chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd shot side effects - Feeling achy; Feeling tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 19th August 2021, the patient received the 2nd dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine, the day before reporting date and was feeling achy and tired.
Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second (Interchange of vaccine products).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the pharmacist called to report that they had a mix up of the Pfizer Covid-19 vaccine and the Moderna Covid-19 vaccine.  A patient received both brands, receiving first the Pfizer Covid-19 vaccine and then the Moderna Covid-19 vaccine second.  Consent given to Safety for follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second, was considered resolved on unknown date.; Reporter's Comments: This report refers to a product administration error where the patient who had received first dose of Pfizer vaccine was then administered mRNA-1273 as the second dose. There were no reported AE's associated with this case of wrong product administered.
Still contracted Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still contracted Covid-19) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still contracted Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of Two doses in morning and two doses in evening. At the time of the report, COVID-19 (Still contracted Covid-19) outcome was unknown.            Concomitant medication was not reported.  Patient took all of his Covid-19 vaccinations. One dose was the Pfizer Covid-19 vaccine. The other doses were Moderna. Still contracted Covid-19 despite this. Patient took Paxlovid two pills in the morning and two pills in the evening. Experienced a bitter and metallic taste every time he took the medication.
Hospitalization for stroke symptoms and also tested positive for COVID-19 on dates 8/5/2022-8/8/2022. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX 23 during the time period of 14-SEP-2012 through 18-SEP-2012. The PNEUMOVAX 23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested. Follow up information was provided during a phone call on 26-SEP-2012 stating the health care professional could not supply the dates of vaccination or dates of events. Follow up received on 26-SEP-2012 reported that the 59 year old male patient received an expired dose of PNEUMOVAX 23 (lot # 669382/1490Z) on 13-SEP-2012. The source case 1209USA008402 was split into three cases. This case is also linked to case 1210USA000520.
HEADACHE DAY AFTER VACCINE ALONF WITH FATIGUE, CHILLS, BODY ACHES, NO FEVER, MISSED 1 DAY OF WORK.
Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Spontaneous severe bilateral subarachnoid bleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Right), administration date: 10Jan2021, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right), administration date: 20Dec2020, for COVID-19 immunization. The following information was reported: SUBARACHNOID HAEMORRHAGE (hospitalization, medically significant, life threatning) with onset 11Apr2022, outcome "unknown", described as "Spontaneous severe bilateral subarachnoid bleed". The patient was hospitalized for subarachnoid haemorrhage (hospitalization duration: 16 day(s)). The event "spontaneous severe bilateral subarachnoid bleed" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Negative. Therapeutic measures were taken as a result of subarachnoid haemorrhage.  Case Narrative: Spontaneous severe bilateral subarachnoid bleed, etiology unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Device Date: 31May2022.
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Bedridden all day, severe joint pains especially in right knee.  Sustained efforts of walking led to almost passing out. Was difficult to breathe effectively and found myself breathing in an abnormal pattern
pt recv vax & a home pregnancy test indicated pt was pregnant (LMP 18SEP96);@ 32wk pt exp pre-term labor & pre-term rupture of the membrane;8MAY97 @ 33wk pt delivered a 4lb 80z male;tx for sepsis since mom was positive for strep;
On 03/26/01 employee in employee health for laceration to the left hand approximately 1 cm from metal trash can. Last record TD 03/17/92. Td consent signed and vaccine given 03/26/01 at left deltoid. Temperature 96.6, cut cleaned, steri strips applied, dressed and splinted. Follow up scheduled for 03/28/01. On 03/27/01, employee called complaining of fever of 100.8. Reported laceration area was not red, swollen or tender. Complained of sore throat and fever, referred to occupational health clinic (OHC) near her work site for evaluation of left hand for possible infection. Follow up paper work from OHC receive via fax had diagnosis of "hand laceration / pharyngitis- strep-NWR" made aware of hospital admission 03/29/01 with possible adverse reaction to TD.
