chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 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: "Acne" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 11Nov2022, stop date: 03Dec2022; DOXYCYCLINE HYCLATE, start date: 11Nov2022, stop date: 03Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Still positive; (21Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment was Spironolactone, Doxycycline Hyclate. The patient was previously receive a COVID-19 Vaccine. Patient known allergies was none reported. Patient received Paxlovid start date: 10Dec2022 and stop date: 15Dec2022 for COVID-19 Treatment. Initial sore throat symptoms cleared up by day 7-10 after initial test (17Dec2022-20Dec2022), but runny nose and congestion (new symptoms) appeared on 21Dec2022 with a positive rapid antigen test. Runny nose and congestion has continued, tapering off until today 26Dec2022 (5th day of re-isolation) where little to no congestion or runny nose is present. However, RAT is still positive and am continuing to isolate.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Two min. post vaccine given client became pale, sweaty with eyes looking dazed.  Vaccination nurse attended to client stated he was feeling dizzy for a minute.  Client was escorted to DOH observation site for further observation by paramedics on standby.
I received my shot at 1347 and within 5-10 minutes after receiving the shot I got a hot flush feeling through my body. My heart then began to race and I became dizzy. I started to get a tickle feeling in my throat. Soon after my lips and tongue felt numb. My tongue had the feeling of having been burned by hot soup. I also had red splotches over my entire body (not a rash but redness).  When I alerted the vaccination staff that I thought I was having a reaction they all seemed shocked. They didn?t really know what to do and asked me what I wanted to do. I, myself, was having a hard time making choices since I was in a bit of a panic. They wanted to give me oral Benadryl but since I was having the reaction in my throat and mouth one of the nurses suggested IM Benadryl.  They gave me that shot around 1405. They watched me for about an hour and I still had the numbness in my lips and tongue and the red splotches over my entire body.  (During this entire time no one took my BP or pulse).  I had 2 work friends (RNs) come to check on me. It was only then that one of them took my pulse. I was still had tachycardia. Since my symptoms were not fully resolving they sent me to the ER where I got solumedrol and Pepcid. They sent me home still having slight numbness in my lips and tongue.
Breakthrough Case of COVID; Raised Tep, trouble breathing, weakness, lack of appetite, a lot coughing, and mucus drainage.
On 11/14/21, nursing staff noticed that PT oxygen sats were low and continue to drop.   She presented with labored breathing and chest congestion. She was taken to the ER at 4:01PM and sent to Hopital.
Pt stated L arm swollen after administration of PNEUMOVAX vaccine.  Advise pt to go to ER if arm worsen or if any pain/fever develop.  Dr. advised to take BENADRYL.  Pt recovered well after two days.
pt recvd vax & had inc bruising; exam revealed multiple bruises, petechia; purpura; admitted 20sep IU gammaglobulin x2; discharged 22sep; probable ITP;
Pt recvd 2nd dose of Hep B vax w/in 24 hrs pt devel restlessness & sleeplessness w/pain or tightnes of the jaw; 15NOV90 all sx had subsided;
Patient was given her 1st COVID/Janssen  dose of 0.5ml @ 2:45pm. Patient states @2:52pm she was breaking out with a rash. Patient showed me her rash. Patient began to feel flush. Supervisor was notified. Steps were taken to monitor and relieve symptoms from the reaction. 50mg of Benadryl was given orally with water in tablet form at 2:55pm. Vitals were monitored over 30min time period and collected 3 times before patient was released. Patients rash subsided vitals returned to normal range. BP 120/84, Pulse 99, Resp. 12, O2- 99%, Temp. 98.9.  Patient was releases at 3:35pm 2-1-23. Follow up call was attempted 2-2-23 no answer, message left to return call to Health Dept.. Attempt #2 for follow call was made 2-3-23. Message was left to return call to Health Dept. Patient returned call to Health Dept. @ 8:55am 2-3-23.  Patient states on 2-2-23 she wasn't feeling well and spiked a fever along with an elevated heartrate.  Patient states she was seen by a Dr. at work an EKG was performed and results were normal. Patient states her fever was 101 degrees. Patient states she feels well today and is having no complications. Advised Patient if any new issues arise contact the Health Dept and seek medical attention if needed.
pt had been crying since vax; lt hand was swollen & could not use it & the upper arm was swollen w/great big blotches around it; t101.7; @ hosp visit temp reached 103;pt crying;lt hand swollen & can't use it;
Discovery of pregnancy on 18 Aug 10 following receipt of AVA #1 and typhoid vaccines on 11 Aug 10, LMP 19 Jul 10. Pt lost to f/u. Review of records noted that pt was evaluated in ED on 21 Aug 10 with spotting (EGA 5 wks by dates) and TVUltrasound showing only enlarged uterus and low bHCG (213). Bleeding increased and on 25 Aug HCG was 92. On 27 Aug a TVU was performed without evidence of pregnancy. On 31 Aug HCG's have plateaued, bleeding decreased, cramping persists. She was pos for chlamydia and treated. Repeat TVU without evidence of pregnancy. Pt treated with methotrexate.
