chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upon administering the vaccine some of the vaccine leaked out from the syringe down the recipient's arm; not completely tighten a syringe; vaccine leaked out from the syringe down the; A spontaneous report was received from a healthcare professional concerning a patient with unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced upon administering the vaccine some of the vaccine leaked out from the syringe down the recipient's arm as vaccinator did not completely tighten a syringe   The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an unspecified date, the patient was administered a dose of  mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient was not administered the full  dose of the vaccine, as a not completely tightened syringe was used and upon administering the vaccine some of the vaccine leaked out from the syringe down the recipient's arm. There was no way to tell how much. No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The events of incorrect dose administered, vaccine leaked out from the syringe down the patient's arm, and syringe issue was considered resolved.; Reporter's Comments: This case concerns patient with unknown age and gender who received a dose of  mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection and experienced upon administering the vaccine some of the vaccine leaked out from the syringe down the recipient's arm as vaccinator did not completely tighten a syringe. There were no reported adverse events in this case of syringe issue, exposure via skin contact and incorrect dose administered.
multiple outbreaks of shingles, had 3 Shingrex vaccines; shingles; had 3 Shingrex vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient requested Glaxosmithkline (GSK) to do more research and develop a vaccine that works for the immune compromised. The patient reported that this was such a terrible infection.  The patient too had multiple outbreaks of shingles. The patient had 3 Shingrix vaccines and was very thankful because he/she knew that it had lessened severity but keep working to find maybe a MAB that could work better for the huge group of immune compromised.  The patient thanked heaven to had this now.  Additional Supportive Information: The patient received 3 doses of Shingrix vaccine, which led to extra dose administered. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
loss of taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
pt recvd vax; started swelling; cont swelling to size of tennis ball; hot to touch;red in appearance, cont to swell x 3 days; began to dec in size on 4th day
Information has been received from a physician concerning a female patient who was vaccinated with a third dose of Gardasil (site, route, lot # not reported). The physician reported that the patient received her third dose of Gardasil and couple of weeks later at "end of 2007" she was diagnosed with idiopathic viral syndrome induced thrombocytopenia. She saw a hematologist. At the time of this report she had not fully recovered. No further information was provided. Upon internal review idiopathic viral-syndrome induced thrombocytopenia was determined to be an other important medical event (OME). Additional information has been requested. 4/14/08-records received-seen on 12/27/07-C/O increased bruising over shins, thigh, flank and arm. Rash on shins. One week of gum bleding difficult to control. Awoke once with blood in mouth and had epistaxis once. Menses longer in duration. Tingling before bruises, especially behind knee. Decreased appetite attributed to decreased exercise. Seen on 12/31/07-Idiopathic thrombocytopenia. continues with light menses has not restarted her BCP. Bruising and light gum bleeding. Seen on 2/28/08-Now C/O menometrorrhagia. Missed taking 2 of her BCP. 6/9/08-records received for DOS 5/13/08-seen for gyn exam. denies any irregular bleeding, menses are regular now. Started distance running again, yeast infection recently.
she felt bad; fever; pain at the injection site; chills/ shivers; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (she felt bad), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills/ shivers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she felt bad), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills/ shivers). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form four times per week. At the time of the report, FEELING ABNORMAL (she felt bad), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site) and CHILLS (chills/ shivers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported
Headache, Myalgia, NauseaVomiting, Weakness Narrative:
Initial report was received from a healthcare professional on 18 January 2013. A six-month-old male patient had received the following injections of 07 January 2013: a dose one intramuscular injection in the right thigh of FLUZONE, lot number U4483BA, a dose one intramuscular injection in the left thigh of PENTACEL, lot number C4270AA and a dose one intramuscular injection in the right thigh of PREVNAR, Wyeth, lot number 166401. On 08 January 2013, the patient was weak and had a weak cry. The patient was taken to the emergency room (ER) and discharged. The patient returned to the ER on 09 January 2013 and was admitted for weakness, dehydration and was on a ventilator with a diagnosis of transverse myelitis. Laboratory results from 09 January 2013 included: sodium 130, potassium 4.9, glucose 96, BUN 9, creatinine 0.4, WBC 12.7, hemoglobin 11.8, platelets 422, differential no shift to left, RSV and Flu negative, and "BC pending". The patient was hospitalized for 10 days. The patient had no illness at the time of vaccination but might have had a viral illness earlier. The patient had no known allergies (NKA). Outcome was not recovered. Documents held by sender: None.
