chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncontrollable chills; Body aches; Headache; fatigue; Fog brain; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-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 right arm on 01May2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) 81mg, prenatal vitamins (MANAFACTURER UNKNOWN) all from an unknown for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 22:00 the patient experienced uncontrollable chills, body aches, head ache, brain fog, fatigue. No therapeutic measures were taken for the events. The clinical outcome of the events chills, general body pain, headache, fatigue, foggy feeling in head recovered on an unspecified date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended patient tab, historical vaccine, Concomitant drug recoded, treatment received checked no and updated in narrative, therapeutic measures no updated in narrative.
since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm; pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm; excruciating pain.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021F and 024L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.). At the time of the report, LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-325319 (Patient Link).
I am experiencing pain in the folds of my groin area and pain in both hips I just took a hot bath and two Tylenol
24 hours after receiving 2nd dose, patient began feeling dizzy. Seen by MD 9 days after and current working diagnosis is vestibular neuronitis. Symptoms are slowly improving. Repeated testing confirms this is not an inner ear issue but rather a central problem.
(R) arm red, swollen, warm and tender to touch. Rash, itching. Started on KEFLEX 500mg TID x 7 days.
pt recv vax & devel blood glucose levels greater than 200;the pt also exp chills;no further info was available @ the date of this report;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 09-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS #1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008981, 1405USA008982). Additional information has been requested.
From the day following the injection, I felt to be in a mental fog that has very slowly nearly abated.  Uncommonly tired, no headache fever, chills, or neurodeficit otherwise.  ( I am a retired physician).  This lead to change in gait: slow, foot dragging, unstable.  Near accident in driving auto.  More than 4 time of urinary incontinence ie incontinence when bladder overfilled.  Mental clarity lost.  speech impaired by word searching.  Obvious change in behavior to those around me.
Patient received the SHINGRIX vaccine on 05/14/18. On 05/16/18, patient called in the morning to report that there was an adverse reaction at the site of injection. Her arm is swollen at the site of injection, it feels heated/warm, there is a rash, and her arm feels sore. She has also experienced chills. Patient has been taking pain medication to help and putting cool compress on the area. She says it is not getting worse, but it hasn't resolved yet. Pharmacy will follow up in a few days to see how patient is doing.
Patient had notable swelling of the upper arm and a fever of 101 F the next morning. She felt extremely dizzy and nauseated. Told her to take BENADRYL 50mg, TYLENOL PRN, cool compresses to arm. Patient had just redness and swelling on Monday. Patient just has itching left as of 10/20/16.
Pain in chest; Pain in back; Lymph nodes discomfort in same arm of injection; Pain in shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer. Concurrent medical conditions included Blood pressure high, Anxiety and Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Lymph node disorder, Pain chest, Pain back and Shoulder pain, at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            Diagnostic tests included X-ray and blood tests on 01Mar2021 and it was confirmed that patient's heart was fine. No specific findings were provided.   Patient did not experience any adverse event after the first dose.  concomitant product included pills for blood pressure, cholesterol and anxiety  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
heart rate today is 130 which is increased from heart rate yesterday of 100; light-headedness; nausea; The primary reporter is the patient who stated he received the second dose of the GARDASIL 9 vaccination on 02/29/2020/; This spontaneous report was received from a 40 years old male patient referring to himself. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.  On 29-FEB-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (one injection, lot # R036912, expiration date 23-SEP-2021; dose was not reported) via intramuscular for better protect himself from cancer ((prophylaxis)(PT: product use issue)).  On the same date, one hour after receiving his second dose, the patient began experiencing light-headedness and nausea. No treatment was given for adverse events. Blood work was performed (no result was provided). The patient had sought medical attention, he went to primary care. On 03-MAR-2020 (reported as today) the patient's heart rate was 130 (unit not provided) which was increased from heart rate on 02-MAR-2020 (reported as yesterday) of 100 (unit not provided).  Outcome of light-headedness and nausea was not recovered. Outcome of heart rate increased was unknown. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R036912; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever, shivering, muscle pain, join pain, headache, nausea, fatigue, stuffy nose. Took Tylenol migraine and sudafed.
