chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Excursion cumulative duration 19.3 hours; No adverse event; First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours).    No concomitant medications were reported.   It was reported that, excursion took place on 15-Dec-2022 through 27-Dec-2022 and maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. HCP informed that no reports of side effects had been reported to them.  No treatment details were reported.
Pt developed a generalized erythematous rash which was pruritic and urticaria. Treated with Zyrtec.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2021 HYPERCHOLESTEROLEMIA R09.02 HYPOXEMIA 3/19/2021 HYPERCHOLESTEROLEMIA
tachycardia (fast heart beat); weakness; dizziness; hands were clammy; more than 35 days passed and she did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-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 TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose). At the time of the report, TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness) and COLD SWEAT (hands were clammy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication were provided.  No treatment medication were provided.  No lab data were provided.  Reporter decided not to get the second dose as she did not knew if she was allergic or not. Now she was thinking of getting the second dose and she wonders if she should get it, given her reaction and if she were to get it should she start the series all over and Would it be the same to get a booster shot.
Patient was coherent during initial injection, as I removed my gloves and asked he remain in the waiting area for 15 minutes his chin fell to his chest and he began to breath heavily. I spoke to him and there was no response. He then began making snoring type noises and lifted his head but again was unresponsive. Patient then slumped sideways in the chair. I made one last attempt to arouse him with firm strikes to the chest and calling his name. I retrieved the EpiPen from the e-kit and as I removed it from the box he became conscious. He opened his eyes and gasped and tremored slightly. He was not immediately responsive verbally. I observed him carefully to evaluate if he was going to have a seizure, but he then became coherent. He was alert and oriented to time and place but did ask how ling it had been since the vaccine. He admitted to having a problem with needles and stated that was the root of the reaction. He does not remember any reactions to previous vaccines but also could not recall his last vaccination. We brought the patient water and offered snacks while he recovered in the patient care area. Approximately 20-30 minutes after the initial event the patient began vomiting. After a few minutes of vomiting he said he felt a little better and wanted to go to his car to lay down. Multiple times we asked if we could call someone to come pick him up and offered to have him seen by paramedics that happened to be shopping in store. He declined both offers and stated he would lie down in his car and call someone if he did not feel well after awhile. Staff checked on him in his car and he was instructed to call in before leaving. Upon trying to check on him again it was noted his car was gone. I called the patient and he assured me he was ok and he was now at home.
Narrative:  Pt received the PPSV23 vaccine and then called back to let staff know he had a rash "head to toe." He was prescribed a medrol dose pack, and no complaints were noted after medication mailed.
Mild aches; lethargy; fever 100.7; This is a spontaneous report from a contactable Consumer (patient). A 51-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via unspecified route of administration in left arm on 17Feb2021 15:45 (age at vaccination was 51 years), as DOSE 2, SINGLE for COVID-19 immunisation at hospital. The patient medical history included known allergies of penicillin. He did not receive other vaccine in four weeks. He received gabapentin (NEURONTIN) in two weeks. He had not Covid prior vaccination and he did not test Covid post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced Mild aches, 100.7 fever, lethargy on 18Feb2021 07:00 AM. He did not receive treatment for adverse events. The outcome of events was recovering.  Information about lot/batch number has been requested. Follow-up attempts were completed. No further information was expected.
weak.numb, abdominal pain, dizzy, dry mouth, EMS evaluated, pt. refused transport.
Patients received half a dose for booster purple border (0.25mL); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611784 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611784:Patient 1
My symptoms began on March 7, 2023, in the afternoon when I started sneezing followed by congestion.  Just after that I had tightness in my upper chest and phlegm.  This happened very fast.  The next day I felt the same, but I was very tired and had head congestion.  I lost my voice.  I tested positive for COVID-19 on March 9, 2023.  I spoke with my doctor and got a prescription for Paxlovid.  For several days I took two naps a day.  I am still a little bit fatigued today.
t103, rash on rt leg 1JUN97;4JUN97 seen for fever x 4 days;5JUN97 fever, broke out in rash;9JUN97 fever 104.4;
patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster).    No concomitant medications were reported. It was reported that  patient received a Moderna covid19 booster dose for children was given to adult and reports 0.5mL of the NDC 8077727599 which is the Moderna Covid 19 vaccine booster doses for pediatrics blue cap/purple border label. Caller does not know what is the next step for the patient in resolving this issue. Caller does not have patient information at this time. Caller provided phone number if safety team needed to follow up. No treatment medications were reported.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications
16OCT97 310PM mom reports pt fussy yesterday evening & gone;APAP given;3AM 16OCT97 sick w/stomach--given APAP but last dose 830AM;babysitter reports pt w/blue hands-white around mouth;ot active as usual;
Pt recv vax on 12/14/98; on same day pt exp fever (104F)
Temperature peaked at 101.7, chills, little confusion, but the temperature is coming down due to vinegar and water on head.
