chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (COMIRNATY), on 19Sep2023 at 12:15 as dose 1, single (Lot number: HF9275EXP) at the age of 52 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of fatigue, headache.  No follow-up attempts are possible. No further information is expected.
Information was received from a medical assistant referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have received an improperly stored dose of VARIVAX injection (lot # M024675, expiration date 01-JUN-2018; lot # M024675, expiration date 18-MAY-2018; dose unknown) subcutaneously. No adverse effects were reported. The vaccines were stored under the temperature 7.9 Fahrenheit degree for 40 minutes. Additional information has been requested.
Low grade fever (not even 100) 5/26 in the evening followed by redness and swelling at the site on 5/27. Fever gone 5/28 although redness & swelling still present.  Will be followed.  IPV also given on upper outer aspect of left arm.
Information has been received from a 69 year old female patient who on 04-JAN-2011 was vaccinated with PNEUMOVAX 23 (lot# not reported, manufacturer unknown). The patient started to feel sick with the next day on 05-JAN-2011. At the time of reporting, the outcome of the event was not reported. The patient sought medical attention via phone call. Follow up information has been received from a nurse after we sent letters to the physician. The nurse reported that the patient was not their patient. The patient had a history of flu symptoms after prior vaccination with influenza virus split virion 3v vaccine inactivated (lot# and manufacturer not reported, WAES 1101USA02240). Additional information is not expected.
Influenza was given below the acromion process resulting in pain with ROM, numbness/tingling.
Very High Blood Pressure 245/110, went to ER and treated with BP Meds on 03/08/2022 Primary Dr changed Medication twice after this episode
Experiencing reaction on her face and arms; Felt like she had a really bad sunburn; Throat froze; Redness; Very sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Experiencing reaction on her face and arms), RASH ERYTHEMATOUS (Felt like she had a really bad sunburn), OROPHARYNGEAL DISCOMFORT (Throat froze), ERYTHEMA (Redness) and MYALGIA (Very sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Experiencing reaction on her face and arms), RASH ERYTHEMATOUS (Felt like she had a really bad sunburn), OROPHARYNGEAL DISCOMFORT (Throat froze), ERYTHEMA (Redness) and MYALGIA (Very sore). At the time of the report, HYPERSENSITIVITY (Experiencing reaction on her face and arms), RASH ERYTHEMATOUS (Felt like she had a really bad sunburn), OROPHARYNGEAL DISCOMFORT (Throat froze), ERYTHEMA (Redness) and MYALGIA (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller calls on behalf of his wife; I ended up speaking to the wife. She received the Moderna Covid-19 vaccine on Saturday 27FEB2021, today she is experiencing a reaction on her face and arms. Felt like she had a really bad sunburn, she could feel it coming on, then it went down the face and arms and body. Really red, still very sore, throat froze. Patient is a 75 year old female who received the vaccine in her left arm at County Community College.
Just wanted to say I got several lip cold sores and two on my tongue about 30 hr after the vaccine.  I am a physician and I have not history of regular cold sores.   Mild sore throat.  The cold sores were unexpected and this is why I'm reporting them.   Other than that sore arm.
Severe swelling and tightening of the throat for a period of about 24 hours.
May be pregnant but im not sure; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (May be pregnant but im not sure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (May be pregnant but im not sure). On 24-May-2021, EXPOSURE DURING PREGNANCY (May be pregnant but im not sure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of vaccine reported that they realized that the patient might be pregnant, but the patient was not sure.  No Concomitant product use was reported. No treatment information was provided.
itchy throat after Covid shot #2 was given. Patient stating that she had same reaction after shot #1 and was given 25mg of Benadryl. seen and evaluated by this provider. After 30 minute wait, doing well after the 25mg of diphenhydramine; reports no difficulty breathing, no swelling, no worsening of symptoms. Patient discharged and instructed to call with any changes.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with amoxicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of PNEUMOVAX23 (lot # not reported) 0.5 mL intramuscular on 29-JAN-2013. No other co-suspects were reported. There were no concomitant medications. On 31-JAN-2013 the patient developed cellulitis, after PNEUMOVAX23 was administered. No Lab diagnostics were performed. There was no treatment given for the event. The outcome of cellulitis was reported as recovering/resolving. The patient contacted the pharmacist. The relatedness for cellulitis was unknown for PNEUMOVAX23. Additional information is not expected.