Had immunization at 12:15 pm on Thurs 10-9-08 c/o headache starting at 11 pm that night; woke up w/headache - severe at 4:30 - headache described as back of head behind eyes. C/o nausea this AM V/S-T-100 AP -92- R-22 BP-112/70 at 9AM on 10/10/08
Itch at injection site; swelling; small red splotches noted on right back, right arm, right leg; large area on upper arm with raised red patches, and continued itching; large area on upper arm with raised red patches, and continued itching; This is a spontaneous report received from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL0142), via an unspecified route of administration in the left arm on unspecified date in Jan2021, as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified). Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), atenolol, chlorthalidone (MANUFACTURER UNKNOWN), and amitriptyline hydrochloride (AMITRIPT): all for unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced itch at injection site two weeks after vaccination and over 3 weeks swelling and large area on upper arm with raised red patches and continued itching. The patient also experienced small red splotches noted on right back, right arm and right leg. Therapeutic measures were taken as a result of the reported events and included treatment with topical hydro cream with BENADRYL and unspecified oral medication. 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 vaccination site pruritus, swelling, patchy rash and red blotches was recovering.  No follow-up attempts are possible. No further information is expected.
The first two doses of Moderna were done, (05/01/21 and 05/29/21) respectively, followed by severe migraines, temperature fluctuations, nausea, fatigue, and chills. These symptoms passed after 2-3 days.  The third dose of Moderna, (02/18/22), was followed with migraines, bruising at the injection site, and excema at the injection site. The migraines and bruising did fade after 3-4 days. The excema moved from my top left shoulder to my fingers and knuckles, parts of my face, parts of my head where my hair is, and spots on my back. I have noticed that consuming sugar and gluten does worsen the excema (I had a cheat day). I am using two different creams for my body excema and honey for my face excema. This seems to mitigate skin breaking and itching. Also, cold showers help too.
After about 7 days post vaccine I am experiencing headaches, tremors throughout my body. However, the worst symptom was on Thursday till present---I had an out of body experience and feel like I am having a nervous break-down and palpitations. This is now day four with these symptoms.
Large swollen area at vaccination site. Recommend Ibuprofen, wait a little and see if it improves, report back.
My scalp became extremely itchy approximately 30-45 minutes after receiving the vaccine. I took benadryl as soon as I got home about 90 minutes after receiving the vaccine. Itchiness continued is I took another Benadryl about 3 hours post receiving the vaccine. After 2nd dose of Benadryl, itchiness subsided.
Initial unsolicited report received from a nurse on 23 May 2018. This case involve a child (age and gender not reported) who received only Dtap/IPV portion without first reconstituting the ACTHIB component of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a actual medication error due to inappropriate reconstitution technique. 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. Documents held by sender: none.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated that he felt he was going to pass out.  Had him sit in the administration chair since it had arm rests.  Pt was shaky and clammy and did breifly pass out for about 30 seconds.  As his body slumped I assisted in manuevering him to the floor and keeping him from injuring his head.  After laying on the floor for a few minutes he felt that he could sit up.  He stayed in that position for several more minutes while monitored and was given water before eventually feeling well enough
Mom states 48 hours after DTaP, hib and PREVNAR bad temp up to 102, refused to get out of bed for 3P, ate only 1/2 meal/day for 2 weeks. Mom states 1st step therapists thinks he's "out of it". Had 2 loose stools/day.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: FAINTING LEAD TO SCRAPE ON FOREHEAD-Severe
