chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was in sighificant pain; Most sore when I lift it up or am changing shirts; This spontaneous case was received on 16-Nov-2020 via Med Communications (reference number: SEQW20-05139) from pharmacist with an additional document received on the same day from the same reporter (being processed together) and concerned a 30-year-old, female patient.  The patient's relevant medical history was not reported. The patient's concomitant medication was Kariva (desogestrel, ethinylestradiol), used for birth control. The patient's vaccination history included annual flu shot for many years.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: upper left arm, route of administration: intramuscular, dose: not reported) for flu prophylaxis for the first time. The batch number reported was 276580 and expiry date was 30-Jun-2021.  On the same day, by evening, after receiving Flucelvax QIV, the patient's arm was in significant pain where she could not use it.   On 03-Oct-2020, reported as next morning, most of the pain had resolved, but it was still sore.  At the time of initial reporting on 16-Nov-2020, the patient had not recover from the events, as she reported her arm had been sore every day since vaccination, and it was still sore, now. It was the most sore when the patient lifted it up or she was changing shirts.  The reporter assessed the events to related to Flucelvax QIV. The reporter stated, would like to report an adverse event with Flucelvax.  The reporter assessed the events as non-serious.  Company comment: A 30-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced pain in extremity. Reportedly, it was the most sore when the patient lifted it up or she was changing shirts. Causality is assessed as possibly related for pain in extremity and pain upon movement, due to plausible temporal relationship and no alternative aetiology provided.; Reporter's Comments: The reporter stated, would like to report an adverse event with Flucelvax.; Sender's Comments: A 30-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient experienced pain in extremity. Reportedly, it was the most sore when the patient lifted it up or she was changing shirts. Causality is assessed as possibly related for pain in extremity and pain upon movement, due to plausible temporal relationship and no alternative aetiology provided.
PATIENT RECEIVED COVID VACCINE, THEN IMMEDIATLY RECEIVED FLU VACCINE. FOLLOWING FLU VACCINE, PATIENT EXPERIENCED SYNCOPE FOR ABOUT 10-15 SECONDS AND THEN RETURNED TO FULL CONSCIOUS STATE. PATIENT WAS ASKED SERIES OF QUESTIONS TO DETERMINE MENTAL AWARENESS. PATIENT HAD FORHEARD ABRASION.  PATIENT WAS MONITORED AND GIVEN WATER FOR 30 MINUTES POST VACCINE.
Expired vaccine used; There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
patient felt weak; light headed; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHENIA (patient felt weak) and DIZZINESS (light headed) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (patient felt weak) and DIZZINESS (light headed). At the time of the report, ASTHENIA (patient felt weak) and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Initial unsolicited report received from a pharmacist on 07-Apr-2017. This case involves a 69-year-old patient (gender not reported) who was vaccinated with a first dose of ADACEL (batch number U5292AA, expiry date: 14 April 2018, dose form, frequency and route of administration not reported) in the right deltoid on 04-Apr-2017. The illness at time of vaccination, birth defects and medical conditions were not reported. Pre existing physician diagnosed allergies included allergies to Sulfa drugs, penicillin and morphine. Any other vaccine within four weeks of vaccination was reported as unknown. Concomitant medications were not reported. On 05-Apr-2017, in the morning one day following the vaccination the patient developed jaw pain. It was unknown if pain was radiating from anywhere or if it's concentrated to a side. Patient was advised to seek medical attention either from her PCP or an emergency room. Relevant laboratory investigations were reported as none. Corrective treatment was not reported. The patient was not yet recovered from the event. List of documents held by the sender: None
pt recvd vax & 20hrs post vax exp wheezing & coughing;pt was seen by MD 1DEC94 & treated w/nebulizer & bronchodilator which relieved sx;
Diarrhea (severe) lasted from 10/21/11 to 10/26/11. Fatigue, muscle ache, joint ache, loss of appetite, fever/chills, perspiration.
