chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment/Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. Anti-viral details was product-COVID 19 Treatment was Paxlovid, treatment start date-07May2022, treatment stop date-12May2022 for Treatment of COVID-19. 4 days after completing patient 5 days of Paxlovid, my Covid symptoms returned. Headache, congestion, sore throat, fatigue. They had gone away completely within 36 hours of the first dose.  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-202200725686 Same patient, different product and event
Hives, developed all over the body throughout the day.  Very itchy, red.  Prednisone orally, antihistamines.
symptoms like allergies; tired; arms were heavy; chills; This spontaneous case was reported by a physician and describes the occurrence of LIMB DISCOMFORT (arms were heavy), CHILLS (chills), ALLERGY TO VACCINE (symptoms like allergies) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), LOSARTAN POTASSIUM (LOSARTIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), MULTIVITAMIN IRON and PROBIOTICS NOS for an unknown indication.    On 25-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Sep-2022, the patient experienced LIMB DISCOMFORT (arms were heavy) and CHILLS (chills). On 01-Oct-2022, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced ALLERGY TO VACCINE (symptoms like allergies). The patient was treated with IBUPROFEN on 26-Sep-2022 at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arms were heavy), CHILLS (chills), ALLERGY TO VACCINE (symptoms like allergies) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2022, SARS-CoV-2 test: (Positive) Positive.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had bivalent booster dose. It was reported that patient had also experienced chills with some of her previous Moderna vaccines.   This case was linked to US-MODERNATX, INC.-MOD-2022-654635 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654635:bivalent booster
Extreme weakness in hips and legs evidencing Parkinson's.  Previously reported on. Went to physical therapy at 2:00 after receiving the shot about 11:30.  Walked in, having been walking all along.  PT said she fell or almost fell several times during PT.  When finished came out to the car using a walker with the PT holding her by a belt around her waist.  Has had to use the walker ever since. Diagnosed with Parkinson's on 7-16-22 by MD.  Did the Covid shot trigger the Parkinson's?
0608 am 2-month-old otherwise healthy male arrives to the emergency department in cardiopulmonary arrest.  Per the transporting crew, patient was last seen alive during a feeding between 10 - 11 PM on 6/21/21.  The ER was contacted at 5:15 AM 6/22/21 when the patient was found unresponsive.  The transporting crew reports that they found the infant cyanotic with rigor mortis but CPR was performed and intubation was unsuccessful due to jaw rigidity. Asystole for 45mins prior to emergency department arrival.
Have had severe diarrhea for almost 72 hours that is not going away.; Developed fever of 100.2; headache; chills; aching joints for first 2 days; This is a spontaneous report from a contactable consumer(patient).   A 69-years-old female non pregnant patient received second dose of BNT162B2 (BNT162B2, PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in arm right on 18Feb2021 at 12:00 as single dose for covid-19 immunisa-tion. The patient medical history was not reported and concomitant medications were none. His-torical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via via an unspecified route of administration, in arm right on 28Jan2021 at 12:15 as single dose for covid-19 immunisation. On 18Feb2021 at 15:00, the patient experienced severe diarrhea for almost 72 hours which did not fo away, developed fever of 100.2, headache, chills and aching joints for first 2 days. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient treatment medications included tylenol for first 2 day and immodium and pepto bismol for three days. Patient did not had COVID-19 prior or since vaccination. The outcome of the events was not recovered.
A spontaneous report of serious event of autoimmune reaction manifested by hair loss from eyelashes and eyebrow and non-serious event of "received H1N1 LAIV on Oct 2009 and Jan 2010" has been received from a mother/consumer concerning a nine-year-old female, subsequent to H1N1 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in Oct -2009, the patient received first dose and on an unknown date in Jan-2010, received second dose of H1N1 2009 Monovalent Vaccine Live, Intranasal, for an unknown indication. Two weeks after the dose in January, the child started loosing her eyelashes and part of eyebrow. The child was seen by a doctor, who diagnosed it as an autoimmune reaction. As per reporter the event was due to the vaccine. The outcome for the reported adverse event received H1N1 LAIV on Oct 2009 and Jan 2010 was considered  resolved and outcome of the event autoimmune reaction was unknown at the time of reporting. Additional information was received on 20-Apr-2010 and incorporated into the narrative: reporter type, medical history and concomitant medication, vaccination dates, route of vaccination. Other information received on 20-Apr-2010 are: county name, vaccinated at, DOB of patient, lot number of both H1N1 vaccines. Additional information received on 18-May-2010 and incorporated into the narrative: information on medical test and outcome of event. Other information received was: reporter name.
Ever since first shot my fibromyalgia has been going through the worst inflammatory flare ever.  Arms hurt. Biceps hurt. Forearms hurt. Thighs hurt. Calves hurt. Everything hurts.  My fibromyalgia was under control until I had the Moderna vaccine.  Over five weeks now and am in constant pain.
