chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy arm and soreness; itchy arm and soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "itchy arm and soreness".   Additional Context:  The report is cross referenced to report ID: (Withheld) Received call from consumer who provided her middle initial as (Withheld). She had her Booster shot of the Pfizer COVID vaccine last Wednesday, 20Oct2021.  She had the two previous ones in Feb and then space and got another one.  She had no effects from the others at all except an itchy arm.  This time it has been worse.  While reporting for herself, she mentioned that she has an itchy arm and soreness and everyone has had that. She did not have anyone specific to report on except two ladies that live in the same senior community.   They had an itchy arm and soreness.  Other than that, they were fine and did not have any lethargy, sore throat, and did not have the feeling that they were not going to be able to make it that she had.  She did not wish to complete a report for them.  This report is to capture information for the second lady.   Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Took blood pressure noticed it was in the low range; irregular heartbeat; Tightness of chest; trouble taking deep breath; felt lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (age at the time of vaccination was 39-year-old) as dose 1, single for COVID-19 immunization. No Medical history was reported. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported.The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the tightness of chest and trouble taking deep breaths around 8 PM and next morning felt lightheaded and dizzy on 24May2021. The patient also experienced blood pressure noticed it was in the low range and irregular heartbeat on 25May2021. Those symptoms continued for roughly a month. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for events (Testing and referral for further testing). It was reported that patient saw PCP and after testing was done suggested the patient to visit a neurologist, appointment with neurologist was in Sep2021. Device Date was reported as 21Aug2021. Outcome of all the events was reported as Unknown at this time of the report.   Follow-up attempts are completed. No further information is expected.
Light Headed, Chills, Fevers, Nausea, Body Ache, Headaches.  Symptoms started Monday night- last headache treated with Tylenol 04:30pm Wednesday 09/29/21.
Pt was hospitalized on 8/13/2021 and passed away on 8/21/2021.
Progressive difficulty walking, lifting leg on steps until 12/29/11 admitted Hosp. pulmonary embolism of both lungs, and paralysis.  Discharged 1/2/12 to Rehab/NH disch. 4/12/12 to home recup. and therapy still unable to walk with no diagnosis & paralysis.  Later diff. moving, rotating R. arm Dec. 2012 vaccine.
Two hours after receiving the shot my arm was very sore and painful to move. My back where I had back surgery three years ago and has rods and screws was adversely effected with pain and soreness. The arm was more useable on day two but red and hot to touch still difficult to move arm. Day three the redness had spread to my elbow and to the top of my shoulder. Day four and five the soreness still there but tolarable. I took pain meds for back and helped the arm. HYDROCO/APAP 325 mg
Injection site reaction left thigh swelling and redness and warmth. Afebrile non pruritic, no ecchymosis.
Patient had 1st flu vaccine on 9-26-09.  Patient received 2nd flu vaccine on 10-10-09.  Inadvertently (less than 4 weeks).
Bump on my skin; 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 VACCINATION SITE RASH (Bump on my skin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Bump on my skin). At the time of the report, VACCINATION SITE RASH (Bump on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report as received from a Physician's Assistant refers to a 22 year old female patient. On 20-MAR-2012, the patient was vaccinated with GARDASIL dose 1. On 14-NOV-2013 (reported also as today), 605 days after dose 1, the patient was in office to receive her second dose. No further information available. Dosage information, lot and expiry date were unknown for both doses. Additional information has been requested.
Pt. states that after receiving the 3rd dose of Phizer Booster 09/27/2021, started experiencing symptoms 09/28/2021 of having stomach pains, feeling a burning sensation throughout the abdominal area, and pain while bending. Primary communications recommendation to follow-up with Primary 09/29/2021 if symptoms continue.
Patient developed chest pain and found to have myocarditis with elevated troponins. Chest pain responding to Ibuprofen monotherapy.
pt recv vax;called hlth services 24 hrs p/ vax,c/o arm sore,red w/ large knot at inject site;referred to md but pt did not go
parents report that pt had low garde fever & two szs w/in about five hrs of receiving vax & that following this had severe regression in deve from which pt took many months to recover;
administration of frozen vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The unknown number of patients had been receiving Shingrix vaccine doses that had a previous temperature excursion on which they were frozen, which led to incorrect storage of drug. No more information was available at the time of reporting. The reporter consented to follow up.
Patient was given a duplicate Flu shot for 2021-2022 season. First Fluad was administered on 9/9/2021. No adverse effects were experienced by patient after second flu shot on 11/3/2021.
Patient received second dose of infant Pfizer COVID-19 vaccine that was diluted with 0.22mL of diluent instead of 2.2mL of diluent in the vial. Error was discovered after patient had left clinic. Parent was contacted and indicated that her son appears to be okay and is running at a pumpkin patch. Parent was advised to call their healthcare provider if any signs seemed to be unmanageable. She agreed she would and mentioned he had received a flu vaccine as well.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient had sore arm from the first two Moderna COVID19 Vaccines, but otherwise had no other adverse reactions.   This case was linked to MOD-2021-369011, MOD-2021-373853 (Patient Link).
