chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one of her nurses just got a little pentacel splashed in her eye, she rinsed it out with water with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient of unknown age and it was reported one of her nurses just got a little diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] splashed in her eye, she rinsed it out with water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, one of her nurses just got a little diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] Suspension for injection (batch/lot number, expiry date: not reported) splashed in her eye, she rinsed it out with water with no reported adverse event (accidental exposure to product) (latency: same day). Information on the batch number was requested.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Hardened lump under skin at injection site, warm to touch, and red area measuring approximately 6" in diameter.
Swelling, redness, itching at and around the injection site. Swelling and redness continued to increase 48 hours after injection. Pt was seen by a physician 48 hours after injection and determined to have a localized infection.
After pt left our center pt called to c/o nausea, vomiting, and headache starting 15-20 mins after receiving MMR and varicella vaccines at our center. Pt instructed to f/u PCP or ER with worsening sxs. Pt told to f/u with us with any questions.
I am positive for Covid after receiving 3 Pfizer Covid Vaccines; I am positive for Covid after receiving 3 Pfizer Covid Vaccines; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Lot number: EW0153), as dose 2, single (Lot number: EW0171) and in 2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN B12 [CYANOCOBALAMIN].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I am positive for Covid after receiving 3 Pfizer Covid Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2023) Positive, notes: I am positive for Covid after receiving 3 Pfizer Covid Vac-cines. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 14:00 (Lot number: EN6208) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (ongoing), notes: Diagnosed 3-4 years ago; states he takes no medication for it. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Apr2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional Information: Initially told caller that we have no info on the onset and duration. But upon carefully reviewing the documents available, I saw the attached document and immediately called back consumer to correct the information. Also, consumer confirmed that he called in on his HCP/physician clinic and physician confirmed that it was a delayed response for his adverse event. States when he first started experiencing this fatigue, he thought it might be from his diabetes but as it persisted, he doesn't think that is it. States if it is form the diabetes, usually if he eats something it goes away. Any AE(s) require a visit to: Emergency Room: No, Physician Office: No. No prior vaccinations (within 4 weeks). No family medical history relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
I may have experienced a breakthrough case of COVID-19. After about a week of Covid I started having pains in my ribs and back. I called a Doctor Who told me to go get seen in the emergency room. The emergency room staff told me I had bilateral pulmonary embolism with infarction. I spent three days in the hospital. I am now on blood thinners. I wish I knew the status of the blood clots at this point, but I do not. I definitely feel much better.
Patient made an appointment the previous week to get the Moderna Bivalent Covid-19 Vaccine on  1/18/2023 and received it, although she did not realize she had gotten the same vaccine in the fall of 2022.  Spoke with her on 1/18/2022 after she received the vaccine when she realized she may have already gotten the same vaccine and she felt fine and then followed up with her again on 1/20/2023 and again she stated she felt fine.   (Contributing factors included incorrect name spelling and DOB on Appointment Scheduler Report causing patient not to be found in database which we use to  confirm previous vaccines received so had to rely solely on patient's Vaccine cards which did not reflect "Bivalent" vaccine given and insurance did not reject from being billed for a second Moderna Bivalent Covid-19 vaccine.)
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I cannot tell if it is stomachache or abdominal pain. The entire area from stomach to abdomen is in pain, and feel a little bloating. No burp, no fart. The symptom started about 40 hours after I received the vaccine, and lasted about 6 hours, from about 3:30am to about 9:30am.
i don't get the flu, but 2- 3 days later, I feel like crap, for 2-3 days; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown demographics who did not get the flu, but 2- 3 days later, felt like crap, for 2-3 days (Feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date unknown) via unknown route at unknown site of administration for prophylactic vaccination.  On an unknown date, the patient did not get the flu, but 2- 3 days later, felt like crap, for 2-3 days (feeling abnormal) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for feeling abnormal.  There will be no information available on the batch number for this case. No further information was reported.
Onset of depressive episode night of vaccine. Uncontrollable crying  for hours and sadness still lasting up to 5 days after vaccine. High irritability.
Fever of 104.1 the following day. Patient treated at home with OTC extra strength Tylenol.
Sore Arm; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 12:00 (Lot number: EL3247) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Disease (Underactive)" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHYROID. Vaccination history included: Bnt162b2 (brand=Pfizer / BioNTech, lot_number: EL3247, administration_time=09:30 AM), administration date: 23Feb2021, when the patient was 42 years old, for Covid-19 immunisation. The vaccine was administered in other facility. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with Covid prior vaccination and was not tested for Covid after vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 13:00, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 17Mar2021 13:00, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Hospitalized 1/13/22-1/26/22  for acute mental changes and COVID viral infection. Not candidate for remdesivir per MD. Expired 1/26/22.
got vaccine on Friday 2/5/2021, symptoms started on 2/6/2021 with fever chills, aches, and headache
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple female patients of child bearing age and unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series is 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that she heard people talking about blood clots with JNJ covid 19 vaccine and that the ones who got blood clots are women with child bearing age that are on birth control pills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220105023 and 20220105260.; Sender's Comments: V0-20220105183-Covid-19 vaccine ad26.CoV-2.s- Blood clot. This event(s) is considered unassessable. 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).
Late Saturday felt tired and went to bed early. Woke up on and off and was shivering severely; took Tylenol.  Next day woke up and was wet all over, felt cold, and was shivering on and off.   Also felt tired, had headache, diarrhea, and rapid heart beat. Blood pressure and pulse rate stable usually stable at 110 because of medication she takes.  By bed time, BP had risen from the normal 120/70 to 144/94; patient had nausea but did not vomit.  Patient reports no problems after the first dose of shingles or after Zostavax vaccine.  Patient did not call doctor at any time over the weekend.  Symptoms continued by 1pm Sunday.  By Sunday evening symptoms resolved completely. Patient will notify pharmacist of incident. Patient did not get a sore arm.
