chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, frequency time 1 total was administered on left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient was tested negative for COVID-19 antibody test and had confirmed immunological vaccine failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189474.; Sender's Comments: V:20210826496-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
No other AE/PQC reported; an expired dose of RECOMBIVAX HB was inadvertently administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 10-JUN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R031056, expiration date: 04-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R031056; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via agency (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907371 and 201907372 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.
Patient became cold and had left leg shaking. Patient was provided with blankets. Patient then felt better and was able to ambulate independently.
She got a little light headed and sick to her stomach.  Did not vomit.  Recovered quickly.
When ordering tetanus diphtheria toxoids (adult) from the computer system a technician ordered tetanus diphtheria acellular pertussis (pediatric) vaccines. The error is easy to make because 15 vaccine products appear beginning with the Tetanus and 6 appear beginning with Diphtheria. The wrong product was dispensed as floor stock to an outpatient clinic and mistakenly administered to several adults. The logo on the two vaccine packages is similar but the products are clearly labeled. Only one of 36 outpatients who received the wrong product had a possible reaction, local area soreness. The soreness was temporary. The problems is how similar products look on ordering screens. Stock bin for Tetanus diphtheria toxoids had been labeled with the wrong drug label rather than with a bar-coded shelf label that is standard practice for formulary drugs. Pharmacists now double check floor stock requests for accuracy and appropriateness for intended use. Correct bar code label has been placed on shelf bin. Pharmacist must approve any non formulary product ordered. Pharmacists and nurses have been inserviced on vaccines and checking procedures.
PAIN ON INJECTION SITE,MUSCULAR PAIN,JOINT PAIN,PAIN ON EAR AND JAWS.
Diarrhea; Appetite comes and goes; Two toenails are falling off; Hand and foot symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Breast cancer.    Concurrent medical conditions included Breast neoplasm malignant female. Concomitant products included CAPECITABINE (XELODA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, TUCATINIB (TUKYSA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms). At the time of the report, DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include fluids and lotion to treat the Hand and foot symptoms. Scan showed tumors are continuing to grow on her liver.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated events and concomitant medication. On 19-May-2021: Updated information regarding patient's use of Tukysa
No adverse affects reported.; Nurse called reporting improperly stored VARIVAX was administered to patient on 21-MAY-2020.; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not reported.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) (lot number S012036, which has been verified to be valid, expiration date reported and validated as 17-APR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The administered dose of the vaccine experienced a temperature and time frame of 48.2 degrees Fahrenheit for 4 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.
No additional adverse effect reported; patient received one improperly stored dose of VARIVAX on 06-MAR-2020; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 06-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028920 and expiration date: 16-SEP-2021) for prophylaxis (dose and anatomical location were not reported). Properly stored sterile diluent (lot#, expiration date were not reported) was used to reconstitute improperly stored vaccine. There was no adverse effect reported The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 6 degrees of Fahrenheit (F) to 14 degrees of F (5.69 degrees of F) during a time frame of 1 second. There was previous temperature excursion reported: from 6 degrees of F to 14 degrees of F (5.81 degrees of F) for 28 minutes. Digital Data Logger was involved.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 12:01 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.22 for dose administered on 27-Feb-2021 and 72.29 for dose administered on 27-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature from 33 to 35 degrees Fahrenheit from 09:00 AM to 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and  BUD date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 10:00 AM . This vial was moved to fridge on 23-Mar-2021 and BUD date for the vial was reported as 22-April-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
red spots under my eyes, it started with only itchiness now I can see the spots and burn a tiny tiny bit.  have tried all kinds of creams and my dr told me to talk Benadryl which I have done for 1 day.  I have it on both eyes, not a lot but enough that is visible
Headache, NauseaVomiting, Chills, sweats Narrative: Off work one day
father reports that his child was accidentally given adult dose of Havrix; p/24 hr pt was reported to be asymptomatic x/for bloodshot eyes; No tx was given; outcome unk; referred to MD for f/u;
"I had a monster headache Wednesday from that shot. And I had loose bowels... well... still. Just behind the crest of my forehead, about halfway between crown and hairline. In the middle. Pain level 5 on 1-10, unignorable.  I was quite light sensitive. (0 = no noticible effect, 10=unbearable -- 6.). I did not try any NSAIDS or anything. Started with aura-y stuff (just out of sorts, everything seemed bright) Weds AM, 12-14 hours after the shot, by the time I got to work 30-60 later, it hurt, and I came pretty much straight home and put my head under a blanket and slept. It was mostly resolved 12-16 hours later."