Rec telephone call on 3/11/09 from client's mother stating she took ct to dr for rash and swollen lymph nodes.  Dr diagnosed her with reaction to MMR vaccine.  Rash spread from legs to arms and back.  Left lymph node more swollen than right on neck.  As of 3/11, rash had resolved, but lymph nodes still swollen.
an expired dose of PROQUAD that was given to a patient; This spontaneous report was received from a physician referring to a 3 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 06-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (0.5 milliliter (ml), lot # S007075, expiration date reported as 06-AUG-2020, but upon internal validation established as 06-SEP-2020; strength, frequency and route of administration were not reported) for prophylaxis (expired product administered).
Moderna COVID-19 vaccine  Approximately one week after the injection, the injection site on left arm became, red, swollen, bumpy,  and feverish to touch.  It was two plus inches wide and one and one-half inches long in a roundish/oval shape.  It began to fade on 2/12 until I thought it was completely gone.  On 2/14, it was redder with a bolder outline.  It is now over 2 weeks since the injection and it is still red with a brighter outline but it is not as bright as it was a week ago.  It does not hurt and never did.
Resident was on quarantine from spouse testing positive.  Felt ill the next day and a test was conducted that day and sent to lab.
STROKE; HEART ATTACK; WEAK HEART; LOW EJECTION FRACTION; This spontaneous report received from a health care professional (patient's father) concerned a 55 year old male. Initial information was processed along with additional information on 24-JUN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was healthy and strong. Patient's father (parent) is an healthcare professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry date: 18-FEB-2022) dose was not reported, 1 total administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced stroke and was walking lopsided, heart attack, weak heart, low ejection fraction. On an unspecified date patient was hospitalized for couple of weeks. Reporter (Father) called police after finding son in apartment patient was walking lopsided and stayed in hospital for a couple of weeks then was in rehab (care center). The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, heart attack, weak heart, low ejection fraction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649327-COVID-19 VACCINE AD26.COV2.S-stroke, heart attack, weak heart, low ejection fraction. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
The patient is a 75 y male with a history of hypertension, CAD on Eliquis, COPD, lung cancer on immunotherapy, and Asthma presenting to the ED with complaints of worsening shortness of breath.  He states he has chronic shortness of breath, worse with exertion, using 2 L home oxygen as well as a chronic cough but was needing more oxygen up to 4 L. Pt also reports a fever, chills, and generalized body aches that is worse in his back for one week, as well as nausea. Acute hypoxemic respiratory failure due to COVID-19.
angioedema; red bumps; hives; A spontaneous report was received from a consumer concerning a 65 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red bumps, hives and Angioedema.  The patient's medical history was not provided. Concomitant product use included sertraline hydrochloride and zolpidem tartrate.   On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no: 025J20A intramuscularly in the left arm for prophylaxis of COVID-19 infection.  About a week post vaccination (17 Jan 2021), the patient noticed some red bumps on body which accelerated to hives all over body within a few days. Eventually, on 01 Feb 2021, the patient experienced an episode of angioedema and went to the emergency room.   Treatment included self-medication with antihistamines Benadryl and Xyrtec.   The outcome of the events is unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Moderate to severe left sided neck pain and stiffness lasting 30-45 days with ongoing mild symptoms. I reported this earlier and had spoke to someone but they did not follow up.
Anaphylaxis in the form of swelling of the tongue after eating pineapple.  Patient had never had an allergy to any food prior to this.
she was diagnosed with Covid this past Monday; she was diagnosed with Covid this past Monday; 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 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "she was diagnosed with Covid this past Monday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was diagnosed with Covid this past Monday. Patient realized that she came in contact with Covid from a contractor she was around while she was checking on a property. Stated that she did a virtual visit with her doctor. Patient was vaccinated with "2 Pfizer boosters and was on route to getting her bivalent" until she came down with the rash and exposure to Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician refers to a 2 month old patient of unknown gender. On 17-SEP-2013, the patient ws vaccinated with a dose of PNEUMOVAX23 (lot#, expiry not reported) instead of PREVNAR. No adverse symptoms reported. Additional information has been requested.
