chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 17:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 12Apr2023 to 17Apr2023 . The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
The pt experienced a high fever of 104, rash, listlessness. The pt was taken to the ER. IV was given and the temp decreased. The pt was no longer listless and was sent home.
The lymph nodes under my left arm swelled up to the size of the palm of my hand and extended towards my left breast area. It hurt to put my arm down to my side for about a day and a half. I would have sudden throbbing pain off and on and slight numbness and muscle ache in both arms . I also experienced a slight fever (99.3 & 100.3), body aches, leg aches, chills and a severe lower back ache. I applied heat under my arm the first day, it provided a little comfort, I also took Tylenol. It got better over time.
Hospitalized Nov. 18, 2009 for abnormal EKG chest pain & "some kind of flu". Nov. 23, 2009 informed by health dept, that patient positive for H1N1. Patient received H1N1 vaccine 10/16/09. 12/09/09 Medical record received for DOS 11/23/09 report to Health Dept.: pt positive for H1N1. Pt. doing well after discharge.  12/10/09 Hospital records received  for DOS 11/18-11/24/09. Pt. presented with fever, chills, diaphoresis, nausea, pain, and URI symptoms. Pt. was admitted to r/o acute coronary syndrome and manage acute episode of upper respiratory infection.  Treated with IV fluids, Tamiflu x 5 days and ciprofloxacin for UTI. Discharged home, hemodynamically stable, DC DX: abnormal EKG with mild elevation of troponins; hypertension; upper respiratory tract infection; urinary tract infection
The day after vaccination the patinet had headaches, tender arms to the point where she would not sleep, nausea, vomiting. This improved on 9/25/2022. On 9/25/2022 she started to have vaginal discharge that was brown, malodorous, and had mucous. She still has abnormal vaginal bleeding.
Patient presents to the ED with shortness of breath, cough, and wheezing. Patient admitted for further evaluation and treated with remdesivir.
pt recv vax 15AUG97 & mom noticed enlarged lymph nodes on 22AUG97;no other sx;saw MD 22AUG97;MD did lab values w/everything nl;MD told mom felt enlarged lymph nodes d/t to MMR;nodes are in both groins & cervical area;
I started  to feel  vertigo and nausea and a light  headache, the nausea. Vertigo is every day after two weeks  of the vaccine every  time i have  vertigo i start  to get nausea and headche. I get  vertigo when  i turn my head  stand up sin down or make an effort  to lift  something.
New onset PE treatment: started on Eliquis 5 mg BID outcome: discharged home after treatment of COVID as well
Had chest pain 2 days post-vaccination of 1st Pfizer shot, continued to have on and off chest pain so came to my office on 8/25/21 and concern for pericarditis from ecg done in clinic. I sent him to the cardiologist the same day-Doctor who confirmed it was pericarditis and started him on medrol dose pack.
FROZEN VACCINE ADMINISTRATION; VACCINE WAS FROZEN IMMEDIATELY UPON RECEIPT BY ACCIDENT AND WAS WITHIN EXCURSION LIMITS BETWEEN -1.7 TO 2.0F; This spontaneous report received from a pharmacist concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced frozen vaccine administration. On 13-MAY-2021, the subject experienced vaccine was frozen immediately upon receipt by accident and was within excursion limits between -1.7 to 2.0f. The action taken with covid-19 vaccine  was not applicable. The outcome of the frozen vaccine administration and vaccine was frozen immediately upon receipt by accident and was within excursion limits between -1.7 to 2.0f was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534639 and 20210534954.
12 hours after receiving shot spiked fever of 102, severe migraine body aches, chills, nausea, vomiting and diarrhea. By day 2 my shaking became so uncontrollable couldn?t sleep. Symptoms began to lesson after six days, but an exhaustion soon kicked in that had me drained and made every day activities difficult to impossible. By the 3 or 4th week I noticed the lumps in my breast and kept having specific point pain throughout various areas of my body. I was soon diagnosed with lymphadenopathy. My blood pressure has been recorded higher then normal as well as my heart rate. The lymphadenopathy is constant and at times debilitating. My migraines increased in frequency despite medication given to prevent them. Prednisone is given off and on to help with lymph node flare ups. Sometimes the exhaustion makes it hard to function and creates a fog. My mind will at times go black and I find myself almost ?lost?. Multiple scans, X-rays, CTs and blood work has been done and all I?m told is-it?s a side effect from the vaccine.