I had severe chills, aching, sweats, coughing, severe sore throat, congestion, headache, fever, extreme fatigue. I took a home COVID-19 test that came back positive. I called my doctor, made an appointment for later that day. I was prescribed PAXLOVID that I started taking as soon I picked it up from my pharmacy. Around day eight I started to feel better, but I ended up getting rebound COVID-19, although I finally started tested negative by February 27, I still do not feel like myself 100 percent.
pt recvd vax;pt reported soreness in Rt arm following vax in Rt deltoid; pain worsened over next 2 wks & was worst in 3rd wk;pain had since subsided;2 visits to chiropracter who reported rotater cuff injury;
Arm swollen and redness at the site of injection. He also developed a low grade temperature. mom gave ibuprofen and Benadryl.
red rash about 3 inches by 6 inches on arm where the vaccine was given; red rash about 3 inches by 6 inches on arm where the vaccine was given; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given). At the time of the report, VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given) outcome was unknown.
Headache pain in left thigh Chill muscle pain  back pain pinching feeling in my chest
booster; patient received dose with a stability excursion; patient received dose with a stability excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Dec2021 10:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 10:00, outcome "unknown", described as "booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 08Dec2021 10:00, outcome "unknown" and all described as "patient received dose with a stability excursion".  Additional information: The caller reported that last night (07Dec2021) at 7 PM the vaccine was reconstituted and one dose is left at the temperature over night. The doses subsequent were taken out of the box, 4 doses were taken out of the box at 10:00 AM and administered as booster dose to patient. It was further reported that the COVID vaccine vial was reconstituted, she asks, you can get 5 doses from one vial right? She believes that you can. They took one dose out of the vial when it was reconstituted yesterday at 7:00 PM, so they used one dose, and then their policy after that is to damage the rest of it and don't use the rest of the vial. They close at 9:00 so the 6 hour time frame that it can be used would be after hours. The vial that was reconstituted was not damaged out and it was kept on the counter. They have two immunizers there and one thought that the other had reconstituted the vial that morning and the other thought the same. Caller knows that in the past she has been given some data on excursion stability from a regulatory authority and she didn't know if a regulatory authority had any stability data beyond the 6 hours or if she would have to go to a medical institute. She says that she thought that she was being transferred to see about the stability information. Other Products, Patient History and Investigation Assessment were not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101752818 Same reporter/drug/AE, different patient;US-PFIZER INC-202101752817 Same reporter/drug/AE, different patient;US-PFIZER INC-202101752816 Same reporter/drug/AE, different patient
Arm swollen with hard area, very painful shaking, sweaty, vomiting. 3-4 hours after receiving vaccine. 1 week stated on visit f/u 1 day after injection.
pt recv vax 21OCT96 & same day pt devel severe swelling of arm from inj site to elbow all the way around;arm was twice the size;21OCT96 pt also devel painful red streaks down arm;
my lower legs felt like were getting itchy/lower legs were itchy; with any kind of exertion and heart jumping out of chest; heart pounding; trouble breathing/Difficulty breathing with any kind of exertion; with minimal walking she had to sit and take it easy; This is spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 08Apr2021 at 10:00 AM as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included ongoing autoimmune breathing issue (started 6 years ago). No family medical history relevant to adverse events. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She had her first shot 3 weeks ago, on 08Apr2021 and she was due to second shot on 29Apr2021 this Thursday. She had the first shot on a Thursday and she was fine Thursday through Sunday. Did not have any symptoms until 4 days afterwards on 11Apr2021. She started having trouble breathing/difficulty breathing for the next several days with any kind of exertion and her heart was jumping out of chest with exertion, heart pounding a lot that lasted a good week probably 8 days and then it subsided. It lasted every day, for 4 days it was really difficult to breathe and then on 23Apr2021, then probably 2 weeks into started at night her lower legs felt like were getting itchy and scratching it didn't make a difference because it was on the inside. With minimal walking she had to sit and take it easy. It lasted about a week and she is feeling better. She put some topical itch cream that seemed to help and took a Benadryl and it made it better, it seemed to dissipate. She is concerned about the second shot, would her breathing and heart issue would be worse. She called her breathing doctor and he said he thinks it was still better to take the second vaccine because of the seriousness of the COVID-19 disease. The patient did not visit emergency room or physician office. The patient received treatment due to the events with topical itch cream and Benadryl. The outcome of my lower legs felt like were getting itchy/lower legs were itchy was recovered on 26Apr2021, while with other events trouble breathing/Difficulty breathing with any kind of exertion; with minimal walking she had to sit and take it easy and with any kind of exertion and heart jumping out of chest; heart pounding was recovered on 21Apr2021. No follow-up attempts are possible. No further information is expected.
