chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hasn't been feeling well; Fever; Had aches in her back of her neck; Arm was a little sore; Aches in her shoulder; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event (No recorded medical history).   On 11-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) (unknown route) 1 dosage form. In February 2021, the patient experienced NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications reported by investigator
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 ATHEROSCLEROSIS OF AORTA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 HYPOXIA ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 HYPOXIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 HYPOXIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 HYPOXIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 AMBULATORY OXYGEN THERAPY DEPENDENCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 AMBULATORY OXYGEN THERAPY DEPENDENCE
Client received flu vaccine at Emergency Management Drill. She reported no hx of egg or latex allergy and no reaction from previous flu shots. She did report being allergic to sulfa and augmentin. She was instructed to wait 15" after vaccine, but chose to drove off. She then developed SOB, chest pain, and nausea, and returned to clinic site. She was then transported to ER by ambulance, where she received Epinephrine and oral steroids. She was d/c'd from ER after 45 minutes.
This spontaneous report was received from a pharmacist concerning an 83 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M041394  with expiration date of 23-MAY-2018, for prophylaxis (dose and route of administration were not reported). On 16-OCT-2017, at unspecified time after receiving PNEUMOVAX 23, the patient experienced severe dizziness and blurred vision. The patient did not receive any treatment and had no laboratory diagnostics or studies performed. At the time of reporting the patient did not recovered from blurred vision and severe dizziness. The patient did not receive any treatment. The causal relationship between severe dizziness and blurred vision with therapy with PNEUMOVAX 23 was not reported.
Pfizer-BioNTech COVID-19 Vaccine EUA  I experienced almost all of the listed potential symptoms after the SECOND shot (fever, chills, headache, nausea, tiredness, muscle pain, feeling unwell), and then also got an intensely itching rash on the inside of my left thigh which gradually got worse and spread up to my vaginal area, skipped across it and started a little bit on the right inside thigh. This was listed as a potential allergic reaction
Costochondritis; Dose 1: 21Feb2021; Dose 2: 22Feb2022; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 22Feb2022 as dose 2, single (Lot number: unknown), at the age of 28 years, Intramuscular, in the right arm for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillins and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Route of administration: Intramuscular; Anatomical site; Left arm), administration date: 21Feb2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset an unknown date in Feb2022, outcome "unknown", described as "Dose 1: 21Feb2021; Dose 2: 22Feb2022"; COSTOCHONDRITIS (non-serious) with onset 26Apr2022 at 12:00, outcome "not recovered". Therapeutic measures were taken as a result of costochondritis.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the event costochondritis included non-steroidal anti-inflammatory drugs (NSAID). Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
He has a history of lightheadedness with needles, and had a recurrence with this vaccination.
pt recvd vax & reported seizure like activity, lasting for a few seconds; pt had facial twitching arms were stiff & drawn up, pt fainted;
patient receive full concentrated vial of Pfizer vaccine.  Patients s/s over 4 day extreme fatigue, head ache, body aches, extreme arm pain  with raised bump that was red and warm to touch that has become itchy.  2 days after diarrhea and loss of apatite. Which has resolve.
Severe Joint pain & aches since day after vaccine. So bad that i have to take tylenol & ibuprofen together every 4 hours, because if I don?t the pain is so extreme it makes me nauseous.
both hands were red; both hands were very pale white; Both hands felt very numb; Both hands were tingling; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 10:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included gilberts syndrome 10 years ago and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid(ALKA SELTZER) from an unknown date for an unknown indication and unknown if ongoing. On 24Apr2021 at 07:00 the patients both hands were red and very pale white, felt very numb and tingling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with anti inflammatory drugs.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both hands were red and very pale white, felt very numb and tingling were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 76-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 7th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 8th September 2018, the patient experienced injection site erythema. On 10th September 2018, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the cellulitis and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a nurse practitioner (NP). The patient received SHINGRIX vaccine in the left arm inadvertently administered in to the soft tissue above the elbow and not intramuscularly, which led to wrong route of vaccination. Two days after receiving SHINGRIX, the patient had a pink spot at the injection site and 3 days after receiving SHINGRIX, the patient developed cellulitis (not further specified). The reported batch number for SHINGRIX did not exist and was updated from M7784 to M77B4 as per sales database.
Had s foul smell at night before bed.amd bad headache on left side of my head
Loss of smell, taste, fever, Bodyaches, fatigue   Patient reports first dose of COVID19 Moderna Vaccine on August 19, 2021.  Twenty-four hours after vaccine patient completely lost sense of smell and taste.  The senses of taste and smell did not return for 9 days.  She developed fever for 3 days.  She had nasal congestion for 3 days.  She did not have cough.  She had extreme fatigue and body aches for 9 days, and had to rest in be often during those 9 days.  She did not go to the doctor or emergency room during this time.  She did not obtain a Covid test.  She has completely recovered at this time(December 2021) with no long term effects.  She declines to get the second dose of COVID vaccine.
