chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Is pregnant: Yes; constant ringing in the ears; dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional reported information for both mother and fetus/baby. This is a maternal report. An 87-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration, administered in arm left on 12Mar2021 13:00 (at the age of 87-year-old) as single dose for COVID-19 immunisation. Medical history included carcinoma (CA) and allergies to Sulfa; both from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN); alectinib hydrochloride (ALECENSA); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS; LACTOBACILLUS ACIDOPHILUS]); biotin (MANUFACTURER UNKNOWN); aspirin [acetylsalicylic acid] (MANUFACTURER UNKNOWN); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Covid prior vaccination and covid tested post vaccination was reported as no. The patient experienced constant ringing in the ears, dizziness on 13Mar2021 06:00. The mother reported she became pregnant while taking bnt162b2. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included hydration. The outcome of the events was reported as resolved with sequel.  Information about lot/batch number has been requested.
At time of visit after waiting 5 minutes pt appeared to not have any adverse reactions. Parent states about 24 hours later pt began to have  hives, low grade fever, and redness on both cheeks but more red on left side. Left thigh were PCV13 was given  is warm to touch and has small lump. PT came in office to have provider look at reaction. provider plan of treatment is to apply cool compresses to thigh and face, gave instructions on what signs to look out for in case pt needs to be seen at an ER . parents agree w plan of care.
pt recv vax 16DEC96 & 30APR97 pt devel shingles;
I noticed a rash on both arms at the antecubital fossa  on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched.  I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed  raised red bumps from my  olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
Fever started the following morning and increased to 102 degrees.  Left arm sore but also welt formed the following day. Arm was sore for nearly a week. I had headaches, joint pains and fatigue. The fever lasted for approximately a day and a half. 102 for the first and evening. Took 2 Advil and the fever broke but returned but was only low grade. Fatigued lasted a week but that could have been because my seasonal allergies started around the same time (not sure if it came on naturally or from the vaccine).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 23-FEB-2015 the patient was vaccinated with expired ZOSTAVAX lot # J014812, Expiry: 20-FEB-2015, 0.65 ml, once subcutaneous. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
pt presented requesting booster dose not realizing there was a difference between booster and second primary series dose. She was given bivalent booster when she actually needed 2nd monovalent dose. The mistake was realized prior to her departure and pt was provided printout of CDC recommendations with option for waiting vs no interval and receiving primary monovalent dose that was needed to complete her primary series right away. The pt choose to have the second primary monovalent dose at this time.  Patient was observed and had no complaints.
Patient began getting swollen cuticles on fingers. Became red and irritated - looked like a fungal infection. She then got a slightly raised, red rash on her upper arms that began to extend across her breasts. The rash is not itchy and is still there - it has spread to her upper thighs then down her legs. Today, 2/11/19.
"Covid Arm" large area near injection site red, swollen, and warm to the touch. Same symptoms for my husband and his itches too.
Patient stated she developed a rash on her neck 48 hours after receiving spikevax with no other symptoms
Immediately upon receiving the shot in the upper left arm, pain began to travel directly down the arm and triggered fairly substantial pain within the elbow joint and further to the hand. The pain and a hot sensation also traveled up the arm and spread throughout the body. Within several hours, the pain had concentrated in joints and involved muscle aches and slight weakness/stiffness in all extremities. Ten to eighteen hours after the shot, the pain was accompanied by a moderate headache and moderate hot/sweating/fever. 24 hours after the shot, joint pain has subsided to mild, however muscle aches remain moderate in the back and in extremities. A general malaise and moderate to substantial fatigue is present. Movement/work exacerbates the remaining symptoms, but I am able to continue since it is office work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu; The last 2 times I got a flu shot, I was sick for 2 weeks; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who had flu (influenza) and was sick for 2 weeks (illness), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient was sick for 2 weeks ((illness) after taking the INFLUENZA VACCINE (flu shot) the last 2 times. The doctor told that the patient had flu (influenza) and the patient wasn't sick before taking it.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Patient received 2nd COVID-19 vaccination on 3/13/21.  Manufacturer and lot # of vaccine not available as administered at outlying clinic/facility.  Date of 1st vaccination also unknown.  Patient presents to ED after fall.  Patient states that she has had significant weakness since receiving 2nd COVID vaccination.  Patient states prior to COVID vaccine she was in her normal state of health.  Patient troponin was elevated at 0.99.  Patient denies any chest pain or shortness of breath.  Patient diagnosed with non-STEMI.  Treated with  medical management including heparin drip and continue aspirin + Plavix + statin therapy.  Patient was discharged to rehab facility on 3/18/21.
