chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time; This is a spontaneous report from a Pfizer sponsored program  support. A contactable consumer (patient's mother) reported for a 14-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0187 and expiry date: Aug2021, patient was 14-years old at the time of vaccination), via an unspecified route of administration in Arm Left on 17May2021 as a single dose for COVID-19 immunisation. The patient's medical history and family medical history reported as None. The patient's concomitant medications were not reported. Patient took Pfizer covid vaccine to hopefully not get Covid, no other product and history was reported. On 17May2021, the patient experienced patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time. This report related to a study or programme. Reporter seriousness for First Dose experienced Left Arm Injection Site Pain was unspecified. Patient received treatment with Advil for the event. Reporter reported on behalf of her daughter, who is 14 years old and was scheduled to get her second dose, then states, no she got her second dose of the Pfizer Covid Vaccine on 07Jun2021, and she is complaining of pain under her arm around the arm pit area and wants to know if that is okay or if that is an adverse reaction? Reported that the patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time which lasted about 2 days after her first injection, from 17May2021 to 19May2021, but this time with the second dose, the injection site pain is less than the first time, but now she has pain under her arm at the arm pit area, after the second dose the injection site pain was just that day, so just one day, it wasn't bad. Second dose was received on 07Jun2021, LOT: EW0196, Expiration: Sep2021, also provides the Saline Lot Number for the First Dose of the Covid Vaccine: Saline Lot Number: 21099DK Expiration: 22Sep2021. Vaccine was not administered at Military Facility. Patient not visit emergency Room and physician Office for event. Patient had no prior Vaccinations (within 4 weeks) and not AE(s) following prior vaccinations. The outcome of event was recovered on 19May2021.  Information on lot/batch number was available. Additional information has been requested.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Dose administered after 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 72.66. No concomitant medications were reported. The vial of batch number 025L20A was initially moved to the fridge on 05-Jan-2021 and proposed beyond use date was 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was 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. On 07-Jan-2021 at 15:08., the temperature recorded was 40 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken by 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.   This case was linked to MOD-2022-566976 (Patient Link).
Fever to 102.4 over 24 hours. Fatigue. Muscle soreness.
Little pain at the injection site; Felt flush afterwards; This is a spontaneous report from a non-contactable nurse.  This nurse reported similar events for two patients.  This is the second of two reports.  A patient of unspecified age and gender received the BNT162B2 (BNT162B2; also reported as PFIZER COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient experienced little pain at the injection site and felt flush afterwards. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501372 same reporter/drug/event, different patient
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 21-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 516 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Serious rash covering torso, increasing in severity throughout the day until entire torso was one giant blotch of itchy red and patches covering neck, arms and face
The patient received two vaccines and stated that after 2 days passed from receiving the vaccines they are unable to extend the muscle on the upper arm from the elbow up on 1 arm only. (uncertain of exact time of loss of muscle movement) The patient has not received medical attention, but stated that were going to seek attention from a physician.
pain under ribs on lt side in the evening;painful turning over in bed;decreased pain by next noc;used willowbark tincture for comfort & used thuja (western red cedar);
MMR administered 09/04.  Reports pruritic rash- diffuse on 09/08.
Patient was automatically in a daze from that day onward. He couldn't even find his mouth when he went to out food into his mouth that evening.
Mom brought PT back to clinic. 3-5 mins post vax given, with generalized seizure, resolved after 2 mins. Temp 99.8, glucose 121; 028 at 100 % with blow by after seizure. PT fuzzy out easily counseled by mom, ab??? no preceded by cyanosis or breath-holding spell per mom.
A nurse reported that a female pt received an injection of flu shield on 11/13/2001. That same day, the pt developed a grapefruit-sized welt at the injection site. This is 1 of 4 pts from this facility who had an adverse experience following receipt of flu shield.
This spontaneous report as received from a pharmacy student and refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), and multiple unspecified pediatric patients received adult doses of VAQTA, (N016805, 04-SEP-2018), (Captured in MARRS # 1708USA003849). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error (Product name confusion). No adverse effects were reported (No adverse event). All fields apply to all unspecified patients and all doses of VAQTA. No further information was provided. No product quality compliant (PQC) was present. Outcome of events was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003849:
sick since second dose yesterday; 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 ILLNESS (sick since second dose yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced ILLNESS (sick since second dose yesterday). At the time of the report, ILLNESS (sick since second dose yesterday) outcome was unknown.            Concomitant product use was not provided. No treatment was reported.
