chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case belongs to patient no 21 out of 25 patients.  Concomitant medications were not reported.  No adverse event was reported patient.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Master case
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated.  Received 50mg of Benadryl.
I went to the pharmacy to get the flu vaccine for school. I verbally stated I wanted to the flu vaccine twice, and was asked to fill out a consent form that asked what vaccine I wanted to get. I circled that I wanted the flu vaccine. I was then asked to wait in the waiting area to be called for the vaccine. The pharmacy tech opened the door and stated "Do you want the Pfizer or Moderna?" My fiancé and I looked at her confused because we didn't know who the manufacturer for the flu vaccine was, so we asked her what she recommended. She stated "We do a lot of Pfizer here", so I said "then let's go with that!" She leaves for a few minutes and then comes back and says she'd ready for me to enter the administration room.  I don't like needles, so I did not look at what she was doing. After I received the vaccine, I asked her for documentation to present to my school showing that I received the vaccine. She hands me the paper and I walked a few steps and saw on the paper that she wrote "Covid-19". I immediately went back to the counter and asked her if she gave me the covid vaccine instead of the flu shot. She said she gave me the covid vaccine because she thought that's what I was there for. I explained that I only wanted the flu vaccine and never asked for the covid vaccine. I told her I needed the flu vaccine before tomorrow for school, so she said she would give me the flu vaccine and that I will be "fine" if I receive both vaccines in the same day. I let her administer the flu vaccine in the other arm because I had to have it for school by the next day, but I was very upset. I complained to the Pharmacist and the Store manager and they stated they would file incident reports.
Sudden onset of lower back pain right lower lumbar area - had to go to local ER due to pain.
A non-serious, spontaneous report of "gave expired FLUMIST" was received from a registered nurse concerning a nine-year-old male subsequent to FLUMIST therapy. On 29-Dec-2008, the patient received expired FLUMIST, which had an expiration date of 28-Dec-2008. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Subsequent contact with the initial reporter on 13-Jan-2009 confirmed no adverse event occurrence. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received 09-Apr-2009: product complaint investigation results.
I felt pain in my left arm where the vaccine was injected, but not limited to the site, but also under the arm and in the full arm till the arm wrest.  Also, it included pain in the arm pit.  I didn't go to a doctor.  The pain was reduced after taking two 500 mg Tylenol, but there I still feel my left arm heavy and not normal.
One hour after DTAP and IPV, and no known oral or contact exposures, developed diffuse extremety itching whole body rash and "lump in throat". ER visit-not hives but diffuse macules on skin all else fine. Given 25 mg Benadryl po, epi pen jr and oral prednisone X 5 days
became very restless @8PM; unable to rest or sleep; convuls 830PM shaking, eyes rolled back; fever 102 @ home;
equilibrium was off, felt like she was going to fall,felt off balance; also felt weak; where I swallow isn't right; a little diarrhea today; Felt weak and tired; got nausea really bad; left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium was off, felt like she was going to fall,felt off balance), ASTHENIA (also felt weak), OROPHARYNGEAL DISCOMFORT (where I swallow isn't right), DIARRHOEA (a little diarrhea today) and PAIN IN EXTREMITY (left arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore). On 05-Feb-2021, the patient experienced ASTHENIA (also felt weak), OROPHARYNGEAL DISCOMFORT (where I swallow isn't right), DIARRHOEA (a little diarrhea today), FATIGUE (Felt weak and tired) and NAUSEA (got nausea really bad). On an unknown date, the patient experienced BALANCE DISORDER (equilibrium was off, felt like she was going to fall,felt off balance). At the time of the report, BALANCE DISORDER (equilibrium was off, felt like she was going to fall,felt off balance), ASTHENIA (also felt weak), OROPHARYNGEAL DISCOMFORT (where I swallow isn't right), DIARRHOEA (a little diarrhea today), PAIN IN EXTREMITY (left arm was sore), FATIGUE (Felt weak and tired) and NAUSEA (got nausea really bad) outcome was unknown. Not Provided          No concomitant medications were provided No treatment information provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe papular rash, worse on face, head and neck. Papular urticaria on extremities, anticubicals, backs of knees. Pruritus. Benadryl PO, hydrocortisone cream. Felt like a severe sunburn, skin leathery, eyes swollen closed.
