chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 86 years old female patient with high cholesterol, high blood pressure and a thyroid condition and no drug reactions or allergies. On 21-AUG-2012 the patient was vaccinated SQ with a dose of ZOSTAVAX to prevent shingles (lot # reported as 0242AE, exp. date: 01-APR-2013). On 21-AUG-2012, later after vaccination the patient developed headache, half dollar sized red spot at the site of injection and dizziness. No lab diagnostic studies performed. The pharmacist suggested TYLENOL for the headache. The patient sought medical attention by calling the pharmacy. The outcome of dizziness, half dollar sized red spot at the site of injection and headache was reported as not recovered. Additional information has been requested.
Arm very sore, she has been taking (Rx) RELAFEN and TYLENOL OTC. She thinks the shot was given too high on her arm?
injection in pm on 4Oct93 by 700pm evening mom noticed irritable, fever (101.9 R) temp & glassy eyed. Lasted for 45 minutes. Patient seemed to be staring off into space. No loss of tone.
Patient is describing right eye swelling 1-2 days after receiving vaccine. Some loss of vision as well as headaches. Patient states that she has never had these symptoms prior to vaccination.
someone pat me on my shoulder and I felt pain; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; soreness, redness, some swelling at the injection site.; soreness, redness, some swelling at the injection site.; soreness, redness, some swelling at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm) and FEELING HOT (arm was red, swollen, raised, and warm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included PIRFENIDONE (ESBRIET), FENOFIBRATE, COLESTIPOL, LISINOPRIL, METOPROLOL, OMEPRAZOLE, FLUTICASONE, AZELASTINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FISH OIL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE SWELLING (soreness, redness, some swelling at the injection site.), VACCINATION SITE ERYTHEMA (soreness, redness, some swelling at the injection site.) and VACCINATION SITE PAIN (soreness, redness, some swelling at the injection site.). On 20-Feb-2021, the patient experienced PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm) and FEELING HOT (arm was red, swollen, raised, and warm). At the time of the report, PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm), FEELING HOT (arm was red, swollen, raised, and warm), VACCINATION SITE SWELLING (soreness, redness, some swelling at the injection site.), VACCINATION SITE ERYTHEMA (soreness, redness, some swelling at the injection site.) and VACCINATION SITE PAIN (soreness, redness, some swelling at 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.   No treatment medication details were reported.   This case was linked to MOD-2021-095636 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL (lot# K007828, expiry date 02-MAR-2017, dose and route of administration not reported). On 29-JUN-2015, the patient was inadvertently vaccinated with a 0.5 ml dose of GARDASIL 9 (lot# K026247, expiry date 29-JAN-2017, intramuscularly) instead of a second dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Information has been received from a medical student concerning a female who was vaccinated with a dose of Gardasil. It was reported that "within a few weeks or a few months" after vaccination the patient was diagnosed with cutaneous polyarteritis nodosa. The patient's outcome was unknown. Upon internal review, polyarteritis nodosa was considered to be an other important medical event. Additional information has been requested.
pt recvd vax; exp general body malaise x 3 days, progressively got worse then got better; low grade fever; chills & cold sweats;
felt like she was having COVID again; only wanted to sleep; exhausted; body hurt/she was very achy; very mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient had COVID last July and spent five days in hospital.On December, she got tested and she still has antibodies.) in July 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea). On 02-Mar-2021, SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea) had resolved. Not Provided      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.   Treatment information not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non significant follow up received on 9-JUL-2021 and contains updated email id ,contact information and consent to follow up.
Fainted shortly after administration of Gardisil.  Out for 3-4 seconds. Observed for 45 minutes before going home.  At home and still reports nausea and dizziness.
p/vax began w/back ache which has been continual; + myalgias; ankle & foot joint pain; also epigastric pain intermittently & h/a which are intermittent;
Developed COVID symptoms (cough, sore throat, aches, fever, chills) next day.  However I found out I was exposed to a person who tested positive for COVID. See timeline below: exposed to covid positive individual: 2/2/2021 receive vaccine:2/5/2021 experience symptoms: 2/6/2021 find out the person tests positive: 2/7/2021 test negative on rapid: 2/8/2021 positive results from PCR: 2/10/2021
A health care professional reported the spontaneous non-serious event of administration to a 57-year-old male subsequent to receiving FLUMIST. Neither medical history nor concomitant medications were provided. On 14-Oct-2010, the patient received FLUMIST vaccination. The patient was reported to be healthy at the time of administration. No other symptoms were reported. 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.
Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up"; Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up"; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 030A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") (seriousness criterion medically significant). At the time of the report, SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") outcome was unknown and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  On  17-Dec-2021, a day after patient had the booster dose, patient  claim that he had the same feeling as before - he  was out for under a minute and just woke up.   This case was linked to MOD-2021-417226 (Patient Link).; Sender's Comments: This case concerns a 50-year-old, male patient with no relevant medical history, who experienced the unexpected events of Seizure and Loss of Consciousness. The events occurred approximately 1 day after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Patient called 08/23/13 to report to the pharmacist that during the night of 8/22/13 her leg started hurting to the touch. By the morning of 8/23/13 she was experiencing a non-painful rash on her buttock and down her leg.  She called her doctor who asked her to observe the area until Monday and to come in and be seen if symptoms persist. By Monday 08/26/13 she was seen in the doctor's office where the patient was diagnosed with an active case of shingles and prescribed an antiviral.
I developed a rash on my right arm that went to my forearm after the injection. It was hot to the touch and itchy throughout the day and night. It hurt to lay on the effected arm. The rash developed over a few days, it did not start right away after injection.
Nightmares; an ache in his left ear; I can't sleep at night; I can't pick up my arm where shot was given. I can't lift anything with my arm.; I got the shot and I feel terrible now; I was never like this. I am angry, tired, and my arm feels numb.; I was never like this. I am angry, tired, and my arm feels numb.; I lost a job because I cant perform. I lost job because I get angry/I got a new job but I can only work 4 hours.; I get headaches; I was never like this. I am angry, tired, and my arm feels numb.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I can't pick up my arm where shot was given. I can't lift anything with my arm.), EAR PAIN (an ache in his left ear), INSOMNIA (I can't sleep at night), NIGHTMARE (Nightmares) and FEELING ABNORMAL (I got the shot and I feel terrible now) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced LIMB DISCOMFORT (I can't pick up my arm where shot was given. I can't lift anything with my arm.), INSOMNIA (I can't sleep at night), FEELING ABNORMAL (I got the shot and I feel terrible now), HYPOAESTHESIA (I was never like this. I am angry, tired, and my arm feels numb.), ANGER (I was never like this. I am angry, tired, and my arm feels numb.), IMPAIRED WORK ABILITY (I lost a job because I cant perform. I lost job because I get angry/I got a new job but I can only work 4 hours.), HEADACHE (I get headaches) and FATIGUE (I was never like this. I am angry, tired, and my arm feels numb.). On an unknown date, the patient experienced EAR PAIN (an ache in his left ear) and NIGHTMARE (Nightmares). At the time of the report, LIMB DISCOMFORT (I can't pick up my arm where shot was given. I can't lift anything with my arm.), EAR PAIN (an ache in his left ear), INSOMNIA (I can't sleep at night), FEELING ABNORMAL (I got the shot and I feel terrible now), HYPOAESTHESIA (I was never like this. I am angry, tired, and my arm feels numb.), ANGER (I was never like this. I am angry, tired, and my arm feels numb.), IMPAIRED WORK ABILITY (I lost a job because I cant perform. I lost job because I get angry/I got a new job but I can only work 4 hours.), HEADACHE (I get headaches) and FATIGUE (I was never like this. I am angry, tired, and my arm feels numb.) had not resolved and NIGHTMARE (Nightmares) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-018002 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up received outcome of the event updated.
Pt. was transported to Hospital by ambulance C/O chills/fever, chest and back pressure, nausea, tachycardia.
Onset within 1 hour of administration:significant frontal headache; diarrhea; myalgia; fatigue; diffuse joint aches; fever (3 degrees above baseline).  Symptoms abated spontaneously within 36 hours.
Tingling in head, arms, hands, legs, and feet.  Fullness in head (as if it might explode!). Elevated blood pressure, stiffness/ache in neck, shoulders, and back. Flushed face. Thick feeling in throat. Puffy feeling in lips and tongue. Dizziness. Paramedics called-Benadryl administered.