The injection site was below and posterior to the deltoid muscle. The local reaction was characterized by erythema (measuring 4.5X6 cm), induration, swelling and tenderness. No cellulitis or abscess resulted. It is unknown if the inappropriate manner of injection resulted in inactivation of the mRNA due to missing the muscle cells. Due to being immunocompromised, it was imperative to receive the dose in the prescribed manner to  optimize any possible immune response.
he had a bad fever; This is a spontaneous report from a contactable consumer. A contactable consumer of 60-years-old male patient (himself) reported for himself that received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving first dose of vaccine he experienced a bad fever on an unspecified date that lasted for half an hour. He wanted to know if this is normal. He wondered if he could take the second dose as he heard that some people had worse reactions after the first dose if they had COVID in the past. She wondered if she could take Tylenol before vaccination. The outcome of the event was unknown.  Information about batch/lot number is not provided. No further information is expected.
Fever and suspected otitis media - prescribed amoxicillin 7JUL2023. 11JUL2023 received hepatitis A, MMR, varicella vaccines (first doses of each).  12JUL 2023, presented with hypovolemic and septic shock with subsequent cardiac arrest (CPR 45-60 minutes) requiring VA-ECMO. Initial echo revealed severely depressed RV and LV function and moderate MV and TV regurgitation. She underwent balloon atrial septostomy to decompress the left ventricle on 7/12, and biventricular function recovered well. Required CVVH while on VA-ECMO, decannulated on 7/14. Myocardial biopsy 7/12 showed non-specific changes seen in myocarditis as well as sepsis, however cardiac MRI 7/17 consistent with myocarditis. Treated with IVIG 2g/kg on 7/12 and hydrocortisone 100mg/m2/day 7/12-7/15 for presumed myocarditis. He also completed a 7 day course of Rocephin and vancomycin for septic shock (7/12-7/18). Cardiac MRI also revealed PAPVR and 2:1 shunt across ASD created by balloon septostomy, which will require cardiology follow up for further evaluation and repair. MRI brain 7/17 showed acute infarctions of the hippocampus and left inferior putamen and chronic microhemorrhages with right medulla and left temporal lobe, likely related to VA-ECMO and cardiac arrest. Extubated to RA on 7/19. Started on low dose ASA 7/20 given septostomy and increased risk for stroke. Started on Keppra 100mg BID for seizure prophylaxis, although no clinical seizures or seizure activity on EEG 7/15. Transferred on 7/21. Weaned off Diuril and Aldactone, remained on Lasix for diuresis and Coreg for persistent sinus tachycardia. Concerns for aspiration per SLP.  Discharged from inpatient rehabilitation on 07AUG2023. 1. Myocarditis a. History of severely depressed systolic function b. Recovery of systolic function, normal by echo 8/3/2023 c. IVIG administered 7/12/2023 2. Partial anomalous pulmonary venous connection of the LUPV to the left innominate vein a. Stable 3. History of ECMO a. Status post balloon atrial septostomy (7/12/2023) b. Cannulation from 7/12/23 - 7/14/23 c. Stable 4. Atrial septal defect a. Iatrogenic following balloon atrial septostomy b. Qp:Qs 1.9:1 by CMR 7/17/2023 in setting of ASD and PAPVC c. Appears small by echo with left-2-right shunting (echo 10/11/2023) Continues outpatient rehabilitation
Upon injection there was MUCH more evident pain than my initial shot. Within one minute I felt like I was starting to go into anaphylactic shock. My heart rate went through the roof, I could tell I was starting to get dizzy. I moved out of the walk-way in the store and told the pharmacist. They had me lie down on the ground (ew), while my heart rate raced and I nearly passed out. It was quite scary. After about 15 minutes I sat up a little, drank some juice they gave me and then slowly sat up. I stuck around around 35 minutes.  Also, I have FSGS (which is a kidney disease) and within half a day I had foamy urine (which is a sign of proteinuria for me). This happen after my first injection as well, so I expected it.  I am four days out now, and it is still foamy.
covid test result Positive; covid test result Positive; This is a spontaneous report received from a contactable nurse (patient). A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration in Right Arm on 13Jan2021 09:00 (33 years at the time of vaccination) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 via an unspecified route of administration on an unspecified date. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have any adverse event. The patient did not receive any treatment. Prior to the vaccination, the patient had no covid infection. On 23Feb2021, post vaccination, the patient was tested positive through nasal swab PCR test. Seriousness of the events was medically significant. The outcome of events was unknown.  No follow-up attempts are possible. Information regarding lot/batch cannot be obtained. No further information is expected.
Heat in the arm including an itchy, burning rash.  Severe rash down the arm and encircled the arm (very red).  Patient felt very lethargic.  She self treated with ice, Tylenol, and Benadryl Gel.