I am positive again for Covid.; I am positive again for Covid.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 28Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in right arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing). Concomitant medication(s) included: RELPAX taken for migraine, start date: 01Jun2022, stop date: 01Jun2022; FAMOTIDINE, start date: 19May2022; CALCIUM, start date: 19May2022. Past drug history included: Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jun2022, outcome "recovering" and all described as "I am positive again for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I was negative until today; (20Jun2022) Positive, notes: Monday Jun20. Now I am positive again for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
soreness on the injection site, 4hours later there was a lump and warmth. 4 hours later again it was bruised. around 10 or 11pm my joints were aching and I was very tired. The next day I was very fatigued and run down. I was nauseated and had loss of appetite.  I was a little dizzy. 1000mg of Tylenol
Long lasting soreness along left side of body, redness, and fatigue. started at 6:00pm a few hours after the vaccine was given.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 degrees Fahrenheit and minimum minus 18.9 degrees Fahrenheit. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vials were stored in frozen state. The visual inspection did not noted any vaccine state change.   No treatment information was reported.
4 hours after vaccination had diarrhea for 5 hours, and chills, minor aches. Diarrhea stopped but chills and minor aches continued for 36 hours
Patient received Janssen covid-19 vaccine on 03/19/21 at 0800 pm.  She was fine and about 5 minutes later, she complained she feels like her throat was closing.  She also mentioned it hurts to breathe, her neck turned red in color and her heart rate was140s.  I injected patient with the Epi pen in her left thigh.  Patient responded to the Epi, her heart rate was came down to low 100s after a few minutes and deep breathing.  911 was activated, EMT came and transported patient to another Emergency Room.
Redness, swelling, tenderness & warmth at the injection site.  Initially I couldn?t even see where I received the injection.  However, approximately 12 hours later the injection site became very tender and a hard lump began forming.  Over 72 hours later, the injection site is not improving.    I also feel very fatigued and I have an upset stomach.  Not nausea; more like acidy.  It?s been over 72 hours since the injection and although I feel better than I did in the first 12 hours, I?m still not back to normal.  It?s like an all over fatigue that isn?t related to physical exertion or lack of sleep.    I just want to feel like I did before the vaccine.
COVID positive hospital admission 8/22/21 (dizziness, nausea, chest pain)
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 11:00 as dose 2, single (Lot number: EN6198) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chemotherapy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EM6204, anatomical location: Left arm), administration date: 12Mar2021, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "not recovered", described as "Legs cramp"; BURNING SENSATION (non-serious) with onset Apr2021, outcome "not recovered", described as "both legs and both feet burning and feels like feet are fixing to explode"; RESTLESS LEGS SYNDROME (non-serious) with onset Apr2021, outcome "not recovered", described as "restless leg". Therapeutic measures were not taken as a result of burning sensation, muscle spasms, restless legs syndrome.  . Event did not required the initiation of new medication/other treatment/ procedure.
6 weeks after this vaccine I tested positive for Covid via At-Home Test.  Symptoms: scratchy throat, chills, bad headaches, sneezing, head congestion.  Lasted about 5 days, 3 days with worst symptoms.  Just stayed home resting, Did not seek doctor care,  stayed isolated during symptoms, got rest & hydration, took tylenol at night.  Retested via At-Home Test Kit about  2 weeks after worst symptoms subsided, with negativeresults for Covid.
Head ache; Fatigue; Some nausea; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 19Feb2021 13:15 (at age of 34-years-old) as dose 2, single for covid-19 immunisation in workplace clinic. The patient medical history was not reported. The patient had no known allergies and had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 29Jan2021 13:15 as dose 1, single for covid-19 immunisation. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported and multi vitamin. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Feb2021 at 06:00, the patient experienced headache, fatigue, some nausea. No therapeutic measures were taken in response to the events. The events recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 12/29/2020 and 01/26/2021. Lot numbers are not available to me.   The individual arrived to emergency department via ambulance on 02/23/2022. Primary complaint was respiratory distress/shortness of breath. The individual had recent extensive surgical treatment for a bout of necrotizing fasciitis in the hip area. The individual was non-responsive to emergency department and had complete loss of pulse. After CPR, the individual's pulse recovered and they were transferred to a different hospital for a higher level of care. Given poor prognosis and overall medical frailty, the individual was transitioned to comfort care only on 02/25/2022. The individual died on 03/03/2022.
