chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Fever; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and mild depression. The patient not had known allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and lexoprin(MANUUFACTURER UNKNOWN), both from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 08:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 02:00, the patient experienced fever, nausea, headache and body aches. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, nausea, headache and body aches was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had redness and swelling around vaccine administration site.  It has spread down past her elbow.
Body chills, whole body shaking, diarrhea, nausea, confusion, dizziness, fatigue, severe body aches.
Right arm experiencing pins and needles all the way up to the chest.  Itching on the same arm but no sign of rash. Sensitivity to heat, cold, water and clothing.  Mild visible lump on wrist. Mild numbness of arm/hand while walking.  24 hours of symptoms even while sleeping.  symptoms moving toward middle of chest.
rash 14 days p/vax lots over chest, back (a few on arms, legs & face)-very fussy;
I have had COVID over 8 times; I have had COVID over 8 times; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had COVID over 8 times". Clinical course: Reporter stated she will not give her children any medicine for COVID. She was given every vaccine and every booster she could have. She is a high school teacher and was in the middle of the COVID crockpot with all the students. It was not a vaccine, a vaccine stops it from occurring. She had COVID over 8 times all with conditions. Her kids (4 of them) have no vaccine has not had any symptoms or problems. They were around her every time she was sick with COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from licensed practical nurse concerning a 10 week old male patient with not illness at the time of vaccination who on 17-SEP-2010 at 11:00 am was vaccinated orally with a first dose of ROTATEQ (Lot # 668036/0594Z). The licensed practical nurse reported that on 17-SEP-2010 the patient experienced diarrhea after getting the vaccine 4 to 7 stools per day that lasted 20 days. On approximately 07-OCT-2010 the patient had recovered. The patient did not seek medical attention. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 41-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Benlysta (refer case, US2019GSK017189 and US2019001652). On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site burning and drug administration error. On an unknown date, the outcome of the injection site burning and drug administration error were unknown. It was unknown if the reporter considered the injection site burning to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that when she gave herself her SHINGRIX injection in October or November 2018, that it burned. The reporter stated that she didn't report this because the pharmacist told her that it would be painful and burn.
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 21.24.  Concomitant products were not provided.  On 17-Feb-2021, Excursion time was 09 AM temperature was 22, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.  This case was linked to MOD-2022-566976 (Patient Link).
Patient presented to clinic for follow-up on 2/26/2022. His mother reported he experienced hives 1-2 days after vaccination. Hives were present on patient's chest only. The hives appeared worse in the evenings and improved in the mornings. He denied itching, shortness of breath, cough. He felt headache, lightheadedness and weakness 1 day after receiving vaccine; and mild soreness to right deltoid and right underarm. No hives, rashes, swelling or redness visualized on 2/26/2022 during clinic visit.
Sweats, fever, chills, bronchial hacking cough (non-smoker), headache, brain fog, weak, lethargic, just feel like I'm always sick since that COVID vaccine shot.
About a week or two after the first vaccination shot I noticed my taste was changing.  Some foods were tasting foul.  The first thing was pepperoni sausage, then bacon, and other preserved meats.  Shortly after that, oily foods, like fish and avocados.  Then breads and pastas.  Within 3-4 months just about everything tasted foul.
Info has been received from a medical assistant concerning a female who on 11/12/2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included interferon alfa, albuterol sulfate (+) ipratropium bromide (COMBIVENT), bupropion HCl (WELLBUTRIN SR), chlorpheniramine maleate (+), phenylephrine hydrochloride (+), scopolamine methonitrate EXTENDRYL), budesonide (RHINOCORT), levothyroxine Na (SYNTHROID) and topiramate (TOPAMAX). On approximately 11/12/2002 the pt developed site reaction, redness, swelling, soreness, injection site induration and fever of 101.4. The pt sought unspecified medical attention. Additional info has been requested.
Bronchospasm, resulting in administration of an allergic Rxn cocktail including epinephrine. She was  sent home with Steroids, as well as H1&H2 blockers.