still ended up testing positive; still ended up testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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) all with onset 10Jul2022, outcome "unknown" and all described as "still ended up testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: testing positive on Sunday; (13Jul2022) Positive, notes: yesterday and it was still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated he has received the primary series of Pfizer Covid 19 vaccines followed by two booster doses, states he is a health individual who wears as mask and doesn't smoke. The last booster being 4-5 months ago. He states that he did not have any side effects with the vaccines at all. He takes precautions and still ended up testing positive on Sunday. He began Paxlovid on Tuesday. He relays that he tested again yesterday and it was still positive. He would like to know how long until he tests negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fluid build up in ears; More than 35 days for 2nd dose; Felt like throwing up; Almost passed out; Sweaty; Hot; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PRESYNCOPE (Almost passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced MIDDLE EAR EFFUSION (Fluid build up in ears) and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose). At the time of the report, PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), DIZZINESS (Dizzy), MIDDLE EAR EFFUSION (Fluid build up in ears) and NAUSEA (Felt like throwing up) was resolving and PRODUCT DOSE OMISSION ISSUE (More than 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported. Patient had a reaction after getting the 1st dose of the vaccine and stated that after 24 hours almost passed out due to being sweaty and hot, also reported felt like throwing up and feeling dizzy, had fluid build-up in ears and this may have occurred a week or two later and did not provide exact dates for onset and duration. Patient still gets dizzy but not so pronounced and all of the other adverse events have subsided. Patint may have been given antibiotics for fluid buildup, but not sure and was sure that was prescribed steroids.  Treatment included Steroids and possibly antibiotics. Company comment: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of almost passed out (presyncope). The event occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Patient presented to the ED on 3/25/21 for fatigue. Patient presented to the ED and was subsequently hospitalized on 5/3/21 for chest pain. Patient was hospitalized on 5/11/21 for percutaneous transluminal coronary angioplasty. These visits are within 6 weeks of receiving COVID vaccination.
Six days after the first vaccine on 03/11/2021, my PVC/PACs started to increase in numbers, particularly after the second COVID-19 vaccine on 04/01/2021; I would normally get a few PVC/PACs a day but the vaccine (presumably) really increased the number to about 20-30/day, enough for me to see a cardiologist and get 10-day heart monitor that recorded every heart beat for that duration.  Upon analysis of hundreds of events, the cardiologist said that palpitations were all benign; however, these PVC/PACs were very pronounced, enough to make my life miserable for three months, and enough that I did not even slightly consider gettng a booster shot.  I live in isolation (except for wife).
Pneumonia vaccine received this morning has made me very sick. The pain at the injection site is severe and similar to the pain I had when receiving this vaccine several years ago. Over the course of the day, I developed flu-like symptoms, including body pain, a fever and a headache.
I received my first dose of the Moderna Vaccine on Wednesday, March 3, 2021.  About 4 hours after receiving the vaccine, I began to ache, chill, feel fevered, cramp, be dizzy, and nauseated.  I actually had covid in November and the response to the vaccine was so much worse than actually having the virus.  I am debating about getting the second vaccine since this one made me so sick.  I would appreciate advice.
My mid back is aching and sleep is difficult. I have not experienced this type of back ach in the past. I am taking ibuprophen to help with ach.  This may get better but I wanted to report the problem in case it gets worse. Don't know the cause.
There is no reported adverse event.  I am just reporting  that this patient had received the Johnson and Johnson Covid vaccine at a different site on a different date prior to this vaccine.   The Immunization Registry contacted use at our pharmacy to confirm our vaccine because they somehow new from the previous vaccination facility that he would be seeking  the Pfizer at some point after he received the J and J.  The previous vaccination facility said he knew it was an approved combination but that he was most like going to get both manufacturers of the vaccine.
2 days post vax, the pt experienced itching, swelling and stinging. Mother states the child had chickenpox 2 times as a child. Treated with Benadryl and cold compressed to the arm.
Patient (per parent) was worked up about getting vaccine (anxious).  During vaccination, client was cooperative, but did appear nervous.   About 5 minutes into observation period, patient began vomiting and was pale.  Parent did not identify previous reaction to receiving immunizations.  After resting and drinking some water, patient felt well enough to leave with parent.  Provided recommendations of when to follow-up for additional care.  Per parent follow-up on 11/26/2021, patient did not go to the doctor and continued to improve after leaving clinic.
Vaccine med error. Client inadvertently given MMRV in place of Varicella vaccine. Client alert. No issues or symptoms noted after vaccine administration.