chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 year old pt recieves 5-11 pfizer covid vaccine, no s/s had occurred. followed CDC guidelines and DID NOT repeat dose.
Case number PHEH2014US003797 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 24 Mar 2014. This report refers to an adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that this patient over 55-years of age was vaccinated with a dose of MENVEO (batch number: A11052) intramuscularly into left deltoid at a dose of 0.5 ml on 28 Sep 2013 at 13:43. No adverse events were reported following the maladministration. Follow-up received from a pharmacist on 24 Mar 2014: Patient's demographics, site and time of vaccination updated. Batch number was amended.
Narrative:  57 y/o male with PMH for diabetes, hypothyroidism, hypertension, BPH, hyperlipidemia, and asthma. Pt presented to ED with complaints of fever, cough, chills and fatigue on 5/21/22. Pt admitted to hospital with COVID 19, chest pain and asthma exacerbation. Pt treated w/ remdesivir (05/21-05/23), dexamethasone (05/22, 05/23) and azithromycin (05/21, 05/22). Pt improved and discharged to home on 5/23.
During the injection, she felt pain in and around the arm and down to her hand; Lymph nodes swelling in the left breast area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (During the injection, she felt pain in and around the arm and down to her hand) and LYMPHADENOPATHY (Lymph nodes swelling in the left breast area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (During the injection, she felt pain in and around the arm and down to her hand) and LYMPHADENOPATHY (Lymph nodes swelling in the left breast area). The patient was treated with Manual therapy (ice) for Vaccination site pain. At the time of the report, VACCINATION SITE PAIN (During the injection, she felt pain in and around the arm and down to her hand) and LYMPHADENOPATHY (Lymph nodes swelling in the left breast area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was treated with Manual therapy (ice) for Vaccination site pain.
Starting on 1/11/21 she developed a rash over her entire body with some areas of hives. This got worse the following day. The rash is still present though the itching has improved.
Coughing, Hives near injection site and then spread to chest, back and right arm, Throat Tightening.  Epi pen administered at 1:42 PM.
Symptoms started on 2/26 at 8am and subsided by 2/27 at around 8pm.  Chills ( 6-10 hours), bodyache (24 hours), fatigue (36 hours)
Patient with acute onset at 05:00 AM today. Scattered to upper back abdomen and bilateral upper extremities. Patient on 10 day course of Augmentin which he started on 10/18/2018. Hx of PCN shots with no allergic rxn. Exam: airway patent, no perioral or periorbital swelling, no urticarial. Diffuse papular erythematous rash on face, anterior neck, chest. No evidence of angioedema, anaphylaxis, erythema multiforme. No new detergents, lotions, creams, chemical exposure, food. A/P: DC Augmentin. Decadron and Claritin for rash and itching. Report Augmentin as allergy and report small pox adverse rxn on VAERS.
Syncopal Episode  Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98%  Skin Signs: Clammy, diaphoretic  Circulation: Cap refill 4-5 sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Patient received vaccine, fell to syncope - responsive after 5 seconds. Patient hit concrete floor with a loud sound. Patient awake after 5 seconds. A/Ox5 Patient moved to L lateral position with manual spinal check.  11:50 AM  Vital Signs: BP 99/60 HR 78 Resp 18 O2Sat 97%  Skin Signs: Diaphoretic  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: EMS on scene. Patient assessed by EMS. Spine cleared by EMS. Patient moved to superior posterior. Patient refused further transport to hospital.  12:00 PM  Patient discharged home, escorted by EMS and significant other.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 06-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Tension headaches for 3+ months - still active Migraine headaches for 3+ months - still active Anxiety/panicked/jittery sensations - 2 to 3 days per week for 3+ months - still active Cold/clammy sweat that isn't the same as it was pre-vaccine
This spontaneous report as received from medical assistant refers to a patient of unknown age. No medical history and concurrent conditions were reported. On 19-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of properly stored product was unknown. The reporter considered improperly stored product to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Rash started on chest the evening of 6/28/05, we applied topical Benedryl.  She had small rash symptoms morning of 6/29/05, during the day they became progressively worse and she had hives over her chest, arms and legs, she also felt sick to her stomach. We gave her two Benedryl tablets and applied more topical Benedryl.  The hives are very itchy and the welts are large.  This morning 6/30, she still has the hives and not feeling very well.
