chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (first dose) on 28-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (second dose with batch no EN6201) on 19-Feb-2021. Concurrent medical conditions included Down's syndrome.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided. Her 2nd dose lot  EN6201 on 19-Feb-2021.
Painful headache; This is a spontaneous report from a contactable consumer. This consumer reported in response to vaccine follow-up questionnaire sent in cross-referenced case (patient, self-reported).  A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date was not reported), via intramuscularly, in Arm Right, on 11Feb2021 at 12:00 noon, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK4176 and expiry date was not reported), via intramuscularly, in Arm Right, on 21Jan2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 11 days after receiving second dose on 22Feb2021, the patient had a painful headache. The patient was not prone to headaches and was wondering if that was a delayed reaction. The event did not require the initiation of new medication/other treatment/procedure. Outcome of the event was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
MOTHER'S REPORT STATED RASH AND BUMPS ON NECK, BACK, RIGHT LEG, AND BEHIND EAR. MD REPORTS: possibly d/t MMR or VZV vaccines given 11 days prior. Maculopapular rash known to occur within 1st 3 weeks after these live vaccines given. No vesicular rash, papules all blanch.
Large local reaction 9 x 10cm on (L) arm red warm and spreading over 72 hrs since shot indurated but not tender.
HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt received her Pfizer 2023/2024 covid vaccine (Lot HG4680, Exp 12/31/2023) this morning in clinic at 8:10 AM. Waiting in lobby few minutes afterwards she reports she is feeling tongue and throat swelling- tongue feels "heavy and stiff", throat feels swollen internally. Pt able to speak in full sentences and denies SOB / chest sympmtoms. No wheezing audible or to auscultation. RR 22. SpO2 100%, HR 119. Pt placed supine and Epipen dose 1 administed at 08:19 anterolateral right thigh. Pt initially reported full resolution of tongue and throat symptoms. BP stable. She sat up but then around 08:29 reported a return of altered sensation in tongue and throat, feels like tingling at first but quickly progressed into a swollen and thick sensation. Pt again placed supine and dose 2 of Epipen administered 08:32 anterolateral left thigh. Within 1-2 min pt now states throat and tongue symptoms are disappeared, however says she feels very anxious, feels heart beating in chest, and pt now became chilled and shaky for about 10 mins. Given blanket and allowed to relax. Pt was assured that Epinepherine does create increased heart rate and anxiety symptoms   BP range during visit is 124 - 154 systolic , 83-101 diastolic.  HR range during visit 104-120.   Dr PCP consulted regarding patient. He would like pt evaluated in ED for extended monitoring following Epi treatments. Pt transported to hospital via ambulance.
pt recvd vax & exp headache, "left sided head pain" & vertigo;
Symptoms - ? EE reports at approximately 2:00 pm she began feeling tired and so fatigued she left work.  EE reports at time of call still fatigued, with muscle weakness and joint pain.  EE denies fever.  EE denies COVID-19 exposure without proper PPE and recent travel. Last day of work and shift - ? yesterday Home remedies? -   rest Any improvement? - mild Recommendation?   EE reports she called off of work today due to feeling unwell.  EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns.  EE educated to continue to manage per Illness in the Workplace Policy.  EE verbalized back understanding and denied further questions at this time.
Patient found unresponsive in room with no pulse or respirations.  She was pronounced dead by paramedics at 06:25am on 2/5/2021.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose #1 03/26, Pfizer, dose #2 08/17 pt cc: chills, cough, fever, headache, loss of taste or smell, myalgias, rhinorrhea exposure: unknown 08/19 COVID swab, result: detected 08/18 CXR impression: No acute cardiopulmonary abnormality.
This spontaneous report was received from a nurse via a company representative, referring to an unknown number of unidentified teenagers of unknown age and gender. Information about patient's historical conditions, current conditions, drug reactions or allergies and concomitant medications. were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 for prophylaxis (dose schedule, anatomical location, route of administration, lot number and expiration date were not provided). On an unspecified date in 2015, the patients experienced syncope episodes after their vaccination. At reporting time, the outcome of the event was not provided. The causality assessment between GARDASIL 9 and syncope was not provided. Upon internal review, the syncope was determined to be medically significant.
Patient did not get second dose; tinnitus; arm swollen/rock hard; arm was red; it feels as though you're about to have a stroke or anaphylactic reaction; dizziness,felt as if she got thrown on the high way and hit by the truck,; lymph nodes; fever,; vomiting; joint pain; chills,; all the symptoms on the FAQ sheet given to her: nausea; muscle aches,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red) and FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-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 PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email:  in response to ADR forms. She is in the middle of filling out. Will send later.
pt recvd vax; 4-5 diam erythematous, hot area at inject site;
Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, 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 experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) outcome was unknown.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
necrotizing epithelioid (M(n)-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 1 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, soon after vaccination, the patient experienced non-necrotizing (M-type) skin granuloma. Skin biopsy was positive for iVDRV. The patient was treated with antibiotics with no effect. The patient was also treated with topical steroid with improvement. Additionally the patient was treated with intravenous immunoglobulins with no effect and with nitazoxanide with a result of fewer new lesions. Hematopoietic cell transplantation was performed (outcome not provided). At the time of the report, the patient's outcome was recovering.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372:
Patient received vaccination and felt immediate pain, initially brushing it off as the typical sore muscle pain. She returned after 4 weeks still complaining of pain, RPh at the time told patient the pain was unlikely due to vaccination and that she may have something else going on. Patient visited doctor's office and eventually saw an Orthopedic doctor. Ortho doctor performed imagining and concluded patient had SIRVA due to improper vaccine injection technique (patient most likely received vaccination too high in her arm and it pierced the bursa) leading to indefinite upper arm/shoulder pain.
