chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed maybe 10 years ago. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills".  Additional information: Reporter stated patient previous doses would have been in Feb2021, but she did not have exact dates or any product information to provide. The patient did not visit emergency room and physician office. Reported stated patient had the vaccine Tuesday, 14Dec2021, and tested positive for COVID today. Reporter clarified with the first Pfizer COVID vaccination, patient had a fever, body aches, chills- all that jazz for a couple days. This time, with the booster, patient had all the same things the second day. Yesterday, patient felt pretty good, but today patient was coughing a little bit and tested at work. The test came back positive and patient did not know if it was right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/9/21:  second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen.   Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
Neck pain/neck stiffed up, had pain; Felt some knot in neck; Neck stiffed up; Had fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain/neck stiffed up, had pain), NECK MASS (Felt some knot in neck), MUSCULOSKELETAL STIFFNESS (Neck stiffed up), PYREXIA (Had fever) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain/neck stiffed up, had pain), NECK MASS (Felt some knot in neck), MUSCULOSKELETAL STIFFNESS (Neck stiffed up), PYREXIA (Had fever) and CHILLS (Chills). The patient was treated with CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 milligram; IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and Manual therapy (massage every day to function) for Neck pain. At the time of the report, NECK PAIN (Neck pain/neck stiffed up, had pain) had not resolved, NECK MASS (Felt some knot in neck) and MUSCULOSKELETAL STIFFNESS (Neck stiffed up) outcome was unknown and PYREXIA (Had fever) and CHILLS (Chills) had resolved.            No concomitant medication were reported  After the second dose patient had fever and chills for a day. The pain in neck was pretty bad and it lasted until patient received her booster. The neck was getting better, but it flared up really bad after the booster dose. Doctor gave the patient a trigger point injection and has to get a massage every day to function because the pain was very bad (massage every day since February).   This case was linked to MOD-2022-454652, MOD-2022-454759 (Patient Link).
Major body aches,, chills and nausea. Missed 2 days of work.
Patient felt dizzy and nauseated.  Patient brought back to exam room to lie supine.
Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 04-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-016273
Severe pain and burning left side arm 9 hours later, including shoulder, neck, head, left abdomen, stomach, lung, and top part of leg.  25 mg. of Benadryl helped a little.   Subsided gradually after 3 days.  Still have pain left arm at injection site (12 days after vaccination). And some pain left side of head.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01May2022 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BP occasionally elevated" (unspecified if ongoing), notes: None. Healthy. BP occasionally elevated (128/85) but never this scary high. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Thursday night tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Sep2023 to 26Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300315587 Same patient, different drug/AE.;
PATIENT EXPERIENCED REDNESS/SWELLING FROM INJECTION SITE DOWN PAST ELBOW, PAIN, CHILLS, FEVER, MUSCLE ACHES AND FATIGUE FOR A FEW DAYS AFTER INJECTION
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 28-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash slightly raised papular, mildly red, not of a sandpaper quality, scattered but bit confluent over trunk; present but not enhanced in diaper area. Rash is fine on face and proximal extremities, rash is thick and confluent in the area surrounding right thigh. She has tender nodules at the injection sites. The rash is thickest around the site on her lower right leg and extends to upper right leg. Continue use of Benadryl and Tylenol. Avoid Pertussis vaccine in future.
