chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; crudy; body aches; lethargic; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 014M20A, 012F21A and 048L21A) for COVID-19 prophylaxis.     The patient's past medical history included Cough in 2020, Ache in 2020, Fever in 2020, Flu like symptoms in 2020 and Feeling abnormal in 2020. Concurrent medical conditions included Drug allergy (Amoxicilin allergy).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic). At the time of the report, PYREXIA (fever), ILLNESS (crudy), PAIN (body aches) and LETHARGY (lethargic) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient took 5th dose: Moderna AS7144B - 07Sep2022, 6th dose: Moderna AS7644C - 11Aug2023; patient involved. Patient says she received Spikevax on 11 Oct 2023 and then she felt like a little weak, no major deal. She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic for a day or so, and it goes away 2nd bivalent: she had no reaction at all, so she was very optimistic with the Spikevax After receiving.   This case was linked to MOD-2023-747062 (Patient Link).
Injection site hot, swollen, red, and extremely painful. Back pain, chills, body aches, headache, fatigue, weakness, drowsiness. I used ice on site, ibuprofen for inflammation and pain. Can't sleep or lay on arm. Didn't get off couch for 1.5 days.
Jaw tightness at 3:51pm ; lower lip quivering at 3:51pm; back of tongue swelling at 3:50pm. Administered 0.25mL epinephrine to patient at 3:54pm.  EMS arrived to transport patient to hospital at 4:06.
There were no immediate adverse effects at the time of the vaccine.  I had sciatica 2 1/2 weeks after the first dose.  Four days later, I had the second dose.  The sciatica pain had hip pain added.  The hip pain has grown more intense as the sciatica pain down my leg has abated.  It will be two weeks since the pain first started and the second dose seems to have worsened it.
Patient received his second Pfizer dose 14 days from the first Pfizer dose, he was supposed to have 21 days in between
Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from contactable consumer (patient).   A 68-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E19266) single dose, in the left arm, on 20Feb2021, for COVID-19 immunisation. Relevant medical history included penicillin allergy, aortic valve replacement and diabetes. The patient previously, on 30Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E105318) single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 20Feb2021, the patient experienced somnolence, dizziness, imbalance and high blood pressure. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Post the vaccination, the patient has not been tested for COVID-19. Futher information has been requested.
Headache, Myalgia, Arthralgia, Fever, Chills, Fatigue, Injection site pain
pt recvd vax 27NOV95; presented 29NOV95 w/evidence of cellulitis @ inj site
Pneumonia; sepsis; Valley Fever in Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP", start date: 1990 (ongoing), notes: HBP; "increase cholesterol", start date: 1990 (ongoing), notes: increase cholesterol; "Gastric Ulcer", start date: 2017 (unspecified if ongoing); "Pre diabetic" (ongoing), notes: Pre diabetic; "Ulcer" (ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension (ongoing); METFORMIN oral taken for glucose tolerance impaired (ongoing); TOPROL XL oral taken for hypertension (ongoing); PANTOPRAZOLE oral taken for ulcer (ongoing); ATORVASTATIN oral taken for blood cholesterol increased (ongoing); HTZ oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 01:30 pm, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: EL9262), administration date: 09Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Time: 01:00 pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN0202: Unable to locate or Read the details), administration date: 03Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset Apr2022, outcome "unknown"; COCCIDIOIDOMYCOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "Valley Fever in Apr2022"; SEPSIS (hospitalization, medically significant) with onset Apr2022, outcome "unknown". The patient was hospitalized for pneumonia, sepsis (start date: Apr2022, discharge date: Aug2022). Therapeutic measures were taken as a result of pneumonia, sepsis. Clinical information: No Specific Relevant tests for thromboembolic events with thrombocytopenia. Hospitalized for sepsis and Pneumonia, T4 with Fluconazole 40 mg from Apr to Aug2022.
Immediately following vaccine injection, pt developed hives on both legs surrounding the area of vaccination and also blotchy rash on face. No respiratory distress.
autoimmune condition as the rash is now spreading and becoming painful; the rash is now spreading and becoming painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Testosterone, notes: Prior used Testostorone cream as prescribed by doctor past year or 2 without side effects. Vaccination history included: Bnt162b2 (1st Dose), administration date: Apr2021, for Covid-19 immunization. The following information was reported: AUTOIMMUNE DERMATITIS (non-serious), outcome "unknown", described as "autoimmune condition as the rash is now spreading and becoming painful"; RASH (non-serious), outcome "unknown", described as "the rash is now spreading and becoming painful".  Additional Information: The patient had prior to vaccination used Testosterones cream as prescribed by doctor for the past year or two without any side effects. After the second Covid-19 shot started experiencing a rash in the groin exactly where patient applied the testosterones cream which had to stop. I'm convinced that the Covid-19 shot has caused some autoimmune condition as the rash was now spreading and becoming painful.   The lot number for bnt162b2 was not provided and will be requested during follow up.
administered a dose of ActHIB that was 8 days past its expiration when it was given with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 24-Oct-2022, the patient received 0.5 ml total of dose 4 of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot UJ585AAA and expiry date: 16-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 24-Oct-2022, (latency: same day) the patient was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  It was reported, a patient was administered a dose of ActHIB that was 8 days past its expiration when it was given. A patient was given ActHIB in an unknown injection site on 24Oct2022. The ActHib vaccine that was administered had expired on 16Oct2022.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
10 month old male received PCV, Hep B, and Flu immunizations at same visit. Returned in 3 hours with profuse urticaria.
