chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm redness, swelling, itching and hot to touch that began 1 week after the injection. Rash progressed into pustular lesions requiring treatment of triamcinolone ointment 2-3 times per day. Rash lasted 1 week.
pt recvd vax & arm became red & swollen; hard knot at inject site; some abd cramps;
Local Allergic Reaction. 3" diameter circle rash with stiffness, swelling, and pain.
Patient received moderna vaccine on 4/14/21 and 5/12/21. COVID positive on 4/18/22. Presented to ER on 4/18/22 and admitted. Admitted from a residential facility on 04/18/2022 on account of speech difficulty for the past few days and was diagnosed with subacute infarct in left parietal lobe.   Incidentally, she tested positive to COVID 19 but no evidence of COVID-19 pneumonia or hypoxemia. No arrhythmia documented for the last 11 days.  Discharged on 4/29/22
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 13-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified date, the GARDASIL vaccine had a temperature excursion of 16 hours. The lowest recorded temperature was 33 (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
39 y/o F  with PMHx of migranous vertigo, brain cyst, asthma, migraines with aura began to experience some chest tightness about 10 minutes after receiving the Pfizer vaccine, first dose. She had a previous anaphylaxis to shellfish that required an epipen. She was immediately assessed by paramedics and clinicians on site. She stated that her blood pressure has been relatively high over the past year because she went through a lot of emotional stress. She had her vitals taken and her blood pressure was elevated.  Denies HA currently, numbness, tingling, swelling, flushed skin, rashes, edema, hives, pruritis, dyspnea, SOB, wheezing, n/v     Vitals @11:55 am: BP: 172/108; HR: 98 bpm; SpO2: 98% @ 11:57 am: BP: 167/PMHx migranous headaches, brain cyst, asthma, migraines with aura.  Medications: Tumeric, Vitamin D;  Allergies: NKDA, Shellfish (anaphylaxis)  Vitals @11:55 am BP: 172/108 HR: 98 bpm SpO2: 98%  @ 11:57 am BP: 167/108   Orthostatic vitals BP: 181/119 HR: 105  @ 12:21 BP: 189/103 HR: 106  EKG: 3 Lead and 12 lead completed - showing possible bundle branch block and inverted P waves in contiguous leads (Lead III and aVF)  Transported Patient to  ER for further evaluation and recommended to see a cardiologist for better control of BP and questionnable EKG. Also recommended to go to neurologist due to increased frequency of headaches.
Large cellulitis > 1 week at DTaP site. Probably not an allergic reaction.
Caller is asking for herself if a 4-day fever is a normal response with the vaccine; This is a spontaneous report from a contactable consumer or other non hcp.    A 44-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, the patient experienced caller is asking for herself if a 4-day fever is a normal response with the vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Elevated blood pressure; Pain at injection arm; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure), VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue).   On 27-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure).   The patient was treated with HYDROCHLOROTHIAZIDE for Blood pressure, at an unspecified dose and frequency.   On 23-Jan-2021, VACCINATION SITE PAIN (Pain at injection arm) and FATIGUE (Fatigue) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 78/131 mmHg Borderline. On 27-Jan-2021, Blood pressure measurement: 102/159 mmHg High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Reported Symptoms: 10022061:INJECTION SITE ERYTHEMA; 10022075:INJECTION SITE
This case was reported by a consumer (also the subject) and described the occurrence of miscarriage in a 29-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included Bactrim allergy of rash or hives. The subject had not previously received influenza vaccine. She had not experienced adverse events following previous vaccinations. Concurrent medications included Prenatal vitamins. On 25 August 2009 at 10:00 the subject received 1st dose of FLULAVAL (0.5 ml, unknown route) when she was 8 weeks pregnant. On 25 September 2009, 31 days after vaccination with FLULAVAL, the subject experienced miscarriage. The subject went for a routine check up on 25 September 2009 and no heart beat could be found. Ultrasound determined that the subject had miscarried twins at approximately 8 weeks. This case was assessed as medically serious by GSK. The subject was treated with dilatation and curettage as a same day surgical procedure at the hospital.
This spontaneous report as received from an office manager, refers to an unspecified number of patient whose age and gender were unknown. The patients' pertinent medical history and drug reactions or allergies, if any, were not provided. Concomitant therapies included sterile diluent. The office manager reported that, on unspecified dates, the unspecified patients were inadvertently vaccinated with unspecified doses of VARIVAX (lot number N021317, expiration date 07-AUG-2019); and, PROQUAD (lot number N020012, expiration date 03-JAN-2019) that had been improperly stored (product storage error) on unspecified dates, for prophylaxis (dose numbers, route and anatomical locations of administration were not provided). The doses of both VARIVAX; and, PROQUAD were exposed to a temperature excursion of 5.5 degrees Fahrenheit (°F) for a time frame of 30 minutes, which was detected by the Digital Data Logger. There was not a previous temperature excursion. In addition, the office manager stated that all lots of VARIVAX and PROQUAD were reconstituted with properly stored sterile diluent (lot number and expiration date were unknown by reporter). No adverse effects or product quality complaints were reported. Further information was not provided. This case has been considered to be non-valid, since patients' identifiers were not provided.
