chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection..         Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data added; 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.
Pt received vaccine on 10/10/16 at approx 4pm. Pt reports waking up at 3:30am 10/11/16 with shortness of breath and difficulty breathing.
Second dose scheduled more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.    On 22-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 PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose). At the time of the report, PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose) outcome was unknown.            Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021.
Pt recvd MMR/HIB vax & 5 days following vax pt devel a fever & a patchy rash that progressed to erythema multiforme; rash eventually became pruritic; MD exam indicated pt was asymptomatic & had no neuro sx;
menopause for a little over a year/menstrual like bleeding; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 at the age of 59 years old (Lot Number: EW0181; Expiration Date: Aug2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included hyperlipidaemia and menopause from an unknown date. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for hyperlipidaemia from May2021 and ongoing. The patient had no other prior vaccination (Within four weeks). In Jul2021, the patient stated, "So, I am calling to report a potential side effects from the vaccine, So, I was vaccinated exactly one week ago on the 17Jul2021 and I am 59 years old and I have been out of menopause for a little over a year and today which is just one week after the vaccine actually started last night I had menstrual like bleeding, which is continue through today into this evening." The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
fever(101.6); Fatigue; Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
The vaccinator thought there was vaccine in the syringe when in fact there was nothing in the syringe being used. The Patient received less than 0.5cc of air. Patient came back to receive their actual dose of Moderna vaccine but then changed their mind and left without any notice.
No additional AE reported; reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine.; HCP administered the vaccines due to product confusion because " the vaccines sounded similar/The names of the VARIVAX and VAXELIS vaccines sounds similar; This spontaneous report was received from a physician and refers to a 4-month-old of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number reported and validated as: X000532, expiration date 04-JAN-2025; dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) as prophylaxis, instead of  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (which lot number and expiration date were not reported). The health care professional (HCP) stated that they administered the wrong vaccine (Wrong product administered) due to product confusion because "the names of the vaccines sounded similar" (Product name confusion).  No additional adverse event was reported.   This is one of two reports from  same reporter.; Sender's Comments:  US-009507513-2311USA000285:
Pretty bad headache, chills, fever, and body aches. Pretty badly fatigued and sore arm.
No additional adverse effects reported; Improperly stored dose of Pneumovax23 was administered to a patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 22-JUN-2020, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, route of administration, and anatomical location were not reported; lot number S029265, with an expiration date not reported but validated as 31-MAR-2021) for prophylaxis.   It was reported that the improperly stored vaccine experienced a temperature of 12.1 degrees Celsius for a time frame of 2 hours and 20 minutes. There was not previous temperature excursion and a data logger was involved. No additional adverse effects reported, nor product quality complaints involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
9/11/09-Red and sore at PNEUMOCOCCAL administration site - Also, fever 100.5F and sore throat - Primary care visit diagnosed with influenza like illness. 9/11/09 - Emergency room visit - treated for Cellulitis. 9/14/09- Primary care visit for cellulitis- at flu and PNEUMOCOCCAL sites.
was crying; pulling legs up to chest; seemed to be in pain; This spontaneous report was received from a medical assistant via a company representative and refers to a 2 months old female patient. There was no information about the patient's concomitant medications, pertinent medical history and drug reactions or allergies provided. On 11-MAR-2019, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027272, expiration date: 07-JUN-2020, orally for rotavirus prevention, a dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (route of administration, anatomical location, lot# and expiration date were not reported) and a dose of hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (route of administration, anatomical location, lot# and expiration date were not provided). On 11-MAR-2019, the patient was crying, pulling legs up to chest and seemed to be in pain. The patient sought medical attention by visiting an emergency room on 11-MAR-2019, however it was unknown if she received any treatment for the events. On the same day, the patient was sent home and the symptoms were resolved.  The causality assessment between the events and the suspect therapies was not provided.
