chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red arm; Hard; Hot to the touch; Sore arm; Headache; 17 year old patient received first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red arm), INDURATION (Hard), FEELING HOT (Hot to the touch), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine) and PAIN IN EXTREMITY (Sore arm) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no ear infection or allergy flare-ups.  The patient's past medical history included Sexually transmitted infection (risk of sexually transmitted infection), Fracture of ankle, Ear infection (no recent ear infection.), Laryngitis, Vomiting, Urinary tract disorder (urinary symptoms) and COVID-19 (Tested positive to COVID a year ago (before the vaccine)) in 2021. Concurrent medical conditions included Anxiety, Asthma, Eczema, Family stress (family tension, lots of tension in the family), GERD, Generalized anxiety disorder (GAD), Insomnia (Recent change in status improvement sleeping okay), Migraine (migraines 3-4 a month), Photophobia, Posture abnormal (poor posture) and Tick bite. Concomitant products included ETHINYLESTRADIOL;NORETHINDRONE and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control, ALBUTEROL [SALBUTAMOL], FEXOFENADINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and IBUPROFEN for an unknown indication.    On 04-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced ERYTHEMA (Red arm), INDURATION (Hard), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, ERYTHEMA (Red arm), INDURATION (Hard), FEELING HOT (Hot to the touch), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Tuberculin test: result not provided Result not provided.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No other vaccines were administered within 1 month prior to Moderna COVID-19 vaccine Reporter states that her 17 year old daughter received the Moderna vaccine as the 1st shot, they were going to receive the 2nd dose from Pfizer at the time of report. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: New Reporter added, Patient Initials updated. Medical History added. Lab data added. Concomitant medication (Junel) added. New events added.
Reporting administration error. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration.  Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 61-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 61-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated AE.
Immediately following the vaccine, at 3 minutes into my 15 minute waiting period, I had saw black dots on the ceiling, had rapid heartrate and a dizzy spell. It quickly subsided. Five days later, I experienced another vertigo type dizzy spell and from that time, I have been generally very dizzy. At times, the dizzy spells have also included rapid heart rate and a feeling of near fainting. At the time the dizziness started, I also had spleen pain and gut fizzing. I am now over six weeks past the vaccine, and the rapid heart rate, gut fizzing and spleen pain have subsided but the dizziness is persisting.
Pt received Moderna Vaccines on 03/07/21 and 04/03/21. While hospitalized, pt began experiencing fever, SOB, and hypoxia. Pt was tested for COVID, which came back positive.
I woke up on October 3rd with a sore throat and a lot of postnasal drip. I took a COVID-19 at home test and tested negative. On October 4th I woke up and my sore throat was significantly worse. I tested myself, again, for COVID-19 and tested positive. It has been 22 days since I received the fifth dose of the COVID Vaccine Pfizer (Bivalent). I was a little surprised that I tested positive because I am generally masked, but I was on vacation the week before, around a lot of people, and they were not masked. I was prescribed Paxlovid on October 4th and within 36 hours I was feeling much better and able to go to work. I tested negative on 10/11/2022.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (15Jun2022) positive, notes: Symptoms reoccurred ten days after testing positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had a febrile seizure (temp 104 degrees) 10 days after MMR and IPV. No other symptoms.
Had shot at 3pm by midnight serious pain/aching in thighs. Around 5am awoke with temp of 102.  Migraine headache, blurred vision. Followed by vomiting, diarrhea. Lasted approximately 12 hours then dissipated.
1st day after shot slight arm soreness with stiffness in base of head down right side of neck.  This lasted for few days.   When that subsided gland on right side under jaw was swollen another 3 days.  So after the 1st week following the shot all seemed normal.  Now 2 weeks after shot left arm has a patch approximately 2" wide by 6" in length of redness and is definitely swollen with slight itchiness.  Have started taking Benadryl.
BODY ACHES, LEG ACHES IN AM. BY 3:00 PM HAD FEVER CONTINUING FEVER THROUGH NIGHT.
Red rash over both arms to her back. Her arm doubled in size, fever, Couldn't move arm. Rash is still on her arm. Her doctor told her to use benadryl 25 mg three times daily.
