chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving second COVID shot, world was spinning; Not feeling well emotionally; Not feeling well physically; Prescribed Tyvaso 10-20 breaths inhaled, four times a day; Feeling anxious; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally) and MALAISE (Not feeling well physically) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM from 03-Mar-2017 to an unknown date for Primary pulmonary hypertension, AMBRISENTAN for an unknown indication, SILDENAFIL CITRATE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ANXIETY (Feeling anxious) and DYSPNOEA (Out of breath). On an unknown date, the patient experienced VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day). At the time of the report, ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day) outcome was unknown.            treatment to the events not provided. Treprostinil sodium in regimen 2 the dose strength was 18-54 microgram qid  , in regimen 3 the dose strength was increased to 60-120 microgram qid.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: follow up information received new events , concomitant medications were added.
lymph nodes under left armpit began to swell and generate mild to moderate pain; no swelling anywhere else at this time other than right armpit.; No swelling anywhere else at this time other than right armpit; pain and swelling in left arm; pain and swelling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to walnuts and shellfish and COVID-19. Information on other medications taken within two weeks of vaccination was reported as not applicable. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient first had mild pain and swelling in the left arm (where the shot was inserted). On 10Apr2021 at 18:00 within the following 48 hours, lymph nodes under the left armpit began to swell and generate mild to moderate pain. At this time the pain was not alarming, however, the swelling was medium to severe. The other set of lymph nodes in the right arm were completely normal, and there was no swelling anywhere else at the time of this report other than the right armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events first had mild pain and swelling in the left arm, lymph nodes under the left armpit began to swell and generate mild to moderate pain, and swelling of the right armpit were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 20 minutes after the vaccine she began having nausea and vomiting. That evening she was very achy and had difficulty moving. She couldn't eat and couldn't sleep. She called her PCP who referred her to the ED. She received ibuprofen and Zofran in the ED. Symptoms have improved some, but she is still having hip and back pain and hot and cold chills.
tired; heart flutter; sore arm; dizziness; brain shocks; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutter) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Floppy mitral valve. Concurrent medical conditions included Allergy to antibiotic. Concomitant products included PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, COLECALCIFEROL (VITAMIN D3), LORATADINE (CLARITINE), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), PROBIOTICS NOS and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CARDIAC FLUTTER (heart flutter) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness) and ELECTRIC SHOCK SENSATION (brain shocks). On an unknown date, the patient experienced FATIGUE (tired). On 02-Apr-2021, CARDIAC FLUTTER (heart flutter), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness) and ELECTRIC SHOCK SENSATION (brain shocks) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-121826, MOD21-089543, MOD-2021-121826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Address updated, medical history updated; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
(L) arm at injection site (+) swelling and cellulitis Pt had near syncope, feverish and generalised malaise
needed that one vaccination, however she was given a second one. no adverse effects reported; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who was vaccinated with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U5989AA and expiry date: 27-Aug-2019) via intramuscular route in the left deltoid on 26-Jul-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was actual medication error due to extra dose administered. It was reported that the patient received after the age of 16 years and only needed that one vaccination, however she was given a second one.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Atrial Fibrillation event on 02/09/2023. Prescribed baby aspirin and Diltiazem. Advised to stop taking Benazepril. Referred to cardiologist where I has a stress test. Currently scheduled for a follow up Nuclear Stress Test in the hospital.
pt recv vax 1SEP95 & 24OCT96 pt devel chickenpox;pt recovered;
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The pharmacist reported that a patient received the first dose of GARDASIL (dose, route of vaccination and lot# were not reported) in July 2013, the second dose in October 2014 and at the time of the report, was in the office to receive a third dose. No adverse effects reported. Additional information has been requested.
Patient started to get what looked like chapped lips about 2 days after her vaccine. She then started to develop what originally looked like pimples below her bottom lip. Her lips then began to blister and broke open and didn't look like they were healing with chapstick and Vaseline. She also developed a pimple looking sore on her left cheek and on her left neck, and then got a sore behind her left ear. All of her sores started to blister and then I took her to the doctor on January 27, 2022. The doctor prescribed her generic Valtrex along with Acyclovir Ointment. The sores on her lips and everywhere else mention started to ooze before finally stabbing over. The doctor said she had an out break of cold sores, which she has never had before.  The last sore on her lip finally healed on Sunday, February 7, 2022.
PATIENT RECEIVED MODERNA COVID-19 VACCINE ON 3-29-21 AND THEN RECEIVED PFIZER COVID-19 VACCINE ON 4-20-21. UNABLE TO REACH THE PATIENT TO DETERMINE AND SYMPTOMS, SIGNS, ETC.