Crying, irritable on and off x 2 days small lump on right upper arm.
pt reported had tenderness in lt upper arm the day p/the inject; a few days later pt noticed a dull aching pain in same site w/certain movements such as reaching behind back to hook bra on raising arm up;
pregnant with twins/accidentally stabbed herself with a needle; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92, expiry date 29-SEP-2025) for prophylaxis.   On 17-OCT-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant with twins/accidentally stabbed herself with a needle). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Shingrix): 23 Weeks Pregnancy Exposure (Shingrix): To mother in third trimester Last Menstrual Period Date: 03-MAY-2023 Estimated Delivery/Due date: 04-FEB-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 17-Oct-2023 The reporter reported that after the shingrix was reconstituted and sitting on the counter for 5 minute, she accidentally stuck her self with the needle.   No reactions reported.  However, she was pregnant with twins. The reporter consented to follow-up. A pregnant patient accidentally received a dose of Shingrix, which led to vaccine exposure during pregnancy.
couldn't get out bed; headache; chills; achy all over; flu-like symptoms; lower back pain; started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over). On an unknown date, the patient experienced FATIGUE (couldn't get out bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over) outcome was unknown.            No concomitant medication use was provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
BP 128/64  HR 98 SPO2 98% RA Not Diabetic Patient reported feeling anxious. Patient did not lose consciousness. Patient stood and fell weak to her knees but did not his her head of fall to the floor. Patient assisted by EMT on site. Patient refused further treatment. Patient given a snack and a water. Patient observed in observation area for 30 minutes post incident.
Nausea, headache, fatigue.  Started approximately 4 hours after shot, becoming worse as evening wore on.  After sleeping, woke in morning with symptoms improved but present.  Approximately 24 hours after onset of symptoms they had dissipated.  Treated symptoms with rest.  Soreness in injection site continues but 48 hours after injection is nearly gone.
expired vaccine administered; This spontaneous report as received from medical assistant refers to a patient of unknown age.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.    On 19-DEC-2019 the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015742, expiry date: 02-DEC-2019) therapy type was reported as recombinant human albumin (rha) (expired product administered) for prophylaxis. No temperature excursion. No additional information was provided.  The outcome of expired product administered was unknown.
Same day of vaccine, pt experienced diarrhea, on 3/11/00, pt complained of nausea, fever, and chills, on 3/18/00, pt developed a raised induration in left arm.  Follow up on 05/17/2000: "Patient recovered from adverse event.  It took approximately 6-7 weeks for lump to go away.  There is only a slight lump on left arm that is almost not noticable as in the beginning."  Follow up on 08/29/2000: "Patient received Anthrax vaccine doses 2 & 3 on 03/02/2000 and 04/01/2000 respectively.  Symptoms of diarrhea, nausea, fever and chills lasted 1.5 weeks.  The approximate diameter in of the injection site reaction was about 1 inch.
pt recv vax 28JAN97 & 1hr p/vax throat felt thick;pt took DPH 7hr p/vax (9PM) & noticed rash & fever;12hr p/vax 2AM pt woke up w/hives, SOB, facial swelling, t012;paramedic on street gave DPH & cortisone;next day to PMD given more DPH
presented to the emergency room with symptoms of chest pain. He received Moderna covid vaccine on Tuesday and since then he has been having symptoms of myalgias and chest pain. He mentions that the chest pain is substernal, gets worse with deep breaths. It gets worse when he lays on his back.  And feels better when he sits up. He also had subjective fevers. When he presented to the emergency room he was having crushing chest discomfort with a troponin level at 10 and was referred for an emergent coronary angiography with concerns for acute coronary syndrome.  Diagnosis/Impression: Acute myocarditis after Covid vaccination: Based on positional changes and pleuritic nature of the chest pain. Given troponin level left hand and ongoing crushing chest discomfort he was emergently taken to the Cath Lab where he does not have any significant coronary artery disease or thrombotic occlusions. LV gram shows hyperdynamic LV systolic function. At this time his symptoms are consistent with myocarditis.
PREVNAR 13 given on 4/13/16 - pt. noticed discomfort on 4/16/16. She came to clinic on 4/18/16 and was told to use ice. She returned to clinic on 4/19/16 to see provider. Redness from upper arm (L) to halfway down arm. Warm to touch.
This spontaneous prospective pregnancy report as received from an officer manager refers to a now 21 year old female patient. On 13-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot # J013324, expiration date: 12-FEB-2016, dose reported as 0.5, intramuscular). The second dose was requested by the patient. The first dose administered in 2010, date unspecified. After second dose was administered on 13-JUN-2014, patient asked for pregnancy test, which was positive. Gestational date or Late Menstrual Period (LMP) was unknown at that time, as patient had irregular menstrual cycle. The Expected Delivery Date (EDD) was unknown. The pregnancy outcome was not reported. No (other) adverse effects noted by patient. The patient did not seek medical attention. The outcome of irregular menstrual cycle was unknown. The causality of irregular menstrual cycle and GARDASIL was unknown. Additional information has been requested.
