chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2 weeks after my second dose I started to have to take my rescue inhaler everyday multiple times and up to the limit.  I haven?t had this difficulty in breathing for more that 10 years.  I used my nebulizer but was unable to stop or get my breathing under control.  During this time I was supposed to have my period.  I did but it was strange that month.  Very light and almost non-existing over 2 days.  I went to my family physician.  I asked to be placed back on pulmicort as singular wasn?t helping at all.  She agreed and I started back on a regimen of 4 daily puff to try and get my breathing under control.  I went to see her again I late April/early May.  I had taken a fall.  I was having extreme inflammation and knee pain.  She scheduled physical therapy and an appoint with our Orthopedist.  I told her my period had stopped all of a sudden.  My period has been clockwork my whole life.  It has a 27 day cycle and is always on time.  She brushed that off as due to my age, even though my mother had her period clockwork until her hysterectomy at 58.  Saw the orthopedic PA.  She gave me a shot of cortisone in both knees and 3 doses of euflexxa over May - July.  Joint pain reduced but inflammation is intermittent.  In July I went back to my family physician.  She gave me  furosemide for edema from an unknown origin.  I take it off and on when I notice I have swelling.  I told her my period had still not restarted.  Again she brushed it off as age.  I know need to go to a foot specialist due an inflamed nerve bundle on the bottom of right foot that has appeared.  Finally had a period on July 25.  It was weird and extremely brief.  However, I have had periods again systematically every 26 days again.  I still use the pulmicort to control my asthma and have a continued pain issue in all my nerves.
have swelling of the heart muscle after getting vaccinated.; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient experienced swelling of the heart muscle after getting vaccinated. The clinical outcome of swelling of the heart muscle after getting vaccinated was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.      Amendment: This follow-up report is being submitted to amend previously report: patient initials updated.   Follow-up attempts are completed; information about lot number cannot be obtained.          Follow-up (25May2021): This is a follow-up report to notify that the case 2021475747 and case 2021600303 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021600303.
Patient received a 2nd dose of Moderna only 22 days after their 1st dose.
Was extremely ill for several days including a fever over 100° and my milk supply completely dried up the day after the vaccine after months of effort to get it increased.
Through quality checks it was discovered the patient likely did not receive a full dose. Patient notified that it is recommended they are revaccinated.
The pt received Hep A/Prevnar on 01/16/2002. On 01/17/2002, she developed a fever of 101 deg. F.  Red, raised area at the injection site on the left thigh. Contacted the healthcare center and she recomended Tylenol and the symptoms resolved.
This spontaneous report as received from a healthcare worker and a certified medical assistant refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was vaccinated with a dose of  (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Left deltoid site swollen/red/warm 13 cm x 11 cm, cool compress, Benadryl, Keflex soon one PO QID x 10 days.
pt recvd vax; exp generalized tonic clonic sz x 2 min; recurrent sz 15 min later, persisted 2min;
Information has been received from a physician concerning a female patient who on 28-MAY-2003 was vaccinated with a dose of Varivax. On 22-MAY-2006, the patient broke out with a mild case of chickenpox. Additional information has been requested.
REPORTS SWELLING AND PAIN TO ARM FROM INJECTION SITE DISTAL TO HAND THAT STARTED A FEW HOURS AFTER INJECTION.  REPORTED TO ER TWO DAYS LATER WHEN HE NOTED RED STREAK DOWN ARM AND INCREASED PAIN AND SWELLING.  AT ER GIVEN RX FOR KELFLEX FOR 7 DAYS. 2 DAYS AFTER STARTING TREATMENT, NO PAIN OR SWELLING NOTED TO ARM
4th (2nd Booster) and Tdap  vaccine taken together.  15 minutes after vaccination, I started having chills, and confusion. I was mentally and physically unstable. I couldn't walk. I feel nauseous. My eyes were really red/pink.
hoarse voice; sore throat; three and a half weeks later after vaccination got Covid for the first time ever; cough; runny nose; I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), COUGH (cough), DYSPHONIA (hoarse voice), OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (runny nose) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F232A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Surgery (Huge heart surgery on 25Apr2023 involving two valves in the aorta) on 25-Apr-2023. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy.   On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 26-Oct-2023, the patient experienced PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)). On 31-Oct-2023, the patient experienced RHINORRHOEA (runny nose). On 02-Nov-2023, the patient experienced COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever) and COUGH (cough). On an unknown date, the patient experienced DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), RHINORRHOEA (runny nose), PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)) outcome was unknown, COUGH (cough) had not resolved and DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient got really sick.  Patient was still coughing and she had not lost her sense of smell or taste.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow up received is non significant. On 03-Nov-2023: Live follow up received. PQC closed report and references added.