This spontaneous report as received from a physician refers to four unspecified patients of unknown age and gender. On an unknown dates since 21-FEB-2015, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # K005109, expiration date 04-APR-2016, therapy type, dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
intermittent paresthesias left side of face, left arm and left leg, subjective weakness in the left leg
Patient had a seizure on the day of the Pfizer vaccine as well as arm & leg pain due to fall
I developed a large red ichy rash at injection site 7 days after injection and a huge lump in left arm
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Jan2003, stop date: 29Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (26Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 19Oct2023 to 24Oct2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202300350861 Same patient, different drug, different event;
had flu-like symptoms; headache; fatigued; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms), HEADACHE (headache) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Pt recv vax on 9/21/98; on same day pt exp fever, chills, cough, difficulty breathing
Breakthrough symptomatic case with body aches, fever, cough, SOB, hypoxia. currently in Emergency center on 2L O2 (10/6)  Symptom onset 9/28/2021
Mucus discharge; Tingling in the arm; Diarrhea; Runny nose; Headache; Throwed up; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and BOHD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ). At the time of the report, SECRETION DISCHARGE (Mucus discharge), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ) outcome was unknown and PARAESTHESIA (Tingling in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 Fahrenheit.         No concomitant medication was provided by reporter.   No treatment information was provided by reporter.   This case was linked to MOD-2021-090550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received on 10-AUG-2021 contains no significant information. Second dosage regimen added, event outcome updated for tingling and the events were re-arranged from the previous version.
Heavy period, then delayed menses, followed by frequent periods. Cramping, headaches, bloating, acnes. Periods are now every 12 days
Pt. received Tdap and then GARDASIL. she was sitting on end of exam table talking. She stopped talking fell forward into my arms and I laid her back on exam table. Pt appeared to pass out for about 5 seconds.
Developed a severe cellulitis the day after injection given.  Severe swelling and compromised circulation. Mobility effected - limping. Leg dusky colored unless elevated.  Parent called physician for antibiotics, kept leg elevated (mother is RN).  Leg continues with hard lumps felt at injeciton site.
Patient presented to ED 1/10/22 with a chief complaint of shortness of breath secondary to COVID-19. Patient had mild shortness of breath for approximately 10 days. Patient states shortness of breath worsen 5 days ago. Patient used at home oxygen at 3L. Patient had not had to use home oxygen since weight loss.  Patient?s pulmonologist referred patient to ED for further evaluation. CT was done in ED. Patient was positive for PE. Supplemental O2 and anticoagulation therapy initiated. Patient is positive for COVID-19.  Patient received Moderna 1st dose 1/26/2021 and Moderna 2nd dose 2/25/2021 and received Pfizer booster 11/8/2021.  Submitter does not have access to further medical records. If more details are needed, please contact the admitting hospital.
( L ) upper arm pink warm patch 5-6 cm diameter, no induration, no treatment at time of visit.
Patient had 2 months vaccines (Pentacel, PCV 13, Rota at 10/9/12 by PCP, but got another run of the same vaccines + Hep B vc #3 on 10/30/12 in pediatric Clinic brought in by foster care giver when mother was taken away. No reaction noticed since to 11/15/12 when grandmother brought her in (new foster care giver now).
Painful injection site with approximately 3-inch, round area of redness, swelling, heat and pain, which began within about 4 hours of the injection. Continued for quite some time. I think it was about two weeks before it was fully gone. Fever and body aches began sometime in the night through the next day after getting the vaccine. I was free of all issues other than injection site swelling and pain within 4 days.
Information has been received from a special education teacher, concerning a male student between 6 to 7 years old, who on an unspecified date received a dose of MMR II (lot number not available) and on an unspecified date was hospitalized (hospital demographics not available) after he received MMR II. The teacher reported that the student was now in special education school (no further details available). At the time of reporting, the patient was not recovered. This is one of several reports from the same source. This is an amended report. Labeling was changed from yes to no for the AE term of Adverse Event. Additional information is not expected.
MMRV and Varicella were both given to a patient instead of just the MMRV
Reporter was informed after the fact that patient experienced shortness of breath and clamminess after going through the checkout line and paramedics were called. Patient had flu shot prior to shopping and believed it may be involved in her symptoms. Reporter was informed that patient was recovering prior to arrival of paramedics. Per store management, paramedics took patient's vitals and they were normal. Patient declined to go with the paramedics and went home with husband.
24 hours after vaccine, scratchy  sore throat. later  a cough, congestion, headache, feverish but no temperature.  sluggishness, fatigue. 3 days later symptoms remain with site of injection painful.
This spontaneous report as received from a Registered Nurse refers to a 2 month old patient. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 5 microgram/0.5 ml, 0.5 ml dose, intramuscular (lot/batch number, exp. date and indication not reported) and with a dose of PEDIARIX (dose, route, lot/batch number, exp. date and indication not reported) on the same day. No adverse effect reported. Additional information has been requested.
On day of immunization patient developed rash around the site of vaccination; rash spread to the abdomen and lower back next day. On examination - papulomacular rash with some wheals on the right thigh, abdomen and back, rash is pruritic.
24 plus hours after vaccine was given, school nurse noted 6-8 scattered nickel-sized hives on the arm.
reschedule dose 2 and have not been able to achedule; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided   Reporter did not allow further contact