chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 05 April 2013. A 36-year-old female patient had received first intramuscular dose of ADACEL vaccine (Lot number U4612AA, anatomical site of vaccination was not reported) on 05 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 29 August 2012 and the expected date of delivery was reported as 05 June 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 05 April 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
nose bleeds; sores in her nose that she describes as dried blood scabs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 10Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; NOSE DEFORMITY (non-serious), outcome "unknown", described as "sores in her nose that she describes as dried blood scabs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer is the patient who had the Pfizer Covid Vaccine this year and has been having nose bleeds all summer. The other day she had to get on plane and so she had to take a COVID test where they stuck something in her nose, and it came back bloody. She said her nose has been bleeding all summer, she is 58 and has never had nose bleeds her whole life; but in the last months she has been getting nose bleeds and getting sores in her nose. The person said she did not want to alarm her, but she just thought caller should have that addressed; tell her doctor she had the Pfizer Covid Vaccine, inform the doctor that you're having this trouble. So caller called to ask if nose bleeds have been reported with Pfizer Covid Vaccine, if it's relative to the injection. she had to get on plane and so she had to take a COVID test where they stuck something in her nose, and it came back bloody  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headaches; fever; muscle pain; pressure on her chest; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure on her chest), CHILLS (chills), HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure on her chest) and CHILLS (chills). On an unknown date, the patient experienced HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN at a dose of 2 dosage form. At the time of the report, CHEST DISCOMFORT (pressure on her chest), CHILLS (chills), HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ (Lot # L022447, exp date: 26-JUN-2017) oral. The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Severe headache; muscle aches; Joint pain; chills; Fever; Nausea; Vomiting; Fatigue; DOSE 3; DOSE 3; This is a spontaneous report from a contactable consumer (patient). This 71-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: FE3590) at age of 71-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  Medical history included diabetes, Blood pressure high (hbp), cholesterol, Transient ischaemic attack (TIA), Known allergies: sulfa. Concomitant medications included hctz; atenolol; rosuvastatin; clopidogrel; insulin. The patient previously received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EP7534) on 19Mar2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EN6198) on 26Feb2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, metformin and experienced allergies, azithromycin and experienced allergies, Betadine and experienced allergies. The patient experienced severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue on 08Oct2021 19:00. No treatment received for these events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue was recovering, of other events was unknown.
Fever, chills, nausea, fatigue, vomiting, body aches, headache
One week after injection, left arm injection site became red, swollen and itchy Currently on third day, not gone yet but not getting any worse
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. Since 23-MAR-2016, the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L037559, expiration date-29-SEP-2017 (incorrect product storage). No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Temperature was 30.09F for 6 hours. Previous temperature excursion was 47.2F for 2 hours 44 minutes. Temperature was not logged by data logger. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 21-NOV-2012, the patient was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular and on 21-NOV-2013, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
did not receive second dose as scheduled; right elbow became swollen; affected area was still swollen; right elbow warm to the touch; opposite arm from injection arm was bothering her; right elbow getting red; after second medication, redness had lessened, but was still sore; diagnosed with cellulitis, took a month to clear up; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (diagnosed with cellulitis, took a month to clear up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Few months before reporting.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CELLULITIS (diagnosed with cellulitis, took a month to clear up) (seriousness criterion medically significant), LIMB DISCOMFORT (opposite arm from injection arm was bothering her), ERYTHEMA (right elbow getting red) and MYALGIA (after second medication, redness had lessened, but was still sore). On 23-Jan-2021, the patient experienced JOINT SWELLING (right elbow became swollen; affected area was still swollen) and FEELING HOT (right elbow warm to the touch). On 05-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) from 26-Jan-2021 to 04-Feb-2021 for Cellulitis, at an unspecified dose and frequency. At the time of the report, CELLULITIS (diagnosed with cellulitis, took a month to clear up) and ERYTHEMA (right elbow getting red) had resolved, PRODUCT DOSE OMISSION ISSUE (did not receive second dose as scheduled), FEELING HOT (right elbow warm to the touch) and LIMB DISCOMFORT (opposite arm from injection arm was bothering her) outcome was unknown and JOINT SWELLING (right elbow became swollen; affected area was still swollen) and MYALGIA (after second medication, redness had lessened, but was still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter  Patient was kept on combination medication consisting of sulfa and antibiotic after putting her on 10 day course of Keflex which did not help her much.  Company comment- Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the known safety profile of mRNA-1273.