Small (1/2 end of finger) Red blotches-itched like the devil. Perhaps 7/8 at first; more later. Total approx. 15. Given Clobetasol .05% cream by dermatologist. Cleared them up-some still hang on.
9 days after vaccine left arm posterior mid shaft raised indurated 13x5 cm warm skin lesion. no itching, mildly painful.  blotchy skin on volar aspect arm
lost some vision; very frustrated; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 25May2021 at 13:00 (Batch/Lot number was not reported) as dose 2, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history included Covid-19, and Neuropathy . The patient had no known allergies and no other medical history. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 04May2021 at 13:00 (Batch/Lot number was not reported) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation and experienced left eye felt blurry, floater and some distortion. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not tested for Covid post vaccination. The patient started to feel some problems with her left eye on 10May2021 at 08:00. Her left eye felt blurry, had floater and some distortion. She did not take it seriously because she thought her eye contact lenses needs to change or clean by then. Then it was getting worse after the second dose of Covid-19 vaccine on 25May. She started to see an eye doctor and was told she lost some vision on her left eye. She was referred to doctors in hospitals and none of them could not firmly diagnosed what was causing her vision loss even when they completed all kinds of possible tests and procedures. She does not have any ocular disease history before as well as in her family. First, the doctor suspected she have LHON, and the genetic test were negative. She has been very frustrated since it happened in May. The time of each vaccination is definitely correlated to the problem on set. Therapeutic measures taken as a result of the events included infusion and medication. The outcome of the events was not resolved. The events required doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care, with disability or permanent damage.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender: none.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient as of this report has not been revaccinated.
Swollen arm; Arm discomfort; OTC treatment (TYLENOL, BENADRYOL, etc.).
Patient developed body aches and joint pains about 24 hours after administration. She developed pain in the opposite arm as if her nerves were on the outside. Patient had lymph involvement.
Patient called me this morning 9/11 to let me now that she started having reaction to the vaccine last night after receiving it from our store yesterday. Her arm started having swelling and a knot under the area where she received the shot. I told her to go to the dr and let us know what he said.
Patient reported redness, swelling, pain, and some flu like symptoms post vaccination. Instructed the patient that these are possibly side-effects from vaccinations and that they should resolve on their own within a few days. Instructed the patient to reach out to her health care provider if symptoms worsened.
Had the vaccine, and was fine and had problems after the first vaccine as well, which he prescribed benadryl and a Benadryl cream.   He then called her back in a couple of days and she told him that she was fine.  She saw the nurse at the facility who told her to call the eye doctor after the first vaccine, and this is exactly the same as the first vaccine.  Her eye doctor had started her on a 2nd glaucoma drop Ropressor, and then with the reaction told her to stop taking it.  Her eye is worse today than it was yesterday, and has been using cold packs which feel good to her eye.  Was also running a fever of 99.9 and felt achy.
Joint paralysis, arthritic-like sz, loss of memory & loss of equilibrium & accompanying dizziness & unspecified various muscular & skeletal pains reported by husband of pt receiving Fluogen; Vax recvd on 15OCT89;
Day of injection: itching & redness at injection site. Following a.m.: severe leg muscle pain and resultant weakness.
This spontaneous prospective pregnancy report was received from a medical assistant referring to her 21 year old female daughter. The patient's concomitant medication, medical history drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9  (dosage, frequency, lot number and expiration date was not reported) indicated for prophylaxis. On an unknown date, the patient became pregnant (vaccine exposure during pregnancy) with last menstrual period (LMP) on an unspecified date in May or June 2018 and a estimated date of delivery (EDD) of March 2019. It was specified that no adverse effects were reported. The patient did not sought any type of medical attention, it was unknown by the reporter if laboratory diagnoses or studies were performed to the patient. The pregnancy outcome and the fetal outcome were unknown.
fussy & APAP given following vax;slept 1130PM-545AM; fed & slept until 730AM;t101 woke up shaking taken to ER dx febrile sz
Two days following the dose I felt light headed and was lying in bed most of the time for 2 days, since then I am ok.