high anxiety/very anxious; body felt hot; pain and redness in her arm/deltoid pain and redness at injection site; pain and redness in her arm/deltoid pain and redness at injection site; This spontaneous report was received from a 35 years old female nurse via a company representative referring herself. The patient's concurrent conditions included epidural abscess, pulmonary outflow tract obstruction(POTOS), abnormal pulmonary arterial pressure(PAP), attention deficit disorder, anxiety, depression, insomnia, migraine and drug allergy(cyclobenzaprine, penicillin, pregabalin(LYRICA)). Concomitant therapies included tizanidine hydrochloride, amphetamine aspartate(+)amphetamine sulfate(+)dextroamphetamine saccharate(+)dextroamphetamine sulfate(ADDERALL XR), escitalopram oxalate(LEXAPRO) and topiramate(TOPAMAX).   On 31-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, lot # and expiration date were not reported)Intramuscularly (IM) for prophylaxis.      On 01-AUG-2019, the patient experienced pain and redness in her arm,high anxiety(also reported as she developed deltoid pain and redness at injection site and started to get very anxiouse), and body felt hot. On the same day, the patient received dexamethasone (DECADRON) 10 mg intramuscularly and hydroxyzine one to three times daily (also reported as 25 mg as need (PRN)) for anxiety from her primary provider. The outcome of events was reported as recovered on 02-AUG-2019. The reporter considered tizanidine hydrochloride, amphetamine aspartate (+)amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL XR) and topiramate (TOPAMAX) to be related to the events. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
First dose- Injection site soreness; Mild muscle aching and lethargy 18 hours after the first dose.; Mild muscle aching and lethargy 18 hours after the first dose.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: ER8727, EW0173) at the age of 51 years 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: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "First dose- Injection site soreness"; MYALGIA (non-serious), LETHARGY (non-serious) all with onset Apr2021, outcome "recovered" (2021) and all described as "Mild muscle aching and lethargy 18 hours after the first dose.". It was unknown if therapeutic measures were taken as a result of vaccination site pain, myalgia, lethargy.  Additional information: First dose- Injection site soreness, Mild muscle aching and lethargy 18 hours after the first dose. Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours. if other vaccine was administered in four weeks was unknown. It was unknown, if patient had covid prior vaccination and if covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
ITP (platelet count 1,000); This is a spontaneous report from a contactable physician (patient).  A 31-years-old healthy male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The historical vaccine included MMR vaccine in Nov2020 (3 months before 08Feb2021) for immunization and idiopathic thrombocytopenic purpura (ITP). The patient presented with ITP (platelet count 1,000) approximately 2.5 weeks after receiving the 2nd dose of the Pfizer COVID vaccine. Hepatitis C Antibody (reported as Hep. C Ab) was negative. HIV-Ab was pending. The reporter knew there were cases reports of ITP associated with COVID-19 infection. The events outcome was unknown. The reporter asked had anyone noted COVID vaccination-related ITP? He received the MMR vaccine (which has been associated with ITP) 3 months ago. Was it too far out to attribute this case of ITP to the MMR vaccination?  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
a temperature excursion due to unknown reasons Temperature reached 1.7C for 6 minutes with no reported adverse event; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes with no reported adverse event while receiving vaccines[ACT-HIB].  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 HIB (PRP/T) VACCINE with unknown dose lot UJ581AAB via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot C5788BA via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose  lot C5829BA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7191AA via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE with unknown dose lot UJ776AA ,UT7347MA via unknown route in unknown administration site.  On an unknown date the patient had a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of HIB.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (a temperature excursion due to unknown reasons Temperature reached 1.7C for 6 minutes with no reported adverse event).  At time of reporting, the outcome was Unknown for the event a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes with no reported 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 the 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.
Pt had edema noted approx. 1 inch in width & approx 6 inch long (a strip) redness & minor itching noted. Lasted 3 days without pain noted; subsided after 3 days.
Received vaccine 12/16/14. Soreness that night that lasted 3 days. On 12/19/14 area was itchy then swollen 12/22/14. Patient went to MD 12/23 to get clindamycin 300mg - 1 cap 3x day. Area is fine now.
Known seizure disorder, developmental delay, had 7-8 min focal seizure, no cyanosis, transported by squad to ER for further management, but seizure stopped en route.
Patient was instructed to be monitored for 15 minutes after vaccine was administered. Patient stated she was feeling dizzy as she was entering her vehicle. She came back to see me at the consultation window approximately around 1:10p.m. I have her seated on a chair by consultation for close monitoring and informed her to let me know if she feels unwell. She stated she feels better after remained seated for another 15-20minutes.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jul2022 at 14:15 as dose 3 (booster), single (Lot number: FJ4991) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 at 09:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 at 12:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022 at 14:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (01Jan2023) Positive; (06Jan2023) Negative; (07Jan2023) Negative; (09Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Got COVID on 31Dec2022 tested positive just past midnight about 00:30 AM on 01Jan2023. Treated with Paxlovid. Got better and tested negative on 06Jan2023 and 07Jan2023. On 09Jan2023 tested Positive for COVID again. Patient did not have the known allergies.
