chrisvoncsefalvay/vaers-outcomes huggingface dataset:
O2 was 74/with new batteries, it was 88/has been hovering at 93 and 94 for the last hour 1/2; This evening quite suddenly was not feeling right similar to when I had Covid; Breathless; lightheaded; very weak; heart rate was 54 (normally 80); pulse was 113; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Jun2021 11:30 at 52 years of age (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 08May2021 12:00 administered in arm left. Medical history included tachycardia, paroxysmal supraventricular tachycardia (PAT), severe joint pain from 06May2021, fatigue from 06May2021, fever from 06May2021, COVID-19. Patient was not pregnant at the time of  vaccination. Concomitant medications included ibuprofen taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; paracetamol (TYNOL) taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; atomoxetine hydrochloride (STRATTERA); bupropion hydrochloride (WELLBUTRIN); levothyroxine; and atorvastatin. The patient previously took prednisone and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination included Stratera, Wellbutrin, levothyroxine, and atorvastatin. On 06Jun2021 20:45, patient, quite suddenly, was not feeling right, similar to when she had COVID. Patient was breathless, lightheaded, and very weak. Patient got up and got her pulse oximeter. Her heart rate was 54, normally 80. O2 was 74 . Patient changed the batteries just to be sure. With new batteries it was 88, pulse was 113 . O2 steadily climbed to 97 but had been hovering at 93 and 94 for the last hour 1/2. Patient was recovering from the events. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious.
Pt is 16 years old, Moderna vaccine is not authorized for use in 16 year olds. Spoke to mother an hour after the shot was administered, informed of isuue. Spoke to mother three days later, Pt has not had any adverse effects and mother would like him to received the second dose as advised by the CDC.
Fever, fatigue, nausea, diarrhea, arm pain,  joint pain
Pt recv vax on 8/12/98; on 8/13/98 pt exp chest pain,tingling in arms,low fever, fatigue,cough &body aches.  Pt seen by M.D.  Pt tx = acetaminophen, Vicodin &Darvocet.  Pt dx right lower lobe pneumonia.
severe swelling, redness arm & SOB;pt went  to hosp & had IV steroid & IV DPH;sent home w/pred;
Patient?s date of birth was screened with patient?s mother which she reported as 01/13/2017. After vaccine was given I was not able to find the patient in system to document the vaccine. I then double checked all of the information given on the paperwork (name, date of birth) with patient?s mother and was told it was correct. Multiple ways to try to find the patient in was attempted (only using first name and a date of birth, last name and date of birth, asking his mother if he had received other vaccine prior). I then found him with a different date of birth in (06/13/2017) to which the mother reported that she had ?purposefully written the wrong birth date because he had been sick and she can?t have him be sick like that again.? Patient?s mother was counseled on trials for the vaccine in the younger age group almost being completed and approved, the difference in dosages between age groups and what this means for his 2nd dose timing. Patient tolerated the vaccine well and did not have adverse reactions in the office.
Information has been received from a physician concerning a 12 months old patient who on 29-MAR-2010 was vaccinated with the third dose of ROTATEQ by accident. The reporting physician did not have the dates of the first and second doses of ROTATEQ. The patient was not experiencing any known symptoms. It was not specified if the patient sought medical attention. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: sore throat, congestion, watery eyes-Mild
Tendinitis like symptoms in vaccinated arm in elbow.  I am alergic to thimerisol and the vaccine contained thimerisol.
Information has been received from a nurse concerning a female patient (age not reported) who on an unspecified date was vaccinated with a first 0.5 mL dose of GARDASIL.  Immediately after, she experienced a seizure and urinary incontinence.  In approximately February 2008 ("past few months"), the patient experienced a seizure and urinary incontinence immediately after receiving the second dose of GARDASIL.  The nurse reported that the patient recovered within a minute or two with no memory of what had happened.  No treatment was required.  Upon internal review, the patient's seizures were considered other important medical events.  Additional information has been requested.
No adverse event; Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023; Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023), EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 23-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071B22A and 041C21A) for COVID-19 prophylaxis.     Reporter had no medical history information on the patient. It was unknown if patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023), EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023).    Concomitant drugs were not reported.  It was reported that patient had no adverse reaction to dose 1 and dose 2.  Treatment medications were not provided.
