chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discomfort; Fever; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.; Nervous; Experienced pain almost immediately; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast) and LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced NERVOUSNESS (Nervous). 18-Dec-2021, the patient experienced PAIN (Experienced pain almost immediately). On 19-Dec-2021, the patient experienced LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast). 19-Dec-2021, the patient experienced LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.). On 19-Dec-2021 at 1:30 AM, the patient experienced DISCOMFORT (Discomfort) and PYREXIA (Fever). At the time of the report, DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast), LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-421513 (Patient Link).
Swollen lymph nodes, mild-moderate fatigue, slight chills when tired. Nothing bad, reporting for your stats.
No adverse reaction; Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022).    No concomitant drug information was provided.  No treatment drug information was provided.   This case was linked to MOD-2022-688372 (Patient Link).
Redness, heat, swelling,  itching rash down length of vaccine arm, hand and same side leg. Numbness in shin and ankle same side leg. Redness and itching around same side eye. Heart pain 5 times in succession.  Pain and stiffness in same side neck and shoulder. Facial and head itching.  Temperature dropped to 95. Severe chills.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of ROTATEQ (lot # L029615 and expiration date 15-MAY-2017) (lot # M019706 and expiration date 24-OCT-2017) (lot # M031807 and expiration date 02-APR-2018) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010790: US-009507513-1705USA004700: US-009507513-1705USA004698:
the day following vax pt fluish feeling ie: headache, muscle ache especially in neck & shoulder region. No vomiting or diarrhea.
8/9/12 3rd dose Hep B given to Right arm (previous doses given without any problems 8/10-8/13 Right arm sore with stiffness (Ibuprofen started) 8/14-8/16 Right arm sore with no stiffness 8/17 Some redness and swelling noted from hairline on forehead down to between eyebrows. Right top and back of head/scalp soreness. Right arm soreness. Jawline right below Right ear, gland sore and swelling. 8/18 Rash and swollen from hairline down to between eyebrows . Pain and burning. Soreness continues as stated on 8/17. Applied Neosporin and started antibiotic  8/19 Swelling and sorness started to subside 8/20 Some pus noted to forehead area 8/21 Rash starting to heal and crust over.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with several doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # K008931 with expiration date: 04-MAR-2017. The doses were improperly stored with a temperature excursion to 33 Fahrenheit degrees for 2 hours on an unknown date. No adverse effects were reported. Additional information is not expected, because reporter did not wish to be contacted.
Fever 103.0 noted on 11-3-10 at 3:00 AM. Spoke with mother at 0730 on 11-3-10 & temperature was 100.3. No other symptoms, no redness, no swelling, no other symptoms of illness. No return call when attempted to check on child's status 11-3-10 2:00 pm.
Persistent sinusitis infection, coughing, and excess mucous secretion that continues almost 9 months after the shot, although improving slowly. Previously had not had the flu or a cold in 25-30 years.
Patient came to the pharmacy to receive 1st dose of the Pfizer covid vaccine. About 5 minutes later patient felt unwell. According to her mom she passed out for about 5 seconds then jerked up and passed out again for a few seconds and woke up. Mom was unsure but thought it looked like a mini seizure. Both pharmacist was informed and checked on patient. Patient was hot and sweating but breathing was fine. Patient was coherent and could talk. Patient was given water. Blood pressure check was 102/69. Patient remained sitting with head over legs as that made her feel better. EMT arrived at the scene and took patient away on a stretcher for further observation.
deathly sick; Initial information received on 01-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non- health care professional.  This case involves an unknown age male patient who experienced deathly sick (illness) while receiving INFLUENZA VACCINE.  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case
The patient had hives, rash, wrist and knee arthritis (red, hot, swollen, tender), elbow arthritis, and itching. It all occurred in the AM after his shots. The patient was given Ibuprofen the night after his shots and before the rash (it could have been the Ibuprofen, none given since 7/25/00).
