chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt here for flu shot am clinic 12/04/06. Reported cough in chest lots  of questions had not gotten flu vaccine in a long time. Prior to vaccine lots of counseling PC from Rt 12/06/06 5:20 pt states 5pm 12/04/06 vomiting several times, chills, weak, stomach upset bloating, diarrhea, chills, headache, muscle aches, miserable, drinking only water. No anti inflammation, referred to medical provider if conditions worsens, fluids tums, anti inflammatory hard hygiene till I talk with her tomorrow, her relative to call if help needed. Tired 12/07/06 3pm better headache tired but tolerated soup, fluids today.
I had a fever, headaches, chills, fatigue, no appetite, and weakness. I also experienced nerve damage that lasted for two weeks. Tingling and numbness of arms and legs, ringing of the ears and trouble swallowing. I was put on vitamin D.
Patient received expired dose of fluarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number GF2DK, 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.   On 24th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 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 are as follows: Medical assistant reported that a patient received an expired dose of Fluarix, which led to expired vaccine used. The reporter did not consented to follow-up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same repoter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
47 days since first dose; Chest pain; Felt like a stabbing pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (47 days since first dose), CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain). On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (47 days since first dose). On 06-Feb-2021, CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain) had resolved. On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (47 days since first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not provided by the reporter. No Treatment medications were provided by reporter.
Headache since injection; Smelling a feet odor that is not there; some loss of taste and smell; some loss of taste and smell; overall unwell feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache since injection"; PAROSMIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Smelling a feet odor that is not there"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "some loss of taste and smell"; MALAISE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "overall unwell feeling". Therapeutic measures were not taken as a result of headache, parosmia, ageusia, anosmia, malaise. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and didn't receive any other medications in two weeks. Known allergies: No, other medical history: None. The vaccine was administrated in Pharmacy/drug store. Since the vaccination, the patient has not been tested for COVID-19. The events didn't result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Bad headache and fatigue began within 2 hours of injection and lasted for about 36 hours; low fever began approx 5-6 hours after injection and lasted about 6-8 hours; arm pain to the point of difficulty lifting or moving arm began approx 9 hours after injection (injection site never hurt) and lasted approx 10 hours
Large red, swollen, painful injection site reaction with accompanying fever that presented on 9/21/18 at approximately 5:30 pm. She received Clindamycin 300mg capsules to be taken three times daily for 10 days on 9/22/18 from Urgent Care.
Arm of injection is red and hot. Erythema has spread down patient's arm over the past few days.
Patient diagnosed with COVID on 8/5/2021 with a COPD exacerbation. Hospitalist feels the symptoms are more associated with COPD exacerbation and COVID is an incidental finding.  Of note patient did have a confirmed COVID case in November of 0220.
A spontaneous report was received on 18JUN2015 from a medical assistant who stated that an unspecified dose of improperly stored VAQTA 25/0.5 (lot # L09445 expiration 01JUN2017), was administere4d on 18JUN2015 to an unspecified patient. No adverse effects reported. No further information provided. Additional information has been requested.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she was diagnosed COVID positive after first COVID vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Immediately after shot trouble breathing, dizzy.  3 hours later severe headache, fatigue, fever, continued trouble breathing, pain in chest.  Over next few days pain in chest increased, shortness of breath continued, severe fatigue, tingling sensation in extremities.  These symptoms have not gone away since shot.  Prior to COVID vaccine I worked out a lot. I now no longer feel well enough to do so.  My health went from excellent to poor after getting these vaccines.
Vaccine was administered in left arm very near shoulder joint. Minor ache progressed to major discomfort over first 72 hours. Soreness, stiffness and muscle pain extended throughout entire arm into neck, shoulder and upper back. Could not raise arms over head for three weeks. Pain relieved somewhat with Tylenol, but did not begin to lessen until three weeks after vaccine was administered.
BUD date of 01/15/2022; Dose 1 of J&J and Dose 2 Moderna vaccine; Dose 2 given as 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01010H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: janssen. Past adverse reactions to the above products included No adverse event with janssen.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No known drug allergies were reported. No concomitant medications were reported. No treatment medications were reported. Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. Patient notified of error and that a repeat vaccine is not required. Patient denies any adverse effects.
Presented with SOB, hypoxia x 5 days; + covid 3 days PTA; admit to medical with Covid PNA; tx with steroids, remdesivir, zinc, barictinib, singulair, initially on 6 LPM O2, progressed to AirVo; tx to ICU 9/23; intubated 9/27; DNR on 9/28; withdraw of care later on 9/28; spo2 high 80's on 100% FIO2, proned, paralyzed, low Vt (500).  Given very poor prognosis by Pulm.
Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chills, no big deal. Then began to get headache with slight fever and the headache got progressively worse, with nausea and rapid heart rate. The headache was so bad I could not sleep at all - the worst headache I have ever had. I took one extra-strength Tylenol at about 10 or 11 am the next day, March 12, which took the edge off the headache. The headache diminished till it was gone by about 8 or 9 pm. The rapid heart rate, along with tiredness, low energy, and feeling jittery continued for several days, then stopped. About 3 or 4 weeks later...there's more BUT FORM WON'T LET ME GO TO CONTINUATION PAGE
PATIENT HAD REDNESS AND SWELLING IN HER ARM; IT WORRIED HER AS SHE HAS NEVER HAD A REACTION TO THE VACCINE BEFORE. SHE DESCRIBED IT AS A RED SWOLLEN 4 INCH BAND ALL AROUND HER ARM.