Diagnosed with Covid on 26Mar2022.; Diagnosed with Covid on 26Mar2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 19 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Asthma diagnosed around 2 months of age. It was chronic; "antidepressant" (unspecified if ongoing). Family history included: "Covid-19" (unspecified if ongoing), notes: His son is at his mother's and his mother has COVID too; "They are quarantining together." (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for antidepressant therapy, stop date: 26Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Mar2022, outcome "unknown" and all described as "Diagnosed with Covid on 26Mar2022.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The report was not related to a study or programme. His son wasn't boosted but received the vaccines back in Aug2021. The patient was taking Trazodone for depression. His son had been taking it for about six months. The patient had stopped taking Trazodone on (Saturday) 26Mar2022 because of something they read. Doesn't have NDC, lot, and expiry for the Trazodone to provide. That was the only medicine he was on. Reporter's son was prescribed Paxlovid the antiviral for Covid. The patient started taking Paxlovid (Sunday night) on 27Mar2022. The reporter mentioned that PAXLOVID had been working phenomenally for his son. His son had asthma and that was why they put him on Paxlovid. His son had Covid obviously, but reporter was not sure if it was a side effect from Covid or Paxlovid. Reporter clarified that his son was vaccinated against COVID when he got COVID. The reporter confirmed that his son got the Pfizer shot. His son had a sore on his tongue on 29Mar2022. They are in state didn't and go with Moderna. Doesn't have his son's Covid vaccination card to provide NDC, lot, and expiry for the Covid vaccines he received.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Mom called clinic from home reporting child complained of difficulty swallowing, rash on face and face being swollen. Advised call EMS. Was seen in ER and treated with steroid and released.
Patient was exposed to 2 family members, both of which live with him in his home.  The patient was fully vaccinated at the time of the exposure and subsequently developed symptoms and tested positive for COVID-19 on 5/15/21. The patient reported to his supervisor that he was experiencing mild symptoms as of 5/16/21.
2 weeks after vaccination, increasing tingling in right arm radiating to back and sometimes to lower extremity. Intermittent dizziness. Symptoms are persistent, worsening and not relieved.
I had a very abnormal flow of straight blood from my vagina, it was so heavy i bled through my pads & pants for a. Full week, my periods are normally thick & last 3 days max. After that period, I didn't have another one until 5 months later, when an OBGYN had to induce it,  by giving me medicine 3 weeks ago.
Phone call from mom.  Patient received injection on left thigh on 08/11/2003.  Today 08/12/2003 he has red lump over injection site.  No fever, no oozing at site.  Tylenol as needed.
Information has been received from a physician concerning an adult patient who was vaccinated with two doses of varicella virus vaccine live and has not seroconverted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Bells Palsy occurred on 1-31-2021 after receiving the shot on 1-14-2021. No other issues or illness before or after getting the vaccine which would explain getting Bells Palsy. Have not been ill or seen doctor except for regular check-ups as necessary.
missed his second dose; tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID19) and PRODUCT DOSE OMISSION ISSUE (missed his second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID19). On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed his second dose). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed his second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.  On 22Feb2021, he had symptoms of COVID19 (fever, chills, cold-like symptoms) and tested positive for COVID19. He missed his second dose which was scheduled on 11March2021.
Teary eyes, runny eyes; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Teary eyes, runny eyes) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Blood pressure since 2021.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced LACRIMATION INCREASED (Teary eyes, runny eyes). At the time of the report, LACRIMATION INCREASED (Teary eyes, runny eyes) outcome was unknown.            Concomitant medication list was not provided. The event misuse in dosing frequency was given. In 2021, the patient experienced runny eye/ tear eye and patient paused Skyrizi during covid vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided.
Received tetanus/diptheria immunization on 8/1/05. Observed on 8/5/05 - reddened area from mid deltoid on RUE to 2" proximal to the elbow.  Warm to touch, no edema noted.
This is a spontaneous report from a Pfizer sponsored program CVx Social Listening Program (COVID-19 Vaccine) from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced seizure/convulsions, tremors, swollen lymph nodes, brain fog, muscle weakness, rashes on an unspecified date.  The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a woman in a trade services offices concerning a patient who was vaccinated with a dose of mumps virus vaccine live. Subsequently, the patient developed a negative titer. Unspecified medical attention was sought. Additional information has been request.
Difficulty in speaking and breathing/ she can barely breath/ she cannot breathe; Upset; Difficulty in speaking and breathing; Whole body is on fire; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. At the time of report, the patient reported that she was upset and had difficulty in speaking and breathing. The patient mentioned that she could not breathe. The patient received first dose on Friday (Apr2021) and now she could barely breath. She was told to go to the emergency room and the breathing problems started 30 minutes later with other symptoms. She was completely healthy prior to getting the vaccine and after getting the vaccine, the patient felt like her whole body was on fire and had difficulty breathing in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.