Redness, itchiness, and painful to touch at the site of injection - " Palm sized".
Received booster pfizer dose on 4/8/22. Called hospital call center reporting side effects, States she has been feeling dizzy since 4/8/22 after she received her Pfizer booster. PT was advised to go to ED for further evaluation.
pt recv vax 30MAY96 & temp R elevated to 103.8 @ 3AM;moms aid pt spacy & shaking;no convuls;rx w/APAP & Ibuprofen;fever controlled & spaciness & shaking ceased;slept rest of noc & was nl self in morning;
A few hours later developed a headache that lasted for about 4 days. More than a month later (injection 8/18/21, today is 9/24/21) still have shooting pains in my right arm and extremely tender at injection site. Pain from the top of my arm near injection sight down to elbow. Also have a shooting pain on the whole right side of my body when taking a deep breathe, the pain is both on the front of my body as well as the back.
Breakthrough COVID infection. No symptoms. Tested part of routine screening prior to procedure. Positive swab collected 08/17/2022.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 at 13:15 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Mar2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "chronic migraine" (unspecified if ongoing), notes: other medical history: chronic migraine; "prediabetes" (unspecified if ongoing), notes: other medical history: prediabetes; "high body weight" (unspecified if ongoing), notes: other medical history: high body weight; "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: 5 HTP [OXITRIPTAN], start date: 01May2022; KAVINACE ULTRA PM, start date: 08Feb2022, stop date: 03Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: Tested positive on both "Day 5 and "Day 9"; (06Jul2022) Positive, notes: Tested positive on both "Day 5 and "Day 9"; (11Jul2022) Positive, notes: Still testing positive on "Day 14."; (27Jun2022) Positive, notes: Received Paxlovid 27Jun2022, on the same day I tested positive for COVID-19 using home test ("Day 0"). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product Paxlovid, Brand: Pfizer, treatment started on 04Jul2022 to Treatment stopped 09Jul2022 for Indication treatment of COVID-19. If vaccine received: Yes. Other medication in 2weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At about 6 AM on 9-12-21, my daughter woke me up saying she had a sore throat, headache, ear ache, and excessive thirst. When I touched her skin it was cool and clammy but the injection site was warm. I also noted she had sore lymph nodes on her throat when lightly touching them. I took her to Urgent Care and the doctor told me she was sure it was Covid and had nothing to do with the vaccination. She was tested for blood glucose levels, due to the thirst issue, and Covid and sent home with instructions to just take acetaminophen and ibuprofen as needed.
Consumer reported that pt recvd DTP/MMR approx 2 mos ago & exp difficult in swallowing (choking & turning blue) a few wks p/immun; Pt is on a liquid diet & is being eval for a poss heart condition;
Teacher brought student to nurse office. Swelling of face, eyes, mouth, resp shallow, whelps. Skin red and hot. Children's BENADRYL 10 cc. EPI-PEN admin at 10:00 AM (R) thigh 0.3 mg. To hosp. via ambulance.
Heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate increased) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Cardioversion. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), LISINOPRIL, LISINOPRIL (TENSOLISIN), ATORVASTATIN, AMLODIPINE, VITAMIN D NOS and VITAMIN E [VITAMIN E NOS] for an unknown indication.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate increased). At the time of the report, HEART RATE INCREASED (Heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased.         Treatment information was unknown.  Reporter stated that he know from the news that Moderna recommendation is 50 mcg for the booster. He and his wife already got it and received 100 mcg dose.   This case was linked to MOD-2021-310651, MOD-2021-310835 (Patient Link).
i started feeling short of breath. Deep breathing caused pain in my right shoulder blade. This started happening on September 22nd. Went to urgent care. They took an xray and EKG. They could not rule out a PE. They asked me to go to an emergency department. Since i have my primary care and specialist at another location I went to ER Hospital. They gave me a CAT scan which showed PE in both lungs. I was admitted 9/23/23. I was released 9/25/23 with Elliquis.
Nausea, dizziness, light headed, hot flash, tingling and numbness in left arm, migraine
Incomplete vaccines schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on September received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete vaccines schedule). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 16-JUN-2023 A pharmacist reported about a patient who initiated their series of Twinrix in September but did not return to finish the series and wished to know how to proceed.  Reporter states that partial information about the event, patient and incomplete information about the vaccine was given. The vaccine administration facility is the same as primary reporter for 1st dose.   The reporter was consented to follow up. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination.