This spontaneous case, initially received on 02-Feb-2018, was reported by a pharmacist and concerns a 53-year-old, adult female patient. The patient had no medical history and concomitant medications. On 31-Jan-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179905P, expiry date: 31-Mar-2018). On an unspecified date in 2018, the patient developed itching and redness at the injection site about the size of a pin point. The patient used ice at the site of the injection as treatment. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Non-significant follow-up received from the pharmacist on 14-Feb-2018: No additional information was available, hence no changes were made in narrative.
got covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid). At the time of the report, COVID-19 (got covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Company comment-This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Unusual pattern of bruising at injection site - bruising with 3 reddish/purplish small round circles underneath the skin.  Circles are all approximately the same size, and all are on the same horizontal "line".  Bruising started appearing evening of the injection. Left arm was very sore, especially the evening of the injection. Bruising and circles still visible two days later, but pain is negligible.
blood pressure shot up; I could feel my heart beating; insides feeling as if racing; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure shot up), PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to erythromycin), Chronic back pain (2 major back surgeries), Drug allergy (Allergic to Compazine), Thyroid disorder NOS, Scleroderma (autoimmune disease), Pustular psoriasis (autoimmune disease), Drug allergy (Allergic to Darvocet) and Drug allergy (Allergic to Breo). Concomitant products included LEVOTHYROXINE, MORPHINE SULFATE (MORPHINE SULPHATE), PREGABALIN, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], CALCIUM, LATANOPROST and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (TIMOLOL + DORZOLAMIDA ACTAVIS) for an unknown indication.    On 07-Jan-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021 at 2:15 PM, the patient experienced BLOOD PRESSURE INCREASED (blood pressure shot up), PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache). The patient was treated with AMLODIPINE BESILATE for Increased blood pressure, at a dose of 2.5 milligram. At the time of the report, BLOOD PRESSURE INCREASED (blood pressure shot up) was resolving and PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 145/93 mmHg (High) 145/93 in both arms.         The patient stated all other symptoms stopped after taking the very first blood pressure pill.  The patient stated the last 2 weeks without "blood pressure pill in me yet" her blood pressure seemed to be returning to normal levels, with readings of 111/72 and 104/70.   This case was linked to US-MODERNATX, INC.-MOD-2021-077712 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: linked number was added for Dose 2 case On 24-May-2021: Completed ADR form; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077712:DOSE 2
Lost sight in left eye for 30-45 sec; A spontaneous report was received from a consumer concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sight in her left eye for 30-45 sec/ blindness transient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 31 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, around 8 pm, the patient experienced a medically significant event lost sight in her left eye for 30-45 sec when she got home. On 01 Feb 2021, twice the patient lost sight again. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, lost sight in her left eye for 30-45 sec was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Pt rec'd 4 vaccines at PE appt with PCP. He knew he passes out with vaccine administration so was lying down with admin. Mother with pt. Despite lying down - pt still passed out for few seconds only per mother. VSS right after - pale in color. Provided water & juice - pt had been fasting for blood work. After approximately 25 min - felt fine & let go with mother - no injury. Dr aware.
Covid + between doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid + between doses) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 COVID-19 (Covid + between doses). At the time of the report, COVID-19 (Covid + between doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Patient presented to office with complaint of blisters on arm, swelling and itching at site.  Area was about the size of a fifty cent coin, with blister like vesicles, area warm to touch with little swelling.  Prescription of Atrax was given to parent.
15" x 7 1/2 red hot area around inj site noted x 24hr p/vax;pt adm to hosp for IV ATB;
She presented to the ED for concerns of COVID-19.  Four day history of shortness of breath and weakness. Recent exposure to family member who was positive for COVID. She was able to be discharged home.
A few hours after the pain started in the shoulder and increased the painful area over time. This was more muscle pain that shoulder pain. I developed sever chills in the morning but didn't have access to thermometer. In the afternoon the fever peaked at 101.3 with Tylenol on board. Achy and tired through the day into the evening. Fever broke by midnight. Woke up on the 17th feeling better but still tired. Shoulder pain extends into bicep and into chest.
feeling sick; Threw up; Fever; Chills; This is a spontaneous report from a non-contactable consumer (Patient's wife). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. The patient's concomitant medications were not reported. No allergies to medications, food, or other products. It was reported that he received the vaccine on Saturday 30Jan2021 but was feeling sick on Monday (01Feb2021) following, better Tuesday but still sick, Wednesday was better. On 01Feb2021, the patient also threw up, experienced fever and chills. The 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. Since the vaccination, the patient has not been tested for COVID-19. There were no treatment received for the adverse event. The outcome of the event feeling sick was recovered on 03Feb2021, while the other events was recovered on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.