chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine; started having temperature; pain under the arm pit; burning under the arm pit like if it was administered there/burning; appeared like a ball; pain in my legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine) and PYREXIA (started having temperature) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit). On an unknown date, the patient experienced FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 Tylenol. At the time of the report, BURNING SENSATION (burning under the arm pit like if it was administered there/burning) had not resolved and SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2021, Body temperature: high (High) probably 100°F or 101°F (couldn't check it).         Concomitant medication of the patient was not reported.  After the first dose, the patient did not experience any adverse events.  The patient received the second dose at 6 o clock. The burning started between Saturday and Sunday and started to get worried. On 18-Oct-2021, the patient went to urgent care where it was told it was a side effect to the Moderna Vaccine and on Friday the patient had an ultrasound.
I went in for my 12 week appointment and the doctor said the baby's heart had stopped. She said it didn't grow and must have stopped right after my 8 week appt. I got the H1N1 shot at my 8 week appointment. The baby was perfectly healthy, perfect size, and perfect heartbeat at 8 weeks. And from hours to days later it died? 12/7 and 12/9/2009 OB records for ov 12/3/2009 , Dx missed abortion patient for 12 wk f/up visit, Transvaginal US noted no fetal heart rate, had D&C on 12/4/2009,
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 17-APR-2014, 01-MAY-2014 and 17-JUN-2014 the patient was intramuscularly vaccinated with the first, second and third 0.5 ml dose of GARDASIL (lot number for all vaccines J012212, expiration date 18-FEB-2014). No adverse events were reported. Additional information has been requested.
feverish; hardness at injection site; Swelling at injection site; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 78-year-old female patient who was feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) while receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history Drug hypersensitivity (penicillin and aspirin  allergy).  It is unknown if the patient had any other medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that "The patient had not received the covid -19 vaccine yet, hence it is not captured in the structured field. Patient had drug allergy and hence ended up in the hospital with anaphylaxis, swelling of the face and throat and difficulty breathing, it is not captured as event. She had no hives, no shortness of breath but her doctor was apprehensive about her getting the covid vaccine without calling us. She also has allergies to penicillin and aspirin. She has ended up in the hospital with aspirin for experiencing anaphylaxis, swelling of the face and throat and difficulty breathing. She wants to know if its okay for her to receive the first dose of the Pfizer BIoNTech Covid 19 vaccine. Also referred her back to her healthcare professional (HCP).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the events.  There will be no information available on the batch number for this case.
2X period a month for 7 months, irregular period, difficulty trying to conceive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 11:00 (Lot number: EW0161) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Soy" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 19Apr2021 12:00, outcome "recovered with sequelae", described as "2X period a month for 7 months, irregular period, difficulty trying to conceive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The reporter stated the event as non serious.  Follow-up attempts are completed. No further information is expected.
AT 4:00PM THE PATIENT COMPLAINS OF DIZINESS AND HEAD SPINNING.  PATIENT DENIES SHORTNESS OF BREATH. NO INCREASE IN WORKOF BREATHING. PATIENT DENIES THROAT SWELLING OR DIFFICULTY SWALLOWING. OXYGEN IS 99%, HEART RATE IS 117, BLOOD PRESSURE IS 137/99.  HISTORY OF HIGH BLOOD PRESSURE.  PATIENT DENIES ANY CHEEST PAIN OR ANY OTHER COMPLAINTS AT THIS TIME.  RESPIRATION RATE IS 18 WITH NO INCREASE OF WORK OF BREATHING NOTED.  PATIENT REPORTS FEELING BETTER AFTER ASSESSMENT.
The Medical staff of clinic prescreen all their patients for the for covid 19 vaccines.  We the Health Department supply them with the vaccine needed and they vaccinate under our covid PIN.  The Nurse Practitioner vaccinating today thought she was giving the patient her 2nd Moderna in the initial series because only one dose was visible in database.  The patient advised she had a second full dose in different state so she discarded half the dose and gave her .25ml IM of Moderna Monovalent which is no longer authorized as a booster dose.