Not Able to Sleep for 1 Night post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not Able to Sleep for 1 Night post vaccination) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Not Able to Sleep for 1 Night post vaccination). At the time of the report, INSOMNIA (Not Able to Sleep for 1 Night post vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-083018, US-MODERNATX, INC.-MOD-2021-089630 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083018:Crosslinked case US-MODERNATX, INC.-MOD-2021-089630:Crosslinked case
Pulmonary Embolism, 1 in each lung.  Right lung infarction.
diagnosed with eczema/skin started getting bubbles; blood sugar started plummeting; severe headache; severe migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe migraine headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced MIGRAINE (severe migraine headache) (seriousness criterion medically significant). On an unknown date, the patient experienced ECZEMA (diagnosed with eczema/skin started getting bubbles), BLOOD GLUCOSE FLUCTUATION (blood sugar started plummeting) and HEADACHE (severe headache). At the time of the report, MIGRAINE (severe migraine headache), ECZEMA (diagnosed with eczema/skin started getting bubbles), BLOOD GLUCOSE FLUCTUATION (blood sugar started plummeting) and HEADACHE (severe headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  2nd dose was administered on 11Mar2021: 001B21A and Booster dose was administered on 21Dec2021: 032F21A. She also reports having gone to the emergency room on 24Feb2022 with a severe migraine headache.  Company comment: This spontaneous case concerns a 48-year-old female patient, with relevant medical history of Diabetes, who experienced the unexpected serious (medically significant) events Migraine, 378 days after the first dose of mRNA-1273. The patient had gone to the emergency room with a severe migraine headache. At the time of reporting, the outcome was unknown. Medical history of Diabetes could be a confounder for the event headache. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with relevant medical history of Diabetes, who experienced the unexpected serious (medically significant) events Migraine, 378 days after the first dose of mRNA-1273. The patient had gone to the emergency room with a severe migraine headache. At the time of reporting, the outcome was unknown. Medical history of Diabetes could be a confounder for the event headache. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a nurse practitioner (NP) concerning a 12-year-old female with no medical history or allergies, who on 26-JUL-2006 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (lot# 652630/0247F). There was no concomitant medication. On 07-AUG-2006 the patient began the first day of symptoms of breakthrough chickenpox. At the time of the report the patient's symptoms had worsened and the patient had about 26 lesions. Unspecified medical attention was sought and oral diphenhydramine hydrochloride (BENADRYL) was administered. The patient had not recovered. No product quality complaint was involved. The reporter considered the patient's breakthrough chickenpox to be an other important medical event. Additional information has been requested.
pt recvd vax & devel inc temp same day of vax & 24hrs later redness inc on the site measured 5cm diameter
Pt recv vax on 10/19/98; on same day pt exp fever &chills, vision loss, body hurt, seizure, unable to walk or sit up
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their 1st dose of the Moderna vaccine experienced chills.  On 23-Apr-2021, the patient reported that the symptoms had resolved.  No Concomitant product use was reported. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received and Updated the outcome of the event as Resolved.
Pt developed an induration and an injection site reaction characterized as puffy, warm and hard and the size of the bottom of a 2 liter container.
Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a first and second dose of Gardasil (yeast). Subsequently the patient fainted 15 minutes after each vaccination. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician and a nurse practitioner concerning a 16 year old female with drug hypersensitivity to CECLOR who on 13-OCT-2006, at 15:00 was vaccinated, IM into the left arm with a first dose of GARDASIL (lot# 653978/0955F). The patient fainted 15 minutes after vaccination. On 13-Oct-2006, the patient recovered on her own with mild dizziness, oriented times 3. On 13-DEC-2006, at 15:30 the patient was vaccinated, IM into the right arm with a second dose of GARDASIL (lot# 654389/0961F). She again fainted 10 minutes after vaccination. On 13-DEC-2006, the patient recovered on her own, oriented time 3. There were no laboratory or diagnostic test performed. No further information is available.
"COVID arm" is how I have seen this side effect described in news reports/articles. At the injection site, a delayed (7 days after shot) skin reaction. Injection site is very red, hot to the touch, swollen, and itchy. Size of the reaction is about 2.5 in x. 2.5 in. Began on day 7 and has continued into day 8 post-vaccine shot.
bled 2 colors of blood; Cut himself  in his finger (like a paper cut); vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bled 2 colors of blood) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bled 2 colors of blood) (seriousness criterion medically significant), LIMB INJURY (Cut himself  in his finger (like a paper cut)) and VERTIGO (vertigo). At the time of the report, HAEMORRHAGE (bled 2 colors of blood), LIMB INJURY (Cut himself  in his finger (like a paper cut)) and VERTIGO (vertigo) outcome was unknown.            No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-089420 (Patient Link).
