chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: CL8982), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL8982), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Back Pain" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL; ATORVASTATIN; BASAGLAR; VITAMIN D3; TYLENOL; ADVIL [IBUPROFEN]. Past drug history included: Metformin, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including received Paxlovid from 12Aug2022 to 16Aug2022.
Syncope following immunization - while leaving immunization room; became awake while laying down Pt. on exam table with legs elevated.
Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Vacine given 9/16/09; pain, redness and swelling started 09/18/09. Pt parents gave him BENADRYL. Swelling was located ant. deltoid region of L arm and extended down to his elbow and back to his scapula.  Swelling resolved with BENADRYL fully after 2 days of BENADRYL.
Patient reported that she miscarried ~2 weeks following her vaccine (dose #1 of Moderna). She waited for a prolonged period of time prior to receiving 2nd dose (which is when she reported this to us).  Some of the exact details of timing were difficult for her to remember. However, she stated that she was in her 1st trimester and she had miscarried due to placental problems - spontaneous bleeding, leading to miscarriage.
100.3 degree temperature for 2 1/2 days chills, body aches, headache, nausea , soreness and swelling at injection site.
High fever, chills, body aches x 72 hours. Treatment: Tylenol  Vaginal yeast infection x 96 hours. Treatment: Fluconazole  Mouth sores x 36 hours. Treatment: none   Unusual vaginal bleeding, disruption to normal menstrual cycle x 14 days and counting. Treatment: none
Rash on arm in arm pit and traveled throughout the body i.e. ears, groin
Pt became dizzy after receiving vaccine. Pt laid down, oxygen given, fluids - pt upon leaving felt faint again pt laid down again & reassured by physician and discharged after 15 minutes.
DOSE GIVEN OUTSIDE OF 6 HOUR APPROPRIATE STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa antibiotics.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dose given outside of 6 hour appropriate storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside of 6 hour appropriate storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210532044.
Nausea and arm pain at first. Then throughout the day could not keep down food or water without vomiting.  Last vomit was around 5pm. The next morning, was able to keep down fluids and food. Arm still partially painful.
Manufacture revise the expiration date to 8/31/2022 after the vaccine have  been admistered.
Information has been received from a physician through a company representative concerning a male patient (age not specified) who in May 2007 (this week), was vaccinated with oral Rotateq. In May 2007 (this week), the patient experienced bloody stools. The physician also reported as experienced of a female patient (WAES # 0705USA03024) who also had blood stools after vaccination with oral Rotateq. One patient was two months old and the other patient was 4 months old (the representative did not know which patient (male or female) was 2 months old and which patient (male or female) was four months old). This was the first dose for the two month old and the second dose for the 4 month old. The 4 month old had no AE after he/she received the first dose. Upon internal review bloody stools was determined to be an other important medical event. Additional information has been requested.
On 6/23/21, I thought I was having vertigo or a stroke, I was completely shaky, spinning, almost pass out feeling. It lasted 10min. My equilibrium was off all day after, I had four days of severe headaches, my right ear bothered me and had a slight loss of taste. By Sunday 6/27/21 I had to go to urgent care as the right side of my face was not moving and my speech was slurring. They diagnosed me with Bells Palsy and asked if I had had the vaccine. I am still dealing with the Bells Palsy.
Cerebral Venous Sinus Thrombosis Covid vaccine on 12/17/2020, 1/7/2021 and 11/30/2021. After first two I had worsening Menorrhagia So started loestrin in 2/2021. exactly two weeks after my Covid booster I was admitted to the Neuro ICU with the thrombus.
This spontaneous report as received from a licensed practical nurse refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. On 14-JUN-2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # was not reported). On 03-DEC-2013, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (lot # was not reported). On 14-FEB-2014, the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular (lot # was not reported). Concomitant medication was not reported. No adverse effect reported. This is one of two cases from the same reporter (MARRS# 1402USA009214). Additional information has been requested.
