chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; fever for a day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 (He had chronic kidney disease, stage 3 which was diagnosed before he got the vaccine.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired). At the time of the report, ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Antibody test: 2500 greater that 2500.         Patient was 5'10" or 11" tall.  Concomitant medications was not provided by the reporter.  Patient's immunity level was greater that 2500 in Dec2021, so they were advised by their doctor not to get the booster dose yet.  Treatment information was not provided.   This case was linked to MOD-2022-517950, MOD-2022-517821, MOD-2022-517797 (Patient Link).
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer or other non healthcare professional via medical information team. A male patient of an unspecified age received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
A serious clinical trial report of pneumonia and croup has been received from an investigator concerning a 32 month old female, subject number 28351523 who is enrolled in study. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 14-Feb-2008. On 20-Mar-2008, the subject was admitted to the hospital with a one day history of cough and tachypnea. She was found to be hypoxic to the high 80's in the emergency department. Clinically with right lung inspiratory crackles, but also with a barking cough and radiographic evidence of croup (steeple sign). The subject received ceftriaxone as well as racemic epinephrine and decadron x1. The subject had a significant improvement with resolution of her tachypnea and hypoxia as well as improved air movement on the lung exam. The subject was discharged on 21-Mar-2008 with a course of amoxicillin for pneumonia. The subject's mother reported that at night following discharge, the subject seemed to be breathing harder but improved after using a humidifier. The events were considered resolved on 30-Mar-2008. The investigator assessed the pneumonia and croup as not related to FLUMIST. The sponsor assessed the relationship to FLUMIST as not related. Additional information was received on 16-Oct-2008 including: adverse onset date and resolution, rechallenge/dechallenge, suspect vaccine dose and lot#, medical and immunization history, lab and chest x-ray results.
Itching; Fever; large hard red lump; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large hard red lump), PAIN (Pain), PYREXIA (Fever) and PRURITUS (Itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LORATADINE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MASS (large hard red lump) and PAIN (Pain). On 20-Feb-2021, the patient experienced PYREXIA (Fever). On 22-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE MASS (large hard red lump), PAIN (Pain) and PRURITUS (Itching) 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.    relevant concomitant medications included Joint supplement ("move free") and vitamins
We both had a reaction to Shingrix; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the husband of the patient. The age at the vaccination was not reported. The reporter reported that they did not report this to her doctor. The reporter provided the name of his primary care physician who was most familiar with the event. The reporter reported that her spouse also had a reaction to the Shingrix. This case is linked to the case US2020032234, reported by the same reporter for himself.
received her 1st dose on 20Jan2021 and her 2nd dose yesterday 26Jan2021; soreness in the injection site; This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number and expiry date: unknown) via an unspecified route of administration, on 26Jan2021 at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2, on 20Jan2021, for COVID -19 immunization. The patient accidentally received her 2nd dose of the Pfizer Covid vaccine earlier than the recommended interval. She received her first dose on 20Jan2021 and her 2nd dose yesterday, 26Jan2021. She has no other symptoms other than soreness in the injection site on an unspecified date in Jan2021. Outcome of the event soreness in the injection site was unknown.  Information about lot/batch number has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Slight muscle pain in both arms, shoulders, and upper back; sporadic headaches and general fatigue.
A male, now 75 years old, reported that he received an influenza virus vaccine a "couple of years ago" and reportedly could not use his arms shortly afterwards. He could no lift them above his head and he reported that "a virus entered my body when I received the flu shot".
Using retractable syringe to administer Varicella vax to a 13 month old child (Dad had firm grip of child). Vax splashed into both eyes et on face when retracting needle, only mild stinging. Eyes irrigated with contact soln., contacts removed et discorded, face washed, wore glasses. Saw opthomologist following day for mild eye itching. Acute, mild bilateral conjunctivitis - lubricating eye drops prescribed. Eyes feel fine by date of this report.