Patient was in clinic for immunizations.  He was brought in by Aunt who is his legal guardian.  Immunizations had been entered into the system by clerk.  Nurse reviewed the list of vaccines and vaccine forcaster.  The previous dose of MMR had not been entered into the system.  Nurse gave MMR and Varicella vaccines and the DTAP/IPV (Kinrix)  vaccine.  When the nurse entered the information in EHR and printed the Vaccine Certificate the expiration date was for 3/8/2022.  On further review of the child's records, nurse found the documentation of the MMRV that had been given on 2-21-2020.  Patient had received an extra dose today of MMR and Varicella that was not needed.  Patient did not have any adverse reaction at the time of vaccine in clinic.  Incident was reported to RN Supervisor.  Incident reports completed and submitted.
Loss of appetite, confusion, lethargy, excessive mucus. Patient did not want to be hospitalized. Jan 14 thru Jan 18, 4 AM.
arm is sore; swollen; red; itchy; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), INJECTION SITE PRURITUS (itchy) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), INJECTION SITE PRURITUS (itchy) and HEADACHE (headache). The patient was treated with Manual therapy (Ice packs) for Vaccination site pain; Manual therapy (Ice pack) for Vaccination site swelling; Manual therapy (Ice pack) for Vaccination site erythema and Manual therapy (Ice pack) for Injection site pruritus. At the time of the report, VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), INJECTION SITE PRURITUS (itchy) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Began sneezing (near constant) early am day after vaccine received, continued until 10/29/06, gone by evening of 10/29/06. Evening of 10/29/06 onset of dry coughing last 2 days. No other symptoms. Now well with complete resolution of symptoms. no medical provider visit.
dry cough; lethargy; dizziness; confusion; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional (nurse).  This case involves a 70-year-old male patient who developed a dry cough (cough), lethargy (Lethargy), dizziness (dizziness) and confusion (confusional state), while received influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2020, the patient received influenza quadrival a-b high dose hv vaccine (formulation, strength (High-Dose) was unknown) (batch number: UJ511AA and expiration date: 30-Jun-2020) at vaccinated with 0.7 ml (once) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date in Oct-2020, same month after starting the suspect vaccine therapy patient has developed a dry cough, lethargy, dizziness and confusion.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  No further relevant information was reported.
Site: Pain at Injection Site-Mild, Systemic: Seizure-Mild, Additional Details: Patient had seizure twice - within 5 minutes- reported some tingling in the arm of vaccine but after 5 minutes was feeling better
Pt c/o Lt arm pain, local tenderness, erythema, and fever. Temperature at office 100 degrees. Medications prescribed-Duricef 500mg bid x 14 days. Medrol dose pack. Dx: myalgia. R/O early cellulitis.
This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L009649, expiration date 29-NOV-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling, redness, tenderness at site, and lymph node swelling. Headache, fever, body aches, light nausea. Redness extending down towards elbow.
Narrative:  71yo mlae patient with Malignant neoplasm of larynx went to community ER on 10/20/21 with diagnosis of hemorragic stroke. Pt admitted to hospital and died at this hospital on 10/27/2021. Pt had received covid vaccine on 4/28/21 (J&J). This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Presented to ER on 12/10/21 for evaluation of worsening shortness of breath , having tested positive to COVID-19 virus on 12/9/21 but her sympotoms have been ongoing for a week.  Does complain of cough productive of greenish sputum.  She denies chest pain.  No fevers or chills.  She does have watery diarrhea since the past week.  Appetite is very poor.  She is nauseous but no vomiting. In the ED she was given Bamlanivimab-Etesevimab infusion and was supposed to be discharged home however she became hypoxic with oxygen saturations dipping down to 87% on room air.  Subsequently the decision was made to get her admitted.  Of note patient received Moderna vaccination x 2 last Spring. Preop labs are unremarkable except for leukopenia. Chest x-rays shows patch like opacification in the left mid lung and left lower lung concerning for pneumonia.  She has received Rocephin and azithromycin in the ED.Admitted and treated with dexamethasone, remdesivir, and Rocephin. Hospitalized from 12/10/2021 until 12/15/2021. Underwent a 6 minute walk test demonstrating patient needs 2 L nasal cannula continuously at rest and will increase that to 3 L nasal cannula with exertion.  Will be sent with finish up antibiotics as well as dexamethasone for couple more days.  Clinically she has improved symptoms are better.  Her last dose of remdesivir was on 12/14/2021. Discharged on 12/15/21
35 minutes after injection, tingling and swelling of bottom lip; tingling felt on tongue but no swelling. Tingling lasted for 10 minutes and swelling lasted for about 12 hours. No hives, shortness of breath.
Nausea, headache, and chills starting 2 hours after vaccination and lasting 12-24 hours. Redness, swelling, and soreness from left shoulder to left elbow slowly resolving.