Clinical Summary Patient is a 71 y.o. female with a history of right MCA  with residual L-sided hemiparesis (2019), chronic LLE DVT and epilepsy who presented to HCF 11/13/2022 with complaints of shortness of breath and cough. Labs showed positive COVID PCR with acute hypoxemic and hypercapnic respiratory failure. Required brief ICU stay for BiPAP. HCF assumed care upon transfer.     1. Acute on chronic hypoxemic and hypercapnic respiratory failure:  Secondary to viral pneumonia. Intermittently uses 2L NC at home.  Initial ABG: 7.27 / 72. CXR 11/13 showed congestion with patchy bilateral infiltrates. S/p ICU for continuous BiPAP now on LFNC. Has oxygen prescription at home. 2. COVID-19 pneumonia: Status post vaccinated x2 with Pfizer.  Previously admitted 4/29-5/3/22 for Covid. Since then has required intermittent home O2. Covid pos again on 11/13/2022. Completed 5 days of remdesivir on 11/17.  Continued Decadron through 11/22. 3. Leukocytosis: WBC 13-19 from use of systemic steroids as above. Stable. 4. Chronic DVT: LLE DVT in August 2019, continued home Eliquis. 5. History of stroke: In 2019.  Right MCA with residual left-sided hemiparesis, dysphagia and dysarthria.  Continued aspirin and Lipitor.  SLP followed. 6. Hypertension: BP stable on home amlodipine.
I experienced multiple symptoms after my first dose for a couple of days: body aches, fever, head ache, nausea, diarrhea, etc. After my second dose, I experienced nausea, vomiting, body aches, fever, head ache, chest pain, numbness and pain in arms, and shortness of breath. I started to feel chest pain when I woke up Monday (6/07) from 4 am- 10 am and then again Tuesday (6/08) when I woke up from (2 am-4 am). I went to my PCP Monday around 3 pm and they thought I had acid reflux or body aches. I called an ER Tuesday morning and was told chest pain was an emergency and should go to the ER. I went to the ER Tuesday at 4 am and was admitted for elevated heart enzymes and heart inflammation.
Rash appeared on feet and lower portion of legs and at the injection site on the arm. The rash is mainly concentrated on the both the left and right heel and feet but began to spread to the lower legs (below the knee cap) on the third day. The rash is not painful but extremely itchy.
APPROXIMATELY 10 MINUTES AFGER RECEIVING DOSE, PATIENT COMPLAINED OF "WEIRD METALLIC TASTE AND GETTING REALLY HOT" THAT ONLY LASTED A COUPLE MINUTES AND THEN WENT AWAY. .  DENIED ANY OTHER SYMPTOMS.  NO TREATMENT REQUIRED
No adverse event; Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. FP7136) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 18-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a 1st dose of the primary series (monovalent) on 18-Apr-2023).    No concomitant medications were reported.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were not reported.  The patient received first dose of the primary series (monovalent) on 18-Apr-2023. Patient was instructed to come back in four weeks foe the second dose of monovalent to complete the series. The patient came as instructed however the monovalent was no longer authorized to use and was given bivalent dose to complete the immunization.   Reporter later realized that the bivalent dose was given too soon.  Patient was instructed to come back in 2 month to receive another bivalent dose for validation.  No adverse events were reported.  No treatment medications were reported.   This case was linked to MOD-2023-726266 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2023: Significant follow-up received include reporter details, patient details (Race and ethnicity), Suspect product dose details and Narrative was updated.
She is too sick; she has symptoms of her colitis reappearing; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she is too sick, she has symptoms of her colitis reappearing on an unspecified date. Reported as: Caller wanted to know how to make a new appointment as she indicated that she is in the middle of a medical problem and has to have some tests done. She is too sick, but doesn't think it is related to the vaccine as it happened like 5 days after the vaccine and she has symptoms of her colitis reappearing. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported event of feeling sick is likely related to the patient's intercurrent condition and is not related with BNT162B2 use.
Had previous non- anaphylactic reaction with 1st dose of Pfizer vaccine.  Consulted her physician and was encouraged to get the 2nd dose.  Within 5 minutes of 2nd dose vaccination, patient experienced numbness and tingling in the face.  Vital signs within normal linits, but worsening paresthesias.  Sent to ED.  O2 sat in ED 99%.  No shortness of breath.  Noted with scattered hives to torso.  Given Benadryl and famotidine and improved.
Chills, achey joints, headache, backaches, swollen glands under right armpit, tired and sluggishness.
Flu like symptoms starting on 02/07/2019 A topic Dermatitis first noticed after flu symptoms subsided.
Within 23 to 24 hrs of 1st shot, felt faint and legs wobbly. Lied down on kitchen floor with legs raised for about 5 to 7 minutes.  Then within an hour had chills and a fever of 100.1, took Tylenol, then had hot spells. Went to bed about 830pm. Next morning felt fine except for soreness in left underarm, lymph node area in addition to slight pain in injection site.  4 days later underarm less pain but still slight pain at injection.
Waited 15 minutes at clinic. Driving home felt tingling in  tongue.  Went to Hartford Hospital Urgent Care. Developed sunburn rash on arms and upper torso. Given 50 mg benadryl and prednisone injection at 2:52 PM. Observed for 90 minutes. Discharged with prescription for 40 mg prednisone for three days. Had telehealth appointment with Dr on 3/24. Told to continue with prednisone and avoid Pfizer boosters in the future. No breathing issues any time. Pulse ox before prednisone 98% after 100%. rash resolved.