Pt recvd 1st dose Hep B vax 1988 & devel liver function abnormalities & hospitalized; Dx w/Hepatitis; Recvd 2nd dose vax 1988 & hepatitis recurred; exp chronic fatigue synd, chronic liver pain, pos titer CMV, & mononucleosis;
Fever & chills, temperature unmeasured, 1 AM following day Fatigue, 10 AM-10PM following day Dizziness, 3 PM - 10PM following day, 2 Benadryl taken
Rash on arms, legs, around eyes Prescribed: Erythromycin and Triamcinolone ointment use of antihistamine over the counter non-prescription Zyrtec 10 mg/day or Claritin  Still have slight symptoms on arms and around eyes
High Temperature (101), Vomiting, headache, shortness of breath, aches, chills
patient received Pfizer covid 19 vaccine and immediately began complaining of tingling feeling in body, lightheadedness, and feeling like she was going to pass out.  She was pale, and began sweating.  We gave her a cool cloth and ice pack, checked her BP (which was high) then called for EMS and a code white.  She left via ambulance to be checked out at the local hospital
One week after the vaccine I had terrible pain in my legs. It lasted for a week, I went to my doctor  because my calves were swollen he referred my to a vascular surgeon. The vascular surgeon did an ultrasound on my legs but did not find any clots or reasons for my calves to swell. I went back to my Primary Care Physician who order a complete blood panel that back negative for everything. I was referred to another vascular surgeon who specializes in the lymphatic system who did a physical exam and could not find any reason for my legs to be swelling and not going down. He felt it was a side affect of the vaccine and suggested that I wait for six months to see if the swelling in my calves go down.  Next week I will start lymphatic drainage massage to hopefully get some relief.
Twinrix 1st dose, 2nd dose Havrix; Twinrix 1st dose, 2nd dose Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   Concomitant products included hepatitis A vaccine + hepatitis B vaccine (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix 1st dose, 2nd dose Havrix) and wrong vaccine administered (Verbatim: Twinrix 1st dose, 2nd dose Havrix). The outcome of the incomplete course of vaccination and wrong vaccine administered were 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: 17-Apr-2023 The pharmacist called to report that about 5 months ago (from the date of reporting) patient only one dose of Twinrix was administered and one month later Havrix was administered as a second dose. The vaccine administration facility was the same as primary reporter. Information about lot number, dates, patient were asked and declined. The reporter did not consent to follow-up.  The patient received a dose of Havrix as second dose instead of Twinrix, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive second dose of Twinrix (incomplete for Hepatitis-B), which led to incomplete course of vaccination.
Per mother, patient was fine the day the vaccine was given and 24 hrs later, he had difficulty walking, developed fever of 101-102 48 hrs later and the site of vaccine was very sore to the touch.  Unable to go upstairs.  Now he is back to normal.
swelling and redness around injection site.  Patient also has swollen left supraclavicular lymphnode approx 3x2cm that is is tender.
On the day the 1st dose of vax was administered pt presented w/tachycardia, malaise in the total body, lack of appetite, sleepy, tired, irritability, anorexia;
Resident developed a femoral, popliteal and posterior tibial DVT.  Treated with Xarelto with resolution of symptoms by 6/1/21
Soon after flu shot, Patient noted to have a "spot" come up on her right shoulder resembling a ringworm. Spot was treated with with antifungal creams x1 month but got bigger. Patient did not complain of itching. New spots noted to come up on patient. Pt taken to her MD's after hours urgent care where she was diagnose with Granuloma Annulare. Pt prescribed steroid cream, which has not helped. Pt has appt with dermatologist this month. At this time, patient has granuloma annulare spots noted to be covering her arms, legs, abdomen, back, buttocks. Pt did not get the "spots" until after receiving the flu shot.
Patient felt sweaty and  feverish, but did not take temperature. She broke out in  hives. She has  been having hives off and on since receiving the first covid immunizations. She also had shortness of breath for about 24 hours
Information was received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on 17-APR-2017, the patient was inadvertently given a dose of ZOSTAVAX 19400 PFU (lot # M039453, expiration date 19-DEC-2017; route of administration unknown), reconstituted with sterile diluent-MSD (lot number unknown) instead of VARIVAX (unspecified lot number and expiration date) for an unspecified reason. No adverse effect reported. No additional information was provided. Additional information has been requested.
Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild
pneumonia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 27-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered chronic cough and congestion and was diagnosed with pneumonia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  It was considered by the reporter that the pneumonia was a disabling event.  Upon internal review, the pneumonia was a medically significant event.
Developed severe back pain. which she went to the ER to have evaluated.  Upon evaluation, she was diagnosed with a PE and blood clots in her spleen