Pt recvd MMR vax 30MAY90; w/in one or two days p/vax pt devel tenderness, inflammation & non-healing ulcers near inject site; pt was hospitalized; @ time of report had almost recovered althought continued to exp some pain;
Information has been received from a pharmacist concerning a patient who was inadvertently received a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). This occurred at a different site (not where pharmacist works). Follow up information was received from a nurse concerning the 64 year old male was received a dose of VARIVAX (Merck) (lot # 660079/0331X) on 08-MAY-2009 after he requested the chicken pox vaccine. The nurse indicated that it was given to him because that was what the asked for. The patient had no adverse reactions. Follow-up information was received from a registered nurse who reported that on 08-MAY-2009, the male patient was vaccinated with a dose of VARIVAX (Merck) (lot # 60079/0331X), subcutaneously at 10:45 hours. The nurse reported that the patient should have been given ZOSTAVAX (Merck), and that he will be given the vaccine 28 days later. The patient had no adverse events following prior vaccination. No further information was available.
Information has been received from a pharmacist concerning 5 patients who were vaccinated with a dose of ZOSTAVAX (Merck) (lot # 665524/1374Y). All the patients experienced a rash 24 hours after the ZOSTAVAX (Merck) was given. The patients sought medical attention by calling pharmacist. At the time of report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that one of the patients experienced a reaction that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist didn't think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
This spontaneous report as received from an advanced registered nurse refers to a 44 year old female patient. The patient's concurrent conditions included hypothyroidism, deep vein thrombosis and pulmonary embolism. The patient had no drug reaction, allergies or concomitant therapies. On 30-JAN-2018, the patient was vaccinated with one dose of M-M-R II (dosing details, lot # and expiry date unknown) for immunization. On 05-FEB-2018, the patient was diagnosed with shingles. The patient was provided a 7 day treatment with VALTREX. The patient was reported to have recovered from the event on an unknown date in approximately 2018. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Patient received .25 ML instead of .5 ML Patient was notified on 11/22/22 and the Patient will receive another .25 ML of the vaccine
fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19; fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 23-year-old female patient received BNT162b2 (BNT162B2), 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: "Obese" (unspecified if ongoing), notes: obese. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: >35; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient obese (BMI >35), fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19 and went to a test-to-treat site for therapy. Was prescribed Paxlovid but stopped taking after 4 days due to metallic taste.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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 events and suspect drug BNT162B2 cannot be excluded.
Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: covid test type post vaccination=Nasal Swab,. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Complaining of pain in her left upper arm. Having issues with range of motion.  She states that the pain is improved with ibuprofen.  She is without fever, weakness, nausea, vomiting. Patient came into the office on 12/20/19 and was placed in a sling and was prescribed diclofenac sodium (VOTAREN XR) 100 mg 24 tablets and told to take 1 tablet by mouth daily  . Patient ended up in the ER that night. And was prescribed Tramadol 50 mg and told to take 1 tablet by mouth every 8 hours as needed for pain. Spoke with patient today 12/30/19 and she stated that she if feeling a lot better. Pain is gone but still having issues with range of motion.
On 2/19 @ 8:03pm, Red raised rash (bumps) across top of right breast. Burnt and itched.  I took Benadryl as soon as this happened.   I Stopped itching and  was getting better by 2/22/2021.  (Bumps were not itchy, red at top, and stopped raising)
Patient had localized reaction to Dtap and Hib vaccine. Mother elected to have child evaluated at Hospital ER. Patient evaluated, treated and released. Complained of redness, swelling, warmth at injection site.
received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162303:
Patient received Moderna vaccine, Wednesday  12/30. On Saturday 1/3/2021 patient felt pressure/tightness in lower extremity. When patient touched area, a noticeable ball was felt under the skin, tender to the touch and warm. Patient went into urgent care on Monday 1/4/2021 with a confirmed dx of a superficial blood clot. Unknown etiology of whether this is from current birth control or the COVID19 Moderna vaccine.