36 yrs old female healthy report having a rash in the face 25 mins after received a pfizer booster , associated with mild itchiness. patient denies any another symptoms. no swollen face/lips or tongue.  denies feeling tachycardia, denies feeling unwell.  She denies any reaction to the two prior doses of pfizer vaccine. px was observed and check physical exam wnl.  Benadryl 50 mg given and patient report feeling better rash almost resolved.  Went home with husband.
patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) had resolved.        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 Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD21-088359, MOD21-088360, MOD21-088361, MOD21-088363, US-MODERNATX, INC.-MOD-2021-114641, US-MODERNATX, INC.-MOD-2021-114834 (Linked Report).; Sender's Comments:  MOD21-088359:crosslink MOD21-088360:crosslink MOD21-088361:crosslink MOD21-088363:crosslink US-MODERNATX, INC.-MOD-2021-114641:crosslink US-MODERNATX, INC.-MOD-2021-114834:
This spontaneous report has been received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were unknown. It was reported that improperly stored doses of ZOSTAVAX Lot # L035285, expiry date 15-DEC-2016 (dose and route were not reported), were given to unspecified number of patients on unspecified dates. It was reported that the vaccine was at 4 degrees C of temperature and its time frame was 15 days/360 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient received both shots in the same arm and a red area and swelling is visible below where shots were administered. Area was hot to the touch and patient reported experiencing on itching. She went to the ER the morning after shots were administer and was given Hydroxyzine for the itching.
Sneezing; Low grade fever; arthritis; chills; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 14:15 as DOSE 1, SINGLE (at the age of 76-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that in the past she had a flu shot and afterwards contracted the flu. Patient received Pfizer vaccine on Saturday (27Feb2021) and then Sunday (28Feb2021) patient was sneezing, it was uncontrollable, then this morning patient was sneezing and had a fever, a low grade temperature. Patient has chills, describing it as feeling chilly. Patient heard that the second dose was when someone would have a reaction. Patient has a doctor appointment on Wednesday and they are a hematologist, if patient has a fever they won't let her in. Therapeutic measures were taken as a result of events. Patient took Tylenol for her arthritis, but nothing helped her low grade fever and sneezing. Patient also took a fizzle tablet of Vitamin C also, and her vitamins. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Presented to Hospital with acute hypoxia  - Acute Pulmonary embolism, with Thrombocytopenia with no clear cause and no previous heparin 25 days post Covid Vaccine. Heparin was administered to treat PE with further drop in platlet count within 12 hours. VITT reaction considered (PLT 161 11/29 to 55 12/24 ) heparin stopped immediately switched to argatroban infusion with increase in platelets within 24 hours .   Hep-Ind Thrombocytopenia PF4 Ab, IgG lab test sent for evaluation, returned positive see section 19 and continuation page for detail. Transitioned to rivaroxaban (Xarelto) once stable and discharged from the hospital. Mouth/gums were bleeding during the hospital admission PE is being treated - he continues to take anticoagulation medication and  will get further follow up . Platelet count was recovered at time of discharge
Patient woke up on the morning of 2/6 with symptoms of a stroke.  Rushed to hospital where clot found in brain.  Recovered from initial stroke but then had another major stroke on 2/8 and never recovered.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   The age of the patient was reported as 69.93.   No concomitant medications were reported.  On 27-Oct-2021, 6 vials were moved to clinic.   The vial was initially moved to the fridge on 29-Sep-2021 and 05-Oct-2021 and proposed beyond use date was 29-Oct-2021 and 04-Nov-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and at 10:00 A.M, the temperature recorded was 32 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 27-Oct-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
Patient is hospitalized with COVID-19 (testing positive on 8/22/21) and acute respiratory failure with hypoxia.
Local reaction to Dtap #5.  Given in Right thigh.  Reaction is now size of softball.
I am still having pain; This is a spontaneous report from a contactable consumer. This 50-year-old consumer (patient) reported for self. A 50-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks and No, nothing within last couple of years. It was reported that the patient had vaccine a month ago on my right arm. On 13Aug2021, the patient experienced still having pain. The patient underwent lab tests and procedures which included blood test: unknown results. "If I go to my doctor and he did blood work and or I get a urine specimen yesterday I have nothing to do with this. Its irrelevant and nothing to do with my arm from a month ago". The patient receive treatment with Aspirin 81 mg. Outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # K010440, expiry date: 22-JUL-2016 (dose and route not reported). The vaccine was exposed to temperature of 7 degree Fahrenheit for 20 minutes. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
in bed for two days so he lost two days from work; diarrhea; 103 fever / still has the low grade fever for the past two weeks; blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for two days so he lost two days from work), DIARRHOEA (diarrhea), VISION BLURRED (blurry vision) and PYREXIA (103 fever / still has the low grade fever for the past two weeks) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VISION BLURRED (blurry vision). On 09-Apr-2021, the patient experienced BEDRIDDEN (in bed for two days so he lost two days from work), DIARRHOEA (diarrhea) and PYREXIA (103 fever / still has the low grade fever for the past two weeks). On 09-Apr-2021, VISION BLURRED (blurry vision) had resolved. At the time of the report, BEDRIDDEN (in bed for two days so he lost two days from work) outcome was unknown and DIARRHOEA (diarrhea) and PYREXIA (103 fever / still has the low grade fever for the past two weeks) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 103 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up updated medication Clyndomycin  and Second dose added
Headache, fatigue, muscle/ joint pain onset about 10 hours after 2nd dose of moderna vaccine on 3/5/2021. Pain worsened over the next 24 hours but was assuaged using 1000 mg Tylenol.  During this time, injection site was also painful and swollen. These side effects subsided by the morning of 3/7/2021. On the morning of 3/7/2021 injection  site pain also lessened and a minor red rash appeared around the site and is still present to current time (3:00pm on 3/7/2021). Rash is itchy if touched.
On 7/29/03 pt mm noticed swelling and red hot area on left upper arm. This a.m. area much larger. T96.6. 5x6cm erythematous area on left upper arm.
fever (104); vibrations; vertigo; hives; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness) 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 08-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 PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness). At the time of the report, PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details include Zertec, Benadryl.
Within 4 hours of shot, I had tongue swelling, throat tightening, and wheezing. I took 2 Benadryl capsules, and felt relief in about 20 minutes. Withing 1 day, rash appeared. By day 5, large rash on entire upper left arm. Sore muscles and joints on 2nd day.