Has been exhibiting compulsive behaviors recently; seems to have become more severe and consistent since he got H1N1 vaccine about a month ago.
Patient states she started having adverse events to vaccine the evening after she had received it. She developed a headache and reports unable to sleep. The next morning she states she had muscle weakness and difficulty standing, and dizziness. Arm pain after she received vaccine which she reports has continued but is getting better.
10 - 15 minutes post vax pt started seizure activity in the car on the way home. Paramedics were called and child went home okay.  Pt experienced another seizure and paramedics were called and the pt was taken to ER.
Redness, swelling, tender to touch, painful, itchy at the left deltoid at subcutaneous muscle.
Swelling, itchy, very hot, very painful, at 9:30 doubled in size at 11 am, went to the Dr. Took Claritin and applied cortisone cream as directed, took Benadryl at night, woke up today with arm more swollen, larger red area, and a has more pain. On her shoulder blade she has a small bump like blister.
Broke out with hives over most of my body. Severe itchyness and pain. Doctor prescribed Predozone. Was also taking Benadryl.
parents took pt to ER that evening & reporter was notified by legal office that pt died-ER report listed SIDS;autopsy report listed severe viral infect;no adverse events noted @ clinic;
slight mild headache; pain in the shoulder blade right past the left shoulder; pain on the back side of the arm where the injection had been given; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight mild headache), ARTHRALGIA (pain in the shoulder blade right past the left shoulder) and VACCINATION SITE PAIN (pain on the back side of the arm where the injection had been given) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Pain back (constant pain from back injury) and Knee pain (bone on bone knee pain; in need of a total knee replacement). Previously administered products included for an unreported indication: ENALAPRIL (had weird side effects). Concomitant products included OXYBUTYNIN, LEVOTHYROXINE, DEXLANSOPRAZOLE (DEXILANT), MELOXICAM, ROPINIROLE, METFORMIN, SIMVASTATIN, GABAPENTIN and LOSARTAN for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (slight mild headache), ARTHRALGIA (pain in the shoulder blade right past the left shoulder) and VACCINATION SITE PAIN (pain on the back side of the arm where the injection had been given). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 10-Apr-2021, HEADACHE (slight mild headache) had resolved. At the time of the report, ARTHRALGIA (pain in the shoulder blade right past the left shoulder) and VACCINATION SITE PAIN (pain on the back side of the arm where the injection had been given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-162595, US-MODERNATX, INC.-MOD-2021-162621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162621:mother US-MODERNATX, INC.-MOD-2021-162595:mother case
Chills, fever, muscle and joint  pain, nausea resulting in difficulty performing my daily duties
Dizziness, Headache, SkinRash, NauseaVomiting, palpitations, metallic taste instantly after injection Narrative: When injection, the patient immediately tasted a metallic taste, tingling down left arm, headache, flushing, nauseated, numbness and tingling in hands and feet, chest pain- described as palpitations.
pt recv vax 13MAY96 & 20MAY96 pt devel 200 lesions w/severe pruritus & sl fever;reporter was convinced that pt had devel wild type varicella zoster;@ time of report, lesions unable to be biopsied because they were no longer present;
Patient reports taking Pfizer Covid vaccine and 2 hours after that she reports feeling not well.  She recorded that one of the side effects was heart arrhythmias and hence she had her coworker checked her rhythm and she reported that her heart rate was in 180s and hence she was brought to the emergency department for further evaluation.  She reports at the time she had palpitations and felt mild lightheadedness and dizziness.  She was found to be in SVT with heart rate in the range of 1 80-220 and she received 1 dose of 6 mg Adenoscan after which she converted to normal sinus rhythm.  At the time of my evaluation she is in normal sinus rhythm with heart rate in the range of 90-100.  She denies any further palpitations.  She reports she had chest tightness for the last 3 days which was assumed to be secondary to asthma and for which she was prescribed prednisone.  Currently with the prednisone she does not feel any further chest tightness.  She denies any chest pain shortness of breath, fever or chills.  She reports remote history of arrhythmia following her foot surgery in the past however does not recall what arrhythmia she had at that time.