Red itchy rash on back of left calf; Red itchy rash on back of left calf; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the right arm on 16Mar2021 at 10:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and ondansetron (MANUFACTURER UNKNOWN) which were taken daily for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 13:00 (reported as started a few days ago), the patient experienced red itchy rash on back of left calf. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of red itchy rash on back of left calf which included treatment with doxycycline (MANUFACTURER UNKNOWN). The clinical outcomes of the events itchy rash and red rash were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant concerning to an adult patient of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not provided. On 19-DEC-2017, the patient was vaccinated with the first dose of PEDVAXHIB lot # M045207, the expiration date: 30-JUN-2019, (dose and route were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.
Patient scheduled a second dose appointment using an online scheduling tool that is meant to only allow appointments to be made for exactly 28 days from the first dose of Moderna vaccine. This patient had somehow made a second dose appointment after only 3 weeks, and received a second dose of vaccine on day 21. Patient was advised to follow up with the pharmacy the following day and report any side effects to the pharmacy, if applicable.
sore arm that was a little pink, and warm; sore arm that was a little pink, and warm/red arm/was very small spot, slightly raised, sort of pink, and probably the size of a half dollar; small spot, slightly raised, sort of pink, and probably the size of a half dollar; sore arm that was a little pink, and warm; Tired; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6203) on 03Mar2021 at single dose for COVID-19 immunization. Medical history included Shellfish Allergy. Concomitant medications were not provided. After receiving first dose, patient had a little bit of a sore arm that was a little pink, and warm. The red arm after first shot, she clarified was very small spot, slightly raised, sort of pink, and probably the size of a half dollar. Patient stated that she was tired for a couple of hours that day, but didn't experience anything big. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Arm is red not where shot was given but underneath the arm close to the arm pit. It is swollen under her arm too. They think she may have had an allergic reaction to shot.
I began my menstrual cycle a few days after my first injection, which was not on schedule for me to begin it. I have been bleeding heavily since April. It is July 13th.
day of vax pt exp erythema, 8cm circular, lt arm, induration, painful to touch. rx cellulitis
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 23-OCT-2009, patient received improperly stored VARIVAX dose 2, from lot # 664468/0684Y expiry date: 15-MAY-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
36-48 hours from the start of first effect  were the worst side effects severe body aches and multiple joint pain wrists ,knees ankles elbows headaches, and total weakness  very tired the next day and weak and 2nd night 24  march in bed at 830 pm low grade fever and sweated it out throughout the night.  wrists are still in pain with left arm wrist worse and today is 4-15-21. overall most joints are in dull pain
Chronic dizziness continues 3-10 times a day Brain fog improving Static in ears constant Speech interruption improved Continuing under doctors care for dizziness and brain fog... waiting for therapy for balance and prescribed meds that did not help
Fever 102.7, loss of appetite, vomiting, chills, headache, muscle ache. Resolved on their own in 36 hours. Used Tylenol to reduce fever.
redundant shot; I'm concerned that I might have a future problems; This spontaneous report was received from a consumer referring to herself/himself, a 76-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date in 2012 (reported as original date), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, dose, lot #, expiry date, and route of administration were not provided).  On 09-OCT-2022, the patient received a redundant shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by a pharmacy, administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, dose, lot #, expiry date, and route of administration were not provided) (extra dose administered). The patient concerned that he/she might have a future problems and had doubt that if the redundant dose would cause additional side effects (anxiety). The outcome of anxiety was unknown.  The causal relationship between anxiety and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
SEQUENTIAL ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced sequential administration. The action taken with covid-19 vaccine  was not applicable. The outcome of sequential administration was not reported. This report was non-serious.
Initial onset of bilateral lower extremity paresthesias and nausea/vomiting on 4/9/21, lasting 2 days and 1 day respectively.  Improvement then noted with return of right lateral leg paresthesia on 4/18/21.  No treatment attempts made by patient.  Mild right lower leg symptoms persist.  No headache, vision changes, abdominal pain, petechiae or bleeding reported.
A nurse reported that a 5 year old male received an injection of Acel-Imune on 8/24/99 and subsequently developed a 5 cm x 3 cm area of redness at the injeciton site. the child was treated with warm soaks and Tylenol. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lot # 464304.
syptoms that go with sarcoidosis started after getting the vaccine.; This is a spontaneous report from Pfizer-sponsored program,  from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer was asking if any studies were done on sarcoidosis side effects. Clarified if she has this, she said she has not been diagnosed with it yet, but her symptoms point to this. She has taken the  series and states some of the auto-immune symptoms that go with sarcoidosis started after getting the vaccine. Onset 3 weeks ago (Mar2021). The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Injection site rash, swelling and itch. Using cortisone cream for itch. 2nd day today, still there
Legs are super heavy; hard to walk; achy body; generally horrible feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 12:30 (Lot number: EW 0169) at the age of 13 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: LIMB DISCOMFORT (non-serious) with onset 18May2021 10:00, outcome "not recovered", described as "Legs are super heavy"; GAIT DISTURBANCE (non-serious) with onset 18May2021 10:00, outcome "not recovered", described as "hard to walk"; PAIN (non-serious) with onset 18May2021 10:00, outcome "not recovered", described as "achy body"; MALAISE (non-serious) with onset 18May2021 10:00, outcome "not recovered", described as "generally horrible feeling".  Additional information: Patient was not covid tested post vaccination. No other vaccine in four weeks. No other medications Two weeks. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.