Missed miscarriage. Recieved second dose 4/26 at 8:30 am. Felt fatigue, slightly feverish 12 hours after dose. Mild soreness in arm for 48 hours after dose. Had ultrasound to evaluate pregnancy 4/28/21, confirmed heartbeat and growth on track (measured 8 weeks 4 days, due date 12/4/2021). Had follow-up ultrasound 5/6/21, no heartbeat detected, baby measured 8 weeks 5 days.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient passed out from chair about 5 minutes after dose given.  I was helping an intern get her 1-9 information into the ipad.  There was another vaccine patient waiting in a chair, she immediately came and got me, I rushed to the patient to bring him back to consciousness.  I shock his shoulders and he started to come back.  Staff team members were extremely helpful.  They came right away with water and help to assist with anything the patient needed.  Patient stated that he felt hungry.
RASH OVER ENTIRE BODY; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced rash over entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash over entire body. This report was non-serious.
Dizziness & coughing, nausea, slept most of day 4/6/11. 4/7/11 family member took to ER in AM with same symptoms, also knot on Lt arm. Says was given a shot in ER an& has slept most of the week with no appetite.
1hr p/vax pt exp numbness of rt leg to groin;pt devel h/a 4JUN;on day 2 p/vax 29MAY pt began exp numbness in fingers & hypersensitivity on  the arm muscles;shooting pain;myalgia;myoneuropathy;areflexia in lt leg;leg cold;chest pain & tender
I left feeling a cloud 9 light headedness and a little bit of a head ache. At 3 AM I woke up with a headache so painful it felt like my brain was going to explode out of my skull, severe chills and body aches, I could not get warm and every inch of my body, especially my joints were throbbing and aching to the point of tears, the fact that I could not get warm only made it worse because the chills were so bad. I also had nausea and vomiting with severe fatigue, but no fever. I spent most of Saturday in bed, Motrin and Tylenol brought very little relief until late afternoon when I still felt tired but no more pain. I went to sleep and woke up at 1AM Sunday again with severe head ache, body ache, chills, fatigue, and nausea except this time I had night sweats and had to change my clothes several times because being soaked was making the chills worse. I spent another day in bed. On Monday morning, I still did not feel right, I was still experiencing head ache, fatigue, and some joint pain so I stayed home from work and slept, I also began experiencing hot flashes throughout the day. Tuesday morning I woke up around 6:30AM and found my face swollen, discolored with a red rash all over. When I received the first shot I was light headed with a head ache and a little fatigue. After receiving the second shot my reaction was the same as the first until 6AM the following morning when I began experiencing head ache, light headedness, fatigue, chills and body ache on Easter morning and all of that Sunday, My experience with this third shot was the worst and truly scary.
Diarrhea, cramps, fever 100, nausea. Mother gave her Phenergan 25mg PO. She went to sleep, took Phenergan again, ice pack to abdomen. No pain or noticeable reaction around injection site.
This spontaneous report was received from a health professional (nurse) refers to an unspecified number of patients of unknown demographics. Pertinent medical history and drug reactions/allergies were not reported. Reporting nurse stated that these patients may have been administered with improperly stored doses of either GARDASIL or ROTATEQ or improperly stored doses of both on unspecified dates. No adverse effects were report4ed. Additional information has been requested.
24 hrs p/recvd vax pt became very pale & cold; mom called MD who didn't see pt; pt would not eat well; pt taken to ER pt sleepy during episode but able to be aroused;
Patient developed urticaria on the night of 12/5/19 (48 hrs after receiving first dose of HPV)and was seen by ED where she was evaluated and treated with Benadryl. No signs of anaphylaxis. Spoke with mother on 12/6/19 and patient still had hives and was continuing with Benadryl 50 mg every 4-6 hrs.  Patient will follow up next week for allergy testing to rule out other possible cause for hives.
Information has been received from a health professional concerning a 6-year-old female with reactive airways disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (Lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of Varivax. Concomitant therapy included albuterol inhaler. On 28-JAN-2007, the patient experienced approximately 50 lesions on her body. It was noted that the patient's father recently had chicken pox. On 29-JAN-2007 the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back, arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and acetaminophen (TYLENOL). No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. There was no product quality complaint involved. Additional information is not expected. Information has been received from a healthcare professional concerning a 6-year-old female with reactive airwas disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of VARICELLA virus vaccine live (Oka/Merck). It was noted that the patient's father recently had chicken pox. On 29-JAN-2007 the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back, arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and TYLENOL. No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. The was no product quality complain involved. Additional information is not expected. This is one of several reports from the same source.
Tinnitus - ongoing, nothing specifically triggers it, it just comes and goes. Sometimes the ringing is louder than other times. Sometimes it is so loud I have difficulty sleeping