chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse refers to a 8 years old male patient who was inadvertently vaccinated with a dose of GARDASIL (lot # reported as H009746; Exp Date: 11-JAN-2015) on 01-AUG-2012. No adverse effects reported. The reporter stated that the patient was currently in an exam with the physician for a follow up check up. Additional information has been requested.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA306289, 2018SA306316. This case involves unknown age of child patient who received expired PENTACEL, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect PENTACEL lot C5439AA exp date: 29-Oct-2018 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was not reported whether the patient had any adverse event or not after receiving the expired vaccine. 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 and Module VI of the 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. List of documents held by sender: none.
high Fever 101.6; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high Fever 101.6) and NAUSEA (Nauseas) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high Fever 101.6) and NAUSEA (Nauseas). At the time of the report, PYREXIA (high Fever 101.6) and NAUSEA (Nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
pt recv vax & pt exp loss of appetite, anxiety, loss of sleep & severe irritability;No further details were provided;
05/25/2022 08:30AM vaccination. 05/28/2022 I woke up at night with HA and neck pain, in addition to soreness at the injection site. 06/04/2022 I had appointment with message therapist. Therapist had seen other patients with same symptoms; frozen shoulder. 06/06/2022 08:00AM I saw my PA for already scheduled appt for allergies. I brought up how my L side was throbbing to include eye, pain in forehead / temporal area, cheek, neck, the muscles used to rotate the neck and jaw. The Dr. stated it may be sinus issues or allergen issues. They took my blood and I did get my results on 06/08/2022; small trace of allergens. Waiting to get back in for follow up appointment for ongoing pain on L side. I am a very healthy person, I walk 15 miles per week and I know something isn't right. I am hoping it is just sinuses but the remedies are not working and it is all very unusual for me. I am having ongoing disrupted sleep with headaches and L sided pain.
My hair began coming out in handfuls on July 8th.  In under a 2 week period I lot 90-95% of my hair.  I have never had any previous issues with alopecia.
Mom called stating chicken pox going around in school and contracted a mild case of Varicella.
some soreness at the injection site/pain at injection site; Last night I think I had some low-grade fever/fever; Last night I think I had sweats/sweats; This non-serious case was reported by a physician via interactive digital media and described the occurrence of injection site pain in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Arexvy. On 22-AUG-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: some soreness at the injection site/pain at injection site), fever (Verbatim: Last night I think I had some low-grade fever/fever) and sweating (Verbatim: Last night I think I had sweats/sweats).  On 23-AUG-2023, the outcome of the fever and sweating were resolved (duration 1 day). The outcome of the injection site pain was not resolved.   The reporter considered the injection site pain, fever and sweating to be possibly related to Arexvy.     The company considered the injection site pain, fever and sweating to be possibly related to Arexvy.   Additional Information: GSK Receipt date: 22-AUG-2023 and 23-AUG-2023 This case was reported by a patient (physician) via interactive digital media. The patient stated that 20-hour post-vaccination update, not bad at all, some soreness at the injection site. The patient stated that last night had some low-grade fever, sweats, about 30 hours after the shot/jab.  The patient stated that he feels fine this morning. Just wanted to disclose that for full transparency.
Information regarding Prevnar was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal bacteremia and drug ineffective. At 5 months of age, the patient received the third dose on 12-Aug-2005. Relevant medical history was not provided. Concomitant medications were not reported. The patient was hospitalized for a high fever (not specified) and oxygen saturation was 72%. A blood culture was performed which indicated S. pneumoniae. He was diagnosed with pneumococcal bacteremia on 02-Mar-2006. The serotype is pending. The child was treated with Ceftin (strength and frequency unknown). He recovered and was discharged from the hospital on either 11 or 12-Mar-2006. No additional information was available at the time of this report.
After the vaccine for flu I had pain. It got worse. I had to go to my orthopedic Dr and still going to him.
pt recvd vax 15MAY95 & 18JUN95 pt devel fever of 101, nausea, vomiting;No further details were provided;
No known adverse effects; on 04/29/2019, an adult patient received a pediatric dose of VAQTA; Information has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 29-APR-2019, the patient was vaccinated with a pediatric dose of hepatitis vaccine, inactivated (VAQTA) (lot# and expiration date unknown) intramuscularly for prophylaxis. There were no known adverse effects.
Pt recvd 1st 2 doses of Recombivax HB & 3rd dose of Engerix-B; pt was determined to be a non-responder; pt recvd a booster dose of Engerix-B on 3OCT90 & was later determined to have pos HBSAB & hence resolved;
had a blood test that showed he had pancytopenia and "his hcp gave him a preliminary diagnosis of Pre-Leukemia; preleukemia; Fatigue; A spontaneous report was received from a consumer concerning a 74 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue and the patient also reported that he had a blood test that showed he had pancytopenia and "his HCP gave him a preliminary diagnosis of Pre-Leukemia". The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030l20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032h20a) in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, one day after the 2nd vaccine, patient experienced fatigue. On 04 Mar 2021, the patient had a blood test that showed he had pancytopenia and "his HCP  gave him a preliminary diagnosis of Pre-Leukemia".  Patient stated that last year he had normal results and he was going to see a doctor in two weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event Fatigue was reported as resolved on 23 Feb 2021.  The outcome of the events, pancytopenia and preliminary diagnosis of Pre-Leukemia, was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer stated that another consumer reported for a 15-month old patient of an unspecified ethnicity and gender who received a single dose of PREVNAR 13, PENTACEL and MMR II, all via an unspecified route of administration, on an unspecified date, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced onset of apparent peanut allergy with rash on 3rd exposure to peanuts 15 days after receiving the vaccines. Event outcome was unknown at time of report.
Sick; Neither one of us can even lift our heads; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: EW0170) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Neither one of us can even lift our heads". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness. Therapeutic measures were taken as a result of mobility decreased. Additional information: This is the first case out of two cases in which the reporter is reporting for herself. Consumer stated she and her husband went last week to get their first Pfizer vaccine and were both sick. He was 80 and she was 74 and neither one of them could even lift their heads (event captured as verbatim) and plus what was making it worse was they had high temperatures up to 112 and he worked outside and it did not help him any. Consumer stated, yes lab test, not with the shot, did not do. They have to check her all the time because she was going in for surgery (further clarification unknown) next month and so they check because have to see doctors all the time (not clarified further).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100991743 similar report from same reporter
About 5 min after the administration of the second dose of the vaccine I began to experience tachycardia, difficulty to breath, sweating, numbness in arms and legs and trembling of limbs. I have not history of allergies.
10 days after Smallpox vaccine left deltoid, developed red papular rash on upper chest.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810 with expiration date of 28-JUN-2019, and lot# M018810 with expiration date of 28-MAY-2018, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 36-45 degrees Fahrenheit  (35.7F) for 15 Hours (worst case). Previous temperature excursion was reported as 47 - 77 degrees Fahrenheit (54.2F) for 3 Hours. The call was because of a "data logger". The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
PANIC ATTACK POST VACCINE. PT ASSESSED. VITALS OBTAINED.  STABLE. PT DISCHARGED WITH FAMILY
12/23 injection site pain immediately  12/24 arm pain and slept 11 hours - tiredness 12/25 no symptoms 12/26 returned with injection site stabbing pain
approx 1/2 hrs following vax pt awoke from sleep crying w/rt leg red & swollen from knee to hips; pt taken to ER t101; poss react to DTP; pt fussy;
Received Pfizer vaccine had pain under right arm after exercising, thought would subside, also have low platelet count.
Sneezing, watery eyes, runny nose, fever 101.8 degrees.
Patient felt very flushed and felt that her heart was beating fast, so we took her blood pressure and it was very high. we called 911 and they took her to the hospital and kept her there for a few hours til her blood pressure went down.
A week after receiving first shot, the lymphnode under my right armpit, which is the side I got the shot on (right arm) got sore and swollen. It lasted for 2 days, about 48 hours. I could still feel the soreness a bit a third day but it was much better, and gone by 4 days. I called Employee Health (I got it through work) to report this and check if any major concerns - they gave me this reporting system to report it.
Patient was given a shot that had expired two days prior. No symptoms, signs, etc. Pt will be informed of this and per manufacturer no harm was done to pt, they will however need a new shot.
fatigue; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in Mar2021 (Lot Number: EP7534) on left arm at single dose for COVID-19 immunization. Ongoing medical history included patient was diagnosed with congestive heart failure probably 10 years ago, was diagnosed with diabetes probably 20 years ago, had been undergoing dialysis for 3.5 years. Concomitant mediation included a blood thinner. The patient experienced fatigue after the first dose of the Covid-19 vaccine in 2021. It was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient had been more fatigued since he received the first dose of the Covid-19 vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
achy joints; achiness; patient had a headache for 2 days; heart was racing; got sick; was tired; felt like she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and ARTHRALGIA (achy joints) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and HEADACHE (patient had a headache for 2 days). On an unknown date, the patient experienced ARTHRALGIA (achy joints) and MYALGIA (achiness). On 14-Sep-2021, HEADACHE (patient had a headache for 2 days) had resolved. At the time of the report, PALPITATIONS (heart was racing) had not resolved and ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever), ARTHRALGIA (achy joints) and MYALGIA (achiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient went to the hospital. No treatment medications were reported.   This case was linked to MOD-2022-547014, MOD-2022-547015 (Patient Link).
About 12 hours after 2nd vaccine high fever >104, chills, headaches,  sore throat, fatigue
Mother states left thigh swelling/redness at site noted 05/09/2003. Apprx 7am. Onset 05/10/2003 swelling was 1 inch down to the knee with warmth and T increase 100.6. Taken to ER where he received IV antibiotics and oral antibiotics to be taken at home.
product was given to patient, the product was expired by 3 days with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00315549) was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case involved a patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: NAUJ134AA, expiry date: 11-Oct-2020), on 14-Oct-2020, which expired by 3 days (Expired product administered), via unknown route in unknown administration site for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   It was a case of actual medical error as expired vaccine used.  No adverse event was reported at the time of reporting.  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.
On sunday the 12th I was very tired. The next day I had a scratchy throat, congestion and tested positive for COVID-19 on a home test. I've had worse colds so to me this was very mild. By wednesday I started feeling better but still testing positive. The next day I was given an antibody infusion. I was still testing positive o the 20th. After the 26th I was not positive anymore.
Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblains
syringe used malfunctioned.  when administering dose (0.5mls) had to use more force than usual. Most or all of the volume came out of the hole or arm and barrier band aid.  It went down her right arm and some on the table.  She bled. The blood was contained behind the barrier. I recommended that we give her another full dose.  She was hesitant at first. Then agreed to get in her left arm.
RECEIVED VACCINE TWICE (TWO DOSES); MORE TIRED THAN USUAL; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included no known drug allergies, reported no health conditions and no current medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced received vaccine twice (two doses), and more tired than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine twice (two doses) and more tired than usual was not reported. This report was non-serious.
Pt vaccinated at 1750 and then proceeded to the monitoring area for her 30 minutes of monitoring. At 1820 pt c/o to RN of her throat feeling tingly. No other symptoms reported. RN provided pt with diphenydramine 25mg PO x 1 and water. RN continued to monitor the pt. Tingling improved and pt discharged home with her husband at 1830.
Client was a walkin on covid19 vaccine event. The electronic LINKS system was down and not running properly. The client verbalized that here for first covid19 vaccine requesting Pfizer brand. Pre-vaccine check is reviewed with client and denied receiving previous dose of covid 19 vaccine. Pfizer o.3ml given IM Lt deltoid, client tolerated well. Later the nursing supervisor noted that the client had previously received two doses of Moderna at another facility. The Pfizer dose given on 10-28-21 was 3 months from the last dose of Moderna received (16 weeks,1 day) on 7-7-21. Client also had fist dose of Moderna on 6-3-21. Medication error realized after client left health unit due to not qualifying to receive a booster dose since it was less than six months from last covid 19 vaccine.
patients were given a booster dose of an expired moderna vaccine; 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 (patients were given a booster dose of an expired moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given a booster dose of an expired moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were given a booster dose of an expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Developed muscle and joint pain 3 weeks after 1st vaccine - Sudden onset diagnosed with Polymyalgia Rhumatica
Five minutes post vax, the pt had hives to face, neck, arms, chest, and back. Pt complained of itching. Benadryl given. 911 called. Physician notified. Pt was transported to ER via paramedics.
My healthy 12 year old, and in healthy I mean: "never missing 1 day of school" daughter took GARDASIL 1st shot and within 40 days had unexplained illness, including: fever, difficult breathing, leg numbness and aches and pains. It was bad enough we took her to the emergency room. The ER couldn't find the problem but we are clear now on the cause. No more second or third shots of GARDASIL for us.