Patient was administered a pediatric dose of Hepatitis B vaccine.  No known adverse event has occurred, only an administration error.
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 30-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt has a hx of full term SVD. Presented at 19 weeks with incompetent cervix. No hx of any cervical procedures between pregnancies. Pt quickly went on to deliver a nonviable fetus.  Pt was 11 days s/p COVID vaccine. I do not know which one.
pt recv vax 6NOV97 & 26FEB98 pt lab test revealed a lack of seroconversion;
Patient received the lower dose of Pfizer vaccine instead of the higher dose Pfizer.  The patient does not have any problems
stomach a little bit upset; Typical side effects; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 027C21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other little bit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-341194, MOD-2021-341167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: TCR attached-significant patient age, event added, out come of the events provided.
Pain and swelling at the injection site, fever of 101, body aches, chills, headache, tiredness.
2nd day post vaccine, left sided neck swelling and tenderness. Supraclavicular lymphadenopathy. 3rd day post vaccine left elbow joint pain. No fever, no signs of cellulitis at injection site. CBC normal. Symptoms resolving by day 7 post vaccine no specific treatment.
patient cannot move; flu like symptoms; chest pain; scratchy throat; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome (the patient has lupus.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.7 (Inconclusive) fever of 101.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. List of concomitant medication were not given.   This case was linked to MOD-2021-118963 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 128 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
pt with metastatic lung CA found after evaluation of a dry cough; pt tool 1 round of chemotherapy and declined any more treatments; asked for hospice care; while in hospice pt expired on 9/21; COVID test performed on 9/21 and reported on 9/23/21, the test was positive for COVID 19
Itching at injection site, swelling, hard lump inside arm about 1 inch by 2 inches, slight pinkish color at site of injection. Symptom started 8 days after injection of vaccine.
Pale today (3/30/10), feels hot when she stands up and very dizzy on 3/30/10. She had a busy weekend and she is tired. Didn't eat last night and went to bed at 6 pm.
Client received 1st covid vaccine dose of Moderna (037B21A) on 04/16/21 and received 2nd covid vaccine dose of Pfizer (EW0198) on 08/03/21. Client received two different mRNA vaccines,  monitored for 15 minutes and no signs of adverse reaction noted.
February 7 and 8, just slight pain in the arm like what I have after the flu shot.  A week later, February 13, I awoke in the night and felt the same ache in my arm (which had gone away after the 8th).  I also developed a red area and spots around the injection sight.  Some itching.  This has lasted for for 4 days and I still have it.
3h after the vacination, patient experienced excruciating pain, that kept her awake at night. she couldn't move her left arm or raise her left arm. She also has a fever of 100.4 F. She had local reaction including redness and swelling (2*4 inches) and throbbing. she took Tylenol but it didn't help with the pain. As of 12/26, she still experiences a mild pain on her left arm
Didn't receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
C/o L deltoid and shoulder pain with weakness and numbness radiating to the arm since IZs placed 9/2022
no adverse event; 47 patients received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) and NO ADVERSE EVENT (no adverse event) in an adult 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) 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 (47 patients received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 Jul 2023, 6 doses were administered at administration site 2. No treatment medication reported.   The case corresponds to 47th out of 47 adult patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, vaccine administration date information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case(Patient 1)
Yellow fever vaccine was given with normal sterile water instead of the Sodium Chloride, no AE; Initial information received on 20-May-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 30 years old female patient who received 0.5 ml YELLOW FEVER VACCINE - US [YF-VAX] (total, lot UJ371AB and expiration date: 21-Jul-2022) via unknown route in the left arm for prophylactic vaccination on 20-May-2021. It was reported that the vaccine was given with normal sterile water instead of the sodium chloride that was provided for reconstitution (product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other medications (concomitants) or vaccinations were administered at this visit.  It was an actual medication error due to wrong solution used in drug reconstitution (latency: same day) and the caller would like to know if the vaccine needs to be repeated.   At the time of reporting, it was not reported that the patient had any adverse event or not.  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 the 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.
An initial report was received in the USA from a health care professional on 7/27/05. An 11 year old male patient complained of redness, pain and warmth at the left arm injection site one day after he had received a SC injection of Menactra, lot number U1639AA, instead of the IM route. He also received TUBERSOL in the left forearm. Treatment was not reported. Reportedly, he has not recovered.