chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been feeling extremely out of breath; my energy level is low as well; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (I have been feeling extremely out of breath) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced DYSPNOEA (I have been feeling extremely out of breath) (seriousness criterion medically significant) and ASTHENIA (my energy level is low as well). At the time of the report, DYSPNOEA (I have been feeling extremely out of breath) and ASTHENIA (my energy level is low as well) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious event of Dyspnoea and unexpected, non-serious event of Asthenia on an unspecified date after the third dose of mRNA-1273 vaccine. The events had not resolved. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious event of Dyspnoea and unexpected, non-serious event of Asthenia on an unspecified date after the third dose of mRNA-1273 vaccine. The events had not resolved. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Left arm was sore aFter injection and has persisted ever since; 38 days now. Especially painful at night as I am unable to sleep on my LeFt side. Very painFuL trying to raise LeFt arm to bath, use computer, lift cooking utensils, drive and dress.
Admitted to Hospital for cough, chest pain, myalgia, shortness of breath, hypoxemia for 6 days on 12/28/2021.  Patient had been vaccinated for COVID-19.  Per hospital report, did not require mechanical ventilation and was not admitted to the ICU.  Discharged to home on 12/30/2021.
It was sore that night; red patch that surrounded the injection site; body temperature went up to 100.7 F; cannot pick up my left arm; red patch that surrounded the injection site, went under my left arm toward my arm pit and around on the other side of my arm.; She advised me I had a severe reaction; This spontaneous report was received from a 62 year old female patient with hypertension and allergy to penicillin and amlodipine which caused her hives and edema of feet hand legs swell respectively. The patient was vaccinated with pneumococcal 13v conj vaccine in 2018. Concomitant therapies included potassium, vitamins, calcium, biotin and fish oil.  On 12-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left arm for prophylaxis. The patient reported that it was sore that night and by the next morning there was a red patch that surrounded the injection site, went under my left arm toward my arm pit and around on the other side of my arm. The red spot was 4 inches up and down my arm and 6 to 7 inches across my arm. It was very painful, and my body temperature went up to 100.7 degrees Fahrenheit. She called her doctor and went in to see her on that Thursday 15-OCT-2020. She tested her for COVID, but she was negative. She advised her she had a severe reaction. A treatment the patient apply ice and acetaminophen (TYLENOL) every 4 hours , and now acetaminophen (TYLENOL) every 6 hours. Told to rub it but was to painful, but now I can rub it.   At the reporting time, the outcome of the events was reported as recovering, but still cannot pick up my left arm, or pick up anything that weighs more than a pound or two.  Causality was not provided.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 61-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.
on Jun 18th 2021 / received Pediarix /with expiration date on Jun 14th 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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 was provided as follows: The patient received expired Pediarix vaccine, which led to expired vaccine used. The reporter consented to follow up via email. This case was linked with US2021134505, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134505:same reporter
Pt received DTaP and IPV immunizations on 5/22/03, Thursday. Pt's left anterior leg became "red, hot and inflamed". Taken by parent to ER. 5/28/03: Pt walking without problem, redness decreased. Benadryl - OTC - recommended along with ice packs. Per mom, ER physician diagnoses "severe allergic reaction".
Parasthetias, fatigue, chills, and low grade fever (unknown temperature, but was 97.8F on 1/17 at 12pm).
Vaccine administered after 14 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 14 days of puncturing the vial) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 14 days of puncturing the vial). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 14 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim.
Hives. I became itchy four hours or so after getting the shot. I had hives at 10:30 p.m. When I woke up the next morning they were gone though I had some lingering itchiness as of 7:43 a.m. Dec 3.
Vaccine received  Thursday. Friday evening felt unwell; chills, body aches, chest tight and difficulty swallowing. Administered Rescue inhaler and took dose of Benedryl.  Restless night. Saturday morning, left sided headache and eye pain. Experienced dizziness and vertigo., vomited five times. Chest is clear today and no fever any of the days. I check for fever with digital thermometer. Called HC provider and spoke with nurse. She advised a virtual visit. Visit completed with medication  Zofran and Meclazine ordered. If all symptoms have not resolved by Monday, an in person Dr visit will be necessary.  Will be doing bed rest for the remainder of the weekend, and will seek medical treatment if any symptoms worsen.
pt recv vax 14AUG95 & 3APR97 pt exp a low grade fever & devel greater than fifty itchy lesions/papules on trunk & face as well as a few vesicles;tx w/DPH;
SHIVERS; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 12-JUN-2021, the subject experienced shivers. On 12-JUN-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivers, and high fever on 13-JUN-2021. This report was non-serious.
