chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose number: 4 date: 11Apr2022; COVID 19 Treatment; dose number: 4 date: 11Apr2022; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9846) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 24Apr2022, stop date: 24Apr2022; CELECOXIB, start date: 25Apr2022, stop date: 25Apr2022. Past drug history included: Compazine, reaction(s): "known allergies: Compazine".  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "cdose number: 4 date: 11Apr2022; COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "dose number: 4 date: 11Apr2022; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Experienced SOB, fatigue, achiness approx. 4 hrs after flu shot. Client states she also ate a cookie with macadamia nuts that evening and has reacted to macadamia nuts in the past. Client took Tylenol and loratadine prior to bed on 9-17-2015. Client states she woke up with a swollen tongue early AM on 9-18-2015. Took Tylenol and swelling subsided. Client states she felt better on 9-18-2015. Client will contact her allergist to see if she needs to be evaluated. Telephone call to client on 9-21-2015. Client states she spoke with Dr. who said reaction was probably due nuts and not the flu vaccine. Client states she has received flu vaccinations in the past without any problems. Client has a follow-up appt. with Dr. on 10-12-2015 to be tested for nut allergy.
Patient had allergic reaction to adhesive on the band-aids. Pt also had a large red-swollen rash on the arm that recieved the varicella vaccine.
Whole body red, hot, itchy skin rash ?  101.2 temperature - Sore knee joints ? especially in whole knee replacement joint.  After 48 hours was prescribed 6 days of a tapering dose of steroids ? symptoms abated on day three of steroid use.
Hospitalized tachycardia, diarrhea, septic shock symptoms probably dialysis line related. Immunosuppressed Kidney transplant recipient. 2020.  NO respiratory symptoms.    Booster SARS COVID-19  Pfizer lot FC3183 on 9/29/2021
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 24 years old female patient with drug hypersensitivity to penicillin and a family history of breast cancer who on an unspecified dates was vaccinated with the first and second dose of GARDASIL at another unspecified provider's office. On 23-APR-2012 the patient was vaccinated in the medical assistant's office with a third dose of GARDASIL, (lot #: 671994/1537AA; exp date: 21-JUN-2014) 0.5 ml, intramuscular. Concomitant therapy included Prenatal vitamins. The patient was pregnant. No symptoms were noted. The patient's Last Menstrual Period (LMP) was on 05-APR-2012 and estimated delivery date (EDD) was on 10-JAN-2013. No treatment was given for the adverse event. Follow-up information has been received from a physician via an initial pregnancy questionnaire who reported that the 24-years-old female patient with asthma with no previous pregnancies was vaccinated with a third of GARDASIL, 0.5 ml, intramuscularly (Lot # 671994/1537AA). Concomitant therapies included: TRIPHASIL. The physician reported that on 11-JUN-2012 an ultrasound was performed which results were as follows: 8 weeks of pregnancy in Vitro Embryo Production (IVP) 2 cm, 2 cm, subchorionic bleed, ovarian dermoid. At the time of reporting, the patient's outcome from subchorionic bleed and ovarian dermoid was unknown. The relatedness between vaccination with GARDASIL and adverse events was not reported. Follow-up information was received and it was reported that the Estimate Delivery date was on 11-JAN-2013. The infant was normal and had no congenital anomaly. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 12-OCT-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R009408 (expiration date: 07-MAR-2020), lot # R002084 (expiration date: 26-OCT-2019) or lot # R016640 (expiration date: 28-JAN-2020) for prophylaxis (strength, dose, frequency and route of administration were not reported). The nurse was unsure which lot number was administered to the patient, so all lot numbers in stock were provided. Temperature excursion was 32°F up to 35°F ° and time frame was 38 minutes as recorded by a data logger. No adverse effects were reported.
shortness of breath; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath on an unspecified date. Clinical course: Pharmacist has a patient who took the 1st dose of Covid vaccine and then went to the Emergency Room with shortness of breath. The ER doctor would like to give patient Monoclonal Antibodies. They would like to know what to do about next dose. The outcome of the event was unknown.   No follow-up attempts possible; information about lot/batch number cannot be obtained.
seen in ER for paleness, & nausea approx 2-3 hrs p/inject; given suppository for nausea & told to give APAP;
In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering wheel and then went rigid again with seizure like activity.  Each one lasted approx. 15 -20 seconds.    No medical hx of seizures per patients.