No adverse event; Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022).    No concomitant product reported by reporter. More or less 170 - monovalent and 20 bivalent doses had been administered which were beyond the 30 day beyond use date. Vaccine administered on 23-Feb-2022 with lot number 042J21A after 30 days BUD date which was 17-Feb-2022. No treatment medication reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-704416 ( Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow-up received. Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
elevated heart rate. Normal is 65 BPM. At around 11:30 pm hear rate was 113 BPM. Today is back at around 70 BPM
fever; rash on his face; throwing up; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00796584) and transmitted to Sanofi on 04-Oct-2021.  This case involves an 18-year-old male patient who experienced fever (pyrexia), rash on his face (rash) and throwing up (vomiting) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date the patient received dose (once) of suspect INFLUENZA QUADRIVAL A-B VACCINE (Solution for injection in pre-filled syringe) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On 02-OCT-2021 the patient developed a non-serious fever (pyrexia), rash on his face (rash) and throwing up (vomiting) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  He went to HCP on 03OCT2021 and had urine test, COVID test and was given a steroid which was not filled yet.  Product used: Used. First time product used: No.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
87 yo patient arrived at clinic as walk-in.  Did not have vaccine card with her.  Stated she was here for bivalent vaccine.  RN reviewed data form and noted four COVID vaccines on record but failed to note fourth vaccine was Pfizer COVID 19 Bivalent vaccine on 10/24/2022.  Administered Pfizer COVID 19 Bivalent IM to left deltoid.  Realized error when entering data in record.  Patient advised no further bivalent vaccines advised and when to seek medical attention.  Pt remained 15 minutes in observation area with no adverse reaction noted.  Supervisor informed.  VAERS and Occurrence report submitted
This case was reported by a nurse and described the occurrence of accidental overdose in a 18-month-old female patient who received FLULAVAL (batch number 2G3J4, expiry date 30th June 2015. On an unknown date, the patient received FLULAVAL 1 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information: A 18 month old patient was inadvertently administered FLULAVAL QUADRIVALENT.This case was reported by a nurse and described the occurrence of accidental overdose in a 18-month-old female patient who received FLULAVAL (batch number 2G3J4, expiry date 30th June 2015. On an unknown date, the patient received FLULAVAL 1 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information: A 18 month old patient was inadvertently administered FLULAVAL QUADRIVALENT.
This spontaneous report as received from a registered nurse refers to an unspecified patient. On an unknown date the patient who is 40 years old was vaccinated with a dose of PROQUAD (dose, route and lot # not reported). No adverse effects reported. Additional information has been requested.
Ongoing hospitalization, pneumonia from COVID-19 with actute hypoxic respiratory failure. Treatment: decadron, remdesivir
This case was reported by a other health professional via other manufacturer and described the occurrence of sickness in an adult patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included accident (years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, however captured as adult as per vaccine indication. The patient  experienced sickness for 24 hrs after 2nd dose of Shingrix. There were no further details were provided.
in adverted administration of a 4th dose of Engerix-B; was supposed to be receiving the last dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received HBV (Engerix B) (batch number n4ga4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received first 3 doses of Engerix B on an unknown date).   On 12th July 2021, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not reported. The nurse reported that, the patient was supposed to be receiving the last dose of Havrix but received in adverted administration of 4th dose of Engerix-B, which led to extra dose administered and wrong vaccine administered.  No further events were reported. The health care professional agreed on follow-up.
pt recv vax 23SEP97 & 24 & 25SEP97 w/local erythema, induration 4x6cm resolving in 3 days;
A kind of strange feeling; The whole body was tied all over; Slight nausea; Soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (A kind of strange feeling), VACCINATION SITE PAIN (Soreness), FATIGUE (The whole body was tied all over) and NAUSEA (Slight nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027DOA) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 10-Jan-2021, the patient experienced FEELING ABNORMAL (A kind of strange feeling), FATIGUE (The whole body was tied all over) and NAUSEA (Slight nausea). At the time of the report, FEELING ABNORMAL (A kind of strange feeling) and NAUSEA (Slight nausea) had not resolved, VACCINATION SITE PAIN (Soreness) outcome was unknown and FATIGUE (The whole body was tied all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sore arm for nearly one month, worst a couple days after vaccination, getting a little better, but still sore. No rash, itching or lump.
lost sense of smell for weeks after both doses of Shingrix.  Sense of smell later returned.
Patient presented to clinic for second dose of vaccine.  Patient did not report (and site did not confirm) that her first dose was received in January 2021, where she was given the COVID mRNA vaccine manufactured by Moderna.  Patient's second dose had been delayed by COVID diagnosis and subsequent receipt of monoclonal antibody product (after the first dose).  Patient tolerated injection well, but was notified by staff of the error.
dose in October 2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2020).   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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023).    Concomitant medication details not reported by the reporter. Vial did not undergo any temperature excursions. Vial was initially stored in the refrigerator on 16-MAY-2023. Treatment details was not reported by the reporter. This case contains information about 1st patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-730080, US-MODERNATX, INC.-MOD-2023-730081, US-MODERNATX, INC.-MOD-2023-730083, US-MODERNATX, INC.-MOD-2023-730114 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730083:(Patient 04 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730080:(Patient 02 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730081:(Patient 03 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730114:(Patient 05 out of 05 patients)
Itchy face and arms. Felt like poison ivy, but NO rash presented. Throat was swollen and felt like strep throat within an hour of the shot. Swelling went down  18 hours.
More than 24 hours after receiving the first dose of the vaccine, chills suddenly crept up on me.  Upon arriving home, I took my temperature which registered at 101.5.
Patient c/o symptoms starting around 9/22 with chest pain, cough, and back pain in left upper back. COVID test 9/23  Positive. Hx of RA, Asthma, Hyperlipidemia, and COPD on 2 L of Oxygen.
eyes were blood red; This is a spontaneous report received from a contactable consumer (patient). A female patient with age reported as 77 (unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 22Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received the first dose of the vaccine the day before the present report (22Feb2021) in the afternoon. The day of this report (23Feb2021), she noticed her eyes were blood red. She also asked if there were any reports of eyes being blood red. The outcome of the event was unknown.  Information about lot/batch number has been requested.