Unexplained pain right groin and thigh. Continuous. Self administered Advil.
Went to er  on April 11 th for cough and shortness of breathe they said nothing was wrong and sent me home. Did a virtual  apt on 21st because my leg hurt and shortness of breathe. They told me to go see doctor in person . Went to Er April 23rd and was diagnosed with a massive blood clot in my lower right leg.they prescribed xarelto.
Arthralgias in left shoulder -- continued through to today 13 Sep, but seem to have plateaued. No local cutaneous reaction noted, though does have limitation of movement due to pain.
Over the next week following the injection, pt developed progressive itching, edema, erythema and eventually blistering of the L arm. Pt presented with these sxs on 4/11/19, at which time photographs were taken and pt was sent to the ER where she received intravenous steroids with resolution of sxs.
Patient states one an half hour after taking the capsule she felt strange. Two hours after consuming the capsule, she started to experience severe abdominal pain and cramping until about 1:00 AM the next morning. She also had nausea, vomiting, and diarrhea.
inadvertently administered Moderna COVID-19 first dose in an individual 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old). On 18-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No Treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up information received added 2nd reporter, added dose number and updated event term.
2 x 3 inch rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (2 x 3 inch rash) and HEADACHE (Headache ) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Sleep disorder. Concurrent medical conditions included Drug allergy (Tetracycline and Calcium blocker.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Idiopathic hypersomnia, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Stress.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced RASH (2 x 3 inch rash) and HEADACHE (Headache ). On 11-Mar-2021, RASH (2 x 3 inch rash) and HEADACHE (Headache ) had resolved.            No treatment medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applcable   This case was linked to MOD-2021-066858 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received and contains patient demographics, allergies , concomitant medicine indication- dosage details and Outcome of the events (unknown-recovered); Sender's Comments:  MOD-2021-066858:Dose 2
Case number PHHY2013US110239 is an initial literature report received on 26 Sep 2013: In this article, authors have described a case of distal acquired demyelinating symmetric neuropathy (DADS-I) after influenza vaccination. This report refers to a 31-year-old male patient. He was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unknown date. Two months after vaccination he developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following four months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toes extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction study (NCS) showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30% - 50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin Gruber anastomosis was not present. Limb temperature was more than 32 degree Celsius. Two grams per kilogram of IVIG was initiated four months after symptom onset. One gram per kilogram of IVIG was repeated every three weeks. Over the following six months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running three consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. The authors commented that vaccine-associated DADS-I may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, they suspected that vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy in the form of DADS-I.
This is a spontaneous report obtained from a contactable physician that reported about himself. A 87 year-old male patient received, on 10Jun2015, intramuscular PREVNAR 13 0.5 ml, single dose. Relevant medical history included ongoing macular degeneration. Concomitant medications included LUPRON, injections twice a year, every 6 months for the past 10-15 years and an unspecified eye injections. On 11Jun2015, the patient experienced moderate leukocytopenia. The patient did not recover from the event at time of this report. Patient's clinical course was the following: patient received PREVNAR 13 vaccination by his own physician on 10Jun2015. He did not receive any other injections that day. He didn't feel any different. Routine blood work performed on 11Jun2015 showed moderate leukocytopenia.
Pt completed series of 3 Engerix-B vax & exp an elevated bilirubin level.
21SEP90: w/in 8-10 hrs of receiving vax, pt developed influenza-type sx & fever. Events resolved w/in 5 days; No known tx provided;
Began to feel "fatigued" around 8pm the day she received her 2nd dose.  States severe weakness, felt like body was "in shock", & was unable to get out of bed on her own, onset 1am Friday morning.  States she rested entire day, alternated between taking Tylenol & Ibuprofen.  Symptoms began to lessen later that evening.  Feeling "much better" today.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Tested negative for two days after the completion of Paxlovid; Positive, notes: after completion my symptoms have returned and I have tested positive again; Negative, notes: Tested negative for two days after the completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative for two days after the completion of Paxlovid and felt better now the fourth day after completion my symptoms have returned, and I have tested positive again. Patient received vaccine. It was unknown if patient received any other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she had delayed rash, redness, swelling, and itching. it took several weeks for this to subside. started ~ 8 days after first vaccine near injection site.