PT states she received anthrax vaccine on 18OCT12 and almost immediately began to experience headaches, joint pain and swelling at the injection site (L shoulder) PT states this was her third anthrax in the series.  Previously with some local reaction with tenderness, erythema, nodule, but it resolved rapidly.  Denies fever/chills.  Does have radiating pain from site to shoulder and down arm.
Pt recvd 3 doses (dates not recorded) of Engerix B. Titers were checked 6 mos p/ last dose. Titer result was 9.3, indicating a low positive response.
Tested COVID positive, symptoms include cough, shortness of breath, diarrhea, and fatigue.
Week after the vaccine, my left arm became painful. It got progressively more swollen throughout the day. It wasn't red that first day I noticed it but the next day it was a big splotch of bright red about the size of my hand - right on the injection site and underneath it. Hot to touch, painful and swollen. All day Tuesday, Wednesday. I had a Dr's appt on Wednesday. It eased off on Thursday and Friday and it was gone by Saturday. Dr prescribed antibiotics for it and also a creme - Triamcinolone. I still have the photos I took if that would help to see them. Doctor diagnosed as Cellulitis Dermatitis. I did get the same the same reaction the day after (Jan 27) my second dose of vaccine (Jan. 26).
I began losing my hair; fever of 99.6F/Fever of 100.1F; had chills; Tired/was very tired; my head hurt; swollen arm as the size of my hand. My arm was swollen for a week/arm was swollen; It was red/my arm was red; sore arm; I felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It was red/my arm was red), PAIN IN EXTREMITY (sore arm), MALAISE (I felt sick), ALOPECIA (I began losing my hair) and PERIPHERAL SWELLING (swollen arm as the size of my hand. My arm was swollen for a week/arm was swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced ERYTHEMA (It was red/my arm was red), PAIN IN EXTREMITY (sore arm), MALAISE (I felt sick), PERIPHERAL SWELLING (swollen arm as the size of my hand. My arm was swollen for a week/arm was swollen), FATIGUE (Tired/was very tired) and HEADACHE (my head hurt). On 13-Nov-2021, the patient experienced PYREXIA (fever of 99.6F/Fever of 100.1F) and CHILLS (had chills). On 25-Nov-2021, the patient experienced ALOPECIA (I began losing my hair). The patient was treated with COLLAGEN in November 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, PERIPHERAL SWELLING (swollen arm as the size of my hand. My arm was swollen for a week/arm was swollen) had resolved. At the time of the report, ERYTHEMA (It was red/my arm was red), PAIN IN EXTREMITY (sore arm), MALAISE (I felt sick), ALOPECIA (I began losing my hair), PYREXIA (fever of 99.6F/Fever of 100.1F), FATIGUE (Tired/was very tired), HEADACHE (my head hurt) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: high (High) 99.6F. On 14-Nov-2021, Body temperature: high (High) 100.1F.         No concomitant medication was reported.     Treatment medications included ice on arm. On Nov 2021 patient started nail and hair vitamins.    This case was linked to MOD-2021-407226, MOD-2021-407238 (Patient Link).
Date the vial was initially stored in the refrigerator: October 24, 2022; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) in a 46-year-old 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022).    No concomitant medications were reported.   14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 08-Dec-2022 to 10-Jan-2023.  Date the vial was initially stored in the refrigerator was 24-Oct-2022.  Vial did not undergo any temperature excursions.  No treatment medication was provided.  This case pertains to 4th of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live Significant Follow up received included patient demographics and narrative updated. On 24-Jan-2023: Live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult
severe lower back pain with first shot; developed weird rash and neck pain near my clavicle bone; developed weird rash and neck pain near my clavicle bone; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EN6198; Expiry date: 30Jun2021), via an unspecified route of administration, administered in Arm Right on 10Mar2021 (age at vaccination was 65 years) as DOSE 1, SINGLE for Covid-19 immunisation. The relevant medical history was not reported. The concomitant medications were reported as none. Nurse (patient) stated, I had severe lower back pain with first shot on an unspecified date, and I took prednisone (Treatment) for it and on 14Mar2021, I developed weird rash and neck pain near my clavicle bone.It was reported that, there was no allergic reaction to vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER733, expiry date: 31Jul2021) via an unspecified route of administration, administered in left arm on 29Mar2021, for Covid-19 immunisation and experienced the event lot of pain on 29Mar2021. The treatment medication included prednisone for severe lower back pain on 14Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.