This spontaneous report as received from a physician via company representative refers to a 15 months old male patient. On 18-OCT-2013 the patient was vaccinated with PROQUAD (merck) (lot number J005177, expiration date 03-NOV-2014) (dose and route of administration were not reported). The physician reported that he had a patient who was administered with PROQUAD (merck) and was exposed to a child suffering from chickenpox and subsequently developed a breakthrough of chickenpox with the rash occurring all over his entire body on 26-JAN-2014. The patient sought medical attention via office visit. On unspecified date in 2014 the patient recovered from breakthrough of chickenpox. Relatedness between breakthrough of chickenpox and PROQUAD (merck) was unknown. Additional information has been requested.
DOD 4/27/21 AT HOSPICE. SPOKE WITH PATIENT 4/13 AND REPORTS HOSPITALIZATION NOT DUE TO COVID
Patient complained of numbness in the arm of the injection after vaccination.  Onsite EMS was called vitals BP 144/95 HR 106 . Patient feels better. Patient treated and released against medical advice.
15 minutes into post administration observation patient complained of dizziness.  This dizziness intensified over the next few minutes.  Patient moved to a cot in sitting position to obtain BP, O2, and pulse.  Moved into a supine position and complaints of nausea started within 5 minutes. Patient then placed on side and began retching without vomiting. Patient was able to talk and drink sips of water.  Complained of chest pain (described as pressure and similar to heart burn radiating to throat) and headache.  11:55am  911 contacted. Patient denied using or being prescribed nitroglycerin for previous chest pain complaints. Presence of urticaria on neck and upper chest led to the administration of 50mg diphenhydramine solution by mouth at 12:00pm.  Rash dissipated.  Continued monitoring patient's BP, O2, pulse. 12:09pm EMS arrived and monitored patient. Patient still complained of headache and nausea. Patient offered trip to ER at 12:14pm. 12:17pm agreed to ER transportation. Left facility for ER at 12:20pm with EMS.
A person who has psoriasis and is in remission on medication for it, will they relapse? Well it happened to me; A person who has psoriasis and is in remission on medication for it, will they relapse? Well it happened to me; This is a spontaneous report from a non-contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown dose number, single for COVID-19 immunization. The patient medical history and concomitant was not reported. The patient experienced a person who has psoriasis and is in remission on medication for it, will they relapse? well it happened to me on an unspecified date. It was reported that A person who has psoriasis and is in remission on medication for it, will they relapse. Well, it happened to me. It was directly after the injection (caller: age unknown, female -did not remember if it was after the first or 2nd dose of the Pfizer covid vaccine). Now that I was going to need a 3rd injection and I started to clear up I was scared to get it. All of sudden broke out. It was very hard to get back and I'm still dealing with it. I don't want to set it up again or worse again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 103, abd pain, vomiting lasting from 6/12/15 through 6/18/15. Shots given 6/10/15.
inadvertently gave expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called to report that she inadvertently gave expired moderna vaccine to three patients.  She found out that the punctured vial had been left out all day on 09-Aug-2021 - over 12 hours in room temperature.  Pharmacist also confirmed that the expired vial was discarded and put into waste disposal.    No concomitant medications were reported. No treatment medication were reported.
The evening of getting the vaccine I had a temjperature of 102.  The next day my temp stayed in the mid 100's.  The third day it was 99.5.  After the third day I did not have a temp, but during the first three days I had a headache and body aches and was very weak and tired.  The weakness and fatigue continued for a week.
Tightness in chest, pain in heart area, rapid heart rate, trouble breathing, sharp pain in chest after about a week after 2nd dose of vaccine. Mild chest pain leading up to the worst event for a few days.
The same evening of injection the patients face around her eyes, eyelids turned red. No itching remained red for several days. No Dr. visit required. Called back 11/25 no ans.