Patient felt dizzy, eyes were burning, and he had mild respiratory distress.  Patient was seen 2 hours later, and was feeling much better.  His blood pressure was normal.
pain legs/burning pain in my lower legs/painful to stand; On Saturday 30th the spots were barely there and then on Sunday 31st they where worst; Rash legs; linger on head ache; when walking they get more red and more sensitive to the touch; standing is worst; the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch; initially experienced fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch) and RASH (Rash legs) in a 45-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.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (initially experienced fever). On 30-Jan-2021, the patient experienced MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch). On 31-Jan-2021, the patient experienced DYSKINESIA (standing is worst) and HYPERAESTHESIA (when walking they get more red and more sensitive to the touch). On an unknown date, the patient experienced PAIN (pain legs/burning pain in my lower legs/painful to stand), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), RASH (Rash legs) and HEADACHE (linger on head ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch), RASH (Rash legs), PYREXIA (initially experienced fever), HEADACHE (linger on head ache) and MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch) 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 medications were provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Significant follow-up appended as event added
PREGNANCY; This case was reported by a consumer and described the occurrence of pregnancy in a 17-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report.  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  In April 2007 the subject received an unspecified dose of Boostrix (unknown).   On an unspecified date, the subject, who was immunized two months earlier, told the reporter that she was pregnant.   The reporter, who works with providing immunizations to a school district, refused to provide any further details.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
After normal 45 min walk sat down got up 20 minutes later and it felt like rocks were in my right foot.  I couldn?t walk normally.  Bottom of foot was swollen.  Next day the same thing happened a few times but I was able to walk.  Then bottom of right foot turned purple and white kinda like Reynard
Initial information received on 29-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 26 months old male patient who experienced an anaphylactic reaction, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT first dose on 25-SEP-2018 with lot number UT6259JA. The patient's past medical history, medical treatment(s) and family history were not provided. No concomitant vaccines were given. On 28-Nov-2018, the patient received a 0.25 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA and Exp. Date 30-JUN-2019 via intramuscular route in the left (thigh) vastus laterallis. On an unknown date, around 4 pm the patient developed an anaphylactic reaction (anaphylactic reaction) with symptoms of face was swollen and unrecognizable (swelling face), hives (urticaria), became fussy and was not settling down (irritability) and was not breathing well (dyspnoea), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, after receiving the vaccine, later that night, while in bed the child became fussy and was not settling down when the mother turned on the light and pulled down the cover he was covered in hives, his face was swollen and unrecognizable. He was not breathing well. Details of lab data not provided. Final diagnosis was developed an anaphylactic reaction. The patient was dosed with oral steroids and taking oral fluids and then released home with order for continued steroids and an EPI PEN. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a young patient who presented with anaphylactic reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is not known and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
sick; tired; because of the COVID-19 has not the second dose; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, tiredness and social problem. On an unknown date, the outcome of the sickness, tiredness and social problem were unknown.   It was unknown if the reporter considered the sickness and tiredness to be related to Shingrix.  Additional case details were reported as follows: On 19th November 2020, the patient experienced Shingrix. The patient stated after she got the first dose, she remembers being tired and sick. The patient did not remember if she experienced fever or shiver while feeling sick. Due to COVID-19, pharmacy was not administering the vaccine, hence the patient not yet gotten the 2nd dose. The reporter consent to follow up.