Patient lactating mother just received second dose of Moderna.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPOSURE VIA BREAST MILK (Patient lactating mother just received second dose of Moderna.) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Feb-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Patient lactating mother just received second dose of Moderna.). At the time of the report, EXPOSURE VIA BREAST MILK (Patient lactating mother just received second dose of Moderna.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant or treatment medications were reported.   This case was linked to MOD-2021-043893 (Parent-Child Link).   See case MOD-2021-043893 for details regarding the Parent case.
My whole body was aching and I felt totally felt exhausted. I lost my appetite and got a migraine. The pain pounded my head into my neck. Every part of my body ached and felt like this for about a week. I never had a fever but I felt hot and my teeth would chatter. It lasted for about a week and now my back went out and I am still dealing with that.
Patient had injection site swelling & pain of R arm gradually getting larger to max size of 5x6 inches of induration - treated with ice, ibuprofen, antihistamine.
The pt was found deceased at 10:00 am on 9/8/00. Pt did take 6:00 AM feeding without complication. Found face down in corner of a "love seat" where she was sleeping. Autopsy states cause of death consistent with sudden infant death syndrome.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 08:15 as dose 6 (booster), single at the age of 61 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single, as dose 3 (booster), single, as dose 4 (booster), single and as dose 5 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "heart issues". 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 "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Negative; (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
had a sever/sever head/chest cold on Monday following the shot given on Friday was on Z-pack and Mucinex--seems to be working
Vaccine tdap was given to a 9 ½ year old patient; Tdap or pediatric DTaP is inadvertently administered to a child, no adverse event; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years 6 months old patient who received fourth 0.5 mL vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot U62772AA, expiry date-26-04-2021 via intramuscular route in the right deltoid on 23-Sep-2019, instead of DIPHTHERIA AND TETANUS TOXOIDS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   The reported queried that What should be give between the ages of 7-10 for Tetanus and Diphtheria. Reportedly Tdap or pediatric DTaP is inadvertently administered to a child aged 7-9 years instead of Td.  At the time of report 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.  Query for batch number reconfirmation was sent.  Documents held by sender: none.
Vaccine - immediate symptoms: A strong immune response - fever, shaking, muscle aches, headache and it lasted exactly 24 hours and stopped abruptly. Unable to work the next day. Currently, since May - I am experiencing abdominal pain. It's been constant since May. No definitive diagnosis. No treatment. Still experiencing .
pt recv vax 11AUG97 w/t104, given Ibuprofen x 2 today;temp has been staying 102-104;no redness or swelling of thighs;no crying or irritability;drinking some fluids;warm bath given;has not gone to PMD @ this time;
Unexplained intermittent chest pain, intermittent shortness of breath, feeling of weakness in hands.
On 8/3/11 mom noted red spotty macular rash on face, chest, back & legs. No rx. T. 100.1 (R).
Pt got a rash in the morning on the day after the vaccination. The rash progressively got worse. She went to the ER Monday evening and received antibiotics. She was prescribed a 7 day course cephalexin and bactrim. As of this writing the rash was improving.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/10/21 2nd dose02/07/21 Diagnosed covid positive:08/26/21 Symptom onset:08/26/21 Exposure:Travel Symptoms:Fever, fatigue, loss of smell, chills, runny nose,headache, congestion.
MOTHER STATED CLIENT FAINTED AFTER RECEIVING VACCINES. EMT EVALUATED CLIENT AND DECLARED CLIENT RECOVERED. MOTHER STATED CLIENT HAD NOT EATEN PRIOR TO VACCINES.