Injection site developed a small hard red lump a week after injection. Overnight it grew more red, is swollen, warm, and itchy. I read that this will resolve in a few days.
Pt noted a 3" long by 1.5" wide oval rash on her left arm near the injection site.  She notes it was slightly tender 0.5/10 on the pain scale.  As of today 5/23, it is barely noticeable and just a little sore.
chest tightness, dizziness, double vision, shortness of breath, "warm feeling" Patient was given 40 mg of PO Pepcid and 4 mg of PO Decadron at 10:15 am.  Reaction lasted about 20 minutes.
Pt complained of instant headache and itching of skin, rash on back. Pt feels hot all over. Admitted. 3cc Epinephrine 1:1000 stat and Diphenhydramine 50mg 1cc stat.
Patient received the second dose 3 weeks after the first dose instead of 4 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Induration and redness with mild tenderness around injection site 12 cm in diameter in 24 hrs after shot. Patient was asked to follow up. Never did.
Pain, muscle soreness, bruising, and swelling reported at site of injection, even after 5 days later.
Initially pt without co. At 3 wk, she stated her (L) arm at deltoid was numb. Upon testing she had significant muscle weakness in her (L) upper arm. She was referred to neurology, upon, which weakness was resolved. She never lost DTR. GBS was ruled out.
pt recv vax 8APR98 & pt eyes closed & head bowed;pt was placed on floor;immed eyes opened;@ 12:45PM BP was 80/62 & attempted to reach mom @ work; 1:10 BP 120/80;
patient reports by telephone that within 24 hours developed redness swelling approx 2 inches at site of injection, slightly tender too touch 72 hr expanded 4" less
This case was reported by a physician via sales rep and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX. Co-suspect products included ADACEL. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml and ADACEL at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were recovered/resolved. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received a shot of SHINGRIX in one arm and ADACEL in another arm. The patient had fever and myalgia for a week. It was unknown if the reporter considered the fever and myalgia to be related to ADACEL as well.
Covid rapid test positive; Dry throat - same symptom as you would have when the humidity in the house is not; dry nose - same symptom as you would have when the humidity in the house is not; scratchy throat; Scratchy nose; Feels hot; Feels tired; Chills; A spontaneous report was received from a consumer concerning a 34 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired. Patient also experienced a positive COVID-19 rapid test.   The patient's medical history included "cancer treatment last year". Concomitant medications reported included phentermine, bupropion hydrochloride, and neratinb maleate.    On 23 Dec 2020, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient started to have a dry, scratchy nose and throat (noted as "the same symptom as you would have when the humidity in the house is not enough"), chills, felt hot and tired. The patient denies cough, fever and loss of taste. On 27 Dec 2020, the patient has a positive COVID rapid test. The repeat test was also positive. Treatment for the event included paracetamol, ibuprofen, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and dextromethorphan hydrobromide/ guaifenesin/paracetamol/pseudoephedrine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired, was unknown/not reported. The outcome of the event, positive COVID-19 rapid test, was considered resolved.   The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 34 year old female with medical history of neratinib for cancer experienced nonserious unexpected events of dry throat and nose, scratchy throat and nose, feeling hot, and COVID-19 (positive COVID-19 rapid test) and nonserious expected events of chills and fatigue. The events occurred 3 days after first dose of mRNA-1273 administration, and were treated with paracetamol, ibuprofen, dextromethorphan, doxylamine, ephedrine, guaifenesin, and pseudoephedrine.  The events remained ongoing at the time of this report. Based on the available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Fussy, refused a bottle. Noted clonic movements eyes rolled back not making noises - lasted 1.5 minutes. No post-ictal period just cried.
death Narrative:  Patient received Moderna Covid #1 on 3/11/21 in his home  by nurse. On 3/25/21, a note was entered to indicate that is wife had called EMS the day before as "his heart stopped" and he passed en route to the hospital. No further details available. No autopsy results available. 13 days between date of vaccination and date of death.