Chills, headache, stomach/groin cramping, low grade fever. Took ibuprofen 800 mg
Round blister shallow crates mildly erythematous about 2xm; Round blister shallow crates mildly erythematous about 2xm; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Feb2021 at 14:00 (at the age of 90-years-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, heart valves, pre atrial contractions, and atrial fibrillation. The patient was not pregnant at the time of the events. The patient has no known allergies. Concomitant medications included metoprolol succinate (TOPROL), ranolazine (RANEXA), paracetamol (TYLENOL), metoprolol tartrate (LOPRESSOR) and calcium (CALCIUM). The patient did not receive other vaccines in four weeks. Toprol, Ranexa, Tylenol, Lopressor, and calcium were received in two weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination.  On 16Feb2021, the patient experienced round blister shallow crates mildly erythematous about 2xm. No treatment was received for the events. The outcome of the events was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced swelling of eyelids; Red and swollen ears, they were hot; Rash on the whole body; Fever all day (38.5-39°C); Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot), RASH (Rash on the whole body), PYREXIA (Fever all day (38.5-39°C)) and ARTHRALGIA (Joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung embolism in 2019. Concomitant products included FLUOXETINE for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 31-May-2021, the patient experienced SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot) and RASH (Rash on the whole body). The patient was treated with PARACETAMOL (TYLENOL) on 29-May-2021 for Fever, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing from 31-May-2021 for Rash generalised, at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 01-Jun-2021 for Rash generalised, at a dose of 1 dosage form. On 30-May-2021, PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, SWELLING OF EYELID (Experienced swelling of eyelids) and ERYTHEMA (Red and swollen ears, they were hot) outcome was unknown and RASH (Rash on the whole body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Body temperature: 38.5-39°c (High) 38.5-39°C.         Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30 Jun 2021 - Updated Causal Relationship of Vaccine to Lung Embolism as No.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
fever 102-103 degree & crying for 2-4 days; local redness on rt leg;
rash that began in my right arm and fingers and over the next week spread to my entire body including my face/ rash is very itchy; The rash is very itchy and swollen; This is a spontaneous report from a contactable nurse, who is also the patient.  A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Fl0140), via an unspecified route of administration in the right arm on 17Dec2020 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 vaccination.  The patient had no relevant medical history. The patient had no known allergies. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included bupropion hydrochloride (WELLBUTRIN XL) 175mg.  The patient had not received any other vaccine within 4 weeks prior to the vaccine.  On 23Dec2020 at 20:00 the patient broke out in a rash that began in the right arm and fingers and over the next week spread to the patient's entire body including the face. Per the patient the rash was very itchy and swollen. The patient visited an emergency room due to the events. The patient was treated for the events with oral OTC Benadryl and hydrocortisone cream, which the patient stated were not helping. The clinical outcome of the events itchy rash and swelling was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Received flu vaccine, so was observed for 20 min after admin of H1N1 vaccine. No symptoms. 20-25 after leaving observation pt stated he became extremely "lightheaded". All symptoms seemed to resolve with 30 min of onset.
Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Right on 22Feb2021 (at the age of 50 years) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, dose 2 intramuscular, administered in Arm Left on 15Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunization at Workplace clinic. Medical history included hypertension (Under control), cholesterol from an unknown date and unknown if ongoing). Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; quinapril hydrochloride (ACCUPRIL) taken for an unspecified indication, start and stop date were not reported; chlorthalidone taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Oct2021 07:00 the patient experienced tested positive for covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Oct2021 Nasal Swab. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
DEVELOPED CHEST PAIN, LEFT ARM PAIN ON 26TH MAY 2021
Cansancio; dolor de cuerpo intenso; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20May2021 at 14:30(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 02:30 the patient experienced fatigue, abdominal pain intense and full-bodied. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of both the events fatigue, abdominal pain intense and full-bodied was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right hand swelled. Was unable to control arm and hand movements on right arm. Arm was weak. Arm has gotten stronger, but still have trouble with hand movements. Can't sign my name and can not type as fast as previously with right hand. Hard to put fingers on proper keys or press with correct amount pressure.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, concurrent condition and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011717 with expire date 07-DEC-2017, lot # M003659 with expire date 20-SEP-2017, lot # M0041116 with expire date 12-OCT-2017, lot # L018351 with expire date 11-AUG-2017, dose and route unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Lot # M011717 and lot # M0041116 are invalid lot numbers for hpv rl 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.