The day after the shot, my right arm was sore and swollen.  On 4/25/21, I noticed my right arm was red and itched.  The redness continue to spread over my arm.  As of 4/30/21, my arm continues to be red and slight itching.
Fainted about 5 minutes after receiving vaccine. Readily recovered but reported couldn't hear normally in left ear, but didn't seem to last long. Call for follow: Mother reported that as they walked to car from this office, patient reported numbness starting in left hand, then in the car noted vision in left eye was blurry with flashing light sensation. At 4:45 (time of my call) patient was reporting left side of face was still feeling numb since car ride home. No numbness or discomfort in left arm at site of vaccine, just her hand and face. Call for follow up on 8/8/17. Spoke with mother and patient was back to baseline. All numbness cleared in about 3 hours after onset. Mother reports that patient did not seem anxious at all during the above event but did see giddier than usual.
Pt c/o generalized itching, tingling in his mouth, and "feeling like I feel when I need my EpiPen". Given epi, Benadryl IM, transferred to ED.
Low blood pressure; Felt really week/weakness; Numbness in the whole body; High Fever 139.9; Severe muscle pain; Severe Headache; This spontaneous case was reported by a dentist and describes the occurrence of HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9) and MYALGIA (Severe muscle pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache). At the time of the report, HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Body temperature: 139.9 High.   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 relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
SORENESS; CHILLS; NAUSEA; SPLITTING HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced soreness. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced splitting headache. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, splitting headache, chills, and soreness. This report was non-serious.
dizziness; hot flashes; This is a spontaneous report from contactable nurse reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 06Apr2021 16:30 as 1st dose, single for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) were none. Medical history included breast cancer (2 Time Breast Cancer Survivor). Family Medical History included her brother is a prostate cancer survivor and it came back twice, her sister is a breast cancer survivor, and her mother is breast cancer survivor. Concomitant medications included fulvestrant (FASLODEX) (H2 receptor blocker) on 23Mar2021. Historical vaccine included hepatitis vaccine she had 10 years ago for immunisation, she did not seroconvert. She just retested 4 months ago, and she never got any antibodies from the vaccine. She did it twice at different intervals. The patient experienced dizziness (medically significant) on 09Apr2021, hot flashes (medically significant) on 09Apr2021. The event clinical course was as follows: Sometimes at night she was like a heater. States she didn't have hot flashes before the vaccine, she hasn't had them in 20 years. No treatment was received, she just deals with it. The patient started as short waves of dizziness lasting 1-2 minutes. There was no AEs required a visit to emergency room or physician office. The patient was due to get her vaccine but was not sure if there were side effects when taking fulvestrant and the vaccine together. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event hot flashes and dizziness cannot be completely 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.
Two macular erythematous lesion 0.5 x 1 cm; another 0.5 x 0.5 cm diameter. Both on the left upper extremity.
This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 167 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced sore arm / right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 01-APR-2021, and had not recovered from dizziness, and sore arm / right arm pain. This report was non-serious.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2010, the patient was vaccinated with an unspecified PREVENAR 13, however, after checking the vaccination records, it was determined the patient received a dose of PENUMOVAX 23 for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). Then, on 22-MAR-2018, the patient inadvertently received a second dose of PNEUMOVAX 23, lot # N025656 and expiration date on 19-APR-2019, for the same indication (route of administration and anatomical location were not reported). No adverse events were reported for the patient.
Patient was nervous when vaccinated by provider. Once vaccination was complete, the patient stood up and walked over with the clinical coordinator to a sticker table to select a sticker. Patient stated she felt a little dizzy. At which point the clinic coordinator grabbed the patient and lowered her to the floor as her knees began to buckle. Staff were alerted and the patients eggs raised. Patient did not hot her head or lose consciousness during episode. Patient was stayed supine until we were comfortable for her to sit on the floor. Patient was given juice by nurse, and later stood up and walked over to the observation area and was observed for approx 30 minutes. Incident was reported to parent/guardian by school nurse and Onsite medical.