Information has been received from a registered nurse referring to multiple unspecified patients of an unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or drug reactions/allergies. On 04-FEB-2019 (reported as "starting on or after"), the unspecified patients were administered improperly stored doses of VARIVAX with lot number R022116 and expiration date on 02-AUG-2020, (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccines was properly stored. It was reported that on an unknown date, the vaccines were exposed to a temperature excursion on -14 C (Celsius) degrees to -10 C degrees (-12.1 C degrees) for 4 hours. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.
patient experienced syncope roughly 10-15 minutes after receiving afluria.  Patients father reported spasms while conscious. Upon awaking patient was sweating.  Time unconscious was under 5 minutes.
Narrative: Angioedema requiring ED evaluation following 1st dose of Pfizer-BioNTech COVID-19 vaccine.
04/21/2006 9cm oval redness left deltoid with slight induration. Noticed redness and swelling 4/20/06 am circled redness increased on 4/21/06.
I failed my mammogram in Dec 2021 and had an ultrasound. I had a biopsy on 12/29th and received the pathology report later. I was dx'd w/ Non-Hodgkin's Lymphoma. I had a pet scan and saw it was isolated to one lymph node. On 3/7/22, I had surgery to remove the lymph node. I did a follow up on 3/14 and everything was clear.
Headache, Myalgia & NauseaVomiting Narrative:  missed work following second dose due to symptoms  Other Relevant History:
10/10/14 Patient called and stated she had received a flu shot about 3 weeks ago. Arm was sore yet, with pain, weakness and some limited mobility.
Achy, sore arms and hips. Chilled.  Fevered.  Cough. Headache.  Restlessness.  No treatment
Immediate higher pulse rate and it felt like a marble was in my throat when I swallowed.  The pulse rate dropped back down after 10 minutes and marble like swallowing went away too so I thought it was just anxiety.  Upon leaving site, I took a Benadryl.  I continued to experience difficulty swallowing for the next 2 days where I had difficulty swallowing pills and had to think about my swallowing.  By day six, my swallowing had mostly returned to normal with a lingering "soft swallowing" feeling remaining.  I.E. it feels like the muscles performing the act of swallowing are weak.  As of today, 5/15/2021 (46 days after the 1 dose injection), I continue to experience times through out the day where the muscles for swallowing act weak.  It seems to slowly be returning to normal.  This is the first time that I have ever had something affect my throat or ability to swallow.  I have never had any adverse reactions to shots in the past nor do I have any allergies other than seasonal.
Severe hives on face, neck, and arm. Swollen lips and nose. Treated with Benadryl for 1.5 days. Hives contiuned to spread. Visited Urgent Care center, got prescription for, and began taking, Premarin PM on 10/24/2010.
Muscle soreness in arm, neck, and chest for 5 days. Extreme heart burn and chest soreness for 7+ days and ongoing
an expired dose of Fluzone High-Dose from last season was administered to a patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 74 year old male patient who was vaccinated with a 0.5 ml once dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot  number UJ311AB and expiration date 30-Jun-2020) via an intramuscular route in the right deltoid on 03-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccine.  It was an actual medication error case due to expired vaccine used (latency was same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nausea and chills 10 and 1/2 hours after vaccine lasting approx 24 hours Diarrhea  20 hours after vaccine lasting approximately 12 hours Exhaustion 20 hours after vaccine lasting approximately 24 hours
Low grade fever, swelling and pain at injection site, joint pain, fatigue for approximately 24 hrs
Patient seen in office initially on 10/13/21 with complaint of irregular heavy menses which began 6/2021, reported continuous menses for multiple weeks with occasional break for "few days but spotting those days" and would resume again; Pt. reported she had continued to take BCP throughout this time, Stated she had a normal period in May, 2021, prior to recieving vaccine, with symptoms starting in June, 2021;  After researching possibility of Menorrhagia following COVID 19 vaccine administration, found information which stated this was possible side effect; Advised patient of this, instructed her to continue BCP, stay hydrated and if no relief in next few weeks/ months, return to office;   Pt. returned to the office on 12/14/21, reported no change in symptoms, at this time laboratory testing was obtained, Pt. was then instructed to continue BCP, stay hydrated and we would attempt to find further information/ guidance for appropriate managment of this issue:
76 year old female who presented to the emergency room with malaise, weakness for two weeks; she took her covid vaccine in February and tested positive a week ago; she has had a cough and fatigue; she had fevers but not for the last few days; she has had poor appetite and poor po intake; she has been short of air with exertion. Required inpatient admission to telemetry unit.
a lot of headaches; Felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced headache and feeling bad. On an unknown date, the outcome of the headache and feeling bad were unknown.   It was unknown if the reporter considered the headache and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the dose of Shingrix vaccine yesterday and felt really bad, a lot of headaches. The follow-up would not possible, as no contact, details were available.