Paresthesia from the neck down, labored resp., weakness, poor coordination, blurred vision, slurred speech, rapid eye lid  movement, uncontrolled leg  moment. Given IV solumedrol, Ativan, and po Benadryl
Fever, nausea, diarrhea, body ache, fatigue for over 48 hours after injection. Tylenol OTC medications used.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Pain on half face, jaws, ears and neck like bells palsy; Pain on half face, jaws, ears and neck like bells palsy; Pain on half face, jaws, ears and neck like bells palsy; pain on half face, jaws, ears and neck like bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain on half face, jaws, ears and neck like bells palsy), EAR PAIN (Pain on half face, jaws, ears and neck like bells palsy), NECK PAIN (Pain on half face, jaws, ears and neck like bells palsy) and FACIAL PAIN (pain on half face, jaws, ears and neck like bells palsy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN JAW (Pain on half face, jaws, ears and neck like bells palsy), EAR PAIN (Pain on half face, jaws, ears and neck like bells palsy), NECK PAIN (Pain on half face, jaws, ears and neck like bells palsy) and FACIAL PAIN (pain on half face, jaws, ears and neck like bells palsy). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN JAW (Pain on half face, jaws, ears and neck like bells palsy), EAR PAIN (Pain on half face, jaws, ears and neck like bells palsy), NECK PAIN (Pain on half face, jaws, ears and neck like bells palsy) and FACIAL PAIN (pain on half face, jaws, ears and neck like bells palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.
2 days post vax swollen glands, flu like sx, fatigue, weakness, dizziness, & multiple chancre sores inside mouth;
About six hours after the second vaccine my whole body began shaking that lasted several hours.  At the same time I had general malaise.  By morning the tremors were gone but malaise and profound fatigue lasted through the day. By morning of the third day I was feeling better, just still a bit tired. I did not seek any treatment.
Left upper arm swelling (moderate) and slight redness with pain, starting 6-10 hours after vaccines given (IPV #4, DTAP #5 to left deltoid). No difficulty breathing. No vomiting and no swelling to lip, face or tongue.
Information has been received from a physician concerning 6 month old male patient who on 17-DEC-2010 was vaccinated with a dose of ROTATEQ suspension (Lot# 668363/1046Z). No adverse reaction noted. Additional information has been requested.
administered frozen Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree C), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand and would call back later with patient information. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021265861:Same reporter US-GLAXOSMITHKLINE-US2021AMR266362:Same reporter
Received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021; Fever/temperature of 100.3 F; Sore throat; Feeling down; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 20Jul2021 as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021. On an unspecified date in Jul2021 patient experienced a fever/temperature of 100.3 F, sore throat and feeling down for three days. As of current, mother explains that daughter was perfectly fine now. She would like to know if it is ok for daughter to get second dose. The patient underwent lab test which included body temperature measurement, with results as 100.3 Fahrenheit, on an unspecified date in Jul2021, and Covid 19 with positive results on 24Jul2021. The outcome of event for coivd-19 was unknown, and for the rest it was recovered on an unspecified date in Jul2021.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
14FEB99 mom of pt stated that pt was drowsy, limp, sleepy, didn't respond normally p/shot 2DEC98;also stated cried a lot, 20 min straight (not high pitched);
Still sick a week after I got the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Still sick a week after I got the first dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Still sick a week after I got the first dose). At the time of the report, ILLNESS (Still sick a week after I got the first dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (Strength, route, dose, frequency, and anatomical location were unknown) with lot # N027618 and expiration date 04-OCT-2019, and lot # reported as N026082 and  expiration date 20-SEP-2019; and an improperly stored dose of ROTATEQ per oral (strength, dose, frequency, and anatomical location were unknown) with lot # N032565 and expiration date 30-MAR-2019; and lot # N021094 and expiration date 12-MAR-2019; for prophylaxis. The administered dose of vaccines experienced the temperature excursion of 47°F to 77°F  (47.8F) degrees Fahrenheit  for 21 hours. There was a digital data logger involved, and a previous temperature excursion of  47°F to 77°F (51F) degrees Fahrenheit  for 209 Minutes.  No adverse effects were reported.
Approximately one hour after injection I noticed a feeling of slight numbness on the left side of my neck extending up the left side of my face to the top of my ear. Feeling of numbness extends to middle of my cheek on left. No neurological deficit. Sensation to touch of area intact. Sensation continues  through current time with no changes.
redness and itchiness down to elbow (COVID Arm); redness and itchiness down to elbow (COVID Arm); was sleepy/napping; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (was sleepy/napping), ERYTHEMA (redness and itchiness down to elbow (COVID Arm)) and PRURITUS (redness and itchiness down to elbow (COVID Arm)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (redness and itchiness down to elbow (COVID Arm)) and PRURITUS (redness and itchiness down to elbow (COVID Arm)). On an unknown date, the patient experienced SOMNOLENCE (was sleepy/napping). At the time of the report, SOMNOLENCE (was sleepy/napping), ERYTHEMA (redness and itchiness down to elbow (COVID Arm)) and PRURITUS (redness and itchiness down to elbow (COVID Arm)) had resolved. Not Provided          No concomitant and treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077851:Case for dose 2
Patient was given .5ml of Moderna vaccine instead of .25 ml for 2nd covid booster. No adverse reactions reported.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no known adverse events.
Injection site rash; injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received Shingrix. On 7th November 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had red 1 to 2 inch rash around the injection site on the right deltoid. It was reported that had progressed to a larger rash of approximately 3 inches and at the time of reporting the rash was lighter in color. No additional symptoms were reported. The reporter consented to follow up.
administration of Menveo diluent portion only; administration of Menveo diluent portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA653A, expiry date 30th June 2023) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 10-Aug-2022. Reporter's Comments: The registered nurse (RN) reported that the patient administered with Menveo diluent portion only. The reporter (HCP) reported that patient just had a baby as well. The reporter consented to follow up. Additional Supportive Information: The administration of Menveo diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA11910, 1407USA011911). Additional information has been requested.