Covid pnuemonia; Tested positive for Covid 19; A spontaneous report was received from a Consumer concerning male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Positive for Covid-19 and Covid pneumonia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Feb 2021, approximately 8-13 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient tested positive for Covid 19.   On 16 Feb 2021 the patient experienced Covid pneumonia with seriousness criteria. Treatment included steroids and antibiotics.  Laboratory details include SARS-CoV-2 test positive (Positive for covid-19) on 11-FEB-2021.  On 22-feb-2021 the symptoms of covid pneumonia have resolved  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event Positive for covid-19 was unknown and the event of Covid pneumonia considered as recovered/resolved on 22-FEB-2021.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of Covid-19 and Covid  pneumonia, are assessed as unlikely related. Further information has been requested.
Patient advocate stated that bone was hit and the needle may have not retracted after bone was hit. Then after the vaccine the patient started shaking and getting chills. Patient has redness, swelling, edema is gone today but patient not able to lift their arm due to pain.
Sore arm, fever 102F, aches, sore back. Throwing up, cant hold anything down (24 hours now)
11/25/02 5 pm sore RUE, decreased mobility, 11/26/02 - decrease soreness RUE, rash near RUE -> torso, 11/27/02 -Soreness resolved, rash decreased, (?) to call prim. MD, 12/02/02 -Never (?) with MD, Rash resolved (didn't know when).
The morning after the vaccine after I ate my breakfast. My throat on the right side felt like it was closing and my neck hurt to do anything. Move or swallow. It lasted for three weeks until two days after the second dose of the vaccine. I was prescribed two courses of antibiotics , Cephalexin and Doxycycline ,  which only helped a little.  I had gotten an insect bite the week before vaccination. I also had a CT scan after the second dose of vaccination but the pain had gone by then.
Within minutes of getting vaccine patient felt warm and lightheaded. We gave cold water and called 9-1-1. Paramedics evaluated patient and he stated he was better. He refused further care.
Patient received pfizer vaccine on 4/4/21, 5/2/21 and 11/15/21. Presented to ER on 5/30/22 and found to be COVID positive. who presented to the emergency room for issues related worsening weakness.  Recent medical history as noted in the H&P as well.  Workup was positive for COVID-19.  Was placed on dexamethasone and ribs does appear with complete those courses.  Oxygen saturation was followed carefully. Was continued on home meds for psychiatric issues but would require titration down words as he was having some somnolence and worsened mental status.  Prognosis was exceedingly poor.  Had some issues early in the hospital stay with agitation that were addressed with Haldol but by the close of his hospital stay was not requiring any Haldol and was calm and compliant.  Discussion was had with the patient's family most notably his mother and wife about his poor prognosis and decision was made to have patient be placed in hospice but to do so at skilled nursing facility setting.  Patient needed to complete his isolation.  For COVID and after that was complete was discharged in stable condition on hospice care to the loft on 6/10/22.
104 fever for 24 hours. All my joints hurt. Muscular pain all over.
Hot, redness, swelling to left upper arm. Fever for 3 days. Red area 6cm x 10cm.
Patient had Pfizer covid vaccine #2 on 5/7/21.  He presented with low platelet count of reportedly 4 on Thursday 7/22/2021.  He presented to ED on 7/24/2021.  plt 6 on 7/24/21.  He received IVIG 400 mg/kg  x 1 day.  Dexamethasone 40 mg oral daily day 1 - 4.
Information has been received from a nurse regarding to a patient (gender not reported). No concomitant medications, concurrent conditions nor medical history were reported. On 15-JUN-2015, at the age of 20 years old the patient was vaccinated with a dose of GARDASIL (site, lot number and expiration date not reported) for prophylaxis. In approximately 2017 (reported as "aged 22 years"), the patient was vaccinated with a dose of GARDASIL 9 (site, lot number and expiration date not reported) for prophylaxis. No adverse effects were reported.