Fluad vaccine was given to Patien on 8/21/2020. She is still complaining of pain in the arm. Hard time to move the arm. She is reporting it on 10/13/2020
Uticaria Hives over entire body.  Beginning 5/19/2021 and continuing to the present. At first, large painful and itchy welts. Benadryl did not help. Throat became very sore/difficult to swallow so went to the ER. Prescribed Prednisone steroid for 5 days. Skin nearly cleared up but once course ended everything came back.   Prescribed  Zyrtec 10mg 2x day, Hydroxyzine 25mg 3x day, Montelukast 10mg 1x day. Symptoms are managed but redness and itchiness continue. Dermatographia.
warm and sore where I got the Moderna COVID-19 vaccine.; warm and sore where I got the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm and sore where I got the Moderna COVID-19 vaccine.) and VACCINATION SITE PAIN (warm and sore where I got the Moderna COVID-19 vaccine.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm and sore where I got the Moderna COVID-19 vaccine.) and VACCINATION SITE PAIN (warm and sore where I got the Moderna COVID-19 vaccine.). At the time of the report, VACCINATION SITE WARMTH (warm and sore where I got the Moderna COVID-19 vaccine.) and VACCINATION SITE PAIN (warm and sore where I got the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Treatment medications were not reported
Immediately after injection I had a weird taste in my mouth, and of course the sore arm from injection site. Within 2 hours I felt nausea and fatigue and body aches. Within 5 hours my injection arm was so painful I couldn't hold an empty water glass or pull up my pants. The arm pain increasingly worsened spreading to my hand and chest and prevented me from sleeping. 2 days after injection the arm pain , fatigue and constant nausea have not dissipated however the body aches have. I also have developed a sty in my right eye for which I was prescribed antibiotics.
Vaccine injected into blood vessel with bleeding occurring; Vaccine injected into blood vessel with bleeding occurring; I felt dizzy and lightheaded during waiting period; I felt dizzy and lightheaded during waiting period; 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 64-year-old female patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 03Jun2022, outcome "unknown" and all described as "I felt dizzy and lightheaded during waiting period"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), VACCINATION SITE HAEMORRHAGE (non-serious) all with onset 03Jun2022, outcome "unknown" and all described as "Vaccine injected into blood vessel with bleeding occurring".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Itchy, painful unilateral rash. Given valacyclovir as treatment.
Shortly after receiving the first dose of the vaccine, the patient felt faint and passed out in the store about 10 minutes later. Patient previously mentioned that she is afraid of needles and before passing out, she said that she kept replaying the vaccination in her mind over and over. She said that she was familiar with the feeling of passing out and felt it coming on. She declined an ambulance and was given a chair to sit in and another chair to put her feet up, as well as some Gatorade to drink. She felt better afterwards.
Patient waited for 15 mins after vaccination and appeared fine.  At conclusion, patient was walking out and became lightheaded and weak.  Patient returned to clinic and placed in chair.  Patient given choice of visiting ER or taking benadryl.  Patient given benadryl 50 mg at 1100 along with water and cookies.  At 1120, patient states he was feeling better but still weak.  Patient left facility with wife.
Left arm and then left hand began to tingle. Left inside mouth cheek began to swell. Slowly my tongue, uvula, throat, and top of mouth began to swell and feel raw.  I did not call for the medic. I must have been in shock from the reaction. I took a Benadryl tablet there and two more during that day.  I developed hives on my left hand palm, one on my right palm, and a couple on both wrists. I took one Benadryl for each of the next three days and as needed during the next two weeks.
Information has been received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was accidentally vaccinated with an expired dose of M-M-R II (dose, strength, frequency, route of administration and anatomical location were not provided) (lot # L010488 with expiration date 26-MAR-2017), for prophylaxis. No adverse effects were reported. This is one of 2 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010886.
Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023).    No relevant concomitant medications were reported.   It was also reported that there was potentially a second lot number that was expired on 28Feb2023 and was administered to patients on 3Mar2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vials. The vial hadn't undergone any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient states continued pain from vaccinations, she states the vaccinator had given the vaccine "too high" on her arm and after one week of continued pain/discomfort it was notated. Patient has seen provider and no treatment course has been decided on yet.
given vaccine which underwent temperature excursion; No Adverse Event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.
Parents given hx of pt crying greater than 3 hrs continuously p/2nd DTP & fever of 103;
Approximately 10 mins after dose I experienced lightheadedness, diaphoresis, racing heart, chest pressure, nausea and vomiting. I was taken to the ED and given Benadryl, IV fluids and had continued nausea, lightheadedness and developed a headache. After Benadryl the symptom resolved except for lightheadedness and headache. Today I have symptoms very similar to flu headache, lightheadedness, nausea, muscle aches, joint aches and overall fatigue.
who received her first dose of Shingrix 7 years ago. She has not received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix 7 years ago). Concomitant products included valaciclovir (Valacyclovir).   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: who received her first dose of Shingrix 7 years ago. She has not received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The reporter was the patient, who received her 1st dose of Shingrix 7 years ago.  The patient stated that she was currently taking valacyclovir. The patient had not received her 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.