Recipient did not experience an adverse reaction. He inadvertently received the Moderna vaccine before 18 years old. He was 17 years 6 months at the time of vaccination.
The patient was given an extra dose of DTap at the visit instead of her second dose of Hepatitis A.  The last dose of DTap received by the patient was in 4/2019.  Error was caught after patient had left the health center
Within hours I had cold sores covering my lips. 72 hours later, I realized that I had developed tinnitus. The injection site took more than 35 days to heal.
rash on her hands and neck; This is a spontaneous report from a contactable other healthcare professional. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient's medical history included eczema from an unknown date and unknown if ongoing, and allergic to bananas and watermelon. She has been taking Benadryl for symptoms. The patient's concomitant medications were not reported. On 22Dec2020, the patient developed a rash on her hands and neck after receiving her Covid19 vaccine. Patient stated she had a history of eczema, but states this rash presents differently. The patient experienced rash on her hands and neck on 22Dec2020 with outcome of unknown. Therapeutic measures were taken as a result of rash on her hands and neck.  Information on the lot/batch number has been requested.
This spontaneous report as received from a consumer refers to a 64 year old male patient with penicillin allergy. On 14-AUG-2013 the patient was vaccinated with ZOSTAVAX, dose and frequency were unknown. On 14-AUG-2013, 1 day after onset of therapy the patient experienced aches and pains, and stated they felt like they were getting a cold. During this AE report, the patient stated that they missed a dose of BENICAR (unspecified manufacturer/dose/frequency) on 14-AUG-2013, because they were going to receive ZOSTAVAX. No treatment was given for the AE. The patient did not seek medication attention. Routine blood work was performed without result provided. At time of report the patient was not recovered/not resolved. Additional information is not expected.
Patient stated he had noticed a rash starting at the injection site after receiving the vaccine in March which eventually spread to his belt area on the stomach and traveled up the right arm.  Patient stated he saw his PCP and dermatologist and they could not determine the cause of the rash.  The patient reported the incident January 12,2022 to the pharmacy and patient stated the rash was still present since the vaccine was given in March, 10 months later.
In spite of ice application, lt arm shoulder at and below injection site is painful and single large raised red welt the size of the upper muscle, hot to the touch. Fatigue starting that evening and severe the next day, causing cancellation of plans for eldest granddaughter's birthday. Still fatigued on 10/3 but less so, and by evening, the arm was a little less red and hot, and started itching. on 10/4 barely tolerated my usual morning walk (managed 50 minutes of my usual 60), quite fatigued after but recovered quicker, still not being very active. Itching in shoulder worse today, but less pain. and noticed some red pinpoints at the lower edges.
Two crusty lesions, multiple small red bumps on abdomen and back. Possible vaccine failure.
Swelling of the lips and  itchy mouth. The swelling remained for 3 days.
Swollen Lymph node under left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. 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 21Apr2021 the patient experienced swollen lymph node under left arm. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node under left arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
(1) Swelling behind left knee- approximately 1 month after vaccine  (2) Pain inside left thigh and leg area - recurring since taking vaccine, nothing done, just noted (3) Wake up with stiffness in left side of neck approximately 2 times per week- recurring approximately 1 month after taking vaccine (4) Developed a dry cough - present and recurring everyday, approximately 1 month after vaccine (5) Severe insomnia noted after taking vaccine - developed approximately 2 months following vaccine (5) Severe lack of energy and body tiredness
Severe lymph edema left scullery and dorsal left  upper and inner arm bruising
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no drug reactions/allergies. Patient's pertinent medical history was none. On 23-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003360, expiry date 21-JUN-2013) vial, 0.65 milliliter (ml), subcutaneous. Concomitant medications were none. On 23-SEP-2013, the patient developed redness and itching at injections site. No rash was present. Patient sought medical attention (called the pharmacist). Lab diagnostic test performed was none. The patient was treated with Benadryl. The outcome of redness and itching at injections site was reported as not recovered/not resolved. Additional information has been requested.