Patient states he received the Typhoid Vaccine on Monday FEB 27, 2017.  This was his first injection with this vaccine.  Pt began to experience a severe migraine, chills, nausea and diarrhea, light-headedness and a foggy head.  Symptoms lasted for two days.  Pt went to an ER off-post for evaluation.  He states that he was given IV fluids, HA medication through the IV and had blood work done.  States that his headache improved but that he continues to experience nausea and diarrhea five times a day since the injection.  Pt denies that he experienced rash, SOA, chest pain, swelling of the face / throat / extremities, numbness and tingling. Feeling tired (fatigue) and chills. Headache Pounding headache over the frontal lobe. Decreased appetite, nausea, and diarrhea. Dizziness and lightheadedness.
right arm swelling, erythematous from arm to elbow. Tx with ice, Motrin, Benadryl.
Fever starting 8 p.m. 4/19/2021 topping out at 102 degrees and breaking 4 a.m. on 4/21/2021.  Chills and shivering started at 8 p.m. on 4/19/2021 ending 11:30 p.m. 4/19/2021. Tachycardia = 200 bmp started 3:00 a.m. 4/20/2021  lasting through 4:15 a.m. 4/20/2021. Throbbing headache during elevated heart rate.  Bodyache lasting during time of elevated temperature. Extreme soreness at injection site.
Patient was supposed to receive a dose of Pfizer 12+ Bivalent vaccine, but received a dose of Pfizer 12+ Monovalent vaccine instead. Medical assistant accidentally pulled the wrong vial of Pfizer Covid. Patient's PCP is aware of the situation. No harm to patient.
did find but a friend of theirs has a son with a history of high anaphylaxis and asthma, male, aged 14, who is now in the hospital after receiving the vaccine; did find but a friend of theirs has a son with a history of high anaphylaxis and asthma, male, aged 14, who is now in the hospital after receiving the vaccine; This is a spontaneous report from a contactable consumer.  A 14-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose (dose unknown) for COVID-19 immunisation. Medical history and concomitant medications were unknown. At the time of report, the patient with a history of high anaphylaxis and asthma was in the hospital after receiving the vaccine. The outcome of the events was unknown.
Dose of VARIVAX was inadvertently given to an unspecified 50 year old patient on an unspecified date due to human error; This spontaneous report was received from an administrator referring to a 50 years old patient of unknown gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (vaccine dosage detail and route of administration not reported; lot # S000132, expiration date 02-JAN-2021) due to human error for prophylaxis (wrong product administered). The reporter stated that this was not product confusion. No product quality complaint (PQC) was involved in this case.
Student felt her throat was scratchy, tongue felt itchy and was coughing. She took Benadryl 25mg and then repeated the Benadryl again 3 hours later.
Had a SCAD event (spontaneous coronary artery dissection) with heart attack  on 1/28/23  No history of heart disease prior
received first dose / on 08/29/2019 and was unaware about getting the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019 intramuscularly in left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient was unaware about getting the second dose.  The patient inquired whether she should get a second dose or restart the vaccine. The reporter did not had full mailing address, name of the facility, email address to HCP. The reporter did not had lot number or expiration date. The reporter mentioned that, patient received the vaccine from pharmacy intramuscularly in left deltoid. The patient consented to follow up.
Injection site erythema, Injection site swelling - Information has been received from a physican concerning a 9 year old caucasian female patient with a history of cellulities after vaccination with a fifth dose of diphtheria - tetantus toxoids - acellular pertussia vaccine, who on 18 Aug 2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation (lot #635288/0583K).  Within 30 minutes after vaccination, the patient developed erythema, and slight swelling surrounding the injection site.  foxofonadine (Allegra) was administered to the patient at the doctor's office.  It was reported that the patient's mom was upset, and they wer told to apply ice and diphenhydramine HCL (Benadryl).  The Patient has antibiotic allergies to penicillin and arithromycin (zithromax).  The patient has recovered.
Administered IM left deltoid. Small hard raised area developed seconds after injection. Pt returned to pharmacy 2 days later to show 2.5 inch red warm area that itched. No treatment required.
On 4/16/00 had inner ear dizziness all day and took antihistamine. On 4/17/00 and 4/18/00, had red blotch around injection site and used cold compresses.
an 18 month old female patient was given expired Daptacel/no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 24-Jan-2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the left thigh.  It was of actual medication error due to expired vaccine used.   It was reported that no adverse event was experienced by the patient.  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.