BURNING SENSATION DURING VACCINE INJECTION; FATIGUE FOR SEVERAL DAYS; LOW GRADE FEVER
sleepy; 2 waves of nausea; chills; feeling"out of it"; arm ache and soreness for 2 days; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Mar2021 16:30 (Lot number: Er8730) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Reflux" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medications included: LISINOPRIL; ESOMEPRAZOLE; CLARITIN [LORATADINE]. The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "sleepy"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "2 waves of nausea"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling"out of it""; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm ache and soreness for 2 days".  Additional information: Medications received within 2 weeks included Lisinopril 10mg, Esomeprazole 40mg, Claritin and Vita. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Felt hot but temp not taken; Both rt & lt thighs were swollen, hives were present at both thighs around inject site;
Presented in Ventricular tachycardia with acute cardiac ischemia and further reduced EF to 15% from previous baseline of 30%.
Shots given 11/04/2005. Had vomiting episode that night. Woke on 11/05 with large whelps have persisted. Seen 11/07 whelps on face, arms legs, none on trunk. More vomiting on 11/06. Better on 11/07.
Following the vaccine(2 hrs later)the patient developed nausea, vomiting, diarrhea and lethargy.  Later that night she began to spike a fever.  The lethargy, weakness, fever, and fussiness continued to progress over a couple of weeks along with some anorexia.  On 10/18 her speech got worse and she was inable to walk with unwillingness to hold urine or stool.  11/16/06 Received medical records from hospital which reveal patient admitted 10/21/06 after 3 week history of progressive malaise, ataxia, anorexia & decreased speech after being transferred from outlying hospital.  Had developed N/V/D & fever approx 2 hours after flu shot.  Initial exam revealed irritable & lethargic patient with mild shotty lymphadenopathy.  Tx w/high dose steroids. PMH: HOP, eczema, UTI Birth Hx: c-section, 8 lbs, 3.8 oz, No complications. Family Hx: 4 yo brother w/febrile seizure.  D/C dx:  Acute disseminated encephalomyelitis, resolving./ss
he caught the flu; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via social media.  This case involves male patient (unspecified age) who he caught the flu (influenza) while he received vaccine Influenza Vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had a shot, he caught the flu (influenza) (non-serious).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Strong arm soreness unable to flex shoulder at 90 deg. mild sinus ache and headache
Information has been requested from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (dose and route were unknown) lot # M023380 with expiration date 11-MAY-2018, lot # M014309 with expiration date 21-MAR-2018, lot # M009745 (an invalid lot number) with expiration date 23-AUG-2017 and lot # M001152 (an invalid lot number) with expiration date 05-JUL-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received form the mother concerning her 21 year old daughter with a history of drug reaction to VERSED who in October 2006 was vaccinated with a first dose of GARDASIL and on unspecified dates was vaccinated with second and third doses of GARDASIL. Concomitant therapy included FLUSHIELD. It is reported that the patient received all three dose of GARDASIL and then two times in March 2008 she had a PAP Test done and they both came back abnormal. In March 2008, the patient was diagnosed with a mild case of dysplasia (HPV). At the time of reporting, the patient's mild case of dysplasia (HPV) persisted. The patient had sought medical attention of the physician. No further information is available.
