chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with a scratchy throat and a little sinus congestion on Sunday evening, the 12th. On Monday morning, I woke up with a headache, a sore throat, a runny nose, and sneezing. There was a little bit of coughing, but I have coughing with the Cystic Fibrosis. It wasn't more than normal. The next day, I felt okay except for sinus congestion and runny nose. I did have some fatigue. The sinus congestion and runny nose lasted approximately 7-10 days with a periodic headache. I had one incident of loose stool, but I don't know if it was related to COVID-19 or to holiday and traveling. It was very mild. I ended up with a UTI, but I don't know if it was related to COVID-19 or something else.
1) Pain/soreness at injection site - Ongoing 2) Fever Blisters around mouth and lips - Ongoing 3) Large pustule under nose - now healed
Nurse  administered a second dose of Pfizer Lot # EN6208 to patient  and patient had received 1st dose of Moderna Lot # 010A21A on 2/26/21 . Runner employee, ,noticed the patient's Immunization Vaccination Card that the patient had received a dose of Moderna and a dose of Pfizer and he alerted Observation Nurse,  who stated Patient waited in the 15 minute wait area with no issues or side effects.  Per Nurse Manager,  informed patient she received second dose of Pfizer today and patient verbalized no issues.  advised patient to call 911 or go to ER if she experiences any serious side effects such as having difficulty breathing.
Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021; No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 027A21A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
This spontaneous report refers to a 69-year-old female patient who was reporting on herself. The patient did not have any concomitant medications nor pertinent medical history. The patient was allergic to penicillin. In approximately 2012 (reported as about 4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported. On 28-JUN-2016, the patient experienced a mild case of shingles on her abdomen and lower back. The patient received unspecified treatment. There was no lab diagnostics and studies performed. The patient's outcome was reported as not recovered/not resolved. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information is not expected since the healthcare professional's contact details were not provided.
LARGE WARM, INDURATED PAINFUL LOCAL REACTION. PAIN STARTED IN THE EVENING FOLLOWING, ERYTHEMA AND WARMTH STARTED SMALL WITHIN ONE DAY AND HAS RAPIDLY INCREASED IN SIZE. TODAY DEVELOPED  PAIN.
No additional AE reported; GARDASIL 9 had been involved in multiple low temperature excursion; This spontaneous report was received from a medical assistant referring to a 13 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 22-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030749, expiration date 16-MAR-2023) after temperature excursion for prophylaxis (product storage error). The vaccine had been involved in multiple low temperature excursion: 35 F for 0.25 h on 03-NOV-2021, 35 F for 0.75 h on 04-NOV-2021, 35 F for 0. 5 h on 05-NOV-2021, 35 F for 0. 25 h on 12-NOV-2021, 35 F for 1. 5 h on 15-NOV-2021, 33 F for 4. 25 h on 16-NOV-2021, 34 F for 2. 25 h on 17-NOV-2021, 34 F for 1. 25 h on 18-NOV-2021, 34 F for 0. 25 h on 22-NOV-2021. No adverse event was reported.
Injection site lump; minty/metal taste in my mouth; I feel weird; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird) in a female patient of an unknown age 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 INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird). At the time of the report, INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
Arm swollen, red, itchy, hot, with hives. Started around  3/17 continued to worsen for 4 or 5 days. Visibly better on the 22 but I suffered from a headache, upset stomach, and I have been tired. I put topical benadryl on it during the day and took benadryl for 3 nights at bedtime.
fever; headache; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 24Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history included asthma, peanut allergy, and latex allergy. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. The patient experienced fever and headache on 25Jan2021. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
fatigue; loss of appetite; Slight sore arm; headache; my pulse went up 139; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight sore arm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; HEART RATE INCREASED (non-serious), outcome "recovered" (2021), described as "my pulse went up 139". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: This 65 plus year-old female patient received first shot February 16: Slight sore arm headache February 9, next day total fatigue, loss of appetite, my pulse went up 139. Called (Doctor) he said see how day goes, pulse went down to normal by late afternoon.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle aches; joint pain; headache; big red spot that was sore; Big red spot that was sore; diarrhea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue). On 04-Feb-2021, the patient experienced MYALGIA (muscle aches) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown and MYALGIA (muscle aches) and ARTHRALGIA (joint pain) had not resolved.
Patient was administered 2.5 ml of vaccine instead of 0.25ml.  Patient was observed after vaccine for over 30 minutes and was not having any pain or adverse reactions (was not experiencing injection site reaction).  Patient was given pharmacy phone numbers and was also informed that the pharmacy will follow-up tomorrow and the next day.  The manufacturer was called, but they were unable to provide any recommendations.
fatigue for 10 days after second dose. Vertigo started two days after second dose. Delayed menstruation so far - over 6 days late, cycle usually very regular.
Patient is a 68 y.o. female who presents today for chief complaint of weakness with history of multiple sclerosis, sleep apnea, hyperlipidemia, chronic memory loss, hypothyroidism, depression.  She presented to Spectrum Health Big Rapids Emergency Room on January 8, 2022 by EMS for weakness.     Patient reports she slid out of bed onto the floor and her husband was unable to assist her in getting back up off of the floor. They contacted EMS who transported to the emergency room for further evaluation.  Patient reports prior to emergency room visit she was at her previous baseline health although maybe a little weaker and fatigued than normal.  She does feel a little foggy with memory since yesterday.  She was diagnosed with multiple sclerosis in 1993. She does not report recent history of flares from multiple sclerosis or recent hospitalization or steroid use.   She does state that she has noticed some left-sided weakness specifically in her left leg.  She has double vision which she attributes to history of MS without new vision or speech changes.   At baseline she ambulates with a walker at home.  She reports no known sick contacts.  No known recent illness.  She endorses some mild postnasal drip but otherwise no symptoms of illness.  She does self report a history of hepatitis B which she states has been present for years and she has never had difficulties with this diagnosis and is not currently taking any medications. Denies cough, chest pain, heart palpitations, dyspnea, abdominal pain, nausea, vomiting, diarrhea, hematuria, urinary frequency, dysuria, wounds. She denies history of hypertension, stroke, congestive heart failure, cardiac history, DVT, pulmonary embolism, blood clotting or bleeding disorders, kidney disease, diabetes.   In the ED patient was febrile and tachycardia. Labs Signiant for WBC 19, procal 0.15, mildly elevated LFTs. CXR obtained concerning for possible LLL mass. CT thorax obtained showing no evidence of mass but possible pyelonephritis. UA negative for infection. Urine culture ordered. Blood cultures drawn. Patient flipped into afib RVR and required IV and PO Cardizem. She also received 1 L IVF, Tylenol, and Rocephin IV.
