chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid arm; Flu type reaction really bad; I ended up in bed; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ESTRADIOL (ESTRING) for an unknown indication.    Concurrent medical conditions included Cerebral palsy (CP).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ESTRADIOL (ESTRING) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Events were added and the patient denies consent for follow-up
Patient experienced lightheadedness, dizziness, nausea, and emesis x1, non bloody non bilious.  She also had tachycardia. Lung fields with wheezing on exam.  No hypotension. no rash. no angioedema. Patient was treated w epinephrine auto injector  and 911 was called. Paramedics took the patient to the emergency room in stable condition, satting 99 on RA (4L O2 provided for comfort) and BP 144/88 with HR 101.
Flu shot administered into left deltoid 9/7/13. Patient bled a little. Bruised immediately around injection site. Three days later bruise healing. No treatment necessary.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment drugs were not reported.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccine) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 037E21A, 038B21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccine).    The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
After immunization by 0800 the next morning I had body aches (joints), fever of 102.0 F and headache. I took 400mg of Ibuprofen at 0800 and symptoms decreased. Symptoms returned at 1200, when I took 600mg Ibuprofen. Symptoms did not return.
The Community Based Outpatient Clinic Nurse: Shingrix vaccine, lot#: 2739M, exp. 10/06/24. While reconstituting vaccine I noticed a pin-sized black particle. This is the 2nd time this week (1st occurrence 07/17/2023, same lot#.) I did not administer, and saved the vial. I did call the Mfr. Glasgow Smith-Kline and reported the event to the Vaccine Service Center. Also sent an inquiry to the Pharmacy Director regarding protocol for such an event. Fellow clinical staff were asked to look at the vial, with the reconstituted vaccine, to verify presence of the particle in question. The vial has been saved at the request of the Mfr. This vaccine was NOT administered to a patient, thus no patient information was input.
Severe Pain in left arm fro injection site down the forearm. Severe Pain radiating through the left chest and the left shoulder blade. Inability to sleep unable to find a comfortable position for my arm due to tingling, numbness and lack of ability to use my arm in greater than 70 % movement.
2 days post vax presented w/fever that did not respond to APAP or cool baths; temp 106 sz;
Info has been received from a health professional concerning a 7 year old male student who on 8/4/99 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 11/8/05, the pt developed red spots with a flat base on each cheek, three to the chest and 6-8 on his back. Medical attention was not sought. In 11/05, the pt's red spots received. Additional info is not expected.
Moderna COVID-19  .  Dizzyness, fever, neausea, tiredness
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 012A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 99 - 102 (High) fever at 99 in the morning, but the fever is now at 102..         Treatment information was not reported.
Although GSK labels their pre-filled syringes of Hepatitis B Vaccine - ENGERIX-B for adults and children with a yellow and olive band, respectively, to distinguish the products, labeling "except for the strength" 10 mcg/0.5 ml for children and 20 mcg/ml for adults is the only difference. I suggest labeling of the adult product includes: ADULT DOSE I suggest labeling of the pediatric product includes: PEDIATRIC DOSE.
Redness, tenderness, soreness (had to left arm) fever, dizziness. Problem start about 30-40 mins after shot. Medical doctor put patient on antibiotic.
DIZZINESS WITH MOVEMENT; MUSCLE ACHES ALL OVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and dental numbing, and other pre-existing medical conditions included the patient had no known allergies. The patient experienced drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 16:00, the subject experienced dizziness with movement. On 08-MAR-2021 16:00, the subject experienced muscle aches all over. On 08-MAR-2021 16:00, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches all over, dizziness with movement, and slight nausea. This report was non-serious.
Patient reported that injection site reaction occurred one hour after flu shot was given. The size increased to 8 X 6 cm had warmth and swelling. Patient was seen by provider on 10/14/18 and given KEFLEX and anithistamine for treatment.
Starting around 24 hours after the dose, the patient developed body aches and an elevated temperature. Starting 48 hours after the dose, the patient developed a headache, lethargy, fatigue, nausea, vomiting, and diarrhea.
High Fever, shakes, chills, headache Feb 17 p.m.  -  Feb 18 plus all over ache.  Tylenol time release.  Felt good on Feb 19.
p/2nd & 3rd shot, loss of concentration, "spacey" no sweating;pt fine p/24hr;
Received vaccine in September.  The day after started having sore joints; gradually getting worse.   Today took old Prednisone prescription she had because could hardly get out of bed.   Patient has not contacted pharmacy or PCP and doesn't plan to go over there.   Patient has been taking hot showers and applying stuff to skin hoping that muscles release.  Patient has never received a Pneumonia vaccine prior.
Diarrhea beginning today (2/23). No other symptoms, denies bloody stool or abdominal pain.
Patient called stating that Friday, 4 hours after receiving the Flu vaccine she started shivering uncontrollably, could not move or walk, lost complete control over her bladder, she urinated on self, pt. had to be carried by husband to bed and wrapped in blankets, the shivering lasted about 1 hour, by Saturday midday she was feeling better, states this had never happened to her before.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. There was no pertinent medical history, concomitant medications and drug reaction/allergies reported. On an unspecified dates, the patient was vaccinated with two doses series of adult formulation of RECOMBIVAX HB (strength: 10 microgram, dose: 1 ml, route intramuscular, lot number and expiration date were not reported) outside the recommended schedule in RECOMBIVAX HB prescribing information. There was no adverse effects reported. Additional information has ben requested.
Kept smelling cigarette smoke (I was not around cigareettes) for a few weeks; Then I kept smelling burnt popcorn for a few weeks and was not around that smell either. No one else smelled this except me..then I got up one morning and had no sense of smell at all. Still cannot smell anything at all.