Entire core of body and abdomen area became swollen for months. Swelling remains in right shoulder blade are and right lower back/hip.
This study case was received from the investigator in a trial on 24 January 2013. A male subject (age and date of birth not reported) had received the following vaccinations on 24 February 2012: ACAM2000 (lot number and site not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Eight days post-vaccination on 03 March 2012, the subject experienced mild intermittent chest pressure in absence of any other symptoms that was not related to activity. Rapid and lab troponin and ECG were both normal on 05 March 2012. The subject was referred for care due to some suspicion of myopericarditis. The subject had an allergy to penicillin and Lasik surgery in July 2011. No further information was available at the time of the report. The subject's outcome was not recovered. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Atrial Fib found 6/3/21, Muscle Fatigue Found 5/13/21
Positive COVID Test; cough; Allergy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID Test), HYPERSENSITIVITY (Allergy symptoms) and COUGH (cough) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergy symptoms). On 19-Jan-2021, the patient experienced COUGH (cough). On 20-Jan-2021, the patient experienced COVID-19 (Positive COVID Test). At the time of the report, COVID-19 (Positive COVID Test) and HYPERSENSITIVITY (Allergy symptoms) outcome was unknown and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021 Reporter Fax number updated.
Fever 101, shaking, Pulse 123, Blood Pressure  151/66, muscle aches Client took a junior advil gone in a.m.
Fever, chills, headache for approx 24 hours. Onset approx 24 hours after vaccine  Pain, redness, and swelling in arm for 5 days.
syncope type reaction, briefly blacked out. hands became cold and patient looked pale. Also stated that throat felt slightly tingly starting about 20 minutes after vaccine. Checked blood pressure and it was normal. Called 911. Paramedics arrived within 10 minutes. Patient was some better but parents decided to let her be taken to ER to be checked out since she had  recently been diagnoses with an autoimmune disorder.
Information has been received from a 67 year old female consumer with no known medical history or allergies who on 11-APR-2007 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 13-APR-2007 the patient developed numbness in her right hip. On 15-APR-2007 the patient developed several lesions in her groin and back area. She was seen by a physician who advised her that she had and outbreak of shingles. It was reported that the physician had unspecified "neurological"studies performed (results not provided). At the time of the report, the patient had not recovered. No product quality complaint was involved. No additional information is expected.
Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no allergies who on 01-JUL-2008 was vaccinated with the third dose of GARDASIL (lot# 660555/0279X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 02-JUL-2008 the patient experienced headache, chills and nausea.  The patient's headache and chills and nausea persisted.  No symptoms were reported from the first and second doses.  The patient sought medical attention and called the physician's office.  Additional information has been requested.
Shoulder pain, chills and fever of 102.3 first evening - took ibuprofen and slept. Woke with vertigo, weakness, extreme headache, nausea and mild swelling all over (fingers tight to bend, face mildly puffy, etc), took ibuprofen, claritin and omeprazole with soda. Fever dropped to 101 for second day and swelling and headache resolved by 11am. Weakness and fever resolved by end of second day. Did not go to doctor due to lack of driver in the home to take me. Did not call doctor due to extreme headache, weakness, and vertigo - it was all I could do to go to the bathroom and find a can of soda!
pt recvd vax;became febrile 3 hrs p/ vax,ranging from 104.8-105.8;apap given q 3 hrs;cool baths given;not effective in reducing fever;was referred to MD,states that exhibiting signs of hypovolemia;may admit to hosp;
Fever of 104.6 followed by red sores all over hands, forearms, feet & toes. Extreme pain in feet, felt like walking on sharp glass or nails. All finger and toe nails fell off completely, and the skin on my hands and feet peeled off. I couldn't walk normal due to that severe pain in my feet for roughly 3 months. I suffered from severe hives on my body that never went away for about a year, mostly around waist, face, hands and feet. I went to the hospital twice, was told it was caused by the MMR vaccine and then told it was a rash and nothing else was done for me. No tests, no treatments. I was told I was not contagious since my fever had been gone long enough, but I saw my 2 year old nephew the following day from that diagnosis and 2 days later he came down with the same exact injuries as me.
Had large redness, pain and swelling. Rt upper forearm, had redness and bruising Left lower forearm times 2 days.