Within 5 minutes of injection, arms felt heavy and tingly, tongue was tingling, felt nautious and felt dizzy, collapsed in waiting area but did not loose conciousness.  Was disoriented and was slurring while trying to talk, and pulse was 98.  Nurses arrived promptly and gave her orange juice and rested for 15 minutes.  Blood pressure was taken after the rest and pulse returned to normal 72.  Was released to go home.  Felt very tired and sleepy the rest of the evening.
Client did not receive full dose of vaccination. The vial that the client received the booster dose from was inadvertently diluted a second time with saline after vial was used. Regulatory authority notified and gave recommendation to report VAER, notify client, and give recommendation to client that client received some vaccine, but not full booster dose. Due to receiving a partial dose, no further doses are recommended. 10/21/2021, 1606, client notified and given all information with good understanding verbalized.
I got the flu after getting the vaccine and I experienced a ruptured sebaceous cyst on the left side of face. I noticed this on October 26, 2021. I was referred to an ENT who diagnosed it properly. I had surgery on December 08, 2021.
While entering data into the database, our team member noticed that the patient was only 14 years old.  He registered using our automated scheduling system with the date of birth of 3/20/1947.  Upon arrival,  the patient's date of birth is documented on the consent as 4/12/2006.  We checked in and there is no patient listed with a birthdate of 3/20/47.  The 14-year-old is in the database with an extensive vaccination history.    His mother appears as if she completed the paperwork and signed the consent for him. Patient scheduled for 2nd on 4/2 but didn't arrive.  We were going to discuss the incident with the guardian.
how long before the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had side effects. The reporter asked how long before the side effects disappear.
rash on both arms developed day after receiving pfizer bivalent vaccine, resolved by the following day.  did not use anything topically or orally for ADR, did not contact her doctor.  previous vaccinations were with moderna mrna vaccine and no rxn reported
Vomiting after 10 minutes, severe nausea throughout the next 12 hours.
swollen eye; eye that hurts really bad; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen eye that hurts really bad.  The patient's medical history was not provided. No concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown).   On an unknown date, the patient experienced swollen eye that hurts really bad. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, swollen eye that hurts really bad was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
AST - 476; ALT - 103; LFTs elevation; This is a spontaneous report from a contactable consumer (patient) reported for herself. A non-pregnant 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 (at age of 20 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included lithium; lamotrigine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. LFTs elevation 2 weeks post second dose AST (Aspartate aminotransferase):476, ALT (Alanine aminotransferase): 103, Adverse event start date was 21May2021, came back to normal an additional 2 week after this (on 04Jun2021). No treatment received. The outcome of the events was Recovered on 04Jun2021.  information on the lot/batch number has been requested.
Diarrhea; Couldn't see well; Couldn't eat anything.; Lay down for a while; Dry heaves; Dizziness; Fever; Headache; Vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), VISUAL IMPAIRMENT (Couldn't see well), FEEDING DISORDER (Couldn't eat anything.), FEELING ABNORMAL (Lay down for a while) and RETCHING (Dry heaves) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VISUAL IMPAIRMENT (Couldn't see well), FEEDING DISORDER (Couldn't eat anything.), FEELING ABNORMAL (Lay down for a while), RETCHING (Dry heaves), DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). On 16-Mar-2021, VISUAL IMPAIRMENT (Couldn't see well), FEEDING DISORDER (Couldn't eat anything.), FEELING ABNORMAL (Lay down for a while), RETCHING (Dry heaves), DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was specified.   This case was linked to MOD-2021-046614 (Patient Link).
ActHIB(unopened), Fluzone High Dose(unopened), Thyphim(unopened), Ipol(Opened and unopened)  and Tubersol(unopened) reached Lowest temperature was -17C degrees for 63 hour and  45 minutes, did not know the cause of the excursion with o adverse event; Initial information regarding this unsolicited valid non-serious case via the agency (reference number: 00316317) received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case was linked to cases 2020SA288422, 2020SA288477, 2020SA290000 and 2020SA290005.  This case involved 89 years old male patient who was administered with a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot: UJ450AA, expiry date: 30-Jun-2021), on 07-Oct-2020, via unknown route in right deltoid for prophylactic vaccination, which had a temperature excursion along with the vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported for all), at lowest temperature was -17C degrees for 63 hour and  45 minutes.  It was reported that 6- patients received vaccines that were not suitable for use post a temperature excursion. 5 received Fluzone Quadrivalent High Dose and 1 received Act-HIB.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   No adverse event was reported at the time of reporting.  It was a case of actual medical error due to product storage error temperature too low.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of an unspecified age, race and gender received PREVNAR 13 for immunization at single dose via an unspecified route on unknown date. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced swelling and bruising. The outcome of the events were unknown.
Red, papular rash on midriff, upper chest and "bumps" (not red) on upper arms and thighs.