Drowsiness, irritability, vomiting x2, 3 min twitching head to one side, abnormal cry x 3 min, pupils dilated and apparent light sensitivity at same time.
TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210501553.
ARM WEAKNESS, DYSARTHIA, DYSPHAGIA, MOTOR NEURONE DISEASE. PROGRESSIVELY WORSENING SPEECH.
A small amount of bleeding noted by the parents around the colostomy site.  This lasted for no greater than 8 hours and resolved without recurrence.  Patient was evaluated in ED for fever at home, but no documented fever in hosp. Patient admitted and treated with IV antibiotics after blood cultures were drawn. Blood cultures remained negative after 48 hours and patient's antibiotics were discontinued. This event was not related to the vaccination. Patient was well afterward and did go on to have elective surgery on 2/11/10 including exploratory laparotomy, bowel resection, takedown of enterocutaneous fistula and several of ostomies. He was discharged home on 2/21/10. This event also was unrelated to the vaccination.
Reoccurring HSV 2 sores, 1 every month following vaccination. Prior to receiving vaccine, I would only get 1 sore 1-2 times per year.  No other health or lifestyle changes during this time to explain this increase in frequency
Information has been received from a healthcare worker, certified medical assistant (CMA) who reported that multiple unspecified patients received doses of improperly stored RECOMBIVAX HB (lot # K007263 expiration date 09-JUN-2016, therapy type unknown, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
metallic taste; This is a spontaneous report from a 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 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced metallic taste in Dec2020.  The clinical outcome of metallic taste was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504715 same reporter/drug/event, different patient
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was thalamic stroke,
Lump exists at injection site beyond one week. Soreness and tenderness at injection site beyond one week.
I spoke to mom the next day regarding the start of abnormal eye movements the next day mom did not bring her in until 6/1- sent to ophthalmologist- diagnosed with nystagmus
1 week after injection, swelling, redness, inflammation and itchiness as injection site. 4"x3" in area
Started to feel dizzy approximately 5-10 minutes after receiving my vaccine. Attempted to sit down for a while but woke up on the floor, my husband and the pharmacist moved me to the floor and took me outside. Multiple times I nearly lost consciousness and had to lay down on a bench outside, the pharmacist called an ambulance and the paramedics took some tests before ultimately deciding I should go to the ER for further testing since my blood pressure kept dropping and I would nearly faint.
Pt describes pain when arm is lifted above shoulder and he has decreased mobility. He says this has persisted since vaccination from 11/3/14. No pain at rest.
3 days after vaccination, itchy left arm - back and inside of arm, armpit, some chest and upper back. Itchiness/burning sedation comes and goes. Lasting for one week so far.
late for shingrix 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. The registered pharmacist reported that the patient was late for shingrix 2nd dose. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.  The reporter asked if patient should be revaccinated. No other vaccine details were provided. The reporter consented to follow up.
Patient received COVID vaccine (Moderna, dose 1) on 4/14/2022. On approximately 4/15/2022, pt developed chest pain. On 4/16/2022, pt used methamphetamine. On  4/18/2022, pt was evaluated in the hospital emergency department and found to have myocarditis. He was admitted to the hospital. As of today (4/19/2022), he remains inpatient, doing well.
Arm extremely sore for 2-3 days after injection. Continual soreness and reduced range of motion still present five weeks after injection. Upper left arm at injection site.
Patient developed maculo-papular rash on both thighs where vaccines administered within 24 hrs of receiving the vaccines. Rash resolving 3 weeks later. No fever, leg swelling, redness, or other symptoms. Patient's mom made physician aware 3 weeks later.
Headache above left eyebrow and irritated. Nausea, tired. Started the next day.
Dizziness, blurred vision, cold sweat lasting only about 2-3 minutes, but fading away slowly over the next hour. No medical help sought.
have problems; all gotten covid 19; all gotten covid 19; This is a spontaneous report received from Pfizer sponsored program regulatory authority Support. A contactable consumer (sister) reported for male patient (brother).  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Not reported), via an unspecified route of administration on unspecified date as a dose 2, single and dose 1, single for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Reporter was seeking information receiving the 3rd booster shot for her and her husband. She had lupus and fibrosis of the heart and her husband was diabetic. On an unspecified the reporter stated that her brother, sister-in-law and nephew had all got COVID-19 after being fully vaccinated. Reporter stated that they were mostly healthy but they " had problems" her sister-in-law just had got out of the hospital and her brother was still there. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Approximately, 30 minutes after injection, employee experienced redness and warmth at injection site.  Some induration of about 3-4cm has begun.
pt recv vax 19JUL97 & pt devel chickenpox that were described as unusual grouped type;
mom verbalized pt recv vax & same day pt kept going to sleep-like fainting & not wanting to wake up;when pt would wake up eyes looked very funny like was looking @ one thing for a long time;pt taken to hosp-hosp x 3 days;
Patient referred to ER on 11/27/20 due to lower extremity weakness since 11/20/20. Released with diagnosis of Guillain Barre Syndrome.