stayed in bed for a week; very very ill/has been very, very sick; having a high, high fever; had chills up and down her body for almost a week; her lungs have been killing her; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; administered 3rd dose of  Pfizer Covid Vaccine, the booster shot; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as DOSE 3, SINGLE for covid-19 immunization. The patient medical history included the first dose of BNT162B2 on an unspecified date for COVID 19 immunization and the second dose of BNT162B2 in Apr2021 (at the age of 80 years) for COVID-19 immunization. There were no concomitant medications. On 29Sep2021, the patient experienced Off label use and administered 3rd dose of pfizer covid vaccine, the booster shot (immunization). On 30Sep2021 the patient experienced stayed in bed for a week (bedridden), very very ill/has been very, very sick (illness), having a high, high fever (pyrexia), had chills up and down her body for almost a week (chills) and her lungs have been killing her (lung disorder). Very, very, very ill: Onset time unknown. The patient thought she would have to go to the hospital but has not been seen by physician's office, emergency room or hospitalized for this event. She is going to see her doctor tomorrow due to this event; she mentioned her doctor is a she/female. The patient further described event as including her having a high, high fever; she had chills up and down her body for almost a week; she has been very, very sick; her lungs have been killing her. Today, 05Oct2021 is the first day she has felt improved, better since onset of event. The patient verified dosing information including anatomical location of administration is same for all 3 doses. The patient mentioned unrelated information that she had heard a lot of people having problems with Pfizer Covid Vaccine booster shot in her area as well as some in other location as captured in safety report. The patient daughter works for hospice and she had told her if she had known caller was going to get Pfizer Covid Vaccine booster shot she would have told her to wait because they have had so many problems with their hospice patients that have gotten Pfizer Covid Vaccine booster shot. She can't understand why the booster shot is causing so many problems. The outcome of stayed in bed for a week, very very ill/has been very, very sick, having a high, high fever, had chills up and down her body for almost a week and her lungs have been killing her was recovering. The outcome for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sore Arm (Same and Shot 1), Not the same as shot 1: Chills, Headache and Body Ache, Exhaustion, Shivering, Stomach Pain, Possible Fever (Didn't feel well enough to take temp)
After receiving the flu vaccine on Monday child started having a fever 102 degrees F no other symptoms then on Friday started with mild runny nose and slight cough.
Muscle tightness is reported in pt who recvd flu vax & 3 days p/flu shot, pt devel tightness of neck & shoulder muscles; event lasted 3-4 wks & for past 3-4 wks pt has tightness of posterior of thighs & hip muscles;
pt recv vax AUG95 & w/in last 3wk pt devel chickenpox consisting of approx 100 spots;pt indicated was not sick at all;
17 year old female was given Flublok Quadrivalent, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot# QFAA1927, exp date: June 30/2020, via unknown route in the deltoid nos on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
I woke up with a sore throat on 01/27/2022. I went to work and I thought it might go away with some coffee. I felt worse and worse and it did not go away. I could not get an appointment to get tested until 01/29/2022. I tested positive for Covid.
Client received the Fluzone High Dose Quadrivalent instead of the regular Fluzone Quadrivalent which should of been administered due to her being under 65 years of age. No adverse reactions noted from client at this time.
5days after receiving vaccine broke out in rash on upper torso. 9days after receiving vaccine injection site was red and covered a 4"diameter/  still red after 3 more days. No pain
4-5" erythematous rash around inj site;small amount induration;no fever
Patient e-mailed adverse reaction to pneumonia shot. Had swelling & pain in (R) arm approximately 1 hour after the shot. Explained that this is fairly normal since pneumonia is such a potent shot. She stated that a few days to a week she began to have pain that started in the (R) arm & radiates to forearm to middle finger and upward to the neck. Has difficulty sleeping went to Doctor 2 wks ago and he stated vaccine irritated the nerves and may take up to 6 months to heal. Conts to have pain.
I tested positive for COVID-19 on a PCR test on 1/2/2022. I experienced a mild cough, mild congestion, and neck pain during my illness. My symptoms were so mild that if I were still working, I would have gone to work and just avoided people for a day or two.
Swollen left deltoid. Warm, erythematous tender, T 98. Antihistamines, OTC pain control.
I noticed when I was working out that my lungs were burning in a strange way.  I had a fever for 2 days and a cough that went on for about 3 weeks. I tested positive for COVID-19 on June 3rd. I contacted a walk in clinic and went in for a visit. The prescribed Paxlovid. I continued to test positive until June 22, 2022. My fever came down but all other symptoms remained the same. The fever would return if I went for a walk or anything of that nature. I still have a cough occasionally and I have brain fog also. I still find it difficult to exercise due to having to stop to breath more. This is the 3rd time I have had COVID-19 and I just do not get back to my normal capacity when attempting to exercise or physical activity like hiking. I do plan to seek care from a pulmonary specialist.