Sweating; Body aches; Joint pain; Nausea; Chills; Fever; Fatigue; A report was received from a consumer concerning a 48 year old male patient who was participating in the mRNA-1273 and developed nausea, body aches, sweating, chills and fever, joint pain, and fatigue.   The patient's medical history included COVID-19 and blood pressure. No relevant concomitant medications were reported.   On 04 Jan 2021, within one day of the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   That night the patient experienced nausea, body aches, sweating, chills, fever, joint pain and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome nausea, body aches, sweating, chills and fever, joint pain, and fatigue.were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A lot of pain / where / injection was administered; Nickel-sized depression / where / injection was administered; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain and injection site injury. On an unknown date, the outcome of the injection site pain and injection site injury were unknown.   It was unknown if the reporter considered the injection site pain and injection site injury to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. In February 2021, the patient received 1st dose of Shingrix. There was no issues reported with first dose. The patient experienced a lot of pain and small nickel-sized depression developed in the deltoid where the injection was administered. The reporter asked if there had been any reports of this with the vaccine and if so,the deltoids of those patients returned to normal.
appendix irritation; pain on right side under hip; This is a spontaneous report from Contactable other HCP (patient) reported for herself. A 37-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA 7484), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 12:30 (at the age of 37-year-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications received within 2 weeks of vaccination included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA 24 FE), fluoxetine hydrochloride (FLUOXETINE) fluoxetine 40mg, doxycycline (DOXYCYCLINE) doxycycline 100mg all were taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamides and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient other medical history was none. Patient did not have covid prior vaccination and was tested for covid post vaccination. Structured information (Patient episode name) reported as none. The patient experienced appendix irritation on 19Aug2021 and pain on right side under hip on 12Aug2021. The patient was hospitalized for appendix irritation for 1 days. It was reported that, thursday 12Aug patient had pain on right side under hip which faded after 24 hours, on 16Aug pain resumed had urinalysis from MD and on 19Aug went to ER where CT revealed appendix irritation and enlargement emergency appendectomy performed. Event treatment included appendectomy. The patient underwent lab tests and procedures which included computerised tomogram that included appendix irritation on 19Aug2021, it was reported that on 19Aug went to ER where CT revealed appendix irritation and enlargement emergency appendectomy performed. Patient also had sars-cov-2 antibody test that was negative on 19Aug2021. The case was assessed as serious. Event resulted in the Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event appendicitis and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
ZOSTER VACCINE WAS GIVEN TO A 1 YEAR OLD, NO ADVERSE REACIONS.
Pt developed a sore arm with a 15 cm area of erythema, tenderness, induration, hard area, fever and flu like symptoms.
Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; chest and arm are now sore; Headache; This is a spontaneous report from a contactable consumer (reporting for herself). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 09:56 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (lot number: EL1283, expiration date: unknown) on 21Jan2021 for COVID-19 immunization. On 11Feb2021, the patient stated getting a little headache and went to bed. On 12Feb2021, the patient got chills, stated that she started involuntary jerking that she could not control, her chest was pounding and her left arm was pulsating, going in and out. The patient also stated that her chest and arm were sore and it was pounding so hard. The patient was ready to go to the emergency room at 1:30 AM but did not. The patient was encouraged to reach out to her healthcare provider. The outcome of the event chills, involuntary jerking was recovered on 12Feb2021, chest pounding, left arm was pulsating was not recovered and unknown for the other events.
Sick as a dog [Sickness]; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 73-years-old female patient (87.1 kg) who experienced being sick as a dog [sickness] (illness), while she received vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN].  The patient gets sick every year after getting INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment, and family history were not provided.   At the time of the event, the patient had ongoing pulmonary arterial hypertension.  Concomitant medications included RIOCIGUAT (ADEMPAS); and WARFARIN SODIUM (COUMADIN).  On 10-Nov-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  From  01-May-2017, the patient started taking REMODULIN concentration 5.0 mg/ml (TREPROSTINIL SODIUM). The current dose of Remodulin was reported 0.048 µg/kg, continuous via intravenous (IV) route (batch number: 935767 and expiry date: 31-Aug-2021) for pulmonary arterial hypertension.  In 2020, the patient developed a non-serious sick as a dog [sickness] (illness) (unknown latency) following the administration of INFLUENZA VACCINE and of TREPROSTINIL SODIUM   The patient as not increasing pump rate for Remodulin until feel better.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of illness was considered as resolving and the patient was feeling a little better.  The reporter assessed the causal relationship between the IV Remodulin and the event of illness as not related.  There will be no information available on the batch number for influenza vaccine for this case.
An identified patient was vaccinated with her first dose of Gardasil. Subsequently the patient experienced a painful bump at the injection site and incorrect route of administration. No additional follow up is expected.
Three days after the second shot, I am completely covered in a red itchy rash all over my body.