Developed "a bizarre synd of abnormal gait, deviating mildly to lt, but w/out obvious sz activity, subsequent endocrinologic workup revealed biotinidase deficiency. No further abnormality since child placed on Biotin.
Probable wrong site administration of Anthrax immunization.  Anthrax given in left forearm.  Pt reported burning at the site and arm pain immediately following injection.  After 24 hours, area was edematous, indurated and erythematous, warm to touch. Tx with Allegra and Keflex. After 1 wk the edema and tenderness was improved, pt still has a tender raised area.
Patient developed a generalized rash on 12/23, nine days after receiving a varicella vaccine. No complications, parent reported patient having a fever. No additional cases reported among contacts. No laboratory testing was performed for diagnostic purposes. Rash lasted about 14 days.
said a week after he got the Shingrix shot, his left knee got very swollen, 120ml's drained from it, also his ankle got very swollen.  MD diagnosed him with osteoarthritis because of it, it took 7 months to recover and he had to walk with a walker during that time.  he was told not to get the 2nd shot by md.
I started to have rash on my right arm with pumps showing up and is very itchy, itchy and redness with bumps on the right side of my lower face.
At one month post injection pt was having continued pain at injection site. At two months, not much improvement.  Difficulty moving arm. Refused 2nd and 3rd injection because of this reaction.
Extreme fatigue and achiness plus chills. Denies fever. S/S lasted until 10/29/05 at 12:00. Took Tylenol (1gm) time one.
Urticaria, treated with solumedrol and Prednisone, benadryl, Atarax.
Pt recvd 3 doses of Engerix-B & did not convert to HBSAB;
Information has been received from a health professional concerning a 7 year old female with no known drug allergies and no past medical history who was vaccinated with varicella vaccine. There was no concomitant medications. The nurse reported that the pt developed about 10 erythematous papular vesicles on her trunk and arms which were described as chicken pox. On 10/16/2001, the pt was seen in the physician's office. At the time of this report, the nurse did not know when the pt was vaccinated with varicella vaccine. Additional info has been requested.
approx 1 minute after menveo given in left deltoid, mother begins screaming, patient became unconscious, rolled off exam table, struck head, and mother saw patient seizing (upper extremities). When this writer immediately observed patient, head jerking was noted. Pt lost consciousness for approx 20-30 seconds. Airway intact. After 20-30 seconds, pt asking questions 'where am I? What happened?'.  Pt re-oriented. V/s stable. resp's easy and unlabored. Placed on.  EMS immediately called. Small contusion noted to left forehead. Skin intact. Hair examined and posterior scalp intact. Skin intact, but pale.  Pupils PERRLA. Lungs clear and equal bilat. No incontinence noted. Pt began to sit up, but Instructed pt to remain on floor until EMS arrives. Pt c/o posterior neck pain. No n/t/weakness or other sx's. Denies n/v. Mother states he has never had any adverse rxn to an immunization before. Pt has never had a sz before. Mother states his sister has a hx of epilepsy. Pt has not been recently ill. Denies cardiac hx.    Pt still a/o x 4. EMS- c collar/c spine and transferred to hospital. Mother present and updated and agreeable to plan of care. Mother given discharge paperwork.  ***3-4 days later, this writer tried to contact mother to check on pt's status, 3 times, no answer, left VM.
vaccine expired 3 days prior to administration. Manufacture called and stated they support that the vaccine is valid.
A report has been received from a Health Professional concerning a 9 year old, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient received only one half of a dose in one nostril. The outcome of the event of patient received only one half of a dose in one nostril is unknown. The report was considered to be non-serious by the company physician.
pt recv vax & immed p/pt cried & has screamed cont off & on since then;area does not appear red-sl swollen;this was pt 1st DTP/HIB
Acute pericarditis, unspecified; Unspecified disease of pericardium.