Persistent dizziness, persistent headache, nausea, loss of appetite, tingling in arms, increased anxiety. Consulted PCP, prescribed Sumatriptan for headache, scheduled for Neurology follow up.
throat tightness; body tingles; itching; eye and ear pressure; eye and ear pressure; dizziness; weakness; chest tightness; sweating; feeling flushed; This is a spontaneous report from a non-contactable other health professional. A 73-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9264) as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.The patient experienced throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, feeling flushed on 29Jan2021. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, and feeling flushed. She denied hives, loss of sensation, SOB. Therapeutic measures were taken as a result of the events. Treatment included: antihistamines, Benadryl 25 mg, Pepcid 10 mg. Follow up response to treatment was good. Patient was discharged and was Stable to go home and follow up with PCP. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Day 0: Nausea, stomach pain, occasional dizziness     Day 1: dry/scratchy throat, occasional dizziness Day 2: Dry, scratchy throat, cough Day 3: Cough, head congestion, facial pain, headache, fever (99.9'), fatigue, positive Rapid Antigen test Day 4: Cough, head congestion, facial pain, headache, fever (99.9'), fatigue Day 5: Cough, head congestion, facial pain, headache, fatigue Day 6: Cough Day 7-11: Cough, fatigue Day 12: Cough Treatments: drink fluids, take Ex. St. Tylenol on 4-6 hr. schedule
Soreness around the injection site; Itchiness around the injection site; Swelling around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) 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 did not provide any causality assessments.   Concomitant medication includes blood pressure medication, cholesterol medication, and supplements.
tingling tongue; excessive unquenchable thirst/Really thirsty; dry tongue; been to restroom a lot; disturb sleep; sore arm; lethargic; headache; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), HEADACHE (headache), VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site). On 23-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep). The patient was treated with IBUPROFEN for Rash, at an unspecified dose and frequency. On 25-Mar-2021, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic) and HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling tongue) had not resolved, THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) outcome was unknown and VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) had resolved.            Concomitant medications were not provided. The patient said she did not have any issues after second dose.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: additional adverse events were updated
Information has been received from a certified medical assistant (CMA) concerning a male physician who was vaccinated "three times" with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The CMA reported that the physician subsequently failed to seroconvert for mumps all three times. Unspecified medical attention was sought and no other symptoms were noted. At the time of this report, the physician's mumps titer remained negative. Additional information has been requested.
Localized swelling redness aches and pain with inflamed lymph nodes. Malaise of body every shot has increased in swelling and discomfort. Previous shots on 2007/07/06 and 2007/06/13.
Arm was sore  and broke  out in big red patch around area of shot. There was burning and itching in that area.  It has not gone away. I went to the Pharmacist and she gave me a tube of Hydrocortisone 1%  Anti-Itch Cream. This has relieved the itching a little bit but my arm is still red with mild itching.
Had blood drawn for physical 8 days (March 8, 2021) after initial vaccination. Results indicated that platelet count could not be made because of  "clumping platelets."  Did a follow-up blood test on March 29 as recommended by family physician, and had same results.  Have never previously experienced that condition. I am blood type A positive.
Patient said her arms been hurting for several months, but the shot was just given last month in April 08, 2020 and the even was reported today 05/28/2020.  She said she as gun shot wound to her right arm so she has to use her left arm for most of the work she does around the house. I ask if she has been doing a lot of work around the house and she said yes. I suggested that she give her arm a break and try not to do too much.  Suggested she take an NSAID and rest and follow up if the symptoms doesn't get any better.
Patient developed inability to speak or move. She already had underlying right sided hemiparesis from MS. Also found to have very high ESR/CRP in hospital that was not fully attributed to the UTI and no other cause found.
Muscle spasms unable to lift limbs, sore arm, fatigue, chills, swollen lymph nodes, migraine headache, fever, breathing trouble mild, pain throughout body
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Follow up information has been received on 07-APR-2015, it was reported that the freezer in which the vaccines were stored went through "an auto defrost". There were no adverse events. On the same day 07-APR-2015, follow-up information has been received from Healthcare worker who provided patients' identifiers. This report refers to a 4 year old patient, who on 04-MAR-2015, was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml (route was not reported), lot number as K011801, exp. date: 21-AUG-2016. This is one of several reports received from the same source. Additional information has been requested.
t103 since yesterday afternoon 3SEP92; pt given sponge baths & APAP; MD dx DTP reaction; also anemia dx made;