pt recv vax 4SEP96 & 15SEP96 pt devel a rash & a fever;
pt transferred from Health center in town to Hospital for higher level of care; transferred to ICU; positive for COVID;  respiratory failure secondary to COVID pneumonia; intubated;  given dexamethasone, Tocilizumab, ABX; pt's condition worsened; family desired to transition pt to comfort care and she passed away in the hospital
Admit 8/1/2021.  Covid positive 8/1/2021 in ED. previous COVID-19 Vaccination on 3/31/2021.    COVID breakthrough - acute diarrhea, AKI, pneumonia
Patient had first dose 3/25 and developed severe headache, neck pain and fever/chills starting 5-6 days after first dose.  She continued to have neck and back pain despite care of chiropracter.  Received 2nd dose 4/22.  That night worsened headache, fever to 102.7, increased neck/back pain, bodyaches.  Also nausea, vomiting and diarrhea.  Normal neurologic exam in Emergency Department early morning 4/23.  Treated with supportive care (Toradol) with improvement.  Do not suspect any intracranial pathology at this time.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
Received vaccine 1/27, developed fevers that night. She continued to have fever, also had chills, headache, body aches. Developed abdominal distension. Presented to ED on 1/31/2022. Found to have fever, tachycardia, tachypnea, leukocytosis, elevated lactate and abnormal LFTs. She was admitted to the ICU, started on antibiotics for presumed sepsis. Initial suspicion of cholecystitis, went for cholecystectomy and no cholecystitis but liver was inflamed, had biopsy. Subsequently, developed acute hypoxic respiratory failure with CT showing new pulmonary infiltrates. Bronchoscopy done and suggestive of diffuse alveolar hemorrhage, bronch studies pending but so far infectious work up negative. She also developed elevated troponin with normal echo. She developed anemia, required transfusion. She is currently intubated and remains in the ICU with ongoing fevers.
itching at the injection site; redness; swelling; difficulty sleeping; fatigue; pain at the injection site/pain in the upper arm; This case was reported by a nurse and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, erythema, swelling and difficulty sleeping. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was a retired nurse received Shingrix in left upper arm about a month ago from reporting day but she does not know the date. On the same day she had pain at the injection site with redness about 7-8 inches in diameter and swelling which lasted for about 3 days with pain in the upper arm area which was resolved at time of reporting. A week after vaccination patient had some itching at the injection site. Due to the pain at the injected site and upper arm, the patient had difficulty sleeping for about 2 nights. She also reports fatigue which lasted for a week. The patient did not want to provide information about the pharmacy and the MDO. The reporter did not consent to follow-up.
This spontaneous report as received from a health professional (also reported as a medical assistant) refer to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 21-AUG-2015, the patients had been vaccinated with VARIVAX (Merck) (lot # L004654, expiration date 11-FEB-2017, dose and route not reported), which were improperly stored. Information regarding concomitant medications was not reported. No adverse effects reported. Additional information has been requested.
A report has been received from a Health Professional concerning a 52 year old, female subject, who had been receiving FLUMIST QUADRIVALENT.  The patients concurrent disease(s) included Hypothyroidism, Idiopathic sensory neuropathy; Hyperlipidemia and Anxiety. Concomitant medications included Levothyroxine, Montelukast, Omeprazole, Bupropion Hydrochloride, Atorvastatin, Budesonide, Formoterol, Fumarate dihydrate and Fluticasone propionate. FLUMIST QUADRIVALENT started on an unknown date. IT was reported that a 52 years old patient received FLUMIST QUADRIVALENT which started on 06-OCT-2014. The outcome of the event of 52 year old patient received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous report was received from a pharmacist via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. The pharmacist reported that on an unknown date, the patient, who was intended to receive ZOSTAVAX, was inadvertently vaccinated with VARIVAX (dose number, route of administration, lot number, expiration date and indication were not reported). It was also mentioned a sterile diluent used (lot number and expiration date were not provided). On an unspecified date, 1 week after administration of the VARIVAX dose; the patient was vaccinated with a dose of ZOSTAVAX (dose number, route of administration, lot number, expiration date and indication were not reported). No adverse effects were reported.
Pt devel widespread rash several hrs p/recvd Hep B; On MD exam, rash was fine, maculopapular, pustular in areas w/some area of blanching erythema;
fainted apx. 15 hours after the second shot.; About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted apx. 15 hours after the second shot.) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced SYNCOPE (fainted apx. 15 hours after the second shot.) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted apx. 15 hours after the second shot.) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date  EKG was done with unknown results. Concomitant: Blood pressure medicine.  Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Upon follow-up receipt: Reporter information added, event added, dose 1 information added, event start date added and inarrative updated.; Sender'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.