Chills; fatigue; Muscle aches; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Mar2021 09:00 (Lot number: EN6199) at the age of 48 years as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 09:00 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Muscle aches"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she was healthy. Patient received Dose 3 (Batch/Lot number: EW0176), on 30Nov2021 at 4PM, Anatomical site of injection: Left Arm, Route of Administration: Intramuscular. Vaccination facility type: Health clinic/Veterans administration facility. With vaccine 1,2,3 (booster) she had similar symptoms of chills, fatigue, muscle aches and sore throat that lasted 24 hours. With the booster shot she also had wheezing, swollen lips, swollen tongue, soreness and bumpiness of the inside of the cheeks. This lasted about 8 hours. She took Allegra. Prior vaccinations and specific Relevant Test for Thromboembolic Events with Thrombocytopenia was reported as none. She do not have any filler in her lips but 5 years ago she had filler put in around the lips in the smile lines.  No follow-up attempts are possible. No further information is expected.
PAIN AT INJECTION SITE; SEVERE MUSCLE ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, chills, headache, and fatigue on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210320105 and 20210320117.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: pt became very white, started to look like he was going to faint, got wet towels and applied to face, neck, arms. kept him conscious be talking to him, called ems but by the time they arrived, he had color and was ok
Case number PHEH2014US021416 is an initial spontaneous report received from a nurse on 22 Oct 2014. This case refers to a 03 years old male patient 9who is almost 4 years of age). past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 017021A), intramuscularly on 21 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Information has been received from a nurse concerning a 26 year old female who was vaccinated with her "second dose of series" of Gardasil, injection.  Concomitant therapy included "orthotricycline".  About a week after the second dose of Gardasil the patient developed a rash on her forearms and the rash left scars on her forearms as well.  As of 11-JAN-2008, the patient was recovering.  Medical attention was sought from a dermatologist.  The product quality complaint unit was not involved.  Additional information has been requested.
I got a rash, I felt like it started on my legs and spread everywhere. It spared my face, neck and back. I went to the Doctor . The Dr gave me a steroid  shot and some cream to help with the itch.  The rash went away about two days later.
morning, she could not get up and lift her arm; Felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad) and MOVEMENT DISORDER (morning, she could not get up and lift her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 05-Feb-2021, the patient experienced MOVEMENT DISORDER (morning, she could not get up and lift her arm). At the time of the report, FEELING ABNORMAL (Felt bad) and MOVEMENT DISORDER (morning, she could not get up and lift her arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Oxygen saturation: 89 (Low) 89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Oxygen. The patient oxygen level was in 89 and with treatment it went up to 95, but it was fluctuating.
On 7/14/2014 - patient was given an additional dose of Hep A. As of 7/29/14 patient complains of headaches.
Reported signs and symptoms of aches and chills same as after first does. Significant nausea and diarrhea, arm pain and warmth, unable to turn neck without pain, temperature 100.5.
A non-serious spontaneous report of scratchy throat, fatigue, fever and feels achy has been received from a nurse concerning a 30-year-old female, subsequent to H1N1, intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, intranasal on 24-Oct-2009 for unknown indication. Four days after receiving H1N1, intranasal, the patient developed scratchy throat, fatigue, fever and felt achy. The treatment for the events was not provided. The outcome for the reported adverse events was not reported.
84-year-old male who was admitted to the hospital through the emerge department with intractable back pain. He had severe weakness.  He is found to be COVID 19 positive on 11/3/2021.  He developed some acute hypoxic respiratory failure.  He is followed by pulmonary ID and neurology.  He developed an acute encephalopathy with confusion and agitation. Treatment:  oxygen, haldol, baricitinib, remdesivir, decadron. He was discharged to a subacute rehab facility for further rehabilitation.
Information has been received from a registered nurse concerning an approximately 25 year old male scientist with no medical history and no allergies who on Jul 28 2004 was vaccinates in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). Concomitant vaccine therapy given in the right arm included a dose of hepatitis B vaccine, re comb (Energix-B). On the morning of Jul 29 2004 the patient developed a temperature of 101F, and his left arm was swollen and red the size of a baseball with induration the size of a golf ball. No adverse symptoms were noted in the right arm. the patient is taking acetaminophen (Tylenol) and ibuprofen (Advil). The patient called his doctor and was to be seen by him in Jul 30 2004. It was noted that the patient is working with vaccines and his company offered the vaccine to the employee, No product quality complaint was involved. Additional information has been requested.
Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this; Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "Stomach problem" (unspecified if ongoing), notes: for her stomach; "left shoulder pain and inflammation" (unspecified if ongoing); "left shoulder pain and inflammation" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "fibroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for thyroid disorder (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for abdominal pain upper (ongoing); FLUCONAZOLE oral (ongoing); NAPROXEN taken for arthralgia, inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this". When the patient got this COVID it was mild. Stated that the patient has never been on heart medication. The patient was not put on any medication and this occurred before Paxlovid came out. This happened before they had the booster. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative most of the time; positive; X-ray: no pneumonia. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271922 same patient/AE, different vaccine doses;
Fever (102.4F), chills, arthralgia, myalgia, headache, nausea.  Did not resolve until I took ibuprofen 600mg at 17:30 on 1/21/21
Large red warm welt where Prevnar #4 was given. Within 24 hours he stopped trying to walk, stopped talking and would just sit and scream. Ran a low grade fever for 11 days straight. Blister like rash developed late Jan 2015. Low grade fever every day with the exception of a few day. Still has not gained all of his words back. Still will cry and scream sometimes with no known reason.  Acts like he has a sore throat.