Woke up 3/6/2021 extremely dizzy and nauseous.  Felt better after about 2 hours.  Tired all day.  3/6/2021 still tired,  3/7/2021 still tired 3/8/2021 still tired, 3/9/2021 still tired, but less than the other days.  I weigh 102 lbs, might be a factor.
patient received spikevax on 11/4/2023 and she reports having a red round rash around the injection site about 2-2.5 inches in diameter. she reports that the rash has not grown in size, does not feel warm to the touch, has not changed colors since appearing, and is itchy but does not cause pain/discomfort
Similar effects to documented ?covid arm? symptoms, but much faster than other reports. As I report, 11/14/2021 at around 00:30, there is a localized, red,  about 2 inch long and 1 inch tall skin reaction that is warm to the touch at the injection site, which feels firm under the skin. The warmth and firmness do not extend past the edge of the reddened skin. The underarm lymph nodes on the left arm close to the injection side are notably swollen, starting to swell around 12 hours after injection, mildly painful, and cause discomfort in holding the arm at resting position.
The patient experienced swelling at the injection site that has now persisted for 6 days as well as redness and warmth. Also the day after the vaccine she had 3 raised blisters on her index finger that resolved after she popped them that day. She is following up by going to her physician tomorrow.
mom reported throat hurting, swollen @ 630AM today;nauseated-sleeping;T98.6 arm hurting from time shot given to present;no redness/swelling;diabetic BS 270-300;21OCT97 arm still sore throat fine/other problem resolved;
No additional AE reported.; temperature excursion; This spontaneous report has been received from another reporter, concerning a 12-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 29-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, on left thigh (valid lot number W017343 [expiration date 13-DEC-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, after a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes that occurred on 01-DEC-2022 (product storage error).  No additional adverse events (AE) were reported.
9 days after vaccination my right arm became extremely sore.  I have a baseball size rash that is itching and painful and very hot to the touch.  I have taken Benadryl and it has helped but am in discomfort.
101 Fever; Chills; Body ache; Headache; Fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 25Jun2021 as unknown, single for covid-19 immunisation. Medical history was none. Concomitant medications included Doxycycline and Metoprolol. On an unknown date, the patient experienced some serious side effect of 101 fever, chills, body ache, headache and fatigue. The patient underwent lab tests and procedures which included body temperature of 101. The outcome of all the events was reported as unknown.
Shoulder immobility. Loss of ROM shoulder has popped out 4 times today and has never done that before in my life
Patient got Fluarix on 10/24/21. Patient parent came back in 5-10 mins reporting a small rash around mouth and near injection site. Patient told pharmacist at intake that he has had flu vaccines before with no reaction. We told parent to take dose of Benadryl. Patient was not reporting any itching or pain. No difficulty breathing. We called patient parent later in day and he reported that the patient was doing well and that the Benadryl worked.
The patient complained of soreness and redness at the injection site the day after the vaccination. The area around the injection site was approximately 6" long and 4" wide and was raised and red. The patient was treated with Benadryl and Tylenol.
Food poisoning; She is still weak; Not totally feeling well; I am still not as up to par as I was at the first time; I got sick from eating something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD POISONING (non-serious), outcome "unknown", described as "Food poisoning"; ASTHENIA (non-serious), outcome "unknown", described as "She is still weak"; MALAISE (non-serious), outcome "unknown", described as "Not totally feeling well"; ILLNESS (non-serious), outcome "unknown", described as "I am still not as up to par as I was at the first time; I got sick from eating something".  Additional information: Patient stated she didn't get sick from the vaccine, she got sick from eating something that last week, that week. The patient was due to get the shot tomorrow, she was not quite up to par but she was real close, so patient was asking if it was still okay for her to get the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported Information: removed event "missed dose"
initial misuse report received from a healthcare professional on 01 November 2013. The 3.5 year old (41 months) patient had received incorrect does of FLUZONE (lot # and expiration date unknown) that was 0.25 ml in October. (No information was provided regarding the patient). N adverse event was reported. List of documents  held by sender: none.
Injection site pain and soreness; fast heartbeat; mild itching in left arm day after injection
NAUSEA; TRUNCAL RASH; DIARRHEA; This spontaneous case was received from a physician on 13-Jun-2019. It describes a female consumer who had nausea, diarrhea, and truncal rash, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif on 08-Jun-2019. In between the dosing, she had nausea, diarrhea, and truncal rash.   She had no known immunocompromising condition.  Action taken with Vivotif was dosage maintained.  The consumer had been recovering from the diarrhea, while the clinical outcome of the events nausea and truncal rash was unknown.  Company's Comment: In this case, it was reported that had nausea, diarrhea, and truncal rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that had nausea, diarrhea, and truncal rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting VAQTA (Lot number K000578, expiry date 21-SEP-2015). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the unspecified number of patients were administered VAQTA, (dose unspecified) (Lot number K000578, expiry date 21-SEP-2015). Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
Severe pain, weakness and restriction of mobility in left arm. Start of symptoms about 18 hours post administration. X-rays taken. Saw Dr June 21, 2021, June 23, 2021 and October 27, 2021. Started exersizes and received cortisone shot October 27, 2021. As of Februrary 2022 still have severe weakness and pain in left shoulder. Sleep distrubance due to pain.