chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed significant left arm cellulitis beginning 24 hrs after injection administered.  Seen in office on 6/27 for this issue and being treated with antibiotics.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an adult female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of drug exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported drug exposure during pregnancy occurred at unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 14 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 07-Jul-2018. The estimated due date is 13-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported in the left arm. Relevant prenatal testing after exposure during. No lab data reported. Final diagnosis was drug exposure during pregnancy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as not applicable for drug exposure during pregnancy. Additionally, at time of reporting, the pregnancy is still ongoing.
FEELING WARM; HEADACHE; This spontaneous report received from a company representative concerned a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (manufacturer not specified) (suspension for injection, route of administration was not reported, batch number: unknown, expiry date: unknown), dose was not reported, dose number in series was 1, 01 in total, administered on an unspecified date for an prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 2, 01 total administered on 05-FEB-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-FEB-2022, the patient experienced feeling warm, and headache (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and feeling warm was not reported (dose number in series was 2). This report was non-serious. This case, from the same reporter is linked to 20210446964, 20210436394 and 20210420604.
my arm is swollen; a real bad rash on it that is really red and puffy like.; First it itch and then it burns,; very itchy like and its scaly like scale.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jul2022 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. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown manufacturer), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Jul2022, outcome "unknown", described as "First it itch and then it burns,"; RASH (non-serious) with onset Jul2022, outcome "unknown", described as "a real bad rash on it that is really red and puffy like."; PERIPHERAL SWELLING (non-serious) with onset Jul2022, outcome "unknown", described as "my arm is swollen"; SKIN EXFOLIATION (non-serious) with onset Jul2022, outcome "unknown", described as "very itchy like and its scaly like scale.".  Additional information: On the 21st which was last Thursday patient had second Pfizer Booster shot. Patient was having a reaction from it, my arm was swollen and it has a real bad rash on it that was really red and puffy like. I wanted to know if this is normal or what should I do, do I need to go back to the hospital or what. My arm was swollen and it has a real bad rash on it that was really red and puffy like; it itch and then it burns, very itchy like and its scaly like scale.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HIGH DOSE FLU SHOT WAS ADMINISTERED TO 63 YEAR OLD PATIENT.
Taking Paxlovid; Taking Paxlovid; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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), outcome "unknown" and all described as "Taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd Engerix-B on 21MAY92 & 15 min p/inject pt exp rash, swelling, itching, wheezing, tightness in chest; pt adm for observation; tx DPH, Adrenalin, Solu-medrol;
I had the 2nd booster shot on 01/31/2021.  Began having covid symptoms on 07/202021.  Rapid Ag Binax Now home test self administered today,  7/8/2021, was positive for covid. Thus making me sick with a breakthrough covid. The vaccine did not help. Contact tracing has not provided a source for the infection. Please mark my case as a vaccine failure.
Information has been received from a physician concerning a registered nurse who was vaccinated with her first dose of GARDASIL. 6 weeks after her first vaccination the patient experienced a fever and swollen cervical lymph nodes. The patient was treated with steroids. The nurse also experienced a fever and swollen cervical lymph nodes after her second dose of GARDASIL. She was treated again with steroids. The physician reported that the nurse approached her while working at the hospital for medical attention. The physician did not have any additional information since the nurse was not her patient. It was also reported that the patient underwent a CT scan (results not reported). No further information is available.