Temperature (102.4),  nausea, tiredness, headache.  Sorry I actually took the vaccine.  Did not seem worth the illness that followed it after each shot.  This is the 3rd day and there is no longer any temperature but the tiredness and head fog still exists.  The effects lasted 3 days after the first shot so I am hoping this will ease after today.   After the first injection I had an itchy rash on my left arm so I had the 3nd shot on my right arm and have not gotten a reaction on my arm as of todays date.
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
the first one got sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 (Lot number: EN6201) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (ongoing); "bipolar" (ongoing); "asthma" (ongoing); "high blood pressure" (ongoing); "anaphylaxis to MRI contrast" (ongoing). Concomitant medication(s) included: TOPAMAX taken for bipolar disorder (ongoing); PROZAC taken for depression (ongoing); GABAPENTIN taken for depression (ongoing); LISINOPRIL taken for hypertension (ongoing); EPIPEN taken for anaphylactic reaction; VENTOLIN ACCUHALER (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "the first one got sore".  Additional information: Pfizer Covid 19 Vaccine: Indication: She states because she believes in it and because she has asthma and she wanted to get it early, in a state nobody really wants to get it here. Concomitant Medications: EpiPen: Caller states she also carries an EpiPen because she had anaphylaxis to MRI contrast and before she even had the vaccine, she talked to Pfizer and the FDA to make sure there was no matching ingredients and none of the ingredients were the same, so she went ahead with it. First dose: right arm got sore: 12Feb2021, sore arm started within about 2 hours then it was gone within 24 hours. Confirms started 12Feb2021, ended 13Feb2021, and has recovered completely. Caller stated now she's afraid to ever get another one, and she knows they will come around again.Concomitant Products Daily vitamins: (Start: Unspecified Stop: Ongoing)  No follow-up attempts are possible. No further information is expected.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild
Lethargy; Chills; Body aches; Loss of appetite; Fever; General malaise; Headache; Skin pain (hypersensitivity to the surface of "my'' skin on ''my'' arms and legs"); Skin pain (hypersensitivity to the surface of "my skin on my arms and legs"); Nausea; Insomnia; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 07May2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and IBD (inflammatory bowel disease). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and probiotic (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07May2021, within 3 hours of shot, the patient experienced injection site pain. On 08May2021 at 03:00 (12 hours post shot), the patient experienced insomnia. On 08May2021 at 08:00 (the rest began 17 hours later), the patient experienced lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of her skin on her arms and legs), nausea. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in May2021, the patient underwent saliva test (Other) and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events injection site pain, insomnia, lethargy, chills, body aches, loss of appetite, fever, general malaise, headache, skin pain (hypersensitivity to the surface of "her skin on her arms and legs") and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
NO TASTE OR SMELL CONGESTION AND COUGH; Nasal Congestion; Cough.
Day of injection -exhaustion - spent 8hr in bed, HA day 3 an on from elbow to shoulder extreme pain, pain radiates to neck, movement increases pain, same area is swollen dr gave doxycycline. No redness not hot.
This spontaneous report as received from a medical assistant refers to a 70 years old female patient with high cholesterol and osteopenia. The patient had no drug allergy. On 05-SEP-2012, the patient was vaccinated with PNEUMOVAX23 by intramuscularly (lot # 0491AE, expired date: 15-SEP-2013). No other co-suspects were reported. Concomitant medications included calcium with vitamin D (unspecified), aspirin and metronidazole lotion. On 05-SEP-2012 "later that day", the patient experienced fever, sweats, chills, and also swelling at the site of injection. The physician prescribed ibuprofen and TYLENOL for the events. At time of the report, the patient's outcome is recovering. A lot check was requested. The patient sought medical attention by phone to the physician's office. Additional information has been requested.
Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; This is a spontaneous report received from a contactable Other HCP (other health professional). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) via intramuscular at single dose at age of 35-year-old in left arm for COVID-19 immunization, the first dose was on 03Feb2021 (Lot#: EL3247), the second dose of on 24Feb2021 11:15 AM (Lot#: EL3247). Medical history and concomitant medication received within 2 weeks of vaccination were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient contracted COVID-19 on 17Jun2021 and went for testing on 20Jun2021 which was positive. Covid test on 20Jun2021 was positive. The event resulted in doctor or other healthcare professional office/clinic visit. The events was assessed serious due to medically significant, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.
Red Itchy rash appeared on chest approximately 3 days after first shot. It was extremely itchy and sore but very small and contained. After 2nd shot, the rash got much larger on my chest and also spread to other areas of my body? stomach, back, and legs.
erythema and pruritus 8 days after administration. symptoms started with severe itch and rough feeling on skin. On day two, patient developed redness, warmth and 3-4 blister like lesions <1mm. Symptoms stabilized on day 3 and started to improve by day 4. Itching when away first. Faint discoloration seen 14 days after onset. patient used triamcinolone 0.1% ointment daily with complete resolution after 4 days of use.
Developed postural/orthostatic tachycardia (HR 120s) over several days, lowered blood pressure, and sudden onset of atrial fibrillation (HR 150s)  that lasted 4.5 hours on 10/21/2022. No prior or subsequent history of these events.
vaccine given 4/13 in left deltoid, 4/15 swelling in left axilla noted, 4/22 noted redness, swelling, warmth, tenderness and itching 1 inch below vaccination site
Initial report received from an incarcerated consumer on 10 May 2011. A patient (age and birth date not provided) received on an unknown date an injection (route and site not reported) of INFLUENZA VACCINE (unspecified), sanofi pasteur lot number not reported. The patient reported that he received FLUZONE 2010-2011 formula bar code #5961. The patient has a history of seizures and has been on DILANTIN 500 milligrams (mg) daily to control his seizures. Since receiving the vaccine, he reported experiencing extremely more amounts of "petty MA seizures". The patient can not "tie it to anything meaning time of day eating, habits events maybe other than causing a bit more stress on my brain". The outcome was reported as not recovered. Documents held by sender: None.
Incident occured 7-30-09. After administration of HPV and Varicella vaccine,client was escorted to a chair to be obserbed for 15 min. While seated in the chair, mother obserbed that the client was pale, lips cyanotic. Client proceeded to lose conciousness briefly (30 sec) vomited repeatedly approximately 5x.
4yr old patient was given the Covid PFR Bivalent Booster 10mcg/0.2ml MD Vial 5 thru 11 yrs instead of the Covd PFG Bivalent Booster for  6mo-4yr.  Patient at time of vaccine and immediately following had no symptoms.  Patient had no symptoms still at 5 pm  24 hours after the vaccine was given.  There were no adverse affects on patient.  Reporting due to medication error.  Report to patients mother, report to Department of Health and to VAERS.  Corrective action was taken in clinic for re-education of Medication verification prior to giving medication.
bladder cancer; heart ejection fraction failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: BLADDER CANCER (medically significant), outcome "unknown"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart ejection fraction failure". The patient underwent the following laboratory tests and procedures: Cardiac failure: 30-35 %. Customer Verbatim: I received the Pfizer covid vaccine and booster. In the past two months I have been diagnosed with heart ejection fraction failure @30-35(percent) then with cancer of the bladder. The bladder cancer appears to have been caught early and I am scheduled for surgery. The heart failure is a different matter and treatment is undertermined. Since we don't know any longterm effects of the vaccine, I thought it important to let you know. I have never been a smoker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left arm, red, warm, swollen almost down to elbow. The arm was hot and tender.
Patient received 0.25 ml Moderna vaccine IM: according to CDC guidelines should have received 0.5 ml Moderna vaccine
About 2hr after the shot I got light headed, dizzy and hot.  I got my bp taken of 173/100 and I sat for a while to see if it would go down being monitored by 2 NPs in the office.  The BP remained elevated for a while and after about 2hrs it came down.  I developed a headache that got more profound  over time but the dizziness  and feeling of being hot left and about 5hrs  the headach left and  I felt better.  Went to work the next day feeling a little better but got a massive headache so I took some advil and after about 4hrs it finally let up.  The next day I got a slight headache but it left after about an hour and hasnt had anymore symptoms since.