chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous repot has been received from a health care professional, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 08-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a dose of 1 dosage form as prophylaxis (lot number: W020525, which was determined to be valid, with an expiration date on 14-DEC-2023) (strength, scheme, route and anatomical location of administration were not reported).   The administered dose underwent a temperature excursion of 30 degrees Fahrenheit (F) for 3 hours and 15 minutes. There was not any previous temperature excursion. No adverse event was reported. (Improper storage of product in use)
A couple of days after my 2nd shot, I started feeling sharp, deep pains in my heart. They did not last 24 hours, but would come and go, lasting 5-10 minutes each time throughout the day and night for about a week, maybe 10 days. There was no consistency to them. It would happen when I was active or still.
Lethargy, diarrhea, nausea, all over body aches, intense throbbing headache, temperature ranging from 101-104 lasting 24 hours, dull chest pain.
The week prior to my symptoms beginning, my wife and two children had contracted Covid. On 05/26, I began to experience head cold like symptoms, congestion, coughing, stuffiness. I do suffer from seasonal allergies, but I went ahead and took an at home Covid test which came up negative. I was experiencing head stuffiness, cough, persistent nasal drip that lasted from Thursday, 5/26 to the following Monday morning. I went for a PCR test on 05/27 which came back positive. I had a telemedicine visit after receiving my results and the doctor  prescribed Flonase, Sinex nasal spray and a Wixela inhaler. I was also taking Tamiflu cough and cold to help treat the symptoms. They did send a prescription for a Medrol pack which I never ended up using. I was still testing positive for Covid until this morning 06/09, 14 days after testing positive originally.
Moderna Covid-19 vaccine EUA - Patient was administered her 2nd Moderna vaccine 21 days after her 1st Moderna dose.
This spontaneous report was received from a certified medical assistant concerning a 12 week old patient. The Certified Medical Assistant reported that on 02-DEC-2013, the patient was vaccinated with a dose of ROTATEQ (lot # H10063; expiration date 02-NOV-2013), 2 ml one dose, oral. No adverse effect was reported. Patient's outcome was unknown. Additional information has been requested.
June 3rd Patient complained of arm pain but I didn't think much of it. June 4th in the morning, Patient was complaining of pain in left arm and axillary area near armpit. When I checked him out I noticed a lump in his axillary near left armpit. The lump felt slightly smaller than a golf ball. Called pediatrician and they thought it was likely a mild side effect of vaccine and instructed me to give motrin and monitor. Symptoms lasted for about 4 days.
Left arm urticaria starting 01/20/2021. Patient seen on 01/25/2021, only remaining symptom was puritis at the vaccine site. Pt treated with topical steroids.
Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient; Second booster dose administered to 45 year old patient; Second booster dose administered to 45 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 045L21A) for COVID-19 vaccination.     It was reported that patient had no allergies. It was reported that patient never had COVID positive test or diagnosis. It was also reported that patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient received first booster and second booster dose of Moderna COVID-19 vaccine. It was reported that the vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.
started experiencing headaches, nausea, and vomiting; started experiencing headaches, nausea, and vomiting; started experiencing headaches, nausea, and vomiting; Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting), VOMITING (started experiencing headaches, nausea, and vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (The IM injection was given into the right arm with lot number EL9263.) on 20-Jan-2021 and Pfizer (The IM injection was given into the right arm with lot number EN2601.) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021). On 10-Dec-2021, the patient experienced HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting) and VOMITING (started experiencing headaches, nausea, and vomiting). On 09-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021) had resolved. At the time of the report, HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting) and VOMITING (started experiencing headaches, nausea, and vomiting) outcome was unknown.            Patient has no known food or drug allergies. Concomitant medications include Vitamins. Treatment information was not provided.
Pt recvd vax 11MAY92 & approx 10JUN92 pt devel mumps-like illness which was characterized by rt  parotitis w/pain & swelling & fever 103;
A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that a 44 year old female vaccinee developed redness and swelling at the injection site which was warm to touch after receiving Fluvirin on 10/27/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.
This spontaneous report as received from an office manager (also reported as healthcare worker) refers to five unknown patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of ROTATEQ, oral (dose and lot number not reported). No adverse effects were reported. Additional information has been requested.
Right upper arm red, warm to touch, painful, edematous approximately 1 day after vaccine administration. Client states taking Advil, advised warm moist heat. Client states redness and pain subsiding.
given expired Daptacel, No AE; Initial information was received on 18-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA046254, 2020SA046248 and 2020SA046250 (same reporter).  This case involves a 15-month-old female patient (patient: 01) who was vaccinated with 0.5 ml expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 11-Feb-2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included 4th dose of HIB VACCINE CONJ (TET TOX) (ACT-HIB) on 11-Feb-2020.  It was actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
T/C received from pt on 5/3/16 stating that since vaccination she has had felt pressure in her neck and c/o difficulty breathing sometimes. Reports having had fever after vaccine. Still c/o neck pain and feels as though it's difficult to take a deep breath. Saw PCP on 5/2/16 who told her to contact Imm. Clinic. No treatment.
after administration of this shot, patient went shocky (vasovagal). Diaphoretic, tachycardia, tunnel vision, nausea.
Narrative: Patient developed anxiety following first dose of Moderna covid vaccine. Patient was given an ice pack and place to lay down with relief. Patient was able to depart with no additional interventions.