After vaccine, 1 day later, I had body ache and fever, then the next day I had joint pain in elbows. On the 21st, of December, I started feeling very tired and fatigue. On the 22nd, Tuesday, I had the stuffy nose, congestion and sore throat. Today is day three of me being sick.  I was told to go get tested for the virus and report. Yesterday my husband woke up with a fever of 101 as well.
I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash from my upper chest through the top of my face with itching along my jaw lines.  This did not require any visit to ER although a call was made.  The event lasted 24 hrs.
Fever of 102 brought down to 101.6 after treating with Tylenol. Fever and chills lasted for 24 hours. Soreness at site of injection lasting 48 hours. Joint soreness lasting 24 hours.
Employee given  Hep B vaccine #3 on 3/17/2008.I saw the employee in the hall late in the third week of May. Employee was complaining of continued pain at the injection site in her arm.I examined her arm, there was no redness, no lumps and the site was cool to touch. Employee advised to see her physician for evaluation. Employee unable to remember if she had strained or in any other way may have hurt the arm
Covid-19 (COVID + (12/8/21) 33 weeks pregnant was sent by OB/GYN d/t complaints of SOB that she describes is more than what she usually has during her pregnancy. Also c/o chills, body aches, congestion headache.  Was referred to ER for monoclonal antibody infusion. W/U in ER showed COVID pneumonia, and hypertension 179/94.  COVID pneumonia at 34/5 weeks, not hypoxic , but tachypnea present, we are told not candidate for monoclonal antibody because we are making inpatient.  Dexamethasone 6mg IV q12 for COVID and fetal lung maturity. IV Remdesivir. Cefipime 2gm, Infectous disease consult.  discharged today to home
Fever of 103; large area of redness on arm (all the way around arm, from shoulder to elbow); skin became very hot to touch.
Head Ache, Neck Ache, Low Fever, Extreme Fatigue, Loss of Concentration, Diahreah  , nausea for Friday, Saturday, Sunday, Monday
A rash at the injection site that was puffy, very itchy and red; A rash at the injection site that was puffy, very itchy and red; A rash at the injection site that was puffy, very itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L22A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included HYDROCHLOROTHIAZIDE, APIXABAN (ELIQUIS), DONEPEZIL, ESCITALOPRAM, MEMANTINE, SOLIFENACIN and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red). At the time of the report, VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
COVID symptoms returned; COVID symptoms returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Lot number: 003A21A), in left arm, on 10Apr2021 as dose 2, single (Lot number: 036BZ1A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "PVC" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Interchange of vaccines products" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ROSUVASTATIN; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL; MAGNESIUM; LANSOPRAZOLE; BREO ELLIPTA; B12 [CYANOCOBALAMIN]; D3; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; ALBUTEROL [SALBUTAMOL]. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "COVID symptoms returned". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I once again tested positive; negative, notes: having had a negative test shortly after finishing Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
laryngitis of unk origin;pt has hx of CA larynx;no obvious recurrence;? flu rxn;
Received 100mcg Moderna COVID-19 vaccine instead of approved 50mcg dose.
One day after receiving Moderna COVID-19  vaccine, leg inflamed  with trouble walking on next day.  Symptoms partially resolved in one month; interference with activities continuing to 4 months.    (Did not receive second vaccine dose due to this adverse event)
extreme pain at the injection site; difficulty raising arm and lifting objects; SIRVA; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in right deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
Patient had tightness in throat, then syncope shortly after, which let to him falling to the floor from a chair and hitting his head. After patient was released from vaccine site, he developed shortness of breath, and went to the ER, where he was given diphenhydramine, which patient says helped. Patient then had 10 days of symptoms neurological and cardiovascular symptoms (slowed cognition, mood changes, somnolence/hypersomnia, palpitations) and went to ER four times and was diagnosed with a concussion/post concussive syndrome. He was referred to neurology and had an EEG conducted. He was given prednisone during this time.
This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments:  US-009507513-1711USA002012.