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 04-Apr-2022.  No concomitant medications were reported. The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022. No treatment medications were reported.
Staff member gave pt 0.3mL of undiluted covid vaccine. Should have been diluted with 1.1mL of 0.9% sodium chloride (multi dose vial with 3 doses).
Chest Pains, Brain Fog, hearing loss in right ear, frontal headaches, melena, fasiculations, absent reflexes, vertigo, positive Romberg Test, head thrust lag to the right, urine odor/hesitancy, facial rash. Symptoms have progressively worsened since onset.
20 minutes after the injection, I experienced numbness of the mouth. This mouth numbness occurred intermittently for three days. Four days after the injection, the numbness was persistent and had spread to my face and my extremities.
Client received AstraZeneca Covid vaccine with no reaction. Previous vaccine unavailable in the  Janssen given as an alternative on 9.15.21.
No adverse effect reported; an 8 year old male patient was inadvertently administered one dose of GARDASIL 9; This spontaneous report was received from a physician, referring to a 8 year old male patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions and allergies were not reported.  On 19-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (strength, dose number, anatomical injection site, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No adverse events were reported.
Sxs started within 1wk after vac.-eyes rolling & looking up to left side, blinking. Ped Eye Spec. said prob. habitual, fine. Just after Christmas deep sighs in sleep, struggling to breathe (stop breathing for few seconds) saw PCP sent to ENT (tonsil hypertrophy-T&A done). After surgery tics got worse & twitching noticed in sleep (upper body), child complaining "tickles on head & back-PCP sent to Neurologist-EEG Abn. MRI normal (told S&S of seizures) by Neurologist.
Miserable, Temp 100.5, spitting up, insomnia, injection sites on left leg are hard and warm to the touch.