At first I had a headache and nausea. I was trying to concentrate on work, I felt tired and dizzy, and My headache was really bad. i left work early. When I got home I had body aches, I couldn't eat because of nausea. I developed fever of 102 and chills, It flared up my RA whole body hurt to move, tingling all over it hurt to even blink my eyes. It hurt to pee. I developed vertigo.  On the third I went to work still had headache, body aches, and nausea. It it took a week for me to feel better.
Information has been received from a medical assistant referring to a 11 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 21-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012776: US-009507513-1709USA012777:
The patient said she felt terrible after the second dose. Symptoms included fever, diarrhea, dizziness, tiredness, sore arm, fatigue, could not get out of the bed
On 7/23 I had my first of many episodes and these have continued sporadically through today (8/15). Symptoms - feeling unbalanced/lightheaded, fatigue/slight numbness in arms/hands and calves/feet, cloudy brain, slurred speech, eye twitching (sometimes visible by dr, other times it feels like it?s occurring behind my eye internally). Episodes have no consistent onset. Spells can last throughout the day or for only a few hours. Dr provided me with an RX for Meclizine. When taking a dose of that, symptoms subside.
Employee received Flu Vaccination 9/20/2017 during skills fair. On 10/20/2017 employee began to experience symptoms of Dizziness, Blurred Vision, Headache, Confusion, Tremors, unable to stand, bear weight or ambulate. Employee was at home when symptoms began and was brought to the Emergency room for Eval. She was subsequently admitted to ICU. She was transferred to hospital with DX of possible Guillian-Barre Syndrome. Employee was discharged to home on 10/8/2017 for ongoing rehab care. Vaccine Information: Manufacture: GlaxoSmithKline FLULAVAL Lot: 4373E Exp: 5/31/2018.
Pt recv vax on 12/7/98; post vax pt exp red fluid-filled lesions on trunk & face
I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors.  I went to  clinic on 03-26-2021 for evaluation.  They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers.  To this day, I am still having  swelling and edema to both of my feet and ankles.
Shingles 2 weeks after 2nd dose; it did something to my heart; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of tachycardia. Concurrent medical conditions included cardiac valve leak.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and heart disorder. On an unknown date, the outcome of the shingles and heart disorder were unknown.   It was unknown if the reporter considered the shingles and heart disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-Aug-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The reporter was just saying that on another post, caught a Shingles on 2 weeks after the second vaccine and somebody said they did also. The reporter also believed that something to his/her heart had leaky heart value. After Covid vaccine heart been beating like on a rollercoaster. Follow-up would not possible, as no contact, details were available; Sender's Comments:  US-GSK-US2022AMR117009:Same reporter
I was on a cruise ship when I started to experience symptoms of congestion in my head and aches throughout my body. I went to the doctor's office, located on the ship, and was tested for COVID-19. The test came back positive. I was not prescribed PAXLOVID on the ship. I was given FLONASE and SUDAFED D. I tested negative on 01/24/2023.
Pt. had FLUVIRIN immunization at 4:15 PM 12-18-11. Returned to Pharmacy at 4:52 PM with huge bruise (purple) on left wrist. No reaction at injection site. 911 was called due to patient concern and rule out blood clot. Pt. would not go to ER with responders or accept any medical tx. Waive form with EMTs was signed. PCP was notified. Pt. contacted 12-19-11 and doing well. Said will see MD soon for physical.
A physician reported that her husband received an injection of Prevnar on 7/25/00 and subsequently developed an injection site reaction characterized by redness and swelling.
I began seeing hives on my abdomen, by 09/20/14 I was almost covered in hives from my breast to hips and in the same location on my sides and back. I saw my doctor on 09/22/14 and was given prednisone. The hives faded through the week, however my last prednisone pill was 09/28/14.  The very next day 09/29/14 they began to appear again and have progressively gotten worse. I am seeing my doctor again tomorrow.