Swelling, and tenderness to area about 2 inches below injection site about 4-5 cm x 3 cm, and tenderness to area beneath armpit.
Information has been received from a physician concerning a female who on 21-NOV-2008 was vaccinated with a second dose of GARDASIL.  The patient experienced a lump in right arm after second dose of GARDASIL.  The patient sought unspecified medical attention.  At the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Patient collapsed ~5 minutes after receiving shot. She was first of her and her sister to receive second dose of Pfizer COVID vaccine. She states that she felt dizzy. Hit her head on the way down on counter outside of pharmacy and fell to floor. Pt was A&O immediately after. Called EMS and all vital signs were stable. Pt reported no pain. Pt and father decided to go home and monitor for anything out of the ordinary for rest of the day
receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2022 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Numbness in throat 5 minutes after injection.   Blood pressure and heart rate were monitored but nothing substantial to report.   Monitored for a total of 30 minutes, numbness spread through mouth yet did not progress further.  Dizziness upon standing.  No additional symptoms.  Healthcare providers noted that if any progression of symptoms occur to report to the emergency room, however, no additional care was needed.     8-10 days post vaccine severe stomach pains after each meal.  Possibly related to skipping dose of methotrexate.  Pain alleviated within hours once methotrexate injection was administered.  Discussed with rheumatologist at scheduled appointment.
Pericarditis, very low blood pressure, difficulty speaking, thinking, weakness, loss of balance.  Lab reports showing worsening of kidney disease, elevated bnp.  Four weeks of prednisone treatment plus 1 weak weaning off,  6 weeks on colchicine.  Continuing blood pressure issues and weakness, and fatigue.
This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received RECOMBIVAX PEDIATRIC and ADULT (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient has been hospitalized for wheezing and has asthma, FluMist was given at 410pm and patient was kept for monitoring till 540pm
made sicker than ever been in life; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.  This case is linked to case 2020SA296404 (same reporter).  This case involves an unknown demographic patient who became sicker (malaise), after the patient received INFLUENZA VACCINE.  The patient's past vaccination included flu shot (influenza vaccine) for prophylactic vaccination.   The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient became sicker than ever before (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had no influenza vaccine over ten years and never had the flu since and will never get another shot.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
The patient started with sudden onset double vision nd ambulatory dysfunction. The patient was taken via ambulance to R/O CVA. MRI results unremarkable.   The patient was diagnosed with INTERNUCLEAROPHTHALMPOPLEGIA.  Possible cranial nerve 6 palsy.
Patient given Menactra, MMR, Varicella and Tdap. Unsure of vaccine lot numbers.  swelling of left deltoid. Pain with lifting the left arm
On March 27 2021 I got my second covid shot.  Around April 5th I noticed a weird feeling of pressure in my chest.  I had a yearly physical already scheduled for April 9 so I alerted my doctor in advance that I was feeling some chest pressure and fluttering.  On April 9 he did an EKG as part of my physical and did not seem concerned but said to wait a while and see what happens but if I felt faint or chest pains to go to hospital. Sounded reasonable. We did not get a heart image so I have no certainty of anything wrong with my heart. The pressure continued and then I starting having noticeable palpitations later in April and thru June.  They would last minutes.  The palpitations became worse to where my heart felt like it was pounding through my chest and I let my doctor know that I was still feeling them early June.  Still we waited, and around July I noticed that they were not as severe any more and about middle of July I noticed I did not have chest pressure or palpitations anymore.  I bring this up and report it because I am considering the booster and I wonder if the booster will finish off the attack that the second shot may have started in April and kill me this time.  It is a real concern to me and I want it known so if I get the booster and get heart issues and die that this was duly noted to the CDC and my doctor.
Gave injection on 8/17/11. Mom called after they got home and said patient's cheeks and face was swollen. Mom stated patient was not having any trouble breathing.
2nd known apparent sz since receiving vax on 17FEB94; sz lasting 4 to 6 mins body jerking, eyes rolled back, choking on tongue, not breathing; went to ER: now on medicine so won't have another sz; crying unaware of what is happening