Varicella and MMRV were both given at the same time.  No symptoms at the time of discovery.
no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001770: US-009507513-2108USA001789: US-009507513-2108USA001786:
Information has been received from a health professional concerning a 9 year old white female who on 02/03/1997 was vaccinated subcutaneously in the left lateral thigh with a first dose of varicella virus vaccine live.  There was no concomitant medication.  On 02/06/2005, the patient experienced breakthrough chickenpox.  The patient had a mild rash, less than 50 lesions and no fever.  Unspecified medical attention was sought and the child is recovering.  No additional information was provided.  Follow up information indicated that on 02/07/2005 the patient had very mild varicella.  She is now doing fell.  Additional information has been requested.
Painful, red rash developed to area where shot was administered 8 days after shot given. No pruritus, but burning pain.
Patient received 0.25ml as a first dose. Pharmacy realized mistake a month later when she came for her 2nd shot. 2nd shot was given as 0.5ml.  After calling Moderna and checking on CDC website, no guidance as mitigation steps when a month has elapsed with less vaccine given. Has discussed situation with patient and advised a 3rd shot of 0.5ml in April 2022
MASTODitis & Shingles Every 3 to 4 weeks Severe pain/Fever/Fatigue I have Had Shingles since 1990. 1 outbreak 1 to 2 times a year. Same place same size I have Dates and pictures. Since Shinrix I have them every 3 to 4 weeks - continuously since shot. Confirmed/Pictured. Time and dates!
Pt recv vax on 10/20/98; 2 hr later pt exp queasiness, flu-like sx, sore/red/warm/decreased movement arm, sore throat, fever (101), chilled; tx=Benadryl &Tylenol
Uncontrollable shaking; Feeling very cold inside; Joints hurt really badly in his arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable shaking), FEELING COLD (Feeling very cold inside) and ARTHRALGIA (Joints hurt really badly in his arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21H) for COVID-19 vaccination.     No Medical History information was provided.    On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced TREMOR (Uncontrollable shaking), FEELING COLD (Feeling very cold inside) and ARTHRALGIA (Joints hurt really badly in his arm). On 20-May-2021, TREMOR (Uncontrollable shaking), FEELING COLD (Feeling very cold inside) and ARTHRALGIA (Joints hurt really badly in his arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication information provided.  No treatment medication information provided.
Started about 8 hours after shot and lasted 1.5 days. Fever, chills, fatigue, muscle aches, soreness at site, body aches, no appetite, bile function different, couldn't stand up for very long due to fatigue. I am generally a very healthy 60 year old.
Covid19 breakthrough.  1st vaccine received on 03/26/2021.  77 y/o with PMHx of CVA, COPD, HLD, HTN, Pacemaker, CAD/CABG, Valvular heart dz/TAVR, back surgery presents to ED with c/o CP, productive cough, SOB and fevers x1 week.  Room air sat 92%, placed on 2L NC, febrile and Ct with dense consolidation PNA.  Pt started on IV Abx, Steroids and Remdesivir.
Had anaphylactic attack where couldn't breathe.  Administered Epi-pen.
Developed itchy patches across torso, improved slightly with Zyrtec  on 12/01. After, zyrtec not helping, and developing rashes after any mechanical pressure to skin, such as itching, putting on clothes, using a towel to wipe off, etc.
Developed a Urinary Track Infection (UTI)  25 days after first vaccine.  Last UTI prior to that was in July 2020, Physician recommended to get the second vaccine on 4/1/21 and developed a second UTI on 4/17/21, again on 5/3/21 and 7/7/21.
pt recv vax 14OCT96 & 15OCT96 pt exp flu-like sx & fatigue;flu-like sx passed p/a few days;@ the time of report fatigue has persisted for a month;
A few days after his second dose he developed left neck, left arm, and left thigh pain. He described it as a burning pain and a poking pain. It felt exactly like his post-herpetic neuralgia from 2019 - which he developed after herpes zoster.
