chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red mark in the shoulder which hurt; pain in the arm; pain in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red mark in the shoulder which hurt), PAIN IN EXTREMITY (pain in the arm) and ARTHRALGIA (pain in the shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red mark in the shoulder which hurt), PAIN IN EXTREMITY (pain in the arm) and ARTHRALGIA (pain in the shoulder). At the time of the report, ERYTHEMA (red mark in the shoulder which hurt), PAIN IN EXTREMITY (pain in the arm) and ARTHRALGIA (pain in the shoulder) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided. Symptoms experienced after 2nd dose were considered by patient as a normal reaction.
Received 1st does of Pfizer vaccine on 1/16 and 2nd dose on 2/8/21, tested positive for COVID-19 on 4/5/21 during a routine screening test, reported asymptomatic
Patient starting having diarrhea on 11/24/19, bloody, mucous  stools started on 11/25/19.  Last bloody stool was on 11/26/19.
nausea, body ache, chills, part of face felt numb & tingling; also sore throat;
vomiting & diarrhea; taken to urgent care because 103.6 fever & cont to vomit & can not hold in fluids;
Patch is warm to touch and sore; Her arm has a red rash/patch; Patch is warm to touch and sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore) in a 32-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) (oral use) on 10-Oct-2023 at an unspecified dose and frequency. At the time of the report, FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore) was resolving.            Concomitant medication was not provided. Patient received Flu shot and COVID shot. The area below where recipient received the vaccine, she had a large red rash or patch on arm. That patch was warm to touch and sore. Patient took treatment with Nyquil on the night of 10-Oct.
Mom states about 2 1/2 hrs p/vax pt began screaming uncontrollably; unable to console by either parent; states cried & screamed x 3 hrs & finally fell asleep; fitful sleep that noc awakened several times;
Swollen glands in neck up to back of ears, overall feelings of malaise, ongoing. No treatment except TYLENOL, I'm allergic to aspirin.
death; Exposure via transplant; Initial information received from United States on 11-May-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced death and exposure via transplant while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].  cluster case- 2022SA176292, 2022SA177055, 2022SA177145 and 2022SA177654   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site for unknown indiaction.  On an unknown date the patient developed a serious death and exposure via transplant (unknown latency) following the administration of YELLOW FEVER VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) death.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (death, Exposure via transplant).  At time of reporting, the outcome was Fatal for the event death and was Unknown for the event exposure via transplant. It is unknown if an autopsy was done. The cause of death was reported as Death.; Sender's Comments: Sanofi Company Comment on 17-May-2022:This case involves a patient of unknown age and unknown gender who experienced death subsequent to organ transplant. The organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX. Neurologic symptoms were suspected in the patient. Available information is limited. Further information regarding symptoms, medical history, concurrent conditions, concomitant medication, laboratory investigations, autopsy and cause of death are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: death
Redness started on arm and then went away for about 1 week then returned. Now 2 weeks after shot, the arm is still red about 6 x5 inches. Area has slight fever and itches on and off. Advised to follow-up with physician.
Inconsolable screaming and crying, rigid body, screaming worse if moved, weird pitch and tone of crying. Screamed for several hours straight, passed out then resumed screaming until 10 pm. Screamed from 730pm until 12 am next day, then fell into deep sleep, unarousable until 4 pm next day, total if 16 hrs. Continues with screaming fits and sleepiness.
First dose on 18 Jan 2021 and Second dose on 10 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Blood pressure high and Cholesterol. Concomitant products included METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, POTASSIUM CHLORIDE (KLOR-CON), LYSINE, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Jan 2021 and Second dose on 10 Mar 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Circicimide as concomitant.  Treatment details was not reported by the reporter.    This case was linked to MOD-2022-460617 (Patient Link).