I took the vaccine, the last booster of Pfizer Booster and unknowingly that same day I had Covid; I tested myself and had Covid; I was feeling sick; I am sick with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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), outcome "recovering", described as "I took the vaccine, the last booster of Pfizer Booster and unknowingly that same day I had Covid; I tested myself and had Covid"; COVID-19 (medically significant), outcome "recovering", described as "I was feeling sick; I am sick with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: over 102; SARS-CoV-2 test: Positive, notes: I tested myself and had COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the vaccine, the last booster of Pfizer Booster(Clarified as COVID-19 vaccine Booster) and unknowingly that same day patient had COVID-19 and patient did not realized that because patient came back home and was feeling sick. Patient tested self and had COVID. So, patient took the vaccine and had COVID at the same time and patient talked to the doctor. Patient was running a very high fever over 102 and they put on Paxlovid (Intent: Treatment) and patient am getting, appeared to be getting much better in two days, less than 2 days. So, patient was wondering if that vaccine was any good number one, number 2 were there any side effect that patient was going to have from taking of that booster while was sick with COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt's mother reports pt arm is red, warm and swollen post vaccine. Left arm is warm pink with induration approx 4" diameter.
Severe fatigue, extreme dizziness that will not go away after 2 months, rapid heart rate
My menstrual cycle changed. My period was normally every 27-28 days, now it's changed to every 34-36 days, it's really heavy and lasting for about 10 days. I went to my Gynecologist. I had labs done, with X-rays and an MRI. Uterine Fibroids were found. Took birth control for 3 months hoping that it would regulate my period, but it hasn't helped. The next step would be for my doctor to perform an Ablation. I haven't had this done yet.
Vaccine Administered  into left arm.  Bruise at injection site.  Below injection site  skin is itchy, red, swollen.  Left hand finger tips cold and exhibit cramping.
chills; Fever 99.6; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included POTASSIUM for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Tylenol and Advil for fever.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient has a huge circle the size of a softball on left arm, it's super hot, and redness began about 7 hours after administration.
Two hours after injection pain in upper left arm - Traveled down to hand and fingers - severe weakness worse at night cannot sleep or turn - has not subsided to this day - cannot hold anything heavier than a glass - affecting shoulder and neck.
NERVE DAMAGE; FALLOUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune issue lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that the vaccine ruined the patient's life. The patient was 5 months in and still dealing with the fallout. The patient had unspecified surgery 3 weeks ago to fix nerve damage, which was partially successful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nerve damage, and had not recovered from the fallout. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210915702-COVID-19 VACCINE AD26.COV2.S- Nerve damage. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
loss of hair in a spot on the left side of head, later diagnosed as Alopecia Areata.
We received an email from the long term care facility that the patient's family said that patient's medicare was billed 3 times but the facility insisted that patient only received 2 doses. Upon review of vaccine administration records, patient was found to have received 3 doses (12/26/20, 1/16/21, 2/6/21) which were processed by Pharmacy #1 and Pharmacy #2. No adverse reaction reported by LTC.
administered with vaccine stored in refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 days). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP claims that they had vaccines (unknown number of vials) taken out from the freezer and stored in the refrigerator on 15May2021 at 8:00am. An unknown number of vials were taken out on 15Jun2021 and 60 individuals were administered with these vaccines from 15Jun2021 (10:00am) - 29Jun2021 in one vaccination site.
At 3am that night while I was sleeping I kept waking up and my arm was sore so I didn?t get a good nights sleep. When I woke up and got to work I was exhausted and had a mild headache. I  almost fell asleep at 11am at my desk which I never do no matter how tired I am. I also had mild nausea and mild body pain and was about to leave work sick but decided I could push through it. I made it through the day went home and fell asleep for 11 hours. I woke up refreshed, but my arm was still sore. The nausea tiredness and body pain all went away after sleeping for 11 hours the arm pain from where I got the shot however persisted for at least 5 days. Out of all the side effects the soreness of the arm was the worst part I couldn?t lift my arm without being in discomfort or accidentally bumping into something really hurt. I read moving it around helps the pain but it was too uncomfortable for me to do so I just tried to limit my left arm use.
Rash; heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues". The event "rash" required physician office visit.  Additional information: Clarified she was not 100% sure if it was Pfizer, it could have been Moderna or Pfizer, she just heard it was the bivalent covid vaccine. She overheard someone talked about the adverse event at the grocery store. She does not know the name or any contact details of the reporter. The person at the grocery store mentioned that a 65-year-old patient developed a rash, and then went to the doctor and now that patient has heart issues supposedly. She does not know what number dose this was for the patient. She does not have any patient details to provide except the age. Confirms she had no further information to provide. The same person at the grocery store also mentioned a pharmacist that vaccinates patients with covid vaccines, that got cancer. The pharmacist thought the cancer was due to vaccinating patients and not wearing gloves. Unknown gender or any patient details for pharmacist, therefore additional report not created. Caller does not know the manufacturer this pharmacist was using to vaccinate patients with the covid vaccine, manufacturer was not specified. Unknown product details. No lot, ndc, or expiration date to provide. Confirms she has no further information to provide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt feet warm; T101; large vomiting & persisted through night; seen in ER; ua done-neg; tx: w/h2o; juice; vomited x4 days; c/o D; fever persisted x3 day;
The evening of injection the patient had a headache, shivering, injection site was sore, felt like he had flu like symptoms which continued through the next day as well. On the following day (10/20/2018) the patient said he felt ok.
Pt received Covid-1 vaccine. About 15 minutes after shot was given pt waved down parking attendant and asked for a nurse. 2 nurses arrived at pt's car. Pt reported that she first started feeling itchy on a bug bite on her arm which was red. She then stated it went from her bug bite to feeling tingly/burning on her lips. Pt reported she hadn't eaten much today and had drank hardly any water today. Pt's vitals were 152/92 to which pt stated she takes BP meds and her BP is at times higher than that. Her HR was 64, resp 22, SpO2 98%. Pt stayed for an extra 15 minutes then stated she was feeling better and wanted to go home.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that no adverse reactions were reported by patient. No concomitant medication were provided. No treatment information were given.   This case was linked to MOD-2022-501575, MOD-2022-503190 (Patient Link).
Dx 1. drug reaction 2. cellulitis. Erythema, warmth, edema at pneumococcal injection site. In addition, c/o headache, nausea, sweating, and fever. Rx-Keflex, prednisone, ice, elevate, Benadryl, and Tylenol.
Patient presents to Covid Vaccine Clinic for vaccine. Patient received J & J vaccine. Patient later informed staff she was receiving this vaccine because her covid antibody test was negative after received the Moderna Jan/Feb.
Within 1 wk of Lymerix Vax, pt had flu-like sx's; clawing of hands; itching of thigh & buttock, and incompacitating back stiffness. Dx'd w/myalgias; low back pain & limitation of motion. Case is considered serious as it is persistently
Pt  had general weakness, fatigue for  3-4 days prior to her ED visit on 2-17-2021.  No fever or significant pains.  Some chills.  Oral intake OK.  Had second Covid shot a week ago on 2-8-2021.  .  Had paracentesis 2 days ago on 2-15-2021, gets them every 10-14 days for liver disease. B/P 98/33
did not receive their second dose; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided asa follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient need to repeat the series.
The patient is a 44 yo female with a history of severe myalgias, diarrhea, headache, fatigue, probable fever and chills with an onset 4-5 days after vaccine receipt of typhoid and JE #1 in preparation for travel. She was seen in ER but does not believe was given a diagnosis. Her symptom onset of 4-5 days, severity and prolonged duration of two weeks or more is inconsistent with typical systemic adverse reaction to vaccines and it is more likely she had an alternate etiology, most likely viral.
pt recv vax & devel sweating, gen weakness;pt was wobbly;26OCT unsteady taken to ER MD dx as rxn to flu vax;pt hosp w/CVA & released 22OCT97;
Patient received the vaccine and was advised to sit in the waiting area for 15 minutes for monitoring. Patient stood up a few minutes after receiving the vaccine to walk towards the pharmacy counter and passed out, falling onto the floor. 911 was called and patient was kept conscious until paramedics arrived. Patient was transferred to the hospital.