After travel through several airports/airplanes on 10/22/22, I began getting cold symptoms on 10/25/22, sore throat, slight headache, head congestion.  I had some chills (possible fever that I did not guage) and began coughing over the next couple of days. Thinking it was just a cold, I waited until Friday 10/28 to go to the urgent care center. I was diagnosed with sinusitus and COVID. I was prescribed molnupiravir, amoxicillin, and fluticasone.  I seem to be improving and plan to quarantine at least through 11/5/22.
Bell's Palsy Trigeminal nerve pain in jaw Swollen glands and lymph nodes in neck, throat, right breast, under arm
body aches; shortness of breath; general weakness; chills; hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 18:00 (Lot number: ff2589) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "body aches"; DYSPNOEA (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "shortness of breath"; ASTHENIA (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "general weakness"; CHILLS (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "chills"; HOT FLUSH (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "hot flashes". Therapeutic measures were not taken as a result of pain, dyspnoea, asthenia, chills, hot flush.  Additional information:  Patient had no known allergies. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
feeling poorly; severe cardiac incident; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (hospitalization) with onset 26Oct2023, outcome "recovering", described as "feeling poorly"; CARDIAC DISORDER (hospitalization) with onset 26Oct2023, outcome "recovering", described as "severe cardiac incident". The patient was hospitalized for feeling abnormal, cardiac disorder (start date: 26Oct2023). Therapeutic measures were taken as a result of cardiac disorder. Clinical course: Pharmacist was notified by family member that patient withheld who had received a Covid vaccine at PRIVACY a day before started feeling poorly same afternoon that night admitted to hospital with "severe cardiac incident.describing defibrillator was necessary " patient is still in ICU but stable. It was unknown if patient got other vaccine in four weeks. It was unknown if patient got COVID prior vaccination. It was unknown if patient COVID tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
On 11-5-2008 (mom reports) red, itchy, tender with swelling. Applied topical BENADRYL. Came to our office Friday 11-7-2008, no edema still red and tender, itchy. Area was 1 1/2 cm x 1 1/2 cm.
Had onset of feverish feeling, chills and nausea on 26 Sept 09. Persistent nausea for about 10 days to 2 weeks. Then developed leg swelling. Nephrotic syndrome diagnosed on 8 Oct 2009 (2 weeks after receipt of vaccine). Kidney biopsy class 4 lupus nephritis. 12/3/09 Medical records received for date 9/28/09 to 11/12/09. DX: common cold. Pt. c/o fever, chills, HA, vomiting and biting mouth x2days. OV 10/8/09 DX: nephrotic syndrome. Pt c/o bilat leg swelling. 10/27/09 DX: bilat pleural effusion, SLE, nephritis due to SLE. 11/9 OV f/u recent dx. C/o (+)limb swelling. Assessment: limb swelling, (+)facial rash butterfly, decrease breath sounds.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 13:15 as dose 5 (booster), single (Lot number: BJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "M.E./C.F.S" (unspecified if ongoing), notes: M.E./C.F.S; "M.E./C.F.S" (unspecified if ongoing), notes: M.E./C.F.S; "Diverticulosis" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: IBS; "Cancer IDC and radiation induced sarcoma" (unspecified if ongoing), notes: Cancer IDC and radiation induced sarcoma; "Osteoarthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Blepharitis" (unspecified if ongoing); "Lymphodema" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medications within 2 weeks of starting COVID-19 treatment. The patient received paxlovid for COVID-19 treatment (lot number GE1627) from 03Dec2022 till 07Dec2022. The paxlovid seemed to help until day 3 at which time she felt it was doing nothing.  No follow-up attempts are possible. No further information is expected.
Patient woke up in middle of night and felt pain in back.  Woke up again with same pain on right side (sacral illiac pain). Excruciating pain on scale of 1-10, is a 10.  Severe pain, patient could not get up and once up, could not walk due to pain. Patient took  aleve and Tylenol during day to help with pain..  Started to subside in mid afternoon on  10/29.  By 9pm, pain was better and was gone of morning of 10/30.  Patient reported that he had had this type of pain several years earlier, but none since that time until he received the booster.
No adverse event; Total of 47 patients that received the vaccines after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Total of 47 patients that received the vaccines after the use-by 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2023, 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 29-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Total of 47 patients that received the vaccines after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Total of 47 patients that received the vaccines after the use-by 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 (Total of 47 patients that received the vaccines after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 29 Jun 2023, 1 dose was administered at administration site 1. No treatment medication reported.   This case was for the 14th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccination details were added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Highest temp 102.9 on Sunday, Jan 3; January 4 Monday - I started getting body aches; abdominal pain; headaches; wet mucus cough; fatigue; fever; January 5 2 tests for COVID  - both came back positive; dr visit video - Urgent Care - instructed me to take Tylenol;  Cough resolved finally around the 11th.  Returned to work on the 13th.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.99   Concomitant products were not provided. On 15 Apr 2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06 Apr 2021, vial was moved to clinic on 15 Apr 2021. 18 vials were sent to clinic. Vaccine BUD date was 09 May 2021.  On 15 Apr 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.