Patient was given Pfizer vaccine as the 3rd dose of COVID vaccine instead of Moderna, patient had received his 1st and 2nd doses of the COVID vaccine as Moderna in February and March of 2021. Patient aware, currently no side effects present
Patient had symptoms of racing heart and increased blood pressure approx 1 hour after the pneumovax vaccine. Patient went to emergency room and was treated for BP 155/100 to 160/112 and HR 100-110. Vaccine injection site was warm, swollen and red on back of left arm at SQ injection site. Patient had EKG that was normal and told to watch back of left arm. Patient returned to ER next day for continuing elevated BP. Patient diagnosed with an inflammatory hypersensitivity reaction over SQ site that covered the span of the back of the left arm and told to watch area, no antibiotic prescribed. No medication needed for elevated BP, told to see primary physician regarding BP levels.
Patient noted numbness in left axilla immediately after getting her flu shot on left arm  and noted pain at injection site afterwards.  After 15 minutes observation , arm pain resolved and pt states axilla numbness less and improving.  Advised to monitor and would follow up with patient on the phone later in the afternoon.  Patient returned back to the Clinic location about 1 hour post injection due to noted numbness spreading to left flank area, upper and lower back up to waist level on left side only .  Patient then noted numbness in left ankle extending upwards to her left thigh.  Patient was transported to Health Services for further evaluation/ monitoring.  EKG was done. Patient noted some improvement at discharge but still with numbness  and referred to ER for further eval
Fever followed by cold sweats, aching all over body, rapid heart rate 130-135 resting BPM.  Took Motrin for relief from the aching pain.
There was an excursion from their freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gave options for excursions above one hour and not less than, so she did not know how to do the analysis. She stated that her team already knew the recommended temperatures and wanted to know if the vials were okay to be used because they were administered to 118 patients.No concomitant medications were reported.No treatment information was reported.
Feel like getting a cold; Have a bad taste in throat; Felt bad the following day; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feel like getting a cold), TASTE DISORDER (Have a bad taste in throat) and FEELING ABNORMAL (Felt bad the following day) 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 NASOPHARYNGITIS (Feel like getting a cold), TASTE DISORDER (Have a bad taste in throat) and FEELING ABNORMAL (Felt bad the following day). At the time of the report, NASOPHARYNGITIS (Feel like getting a cold), TASTE DISORDER (Have a bad taste in throat) and FEELING ABNORMAL (Felt bad the following day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
PATIENT EXITED SHOT ROOM AND SAT IN WAITING CHAIR.  SHE SLUMPED HER HEAD AND SHOULDERS, LASTED LESS THAN 30-45 SECONDS.  APPEARED TO BE VASOVAGAL SYNCOPE.  SHE WAS SWEATING AND CAME TO ON HER OWN, WITHIN MINUTES WAS REPORTING TO FEEL 'FINE' AFTER BEING GIVEN WATER AND WAS FANNED.  SHE REPORTED THIS HAS HAPPED BEFORE WITH BLOOD DRAWS IN THE PAST, BUT NOTED SHE 'FELT THE LIQUID INSIDE HER ARM MOVING DOWN TO HER RIGHT HAND.' SHE ALSO REMARKED THIS FEELING HAVING HAPPENED BEFORE.
First pill was taken on the evening of 9/2/2018 at which point there was minor nausea and upset stomach for the remainder of that night and into 9/3/2018. I was also flush to the point where people would ask why my cheeks were red. Due to this nausea, I did not eat breakfast and proceeded to return to the clinic on 9/4/2018 for my Hep A and B and 2nd does of Rabies vaccine. After which point, I got lunch and had stomach cramping. At this point the cramping intensified as did the nausea to the point where even drinking some water became painful. The pain would come in waves (with or without eating food or drinking liquid) and last for about an hour. I would turn flush and feel achy. I returned to the clinic on 9/6/18 at which point I was told to stop taking the vaccine. That day, I was still not hungry so ate very little. I did not have severe cramping on this day. By 9/7/18 I was totally normal.
40-50 small papules & vesicles rt arm, chest, neck +scalp area w/low grade fever 24JUN98;siblings w/outbreak of 100 papules & vesicles 2wk later 7JUL98;
Initial report received from a health care professional on 10 February 2011. A 27-year-old male patient received on 06 February 2011 an injection (route and site not reported) of ADACEL, lot number unknown. The patient had no known allergies. Her concomitant medication was chloroquine. It was unknown if the patient was ill at the time of vaccination or if the patient had received any other vaccines within 4 weeks. On 10 February 2011 the patient developed a low grade fever, body aches, loose stools and a slightly increased white blood cell count. He was seen by a physician. No further information was available. The outcome was reported as unknown. Documents held by sender: None.
Her lips started swelling and inside of her mouth also began swelling.  Lips felt numb and she experienced some wheezing.