Fever of 100.7 on May 20 Fatigue may 20, 21 Nausea May 20 Red, inflamed area on left arm, 2.75x4.5 inches, still there today May 22
This spontaneous report as received from a physician refers to a 12 year old female patient. On 06-AUG-2012 and on 28-NOV-2012, the patient was previously vaccinated with the first and the second dose of GARDASIL. On 22-MAR-2013, the patient was vaccinated with third dose of GARDASIL (lot # 0459AE, expiry date was 13-DEC-2014, route and dose were not reported)that was improperly stored at temperature 29 Fahrenheit (F) to 29F. No reactions of any kind was reported. This is one of the four reports received from the same reporter (MARRS# 1305USA017145, 1306USA003145 and 1307USA014755). Additional information is not expected.
Large local reaction right upper arm - red, firm, hot bruise present. Gave appointment to check/Mom later cancelled.
Moderna COVID booster shot (0.25ml) was given to instead of Flucelvax.
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2014 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Rash, hives, developed 3hrs post initial influenza vaccine treated with Benadryl.
Case number PHEH2015US003126, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 16 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 04 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Began choking and vomiting x3 while sleeping.  Continued to vomit into the night.
received twinrix 3/22/04 - late 3/23/04 client developed stomach pains, nausea, diarrhea - continued thru the night and into next day. Pt taking OTC medications for diarrhea, by 3/26/04 had recovered
Used albuterol inhaler- didn't help. Received Hep B immz. at 3:00 pm 4/14/04 at 1 am, 4/15/04 complains of SOB, chest pain, runny nose, headache & slight sore throat. EMT's came & found no reason to transport to hospital. Took to doctor 4/15/04.
Sore arm; swelling of the lymph nodes in right arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm) outcome was unknown.     No concomitant drug was reported. Patient received bivalent vaccine as second booster dose. No treatment drug was reported.   Reporter did not allow further contact
Rash, urticaria & joint swelling (knees and elbows), sore throat.
Patient experienced swelling in the left axilla immediately after each vaccine. He now is experiencing axilla swelling in the same left side at random times and it resolves spontaneously.
This spontaneous report as received from two nurses refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 25-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (dose and route of administration were not provided; lot # L019287, expiration date: 14-SEP-2017). No adverse events were provided.
Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow up include the Reporter information (Alternate phone number), Patient demographics (Race, Ethnic group) and Vaccine information (Anatomical location and Route of administration).
pt recvd vax & 9 hrs later devel momentary paralysis in the lower half of body characterized as loss of movements & sensation; 31AUG93 pt reported sl tingling;
Patient was given an adolescent dose and not an adult dose of the vaccine in error. No adverse reaction noted.
Follow up report to first VAERS report (1248256) - Entire (all over) breast tenderness (the nipple tenderness has been there since within a couple day after the vaccine - and that hasn't gone away). Dr said I'm having an inflammatory response to vaccine and they have referred me to a rheumatologist (gave me a referral) - joint pain and itching hasn't gone away at all. (The really bad rash on my neck, upper chest and torso and back on day three - that rash is gone but that tingling and itching of having the rash hasn't  gone away.) I'm working still but I'm working from home - so that has been okay - although some days I feel worse then others.  I noticed yesterday that my breasts were swollen/lumpiness. Was born with fiber cystic breasts - since menopause that has gotten better but now this feels like it did back then - feels like it did when I was going to start my period. I haven't had a period since five years ago. Eye sensitivity: Normally have dry eyes but it's worsened. I have to put drops in multiple times of day. I literally wake up in the middle of the night with almost a sandpaper feeling in my eyes and have to put drops on them. I have been doing acupuncture - it will be my third time today - it helps with stress and the anxiety from these symptoms.  They wanted me to take steroids - I'm trying not to do something like this because I am so sensitive to these types of things.
feeling sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Aug2022, outcome "unknown", described as "feeling sore".  Additional information: The patient received two shots of the pfizer vaccine and remembered feeling sore the first days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I went to give blood on March 11, 3 weeks after receiving my second dose of the Pfizer vaccine for Covid 19. The nurse told me I had a very irregular erratic pulse and sent me to my physician immediately. While there my EKG confirmed that I had a high amount of Pre-Venticular Contractions (PVC?s). I was sent to the Heart Clinic immediately. They sent me home for two days with a Holter Monitor. The monitor revealed 1/3 of my heartbeats were PVC?s. I was scheduled for a heart ablation surgery on April 29, 2021.
Pfizer given by accident.  Patient was due for a second dose of Moderna instead.  No reaction
Red "splotches" noted on face only. Non-raised. No pain or itching. Symptoms lasted "a day or two". Resolved without treatment.
1st Dose was given on 04-07-21 2nd Dose was given on 04-21-21 The timeframe between the vaccines should be 3 weeks, this vaccine administered to patient was given at 2 weeks apart.
Myalgia, Arthralgia, chills Narrative:  Other Relevant History: