chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 14-year-old patient of unknown gender. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Injection site became red, swollen, hot and itchy within 24 hours. Itching spread from left arm to face, mild itching throughout rest of body. Swelling and heat were gone about 4 days after injection, Redness was gone about 7 days after injection. Itching has continued but is significantly less 9 days after injection.
Never received 2th Moderna shot; Diarrhea; felt incoherent for 5 days; bad reaction; It morphed into a cold in 24 hours; dizzy; I felt sick again; stomach issues; body aches on top of that; swelling in the injection site; Nassau; headache; it was red; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (It morphed into a cold in 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Immunosuppression.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red) outcome was unknown.        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.   No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up appended: Added patient details (DOB), dosage details of vaccine, new events
VOMITING, LETHARGIC SINCE THE MORNING AFTER HE HAD VACCINES.  DOES WANT TO EAT OR DRINK, AND FEVER . MOTHER ADVISED TO PUSH FLUIDS AND TREAT FEVER AND SORENESS WHEN NEEDED AND TO CONTACT OFFICE IF NOT BETTER OR WORSENING BY SATURDAY.
A non-serious, spontaneous report of "gave H1N1 mist to a 57-year-old man" has been received from a registered nurse, subsequent to H1N1 vaccine. The patient's medical history and concomitant medications were not reported. On 21-Oct-2009, the patient received H1N1 Vaccine. The patient is otherwise healthy. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
I've had four Pfizer vaccinations, Covid, and now Paxlovid/ I'm frustrated they aren't better.; I've had four Pfizer vaccinations, Covid, and now Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I've had four Pfizer vaccinations, Covid, and now Paxlovid/ I'm frustrated they aren't better."; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I've had four Pfizer vaccinations, Covid, and now Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. It was reported that patient four Pfizer vaccinations, Covid, and now Paxlovid, and it's a horrible journey.  Patient was grateful the medications exist but patient was frustrated they aren't better.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
When our facility received the Covid - 19 vaccine, I spoke to staff at the local Dept of Health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 staff at the local Dept of Health Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
I received my third Pfifer shot on 11/05/2021. I had previously had an adverse reaction with my second shot 03/22/21 where I developed very painful pleurisy and went to the hospital.   Because of this reaction to the second dose, I went to my doctor and asked if I should get the third. I was advised that there was a study researching long-term issues amongst males 18-40 but since I was not in this demographic and my issues did not go past the one day, that it would be safe for me to get the third vaccine.   A few days after my third shot I developed chest pain and cramps. It was similar to the pain I had when I went to the hospital, but not painful enough to go to the hospital. I went to family practice again where I had blood tests done and an ekg. I was also prescribed a medication to address myocarditis.   The pain persisted with medication but at the following appt I was given pain medication and recommended to use an inhaler. I have a pending echocardiogram but am switching doctors before scheduling.   I continued to have pains after this
Knot developed distal to the injection site 2 days following injection which remained until 8 days following the infection when it turned into a circular rash with associated itching
First dose / in November, 2018 / never went back to get her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   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 case details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist report that a patient had never went back to get her 2nd dose which led to incomplete course of vaccination. Health care professional (HCP) called to know how to proceed with the case. Health care professional did not know the lot number or expiration date of dose 1st that the patient received in 2018 since the vaccine was given in another facility. No further events were reported at the time of the call. The reporter did not consent to follow-up. Health care professional did not consent follow-up, she just wanted the medical information data. VAERS details were reported for 1st dose of Shingrix.
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
inc temp states up to 104 & 105 starting 12APR95 up @ noc crying; states was having some trouble breathing now; recommended that be taken to ER:
This spontaneous report has been received from a medical assistant and referred to a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient had an antibody testing performed and the results were inconclusive (Antibody test abnormal). No adverse effects were reported. At the time of this report, the outcome of antibody test abnormal was unknown. There was no product quality complaint (PQC) involved. The causality assessment between antibody test abnormal and M-M-R II was unknown. Additional information is not expected as there was no contact consent granted.
Uncontrollable vomiting 10-12 episodes 2-2.5 hours after admin of vaccines. Reglan giving to aid with nausea/vomiting.
Initial and follow-up information has been received from a physician concerning a 70 year old female patient with reflux and hypertension who on 17-OCT-2008 was vaccinated intramuscularly with a dose of FLUZONE (U2805AA) in the right deltoid. On 23-OCT-2008, the patient was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 (lot # 657525/0554U) in the left deltoid. Concomitant therapy included omeprazole (MSD), TOPROL XL TABLETS, hydrochlorothiazide (manufacturer unknown), calcium (unspecified) and vitamin D (unspecified). On 24-OCT-2008, the patient had a hot, red shoulder and upper arm. The patient said it was swollen from elbow to shoulder with sore and tender. The patient went to see the physician. The physician examined the patient and regarded the events as local reaction to injection. The physician advised the patient to have cool compress every 2 hours and was prescribed BENADRYL 50 mg every 4 hours. The physician also advised the patient to elevate and rest the arm. As of the reporting time, the patient recovered from the events. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX 23 (lot # 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the center and was released. Additional information is not expected.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported that a 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-years, via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) for anxiety. Patient stated that she started to show symptoms of COVID-19 on 10Feb2021 and tested positive for COVID-19 on 11Feb2021 and her quarantine is going to be over this weekend on 21Feb2021 and scheduled to get a second dose on 25Feb2021 (Thursday) and wondering if it is recommended that she gets the 2nd dose next week since had a positive COVID-19 test. No treatment received. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Initial report was received 16 May 2008 from a health care professional. A 15-year-old female patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2563AA on 04 April 2008, and 30 minutes later, she experienced mood swings, crying and anger. The event last 1.5 hours and the patient recovered from the event. No further information were reported.
swollen; This spontaneous report received from a contactable consumer based on the information received by Pfizer (Reference ID: NVSC2021US106430).   A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included swelling. The patient concomitant medications were not reported (unknown medication for swelling). On an unspecified date, the patient had swollen due to stopping medication after receiving her Covid-19 vaccine.
On same side as vaccine (left side), patient had numbness in lips and cheek. Also reported a scratchy throat.
Although I can't confirm that this condition is related to the vaccine; the vaccine is something that was done prior to the symptoms.  The tip of my tongue feels like it has been burned.  It is also red, so it looks like it's burned.  Similar to when you drink or eat something too hot.  I cannot confirm how long ago I noticed the condition.  I just know that it has been a constant issue for months. It definately started after the vaccine.  I don't think I related it to the vaccine initially.  In September 2021, I realized that it was a chronic issue.  At that time I started thinking about possible reasons for the condition.  My first thought was a change of toothpaste in  April  2021.  I started using Sensodyne recommended by my dental hygienist. .  So after a number of months of experiencing the condition.  I stopped using that toothpaste in September 2021 thinking that it was the source.  So far I have not noticed any change in sensation of the tip of my tongue feeling like it's burning.  .  I visited the Dentist on October 19, 2021 and I asked the Doctor during my visit about the condition.  He stated that he was unaware of what could cause the burning sensation.  He told me he did not believe it was related to the Sensodyne toothpaste.  My next thought was the Moderna vaccine.   The only other thought is the Atorvastatin.  I just thought I'd report it when I received the lasted.  Check about the vaccine.
Scratchy throat, dizzy, fever for 2 days.  Generally felt out of sorts.
Booster; Patient tested positive on 06Jan2022.; Patient tested positive on 06Jan2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cold urticaria" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks prior to vaccination. Vaccination history included: Covid19 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 (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "Patient tested positive on 06Jan2022.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient presented with arm soreness and red hot rash around the injection site of the Prevnar 13 injection. The rash measured 7cm X 9cm on right upper deltoid area with Erythema but without induration.
Right Brachial plexopathy. Began with right periscapular muscle spasms x 5 days followed by right arm paresthesias on day 6 followed by right wrist and hand weakness on day 7 of adverse event.
Patient noticed red dots on foot approximately 48 hrs after influenza vaccination which had spread up to knee and thigh. No itching reported. No swelling.
Macular erythematous rash on legs, arms, trunk and neck; treated with benadryl, zyrtec and hydrocortisone cream; later requiring  oral steroids
Itchy large bumpy (hives) rash on injection side (arm, side and back).; Itchy large bumpy (hives) rash on injection side (arm, side and back).; Itchy large bumpy (hives) rash on injection side (arm, side and back).; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 02Aug2021 at 20:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021, the patient experienced itchy large bumpy (hives) rash on injection side (arm, side and back). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy large bumpy (hives) rash on injection side (arm, side and back) was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:15 (Lot Number: EL9269) at the age of 68 years old as single dose for covid-19 immunisation. Medical history included known allergies: iodine, shellfish, penicillin, Cipro, Nitrofurantoin, wool. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced sore arm, slight rash on chest on 20Feb2021 15:30. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
were vaccinated to avoid Shingles! both got Shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient were vaccinated with Shingles to avoid shingles and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187392:Same reporter, different patient