devel large 15cm by 13 cm red, yellowish area w/inside eruptions progressive 24-48 hrs then began resolution; rx augmentin & DPH;
I had a sensation of coming down with a cold. Scratchy throat, irritated nose, and congestion that lasted 2-3 days. It wasn't severe, so I didn't associate it with Covid, however, it did feel worse than my normal allergies. My symptoms cleared up within a few days on their own.
aches and pains; arm hurting; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (aches and pains), HEADACHE (headache) and PAIN IN EXTREMITY (arm hurting) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced CHILLS (chills), PAIN (aches and pains), HEADACHE (headache) and PAIN IN EXTREMITY (arm hurting). At the time of the report, CHILLS (chills), PAIN (aches and pains), HEADACHE (headache) and PAIN IN EXTREMITY (arm hurting) outcome was unknown.            Reporter did not allow further contact
Rash; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PYREXIA (High Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PYREXIA (High Fever). At the time of the report, RASH (Rash) and PYREXIA (High Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided
Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's.  ED notes as follows.  Discharged in stable condition with a Holter monitor.  Initial Vital Signs [02/02/21 0713] Blood Pressure 139/93 Heart Rate 126 Respiratory Rate 18 Temp 37.2 °C (98.9 °F) Temp src Oral SpO2 99 %  43 y.o. female who arrived to the emergency department for Palpitations and tachycardia.  Patient states that the symptoms started approximately 545 this morning while getting ready for work.  She states that palpitations started spontaneously with no inciting event.  She denies chest pain or shortness of breath.  She states that she felt the palpitations and looked down to her watch and showed a heart rate into the 190s to 220s.  Upon arrival to the emergency department her heart rate is in the 190s.  When she was brought back to the room, her heart rate was around 120-130.  Still denying any chest pain or shortness of breath.  She did receive her second for Covid vaccine yesterday.  No reaction with the first vaccine.  No changes in medication, caffeine intake.  Denies smoking, drinking, drug use.  No history of similar events.  Father has a history of a heart block requiring pacemaker.  Medical history of melanoma varicose veins but no cardiac or pulmonary history including pulmonary embolism.Patient is a nurse in the neurosurgical unit as one of the case managers  During initial evaluation, patient was sitting in bed in no acute distress. Vitals signs stable tachycardia although better than initially arriving. Physical exam unremarkable. Labs indicate elevated D-dimer.  We will proceed with CT PE.  CT scan of scan shows no signs of PE there is evidence of left axillary adenopathy which is consistent with her vaccination yesterday.  Upon repeat evaluation, patient was updated regarding lab and imaging results.  Heart rate had improved greatly down to the 90s to low 100s.  She was able to ambulate around without becoming grossly tachycardic, dizzy, lightheaded or shortness of breath.  Unsure of exact cause of palpitations and tachycardia.  Recommend outpatient monitoring with Holter monitor.  Follow-up with primary care provider or cardiologist.  Return to emergency department if symptoms return or new concerning symptoms occur.   Treatment plan was discussed with the patient who was agreeable and exhibited understanding. Questions were answered to patient's satisfaction. Through shared decision making with the patient and the emergency medicine care team, we discussed and decided the patient is stable and ready for discharge. Patient remained hemodynamically stable in the emergency department. Patient was provided with verbal and written follow-up/discharge instructions and return precautions. Recommend follow up with PCP in 2-3 days for symptom re-evaluation and further management. Patient should return to emergency department if symptoms worsen or new concerning symptoms develop.
This report was received from the investigator in the above mentioned trial on 05 March 2010. A 41-year-old male subject received ACAM2000 (lot number not reported) on 14 May 2009. Two days prior, on 12 May 2009, the subject received anthrax vaccine (manufacturer and lot number were not reported). Thirteen days after receipt of ACAM2000, the subject reportedly experienced an acute myocardial infarction. An electrocardiogram, performed Day 13, was reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.