No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 22-OCT-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # N034411, expiration date 04-DEC-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (rHA) (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was above 9 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects was reported. No product quality complaint (PQC) was involved in this case. Digital data logger was involved.; Sender's Comments:  US-009507513-2005USA003619: US-009507513-1911USA003982: US-009507513-2005USA003627:
No adverse event. Patient to receive 0.25 ml of Moderna booster; received 0.5 ml. Patient last dose was 4/12/2021
The employee received the Janssen COVID vaccine on 9/3/20221 to the left arm and developed pain down the arm and weakness 2 hrs later. That same evening she developed "flu-like symptoms", including HA and weakness all over. She claims her symptoms have persisted the past 18 days and at times decrease an intensity, but have never fully resolved.
Onset of Guillain-Barre Syndrome 2-3 days after vaccination with resultant hospitalization/IVIG and sequelae of leg paralysis and paresthesia.
patient was nausea and passed out the next morning. patient went to hospital.  She had a rash on both arms
headache; chills; nausea; not able to get out of bed the first day after each vaccines.; had the flu after each dose; no appetite; Fever 100.5; injection site pain; severe lower back ache; muscle pain; joint pain; feeling so ill / I felt so ill; dizzy; swollen lymph nodes under right arm; tired/fatigue; body aches; weakness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 60-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via an intramuscular route of administration, administered in Arm Right on 05Mar2021 15:50 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history none. Concomitant medications included calcium. Other medications the patient received within 2 weeks of vaccination included One-A-Day Multivitamin and Calcium 600. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 Friday night-5 pm patient experienced with a headache, chills and nausea. On Saturday - Fever 100.5, injection site pain, tiredness, severe headache and lower back ache, muscle pain, chills, joint pain, nausea, feeling so ill and dizzy remained in bed all day, no appetite, swollen lymph nodes under right arm - took Tylenol at 5 pm. On Sunday - Woke up at 4 am with severe headache. Took Tylenol. Headache has not returned, but still tired, have no appetite and lymph node is still swollen. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understand that all these are possible side effects after receiving the vaccine. I felt like I had the flu after each dose. Symptoms began at night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. The patient underwent lab tests and procedures which included body temperature: 100.5 on unspecified date in 2021. The clinical outcome of the events was recovered for headache in 2021; recovering for chills, nausea, pyrexia, vaccination site pain, back pain, myalgia, arthralgia, illness, dizziness; not recovered for lymphadenopathy, fatigue; unknown for pain, asthenia, influenza like illness, bedridden, decreased appeptite.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101303445 same reporter/product, different patient / event.
0th hour got the shot. 12th hour got a 99.9 degrees Fahrenheit fever. 36th hour fever gone.
Fever of 103 F noted at school, client sent home; recommended acetaminophen to mom and the purchase of a thermometer to monitor temperature. Left message on 6/5/2013 to follow up but did not hear back.
Fever, Chills, Pain in shoulder, metallic taste to food and water within the first 6 hours that lasted into the next day. Second day fever that came and went for the next week, fever broke 3 days later. Joint pain and headache lasted for a week. Joint pain comes and goes at random, mostly in arm along with numbness in left hand.
A report has been received from a Pharmacist concerning a 42 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that while administering FLUMIST QUADRIVALENT the clip was removed first and the entire dose of FLUMIST QUADRIVALENT was administered into one nostril which started on 31-Oct-2013. The outcome of the event of while administering FLUMIST QUADRIVALENT the clip was removed first and the entire dose of FLUMIST QUADRIVALENT was administered into one nostril is unknown. The report was considered to be non-serious by the reporter.
within 2 minutes felt tongue tingling and left side of face itching.   No respiratory involvement.    Gave Benadryl at 25 mg at 15:47 when made aware of the situation.     Itching was 5/10 ,  1/10  @16:20  less than one at 17:03.  Denies tongue swelling at this time.  No respiratory distress Lungs CTABL.   Nia was referred to KP teledoc, could not offer advice at this time. Consulted with onsite MD ee released to call 911 PRN and difficulty breathing.  EE verbalized  understanding.   To contact MD and Allergist for second dose.