AFTER GETTING VACCINES PATIENT FAINTED FOR A COUPLE OF SECONDS. VITAL SIGNS BP:110/67 PULSE 114  10 MINUTES LATER 110/72 PULSE 128
Headache, joint ache, fever, left deltoid swelling and left underarm/armpit swelling (size of half of a tennis ball)
Rash around the injection sight. About 2 inches in diameter and has begun to itch. Has not gotten worse since first noticed
I had a severe case of Anaphylaxis - both eyes swollen 20 hours after second vaccine taken - restless - problem with breathing - high fever - headache and chills
itch; fatigue; swelling face; Ear lobe swelling both; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both), PRURITUS (itch) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20I) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Allergy aggravated since 18-Feb-2021.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both) and FATIGUE (fatigue). On 22-Feb-2021, the patient experienced PRURITUS (itch). At the time of the report, SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both), PRURITUS (itch) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.   This case was linked to MOD-2021-096583 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: event outcome
arm  was extremely sore; swelled; hot and swollen; This spontaneous report as received from a consumer refers to a female patient of unknown age.    On JUN-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On 07-JUN-2019 the patient experienced pain in extremity, injection site warmth and swelling.    The outcome of pain in extremity and injection site warmth is unknown. The outcome of swelling was reported as recovering/resolving.
Inflammation of ulnar nerve ; Went to urgent care at Medical facility on 03-21-2021, received shot of toradol; Went to see Dr. on 3-18-2021 received prednisone and Percocet. Dr. said I did not sustain SIRVA, but instead the moderna caused inflammation of the ulnar nerve; virtually no improvement
This spontaneous report as received from a medical assistant refers to a 10 week old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA010964; US-009507513-1807USA006808; US-009507513-1807USA006809; US-009507513-1807USA006810.
She also has burning sensation.; She started noticing that everything that she drank or ate, she feels that she gets reflux; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux) and BURNING SENSATION (She also has burning sensation.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LINACLOTIDE (LINZESS), FLUOXETINE HYDROCHLORIDE (PROZAC), LORATADINE (CLARITINE) and PHENTERMINE for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux). On an unknown date, the patient experienced BURNING SENSATION (She also has burning sensation.). The patient was treated with ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Acid reflux (esophageal) and Burning sensation, at an unspecified dose and frequency and SIMETICONE (GAS RELIEF) for Acid reflux (esophageal) and Burning sensation, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux) and BURNING SENSATION (She also has burning sensation.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
3 days/p immun. injection site became redden to 17cm X 16cm warm & indurated
temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 4th of 4 reports. This physician reported for a patient of an unknown age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown), via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Patient medical history was reported as COVID-19 positive. Patient concomitant medications were not reported. On an unknown date patient was temporary delayed loss of taste. Outcome of the event was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
Bright red rash not at injection sight which is hard to touch and hot. Border drawn at time of development, exceeding borders drawn with hours.  Developed 5/21/2021 09:00.  Not treatment, just monitoring.
Rt delt arm area red, swollen 1" hard area, painful, advised to alternate warm/cool compress and Ibuprophen PRN office visit if increased inflammation.
constantly coughing; throat is itching; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (constantly coughing) and THROAT IRRITATION (throat is itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ASPIRIN [ACETYLSALICYLIC ACID], ALENDRONATE SODIUM (ALENDRONATE), MONTELUKAST, DICLOFENAC and LORATADINE for an unknown indication.    On 24-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 COUGH (constantly coughing) and THROAT IRRITATION (throat is itching). At the time of the report, COUGH (constantly coughing) and THROAT IRRITATION (throat is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Treatment information was not provided.
pt recv vax & exp fever to 102, chills, myalgia, arthralgia, fatigue, & weakness;
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: multiple prominent lymph nodes (thyroid/neck) demonstrating loss of normal fatty hila-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: extreme fatigue, swollen/sore neck area. sent for ultrasound which presented with 'multiple mildly prominent lymph nodes that are demonstrating loss of normal fatty hila'. Did not present immediately, approx 7 days after 1st dose.
Soreness of the arm 2 hours after injection. The night of the injection I had chills, muscle and joint pain the point I could not sleep and a severe headache and tiredness.
Pediatric patient was administered the Pfizer (5-11y) COVID-19 Bivalent booster (10mcg.ml) which was not diluted. There has been no documented harm during the observation period post-vaccine.
Patient started having severe nausea, resulted in vomiting which he rarely does. Low grade fever, body aches, and flu-like symptoms that lasted 72 hours. Patient stated he went to the emergency room after 48 hours of symptoms afraid he had caught something while in store. They gave him phenergan which helped with the nausea.
Sensation of anxiety and minor "chest pressure" began 1/25/21 and continued at least through 1/26/21.    Watchful waiting was recommended.
After almost two weeks I started feeling feverish and achy all over my body. I had head pain almost to the point of migraine, felt weak and lost my appetite. Every time I stood up I felt sharp pain on the top of my head and got lightheaded. These symptoms responded a little to medication such as Tylenol and DayQuil but steadily worsened over the course of a few days then suddenly worsened. I woke up yesterday feeling more feverish and weak to the point where my mobility was compromised. My head felt like a balloon and hurt around the base of my skull and the top of my head. I had even more severe light sensitivity and could not tolerate sound. I also couldn?t bend down to pick something up or tie my shoes because of the lightheadedness and pain. The headache and migraine symptoms responded well to Toradol and Excedrin but returned full force after any medicine wore off. I am not getting any better despite rest and treatment.