16 hrs after the injection.. i had a shaking chill lasting about 30 min  relieved somewhat by tylenol and motrin, followed by feeling hot and sweaty,  the next day I was wiped out and rested ... the shortness of breath  began somewhat later on weds pm and worsened on Thursday ... I had several breathing treatments thurs and friday which seemed to help somewhat.. On Saturday I am feeling better overall with less dyspnea . still feeling wiped out after several hrs of mild activity.
Monday PM 2/6/17 ate dinner had bloating of abdomen more than would expect for amount of food. Also got stiff neck and headache (had slept on friend's couch 2/3/17 so thinks maybe those 2 symptoms from sleeping on couch). In addition to bloating of abdomen 2/6/17 he had headache through the night and felt achy and run down. He continued to have symptoms 2/7/17 Tuesday so went to ER that afternoon around 4-4:30 PM. ER did lots of tests including blood tests including liver test and other blood work. ER did neurological exam, they did BP and temp. All tests normal. They gave him some IVs. He went home about 8:30 PM that evening 2/7/17. He felt lots better - good appetite, slept well (mild headache then) 2/8/17 Wed am back to normal.
c/o dizziness & became pale & weak about 15 mins p/receiving vax; became sweaty & c/o vision & hearing loss; never lost consciousness; taken to ER; ECG & blood work done; observed for 3 hrs & released; next morning had t101.0;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 11:50, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Itchy, red bump at injection site about 2 inches in diameter. Appeared exactly 1 week after injection.
Student came back to Health office 2/2/2012 and showed right deltoid. Rt Deltoid swollen and red, warm to touch. Complained that site was itchy. Instructed student to put warm compress over site, also told student to have mom put warm compress at home as soon as he gets home from school.
Tiredness, chills, muscle/joint pain, feeling unwell, low grade fever 100 degrees
heart attack; patient experienced an unknown reaction to an unknown medication; This spontaneous report was received from a Medical Assistant referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided     On an unknown date in 2010, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).        The reporter informed that a patient experienced an unknown reaction to an unknown medication. Medical Assistant states that it was reported to her from a Physician to inquire if pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) contains polyglycol or  lumazine due to the Physician believing that Patient experienced an reaction to a medication containing the ingredients polyglycol and lumazine (adverse drug reaction). Medical Assistant reports that Patient experienced this reaction on an unknown date in 2021 (reported as "last year") and received the medication after she had a heart attack (myocardial infarction) and needed to have heart surgery. At the time of reporting, the patient had not received more doses of the vaccine. The outcome of myocardial infarction and adverse drug reaction was unknown.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.   Upon internal review, the event myocardial infarction was determined to be medically significant.
After 1st dose,  patient experienced a 2-3 inch rash at the site of injection approximately later.  She said it was red and warm too touch.   I told her to keep an eye on the area and if  it gets bigger or   she has flu-like symptoms to call MD.
Day of vaccine swelling & redness at injection site the size of a dime. Next day became the size of a nickel to quarter. Two days after injection there is redness & swelling the size of a lemon on RVL. Warm to the touch. Pt does not want it to be touched.
RASH NOS. Information has been received from a registered nurse concerning a 54 year old female on dialysis who on 21-JUL-2003 was vaccinated with a 40mcg dose of hepatitis B virus vaccine rhBsAg (yeast) (lot # 644599/1111M). It was unknown if the patient was on concomitant medications. By the evening of 24-JUL-2003, the patient had developed a rash on both legs. Unspecified medical attention was sought and it was unknown what treatment was required. It was reported that the rash had resolved. No product quality complaint was involved. Additional information has been requested.
After the first shot I had a very sore shoulder/deltoid area that started about 6 hours after the shot and lasted 3 days. After the second shot, I had mild soreness in my shoulder/deltoid that started about 3 hours after the shot and lasted 1 day. I also had a reaction on my skin in the L shoulder area - red with mild swelling and some itching. The size of the redness was about 2 in diameter.