This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 63-year-old female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain (serious criteria disability), rash (serious criteria disability), joint range of motion decreased (serious criteria disability), tendonitis (serious criteria disability) and swollen joints. on an unknown date, the outcome of the shoulder pain and joint range of motion decreased were unchanged and the outcome of the rash, tendonitis and swollen joints were unknown. The reporter considered the shoulder pain, joint range of motion decreased and swollen joints to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the rash and tendonitis to be related to SHINGRIX. Additional information was received as follows: The health care professional (HCP) stated that the patient received SHINGRIX two weeks before the date of reporting, below the deltoid region. The patient experienced severe pain at shoulder, the site was swollen and it was looked like tendonitis. The patient had limited range of motion and constant pain. The vaccine was administered by local pharmacy and the HCP did not have additional information to provide.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per pt, he reported history of feeling faint after vaccination because of fear of needles. Counseled pt prior to vaccination. After administration, patient felt dizzy and faint. Recommended that patient lay down with feet elevated in air.  Patient laid down until he felt comfortable sitting up.  He drank water and felt good after a few seconds. I offered him an ice pack but he refused.
14yo male that was admitted to our hospital's cardiology service prior to after an episode of acute onset tachycardia (possible atrial tachycardia), dizziness, headache at school.  He had his first covid vaccine 8 days prior to the event at school.  He has a coincidental diagnosis of an anomalous left coronary off the right aortic valve cusps, but his coronary course is unusual where he would be very unlikely to be at risk for sudden cardiac arrest.  He had an ECHO in the ED that showed a mild left ventricular dysfunction (EF 45%).  He underwent a cardiac MRI on 5/28/2021 was done that was normal without myocardial edema or scarring.  His ejection fraction on that study (24 hours later) was 54%.  He was discharged home and had a stress test the following week (6/1/2021) that showed blocked PACs at peak exercise (a very usual finding for an otherwise healthy kid) and possible slow atrial tachycardia at baseline.  His laboratory evaluation including CRP and ESR was normal.  72 hour Holter monitor showed blocked PACs and no supraventricular or ventricular tachycardia.  Mother reports that he is "back to baseline" May 31st.    Of note, his father was covid positive with headache in October 2020.  The patient also had a headache for 1 week without fever.  It was presumed that he had covid as well, but was not tested per PCP recommendation.
A report has been received from a Health Professional concerning a 17 year old, male patient. No information regarding relevant history, concomitant disease and concomitant disease and concomitant medications were provided. The patient received FLUMIST (intranasal) started on 18-Dec-2013. The reporting nurse inadvertently administered the entire dose in one nostril on 18-Dec-2013. Not reporting any symptoms. The outcome of the event of entire dose in one nostril was unknown. The report was considered to be non-serious by the reporter. Corrected report 06-May-2014. The case has been updated with full date to KUR term additions for FLUMIST/ Q/Laiv.
Day 2 (Dec 23) woke up at 5 a,m, feeling nauseous, fatigued, light headed; symptoms lasted approximately 10 hours.  By 3 pm I felt completely normal. Day 11 (January 1, 2022) woke up at 4 am with itchy scalp and hives covering the back of my head, back of neck and back of ears.  As the day wore on hives appeared on front of neck, chest, legs, and feet.  At 2 pm the hives continued to get worse.  By 10 pm hives were breaking out all over back  Day 12 (January 2, 2022) woke up at 4 am with hives on thighs, back, torso, front and back, shoulders and breasts. Hives were extremely itchy, red, raised.  At 7 a.m. began to feel tightness in throat which continued for several more hours. at 10 a.m. arrived at the urgent care clinic where I was seen at approximately 10:30 a.m. saw dermatologist the next day.
Moderna 2/12/21, 3/12/21, 11/24/21. Positive on 11/26/22
Sick; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in 2018 (Batch/Lot number was not reported) as single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got sick in 2018 after vaccination. The outcome of event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
For approximately 5-6 weeks post vax, the pt experienced joint ache primarily in legs and arms. Pain diminished but occasionally she still complains about joint aches. Per doc 204163, patient still has occasional joint discomfort. There are no symptoms at this time.