Sever arthritic disablement. Swelling of joints. 60 day follow-up dated 09/27/00 provided no additional data.Doc 210794, annual follow up states that patient still has severe arthritic symptoms.
tingling, pain, burning and weakness in ankles and feet, worst at inside of heels where nerve bundles run down heel of foot and burning to toes , Took naproxen over period of time...symptoms persisted for over a month and continued to present mainly in heels of feet.Much of the tingliness and burning had dissipated.  Had Tdap shot on 7/18/2021. The burning symptoms in feet and pain have worsened the week immediately after having the Tdap. Following up with primary care doctor.
Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and HSV infection. Concomitant products included ACYCLOVIR [ACICLOVIR] for HSV infection, ATORVASTATIN CALCIUM (LIPITOR) and ASA for Hyperlipidemia, LISINOPRIL for Hypertension, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Address was updated, Patient demographics, ethnic group and race were added, Medical history and dose 2 information was added, concomitant medication was added, event outcome was changed from unknown to not recovered.
Initial unsolicited report received from a nurse on 14-Jun-2018. This case involves a patient (age and gender was not reported) who was not vaccinated dose of IPOL but was vaccinated with PEDIARIX (batch number, expiry date, dose series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. 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.
Body aches; fever; a little nausea; headache; pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 10:00 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "ADD" (unspecified if ongoing), notes: verbatim: ADD. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "a little nausea"; HEADACHE (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 26Oct2021 15:00, outcome "recovering" and all described as "pain and swelling at injection site". Therapeutic measures were not taken as a result of pain, pyrexia, nausea, headache, vaccination site pain, vaccination site swelling.  Additional information: Patient was not pregnant at the time of vaccination. Patient had not received other vaccines within 4 weeks prior to vaccination. Patient had received other medications antidepressants and Adderall within 2 weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Patient was not tested with covid-19 since the vaccination. Patient had no known allergies. Patient had concomitant therapy.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The patient fainted after the injection for about 3 seconds. The patient's mom was there is hold the patient in the seat. The patient recovered with orange juice provided the pharmacy after approximately 10 minutes. The patient has a history of fainting with all of her vaccinations in the past. The patient is fine and the patient's mom did not want us to call for any assistance.
This spontaneous report was received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M006103, expiration date 01-AUG-2017 and/or lot # M004891 25-SEP-2017 (dose, dose number, route, and anatomical location were unspecified). The reporter stated that the vaccines were exposed to 5.5F during 10 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red, raised, itchy rash over injection site.  Golfball sized lump at injection site. Started ~3 days after injection.
This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-SEP-2015, patient was vaccinated with her first dose of GARDASIL, the second dose of GARDASIL injection 1 DF (one injection/ three dose series) (lot # not reported) was administered on 19-NOV-2015 followed by the third dose on 19-JAN-2016. The reporter stated that patient was off scheduled for her GARDASIL series (inappropriate schedule of drug administration). No adverse experience reported. No concomitant medications were reported. There was no product quality complaint. Additional information has been requested.
Developed a rash on both legs from thighs down to mid calf.  Noticed the rash at 8:15 on 04/10/21. Rash did not hurt and was not itchy. Took Benadryl and by the morning it was clear.
fainted; This is a spontaneous report received from a contactable consumer. A 12 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19May2021 (at age of 12 years old, Lot Number: EW0172) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient vaccinated after 4 minutes experienced fainted on 19May2021. The reporter asked if he qualifies for second dose or not recommended. The outcome of the event was unknown.
At less than 24 hrs, moderate flu-like symptoms with muscle aches, joints, and even skin which was sensitive to touch, fever, chilIs, and headache.   At less than 48 hours, I noticed the injection site had a small red reaction,  But just below the injection site, there was a much larger red rash approx. 1.5 by 1.5 inches. Note at greater 48 hours after vaccination, flu-like symptoms have abated, but rash still very noticeable.  I cannot verify if rash was there before 48 hours.  There is no itching or burning with this rash.
I am pregnant my due date is August 6th. I am experience pain in my left underarm/armpit.
Pt. recieved vaccine 12 hours past expiration. No adverse event. MD contacted pt. Pt. declined revaccination