Shingles; exhausted; pain/ache; general malaise; burning; stinging nerve pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 26Mar2021 11:45 as dose 1, single (age at vaccination: 28 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 09Apr2021 at 12:30 PM, the patient experienced shingles, symptoms began approx 1 week post dose, exhausted, ache, pain, general malaise. Started with burning, stinging nerve pain inner right thigh also located on right side of scalp. Lesions approx 2 weeks post dose. Started antivirals. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received was antivirals. The clinical outcome of the events was resolving.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
rash and itching around the vaccine site (red rash is at this point circular and about 2" in diameter)
Red, inflammation @ injection site, pre-existing condition in injection arm bone spur in shoulders. Pain from left shoulder to left leg.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for degenerative joint disease left hip. Vaccination took place 3/19/09. According to physician relationship is 'None'.
burning, tingling, pain started in upper extremities during the daytime ! started about 9 days after second dose of Moderna Vaccine.
Felt as if coming down with flu like symptoms and did so 2 days later.  Then 2 more days subsequent, I lost hearing in right ear and total loss of smell and of taste. Went to primary doc. who then sent me to an ENT Spec and from ENT to a Neurologist.  To date, none of the medical doctors can or have identify why the above things happened.  Good news is that I have regained full hearing, but still cannot smell nor taste.  Have no clue if the flu vaccination properties caused these problems but after visiting, at length, with a very learned pharmacist, she advised me to make this known as a "vaccine adverse event".
BRAIN FOG; SHORTNESS OF BREATH; COULD BARELY WALK; EXTREME FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced brain fog. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced could barely walk. On AUG-2021, the patient experienced extreme fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue, brain fog, shortness of breath and could barely walk was not reported. This report was non-serious.
swelling in lt arm since vax 24AUG98;DTAP in lt upper/varivax lt lower deltoid;devel a lot of swelling this AM w/some mild erythema & puffiness last noc;
Woke up with a cough, runny nose, fever 99 degrees, diarrhea and poor appetite. Lasted couple of days and got better.  Three weeks later  runny nose, cough and the rest of the family got sick too.  Since then continues to get sick on and off with cough, runny nose occasionally diarrhea. Mother feels that the FluMist weakened his immune system.  She says she and her husband both get sick with Flu shots.
Trigger finger miraculously gets better; Could not get herself warm; Body ache; Headache; Nausea; Chills; Fever; This spontaneous case was reported by an other and describes the occurrence of TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 23-Feb-2021, the patient experienced TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, TRIGGER FINGER (Trigger finger miraculously gets better) had resolved and FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  The action taken with mRNA-1273 in response to the event was not applicable.
First 48 hours were side effects as documented - soreness at site, "flu like" symptoms for 24-48 hours.  I was then back to status quo for 5 days and have now had "burning mouth syndrome" for past 5 days.  No pain to speak of, but complete/bilateral numbness to lips, tip and bottom of tongue toward throat.  It is as if I have sprayed my mouth with Chloraseptic and it has remained stable with no easing or increasing of the numbness.  I do not have any health co-morbidities such as DM, HTN, etc. and am a very healthy individual, otherwise.
This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of PROQUAD (Lot # K020751, expiration dose: 30-APR-2016; L007229, expiration dose: 03-SEP-2016; L024125, expiration dose: 30-DEC-2016) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Swelling and redness at injection site 6-23-10 and dizziness and headache the following day on 6-24-10. Mom insists on reporting side effects.
The section above is hard to answer because he was given a lot of vaccines in a short amount of time. 5/5/2016: HIB; pneumococcal PCV; Dip, DTap, DT, Td; Poliomyelitis, Hepatitis B. He had many more 2 months later. I had no idea that his health problems were caused by the vaccinations and I completely trusted the doctor, he acted like all of his symptoms were normal. its been years later and I'm just now finding out that I can report his injuries.  He initially had a fever, was lethargic, and was very fussy, he screamed and cried a lot. He soon developed a very severe case of colic, was projectile vomiting, and had acid reflux-this went on for 2 years. the doctor acted like it wasn't a big deal and prescribed a corn based formula and acid reflux medication, he said he would eventually grow out of it but my son was misreable and in a tremendous amount of pain. all he did was scream at the top of his lungs for the first 2 years of his life. he wouldn't keep eye contact, he always had diarrhea and it was a very foul smell, strange texture, and color. When he was old enough to sit up and play he always wanted to play alone, he didn't talk, he often hit his head many times on the floor or objects and ate gravel and dirt. when he was old enough to walk he would constantly fall and hit his head. showed signs of bein autistic
patient received of IMOVAX RABIES vaccine 45 minutes to 1 hour after reconstitution/ NO AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient who received vaccine  in rabies series first dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] and IMMUNOGLOBULIN ANTI-RABIES on 16-Sep-2020, second dose of suspect RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] and third dose of suspect IMOVAX RABIES (administered 45 minutes to 1 hour after reconstitution on 23-Sep-2020) (wrong technique in product usage process) batch number, expiry date not reported via an unknown route at an unknown administration site for post-exposure immunization.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong technique in product usage process (latency: same day).   At the time of reporting, 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 holder's compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
pt recv vax & 1hr p/vax noted redness w/rash over entire body-no s/s of SOB;pt took DPH PRN to help w/itching;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted due to low blood sugar having skipped breakfast.  Recovered within minutes after sitting down and drinking water.
48 hrs p/immun was alert but very quiet; When picked up let out piercing scream, was cold & clammy; would arch back & scream on attempts to lay down; Episode reported 4 consecutive times; No temp; was cyanotic;
Rash started to left arm spreading to both arms, chest, neck & face. Felt tingling sensation, very itchy. Only thing different for this pt was that she received a TDAP the day before.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a three years old patient (gender was not reported) who received IPOL two months before his fourth birthday. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included - HEPATITIS A VACCINE and PREVNAR, VARICELLA VACC. and DAPTACEL. On 08-May-2017, the patient received a fourth dose of 0.5 ml suspect IPOL (lot number: 975970, expiry date: 23-JUN-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if the patient had any adverse event. 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 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. List of documents held by sender: none.
Headache, Sedation, Myalgia, Fever, SWELLING AT INJ SITE Narrative:
The next day after I received vaccine, I noticed bruise on my left thigh (about 1 inch). I did not hit or do anything else to have a bruise, so, I think it is a blood clot.
pt recvd vax;w/in several days post vax exp severe HA,abd cramping & hives;w/in 1 wk exp joint pains,arm & leg pains & d;seen by MD prescribed corticosteroids,w/in the last few days,exp inc episodes of d;
Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0162) via an unspecified route of administration, administered in Arm Right, at the age of 54-year-old, on 19Apr2021 11:45, as SINGLE DOSE for covid-19 immunisation.  Medical history included Auto Immune Mixed Connective Tissue Disease and allergies to sesame seeds. The patient is not pregnant at the time of vaccination. There were no concomitant medications.  The patient previously took codeine and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot Number ER8727) via an unspecified route of administration, administered in Arm Right, at the age of 54-year-old on 29Mar2021 11:30, as SINGLE DOSE for covid-19 immunisation. There are no other vaccines received in four weeks and no other medications in two weeks. On 19Apr2021 12:00 PM, the patient experienced severe allergic reaction requiring ambulance to er hospital and administration of epipen injection, IV steroids, antihistamines and histamine blockers. The patient was admitted in the hospital in Apr2021 for 1 day. Covid test (nasal swab) on 19Apr2021 showed negative result. Outcome was recovering.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Dec-2021: F/U received on 24-DEC-2021 and contains no new information. On 26-Dec-2021: F/U received on 26-dec-2021 contains no new information.
pt reports joint pain in thighs, knees and left shoulder starting 8-10 weeks after vaccination.
Information has been received from a pharmacist referring to 4 newborns (numbered 170, 171, 172, 173). Background: Since June 2015, there had been  1645 times (30 minutes each time-=822.5 hours0 that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 06-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.6 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016 (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.